Reconstructing proximal humeral bone loss in the setting of shoulder arthroplasty can be a daunting task. Proposed techniques include long-stemmed humeral components, allograft-prosthesis composites (APCs), and modular endoprosthetic reconstruction. While unsupported long-stemmed components are at high risk for component loosening, APC reconstruction techniques have been reported with success. However, graft resorption and eventual failure are significant concerns. Modular endoprosthetic systems allow bone deficiencies to be reconstructed with metal, which may allow for a more durable reconstruction.
Continue to: Shoulder arthroplasty is an established procedure...
Shoulder arthroplasty is an established procedure with good results for restoring motion and decreasing pain for a variety of indications, including arthritis, fracture, posttraumatic sequelae, and tumor resection.1-4 As the population ages, the incidence of these shoulder disorders increases, with the incidence of total shoulder arthroplasty (TSA) and reverse total shoulder arthroplasty (RTSA) increasing at faster rates than that of hemiarthroplasty.5,6 These expanding indications will, in turn, result in more revisions that would present challenges for surgeons.1,7,8
The glenoid component is much more commonly revised than the humeral component; however, the humeral component may also require revision or removal to allow exposure of the glenoid component.9 Revision of the humeral stem might be required in cases of infection, periprosthetic fracture, dislocation, or aseptic loosening.10 The survival rate of humeral stems is generally >90% at 10 years and >80% at 20-year follow-up.7 Despite these good survival rates, a revision setting the humeral component requires exchange in about half of all cases.11
Humeral bone loss or deficiency is one of the challenges encountered in both primary and revision TSA. The amount of proximal bone loss can be determined by measuring the distance from the top of the prosthesis laterally to the intact lateral cortex.12 Methods for treating bone loss may involve monoblock revision stems to bypass the deficiency, allografts to rebuild the bone stock, or modular components or endoprostheses to restore the length and stability of the extremity.
Proximal humeral bone loss may make component positioning difficult and may create problems with fixation of the humeral stem. Proper sizing and placement of components are important for improving postoperative function, decreasing component wear and instability, and restoring humeral height and offset. Determining the appropriate center of rotation is important for the function and avoidance of impingement on the acromion, as well as for the restoration of the lever arm of the deltoid without overtensioning. The selection of components with the correct size and the accurate intraoperative placement are important to restore humeral height and offset.13,14 Components must be positioned <4 mm from the height of the greater tuberosity and <8 mm of offset to avoid compromising motion.15 De Wilde and Walch16 described about 3 patients who underwent revision reverse shoulder arthroplasty after failure of the humeral implant because of inadequate proximal humeral bone stock. They concluded that treatment of the bone loss was critical to achieve a successful outcome.
LONG-STEMMED HUMERAL COMPONENTS WITHOUT GRAFTING
There is some evidence indicating that humeral bone loss can be managed without allograft or augmentation. Owens and colleagues17 evaluated the use of intermediate- or long-stemmed humeral components for primary shoulder arthroplasty in 17 patients with severe proximal humeral bone loss and in 18 patients with large humeral canals. The stems were fully cemented, cemented distally only with proximal allografting, and uncemented. Indications for fully cemented stems were loss of proximal bone that could be filled with a proximal cement mantle to ensure a secure fit. Distal cement fixation was applied when there was significant proximal bone loss and was often supplemented with cancellous or structural allograft and/or cancellous autograft. Intraoperative complications included cortical perforation or cement extrusion in 16% of patients. Excellent or satisfactory results were obtained in 21 (60%) of the 35 shoulders, 14 (78%) of the 18 shoulders with large humeral canals, and 7 (41%) of the 17 shoulders with bone loss. All the 17 components implanted in patients with proximal humeral bone loss were stable with no gross loosening at an average 6-year follow-up.
Continue to: Budge and colleagues...
Budge and colleagues12 prospectively enrolled 15 patients with substantial proximal humeral bone loss (38.4 mm) who had conversion to RTSA without allografting after a failed TSA. All patients showed improvements in terms of the American Shoulder and Elbow Surgeons (ASES) score, subjective shoulder value, Constant score, and Visual Analog Scale (VAS) pain score, as well as an improved active range of motion (ROM) and good radiographic outcomes at 2-year follow-up. Although the complication rate was high (7 of 15), most of the complications were minor, with only 2 requiring operative intervention. The only component fracture occurred in a patient with a modular prosthesis that was unsupported by bone proximally. Budge and colleagues12 suggested that concerns about prosthetic fracture can be alleviated using a nonmodular monoblock design. No prosthesis-related complications occurred in their series, leading them to recommend monoblock humeral stems in patients with severe proximal humeral bone loss.
Stephens and colleagues18 reported revision to RTSA in 32 patients with hemiarthroplasties, half of whom had proximal humeral bone loss (average 36.3 mm). Of these 16 patients, 10 were treated with monoblock stems and 6 with modular components, with cement fixation of all implants. At an average 4-year follow-up, patients with proximal bone loss had improved motion and outcomes, and decreased pain compared to their preoperative condition; however, they had lower functional and pain ratings, as well as less ROM compared to those of patients with intact proximal bone stock. Complications occurred in 5 (31%) of those with bone loss and in 1 (0.6%) of those without bone loss. Three of the 16 patients with bone loss had humeral stem loosening, with 2 of the 3 having subsidence. Only 1 patient required return to the operating room for the treatment of a periprosthetic fracture sustained in a fall. Of the 16 patients with bone loss, 14 patients demonstrated scapular notching, which was severe in 5 of them. Because patients with altered humeral length and/or standard length stems had worse outcomes, the authors recommended longer stems to improve fixation and advocated the use of a long-stemmed monoblock prosthesis over an allograft-prosthesis composite (APC).18
However, Werner and colleagues19 reported high rates of loosening and distal migration with the use of long-stemmed humeral implants in 50 patients with revision RTSA. They noted periprosthetic lucency on radiographs in 48% of patients, with more than half of them requiring revision. In 6 patients with subsidence of the humeral shaft, revision was done using custom, modular implants, with the anatomic curve being further stabilized using distal screw and cable fixation to provide rotational stability.
Using a biomechanical model, Cuff and colleagues20 compared 3 RTSA humeral designs, 2 modular designs, and 1 monoblock design in 12 intact models and in 12 models simulating 5 cm of proximal humeral bone loss. They observed that proximal humeral bone loss led to increased humeral component micromotion and rotational instability. The bone loss group had 5 failures compared to 2 in the control group. All failures occurred in those with modular components, whereas those with monoblock implants had no failures.
ALLOGRAFT-PROSTHESIS COMPOSITE
Composite treatment with a humeral stem and a metaphyseal allograft was described by Kassab and colleagues21 in 2005 and Levy and colleagues22 in 2007 (Figures 1A-1C) in patients with tumor resections21 or failed hemiarthroplasties.22 Allograft was used when there was insufficient metaphyseal bone to support the implant, and a graft was fashioned and fixed with cerclage wire before the component was cemented in place. In the 29 patients reported by Levy and colleagues,22 subjective and objective measurements trended toward better results in those with an APC than in those with RTSA alone, but this difference did not reach statistical significance. Several authors have identified a lack of proximal humeral bone support as 1 of the 4 possible causes of failure, and suggested that the allograft provides structural support, serves as an attachment for subscapularis repair, and maximizes deltoid function by increasing lateral offset and setting the moment arm of the deltoid.21-23
Continue to: In a prospective study of RTSA...
In a prospective study of RTSA using structural allografts for failed hemiarthroplasty in 25 patients with an average bone loss of 5 cm, 19 patients (76%) reported good or excellent results, 5 reported satisfactory results, and 1 patient reported an unsatisfactory result.1 Patients had significantly improved forward flexion, abduction, and external rotation and improved outcome scores (ASES and SST). Graft incorporation was good, with 88% and 79% incorporation in the metaphysis and diaphysis, respectively. This technique used a fresh-frozen proximal humeral allograft to fashion a custom proximal block with a lateral step-cut, which was fixed around the stem with cables. A long stem and cement were used. If there was no cement mantle remaining or if the medial portion of the graft was longer than 120 mm, the cement mantle was completely excised. The allograft stump of the subscapularis was used to repair the subscapularis tendon either end-to-end or pants-over-vest. The authors noted that the subscapularis repair provided increased stability; the only dislocation not caused by trauma did not have an identifiable tendon to repair. In this manner, APC reconstruction provided structural and rotational support to the humeral stem as well as bone stock for future revision.1,20
One significant concern with APC reconstruction is the potential for graft resorption, which can lead to humeral stem loosening, loss of contour of the tuberosity, or weakening to the point of fracture.24,25 This may be worsened by stress shielding of the allograft by distal stem cement fixation.26 Other concerns include the cost of the allograft, increased risk of de novo infection, donor-to-host infection, increased operative time and complexity, and failure of allograft incorporation.
The use of a proximal femoral allograft has been described when there is a lack of a proximal humeral allograft.1,27 Kelly and colleagues27 described good results in 2 patients in whom proximal femoral allograft was used along with bone morphogenetic protein, cemented long-stemmed revision implants, and locking plate augmentation.
ENDOPROSTHETIC RECONSTRUCTION
Various forms of prosthetic augmentation have been described to compensate for proximal humeral bone loss, with the majority of reports involving the use of endoprosthetic replacement for tumor procedures.28-31 Use of endoprostheses has also been described for revision procedures in patients with rheumatoid arthritis with massive bone loss, demonstrating modest improvements compared to severe preoperative functional limitations.32
Tumor patients, as well as revision arthroplasty patients, may present difficulties with prosthetic fixation due to massive bone loss. Chao and colleagues29 reported about the long-term outcomes after the use of implants with a porous ongrowth surface and extracortical bridging bone graft in multiple anatomic locations, including the proximal humerus, the proximal and distal femur, and the femoral diaphysis. In 3 patients with proximal humeral reconstruction, the measured ongrowth was only 30%. Given the small number of patients with a proximal humerus, no statistical significance was observed in the prosthesis location and the amount of bony ongrowth, but it was far less than that in the lower extremity.
Continue to: Endoprosthetic reconstruction...
Endoprosthetic reconstruction of the proximal humerus is commonly used for tumor resection that resulted in bone loss. Cannon and colleagues28 reported a 97.6% survival rate at a mean follow-up of 30 months in 83 patients with modular and custom reconstruction with a unipolar head. The ROM was limited, but the prosthesis provided adequate stability to allow elbow and hand function. Proximal migration of the prosthetic head was noticed with increasing frequency as the length of follow-up increased.
Use of an endoprosthesis with compressive osteointegration (Zimmer Biomet) has been described in lower extremities and more recently with follow-up on several cases, including 2 proximal humeral replacements for oncology patients to treat severe bone loss. One case was for a primary sarcoma resection, and the other was for the revision of aseptic loosening of a previous endoprosthesis. Follow-up periods for these 2 patients were 54 and 141 months, respectively. Both these patients had complications, but both retained the endoprosthesis. The authors concluded that this is a salvage operation with high risk.30 In another study, Guven and colleagues31 reported about reverse endoprosthetic reconstruction for tumor resection with bone loss. The ROM was improved, with a mean active forward elevation of 96° (range, 30°-160°), an abduction of 88° (range, 30-160°), and an external rotation of 13° (range, 0°-20°).
Modular endoprostheses have been evaluated as a method for improving bone fixation and restoring soft-tissue tension, while avoiding the complications associated with traditional endoprostheses or allografts (Figures 2A-2D). These systems allow precise adjustments of length using different trial lengths intraoperatively to obtain proper stability and deltoid tension. Of the 12 patients in a 2 center study, 11 had cementless components inserted using a press-fit technique (unpublished data, J. Feldman). At a minimum 2-year follow-up, the patients had an average improvement in forward elevation from 78° to 97°. Excluding 2 patients with loss of the deltoid tuberosity, the forward elevation averaged 109°. There were significant improvements in internal rotation (from 18° to 38°), as well as in the scores of Quick Disabilities of the Arm, Shoulder and Hand (DASH), forward elevation strength, ASES, and VAS pain. However, the overall complication rate was 41%. Therefore, despite these promising early results, longer-term studies are needed.
CONCLUSION
Proximal humeral bone loss remains a significant challenge for the shoulder arthroplasty surgeon. In the setting of a primary or a revision arthroplasty, the bone stock must be thoroughly evaluated during preoperative planning, and a surgical plan for addressing the deficits should be developed. Because proximal humeral bone loss may contribute to prosthetic failure, every effort should be made to reconstitute the bone stock.16 If the bone loss is less extensive, impaction grafting may be considered. Options to address massive proximal humeral bone loss include APCs and endoprosthetic reconstruction. The use of an allograft allows subscapularis repair, which may help stabilize the shoulder and restore the natural lever arm, as well as the tension of the deltoid.1,21-23 In addition, it helps avoid rotational instability and micromotion and provides bone stock for future revisions. However, concern persists regarding allograft resorption over time. More recently, modular endoprosthetic reconstruction systems have been developed to address bone deficiency with metal augmentation. Early clinical results demonstrate a high complication rate in this complex cohort of patients, not unlike those in the series of APCs, but clinical outcomes were improved compared to those in historical series. Nevertheless, longer-term clinical studies are necessary to determine the role of these modular endoprosthetic implant systems.
References
1. Chacon A, Virani N, Shannon R, Levy JC, Pupello D, Frankle M. Revision arthroplasty with use of a reverse shoulder prosthesis-allograft composite. J Bone Joint Surg Am. 2009;91(1):119-127. doi:10.2106/JBJS.H.00094.
2. Hattrup SJ, Waldrop R, Sanchez-Sotelo J. Reverse total shoulder arthroplasty for posttraumatic sequelae. J Orthop Trauma. 2016;30(2):e41-e47. doi:10.1097/BOT.0000000000000416.
3. Sewell MD, Kang SN, Al-Hadithy N, et al. Management of peri-prosthetic fracture of the humerus with severe bone loss and loosening of the humeral component after total shoulder replacement. J Bone Joint Surg Br. 2012;94(10):1382-1389. doi:10.1302/0301-620X.94B10.29248.
4. Trompeter AJ, Gupta RR. The management of complex periprosthetic humeral fractures: a case series of strut allograft augmentation, and a review of the literature. Strategies Trauma Limb Reconstr. 2013;8(1):43-51. doi:10.1007/s11751-013-0155-x.
5. Khatib O, Onyekwelu I, Yu S, Zuckerman JD. Shoulder arthroplasty in New York State, 1991 to 2010: changing patterns of utilization. J Shoulder Elbow Surg. 2015;24(10):e286-e291. doi:10.1016/j.jse.2015.05.038.
6. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
7. Cil A, Veillette CJ, Sanchez-Sotelo J, Sperling JW, Schleck CD, Cofield RH. Survivorship of the humeral component in shoulder arthroplasty. J Shoulder Elbow Surg. 2010;19(1):143-150. doi:10.1016/j.jse.2009.04.011.
8. Wright TW. Revision of humeral components in shoulder arthroplasty. Bull Hosp Jt Dis. 2013;71(2 suppl):S77-S81.
9. Duquin TR, Sperling JW. Revision shoulder arthroplasty—how to manage the humerus. Oper Tech Orthop. 2011;21(1):44-51. doi:10.1053/j.oto.2010.09.008.
10. Cil A, Veillette CJ, Sanchez-Sotelo J, Sperling JW, Schleck C, Cofield RH. Revision of the humeral component for aseptic loosening in arthroplasty of the shoulder. J Bone Joint Surg Br. 2009;91(1):75-81. doi:10.1302/0301-620X.91B1.21094.
11. Cofield RH. Revision of hemiarthroplasty to total shoulder arthroplasty. In: Zuckerman JD, ed. Advanced Reconstruction: Shoulder. 1st edition. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2007;613-622.
12. Budge MD, Moravek JE, Zimel MN, Nolan EM, Wiater JM. Reverse total shoulder arthroplasty for the management of failed shoulder arthroplasty with proximal humeral bone loss: is allograft augmentation necessary? J Shoulder Elbow Surg. 2013;22(6):739-744. doi:10.1016/j.jse.2012.08.008.
13. Boileau P, Walch G. The three-dimensional geometry of the proximal humerus. Implications for surgical technique and prosthetic design. J Bone Joint Surg Br. 1997;79(5):857-865.
14. Throckmorton TW. Reconstructive procedures of the shoulder and elbow. In: Azar FM, Beaty JH, Canale ST, eds. Campbell’s Operative Orthopaedics. 13th edition. Philadelphia, PA: Elsevier; 2017;570-622.
15. Williams GR Jr, Wong KL, Pepe MD, et al. The effect of articular malposition after total shoulder arthroplasty on glenohumeral translations, range of motion, and subacromial impingement. J Shoulder Elbow Surg. 2001;10(5):399-409. doi:10.1067/mse.2001.116871.
16. De Wilde L, Walch G. Humeral prosthetic failure of reversed total shoulder arthroplasty: a report of three cases. J Shoulder Elbow Surg. 2006;15(2):260-264. doi:10.1016/j.jse.2005.07.014.
17. Owens CJ, Sperling JW, Cofield RH. Utility and complications of long-stem humeral components in revision shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(7):e7-e12. doi:10.1016/j.jse.2012.10.034.
18. Stephens SP, Paisley KC, Giveans MR, Wirth MA. The effect of proximal humeral bone loss on revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):1519-1526. doi:10.1016/j.jse.2015.02.020.
19. Werner BS, Abdelkawi AF, Boehm D, et al. Long-term analysis of revision reverse shoulder arthroplasty using cemented long stems. J Shoulder Elbow Surg. 2017;26(2):273-278. doi:10.1016/j.jse.2016.05.015.
20. Cuff D, Levy JC, Gutiérrez S, Frankle MA. Torsional stability of modular and non-modular reverse shoulder humeral components in a proximal humeral bone loss model. J Shoulder Elbow Surg. 2011;20(4):646-651. doi:10.1016/j.jse.2010.10.026.
21. Kassab M, Dumaine V, Babinet A, Ouaknine M, Tomeno B, Anract P. Twenty nine shoulder reconstructions after resection of the proximal humerus for neoplasm with mean 7-year follow-up. Rev Chir Orthop Reparatrice Appar Mot. 2005;91(1):15-23.
22. Levy J, Frankle M, Mighell M, Pupello D. The use of the reverse shoulder prosthesis for the treatment of failed hemiarthroplasty for proximal humeral fracture. J Bone Joint Surg. 2007;98(2):292-300. doi:10.2106/JBJS.E.01310.
23. Gagey O, Pourjamasb B, Court C. Revision arthroplasty of the shoulder for painful glenoid loosening: a series of 14 cases with acromial prostheses reviewed at four year follow up. Rev Chir Reparatrice Appar Mot. 2001;87(3):221-228.
24. Abdeen A, Hoang BH, Althanasina EA, Morris CD, Boland PJ, Healey JH. Allograft-prosthesis composite reconstruction of the proximal part of the humerus: functional outcome and survivorship. J Bone Joint Surg Am. 2009;91(10):2406-2415. doi:10.2106/JBJS.H.00815.
25. Getty PJ, Peabody TD. Complications and functional outcomes of reconstruction with an osteoarticular allograft after intra-articular resection of the proximal aspect of the humerus. J Bone Joint Surg Am. 1999;81(8):1138-1146.
26. Chen CF, Chen WM, Cheng YC, Chiang CC, Huang CK, Chen TH. Extracorporeally irradiated autograft-prosthetic composite arthroplasty using AML® extensively porous-coated stem for proximal femur reconstruction: a clinical analysis of 14 patients. J Surg Oncol. 2009;100(5):418-422. doi:10.1002/jso.21351.
27. Kelly JD 2nd, Purchase RJ, Kam G, Norris TR. Alloprosthetic composite reconstruction using the reverse shoulder arthroplasty. Tech Shoulder Elbow Surg. 2009;10(1):5-10.
28. Cannon CP, Paraliticci GU, Lin PP, Lewis VO, Yasko AW. Functional outcome following endoprosthetic reconstruction of the proximal humerus. J Shoulder Elbow Surg. 2009;18(5):705-710. doi:10.1016/j.jse.2008.10.011.
29. Chao EY, Fuchs B, Rowland CM, Ilstrup DM, Pritchard DJ, Sim FH. Long-term results of segmental prosthesis fixation by extracortical bone-bridging and ingrowth. J Bone Joint Surg Am. 2004;86-A(5):948-955.
30. Goulding KA, Schwartz A, Hattrup SJ, et al. Use of compressive osseointegration endoprostheses for massive bone loss from tumor and failed arthroplasty: a viable option in the upper extremity. Clin Orthop Relat Res. 2017;475(6):1702-1711. doi:10.1007/s11999-017-5258-0.
31. Guven MF, Aslan L, Botanlioglu H, Kaynak G, Kesmezacar H, Babacan M. Functional outcome of reverse shoulder tumor prosthesis in the treatment of proximal humeral tumors. J Shoulder Elbow Surg. 2016;25(1):e1-e6. doi:10.1016/j.jse.2015.06.012.
32. Wang ML, Ballard BL, Kulidjian AA, Abrams RA. Upper extremity reconstruction with a humeral tumor endoprosthesis: a novel salvage procedure after multiple revisions of total shoulder and elbow replacement. J Shoulder Elbow Surg. 2011;20(1):e1-e8. doi:10.1016/j.jse.2010.07.018.
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. Throckmorton reports that he receives royalties and consultant fees from Zimmer Biomet, consulting fees from Pacira, and publishing royalties from Saunders/Mosby-Elsevier. Dr. Power reports no conflict of interest in relation to this article.
Dr. Power is a Sports, Shoulder, and Elbow Fellow, and Dr. Throckmorton is Professor, Residency Program Director, University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee.
Address correspondence to: Thomas W. Throckmorton MD, 1211 Union Avenue, Suite 510, Memphis, TN 38104 (tel, 901-759-3270; fax, 901-759-3278; email, tthrockmorton@campbellclinic.com).
Ian Power, MD Thomas W. Throckmorton, MD . Treating Humeral Bone Loss in Shoulder Arthroplasty: Modular Humeral Components or Allografts. Am J Orthop. February 15, 2018
Authors’ Disclosure Statement: Dr. Throckmorton reports that he receives royalties and consultant fees from Zimmer Biomet, consulting fees from Pacira, and publishing royalties from Saunders/Mosby-Elsevier. Dr. Power reports no conflict of interest in relation to this article.
Dr. Power is a Sports, Shoulder, and Elbow Fellow, and Dr. Throckmorton is Professor, Residency Program Director, University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee.
Address correspondence to: Thomas W. Throckmorton MD, 1211 Union Avenue, Suite 510, Memphis, TN 38104 (tel, 901-759-3270; fax, 901-759-3278; email, tthrockmorton@campbellclinic.com).
Ian Power, MD Thomas W. Throckmorton, MD . Treating Humeral Bone Loss in Shoulder Arthroplasty: Modular Humeral Components or Allografts. Am J Orthop. February 15, 2018
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. Throckmorton reports that he receives royalties and consultant fees from Zimmer Biomet, consulting fees from Pacira, and publishing royalties from Saunders/Mosby-Elsevier. Dr. Power reports no conflict of interest in relation to this article.
Dr. Power is a Sports, Shoulder, and Elbow Fellow, and Dr. Throckmorton is Professor, Residency Program Director, University of Tennessee-Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering, Memphis, Tennessee.
Address correspondence to: Thomas W. Throckmorton MD, 1211 Union Avenue, Suite 510, Memphis, TN 38104 (tel, 901-759-3270; fax, 901-759-3278; email, tthrockmorton@campbellclinic.com).
Ian Power, MD Thomas W. Throckmorton, MD . Treating Humeral Bone Loss in Shoulder Arthroplasty: Modular Humeral Components or Allografts. Am J Orthop. February 15, 2018
ABSTRACT
Reconstructing proximal humeral bone loss in the setting of shoulder arthroplasty can be a daunting task. Proposed techniques include long-stemmed humeral components, allograft-prosthesis composites (APCs), and modular endoprosthetic reconstruction. While unsupported long-stemmed components are at high risk for component loosening, APC reconstruction techniques have been reported with success. However, graft resorption and eventual failure are significant concerns. Modular endoprosthetic systems allow bone deficiencies to be reconstructed with metal, which may allow for a more durable reconstruction.
Continue to: Shoulder arthroplasty is an established procedure...
Shoulder arthroplasty is an established procedure with good results for restoring motion and decreasing pain for a variety of indications, including arthritis, fracture, posttraumatic sequelae, and tumor resection.1-4 As the population ages, the incidence of these shoulder disorders increases, with the incidence of total shoulder arthroplasty (TSA) and reverse total shoulder arthroplasty (RTSA) increasing at faster rates than that of hemiarthroplasty.5,6 These expanding indications will, in turn, result in more revisions that would present challenges for surgeons.1,7,8
The glenoid component is much more commonly revised than the humeral component; however, the humeral component may also require revision or removal to allow exposure of the glenoid component.9 Revision of the humeral stem might be required in cases of infection, periprosthetic fracture, dislocation, or aseptic loosening.10 The survival rate of humeral stems is generally >90% at 10 years and >80% at 20-year follow-up.7 Despite these good survival rates, a revision setting the humeral component requires exchange in about half of all cases.11
Humeral bone loss or deficiency is one of the challenges encountered in both primary and revision TSA. The amount of proximal bone loss can be determined by measuring the distance from the top of the prosthesis laterally to the intact lateral cortex.12 Methods for treating bone loss may involve monoblock revision stems to bypass the deficiency, allografts to rebuild the bone stock, or modular components or endoprostheses to restore the length and stability of the extremity.
Proximal humeral bone loss may make component positioning difficult and may create problems with fixation of the humeral stem. Proper sizing and placement of components are important for improving postoperative function, decreasing component wear and instability, and restoring humeral height and offset. Determining the appropriate center of rotation is important for the function and avoidance of impingement on the acromion, as well as for the restoration of the lever arm of the deltoid without overtensioning. The selection of components with the correct size and the accurate intraoperative placement are important to restore humeral height and offset.13,14 Components must be positioned <4 mm from the height of the greater tuberosity and <8 mm of offset to avoid compromising motion.15 De Wilde and Walch16 described about 3 patients who underwent revision reverse shoulder arthroplasty after failure of the humeral implant because of inadequate proximal humeral bone stock. They concluded that treatment of the bone loss was critical to achieve a successful outcome.
LONG-STEMMED HUMERAL COMPONENTS WITHOUT GRAFTING
There is some evidence indicating that humeral bone loss can be managed without allograft or augmentation. Owens and colleagues17 evaluated the use of intermediate- or long-stemmed humeral components for primary shoulder arthroplasty in 17 patients with severe proximal humeral bone loss and in 18 patients with large humeral canals. The stems were fully cemented, cemented distally only with proximal allografting, and uncemented. Indications for fully cemented stems were loss of proximal bone that could be filled with a proximal cement mantle to ensure a secure fit. Distal cement fixation was applied when there was significant proximal bone loss and was often supplemented with cancellous or structural allograft and/or cancellous autograft. Intraoperative complications included cortical perforation or cement extrusion in 16% of patients. Excellent or satisfactory results were obtained in 21 (60%) of the 35 shoulders, 14 (78%) of the 18 shoulders with large humeral canals, and 7 (41%) of the 17 shoulders with bone loss. All the 17 components implanted in patients with proximal humeral bone loss were stable with no gross loosening at an average 6-year follow-up.
Continue to: Budge and colleagues...
Budge and colleagues12 prospectively enrolled 15 patients with substantial proximal humeral bone loss (38.4 mm) who had conversion to RTSA without allografting after a failed TSA. All patients showed improvements in terms of the American Shoulder and Elbow Surgeons (ASES) score, subjective shoulder value, Constant score, and Visual Analog Scale (VAS) pain score, as well as an improved active range of motion (ROM) and good radiographic outcomes at 2-year follow-up. Although the complication rate was high (7 of 15), most of the complications were minor, with only 2 requiring operative intervention. The only component fracture occurred in a patient with a modular prosthesis that was unsupported by bone proximally. Budge and colleagues12 suggested that concerns about prosthetic fracture can be alleviated using a nonmodular monoblock design. No prosthesis-related complications occurred in their series, leading them to recommend monoblock humeral stems in patients with severe proximal humeral bone loss.
Stephens and colleagues18 reported revision to RTSA in 32 patients with hemiarthroplasties, half of whom had proximal humeral bone loss (average 36.3 mm). Of these 16 patients, 10 were treated with monoblock stems and 6 with modular components, with cement fixation of all implants. At an average 4-year follow-up, patients with proximal bone loss had improved motion and outcomes, and decreased pain compared to their preoperative condition; however, they had lower functional and pain ratings, as well as less ROM compared to those of patients with intact proximal bone stock. Complications occurred in 5 (31%) of those with bone loss and in 1 (0.6%) of those without bone loss. Three of the 16 patients with bone loss had humeral stem loosening, with 2 of the 3 having subsidence. Only 1 patient required return to the operating room for the treatment of a periprosthetic fracture sustained in a fall. Of the 16 patients with bone loss, 14 patients demonstrated scapular notching, which was severe in 5 of them. Because patients with altered humeral length and/or standard length stems had worse outcomes, the authors recommended longer stems to improve fixation and advocated the use of a long-stemmed monoblock prosthesis over an allograft-prosthesis composite (APC).18
However, Werner and colleagues19 reported high rates of loosening and distal migration with the use of long-stemmed humeral implants in 50 patients with revision RTSA. They noted periprosthetic lucency on radiographs in 48% of patients, with more than half of them requiring revision. In 6 patients with subsidence of the humeral shaft, revision was done using custom, modular implants, with the anatomic curve being further stabilized using distal screw and cable fixation to provide rotational stability.
Using a biomechanical model, Cuff and colleagues20 compared 3 RTSA humeral designs, 2 modular designs, and 1 monoblock design in 12 intact models and in 12 models simulating 5 cm of proximal humeral bone loss. They observed that proximal humeral bone loss led to increased humeral component micromotion and rotational instability. The bone loss group had 5 failures compared to 2 in the control group. All failures occurred in those with modular components, whereas those with monoblock implants had no failures.
ALLOGRAFT-PROSTHESIS COMPOSITE
Composite treatment with a humeral stem and a metaphyseal allograft was described by Kassab and colleagues21 in 2005 and Levy and colleagues22 in 2007 (Figures 1A-1C) in patients with tumor resections21 or failed hemiarthroplasties.22 Allograft was used when there was insufficient metaphyseal bone to support the implant, and a graft was fashioned and fixed with cerclage wire before the component was cemented in place. In the 29 patients reported by Levy and colleagues,22 subjective and objective measurements trended toward better results in those with an APC than in those with RTSA alone, but this difference did not reach statistical significance. Several authors have identified a lack of proximal humeral bone support as 1 of the 4 possible causes of failure, and suggested that the allograft provides structural support, serves as an attachment for subscapularis repair, and maximizes deltoid function by increasing lateral offset and setting the moment arm of the deltoid.21-23
Continue to: In a prospective study of RTSA...
In a prospective study of RTSA using structural allografts for failed hemiarthroplasty in 25 patients with an average bone loss of 5 cm, 19 patients (76%) reported good or excellent results, 5 reported satisfactory results, and 1 patient reported an unsatisfactory result.1 Patients had significantly improved forward flexion, abduction, and external rotation and improved outcome scores (ASES and SST). Graft incorporation was good, with 88% and 79% incorporation in the metaphysis and diaphysis, respectively. This technique used a fresh-frozen proximal humeral allograft to fashion a custom proximal block with a lateral step-cut, which was fixed around the stem with cables. A long stem and cement were used. If there was no cement mantle remaining or if the medial portion of the graft was longer than 120 mm, the cement mantle was completely excised. The allograft stump of the subscapularis was used to repair the subscapularis tendon either end-to-end or pants-over-vest. The authors noted that the subscapularis repair provided increased stability; the only dislocation not caused by trauma did not have an identifiable tendon to repair. In this manner, APC reconstruction provided structural and rotational support to the humeral stem as well as bone stock for future revision.1,20
One significant concern with APC reconstruction is the potential for graft resorption, which can lead to humeral stem loosening, loss of contour of the tuberosity, or weakening to the point of fracture.24,25 This may be worsened by stress shielding of the allograft by distal stem cement fixation.26 Other concerns include the cost of the allograft, increased risk of de novo infection, donor-to-host infection, increased operative time and complexity, and failure of allograft incorporation.
The use of a proximal femoral allograft has been described when there is a lack of a proximal humeral allograft.1,27 Kelly and colleagues27 described good results in 2 patients in whom proximal femoral allograft was used along with bone morphogenetic protein, cemented long-stemmed revision implants, and locking plate augmentation.
ENDOPROSTHETIC RECONSTRUCTION
Various forms of prosthetic augmentation have been described to compensate for proximal humeral bone loss, with the majority of reports involving the use of endoprosthetic replacement for tumor procedures.28-31 Use of endoprostheses has also been described for revision procedures in patients with rheumatoid arthritis with massive bone loss, demonstrating modest improvements compared to severe preoperative functional limitations.32
Tumor patients, as well as revision arthroplasty patients, may present difficulties with prosthetic fixation due to massive bone loss. Chao and colleagues29 reported about the long-term outcomes after the use of implants with a porous ongrowth surface and extracortical bridging bone graft in multiple anatomic locations, including the proximal humerus, the proximal and distal femur, and the femoral diaphysis. In 3 patients with proximal humeral reconstruction, the measured ongrowth was only 30%. Given the small number of patients with a proximal humerus, no statistical significance was observed in the prosthesis location and the amount of bony ongrowth, but it was far less than that in the lower extremity.
Continue to: Endoprosthetic reconstruction...
Endoprosthetic reconstruction of the proximal humerus is commonly used for tumor resection that resulted in bone loss. Cannon and colleagues28 reported a 97.6% survival rate at a mean follow-up of 30 months in 83 patients with modular and custom reconstruction with a unipolar head. The ROM was limited, but the prosthesis provided adequate stability to allow elbow and hand function. Proximal migration of the prosthetic head was noticed with increasing frequency as the length of follow-up increased.
Use of an endoprosthesis with compressive osteointegration (Zimmer Biomet) has been described in lower extremities and more recently with follow-up on several cases, including 2 proximal humeral replacements for oncology patients to treat severe bone loss. One case was for a primary sarcoma resection, and the other was for the revision of aseptic loosening of a previous endoprosthesis. Follow-up periods for these 2 patients were 54 and 141 months, respectively. Both these patients had complications, but both retained the endoprosthesis. The authors concluded that this is a salvage operation with high risk.30 In another study, Guven and colleagues31 reported about reverse endoprosthetic reconstruction for tumor resection with bone loss. The ROM was improved, with a mean active forward elevation of 96° (range, 30°-160°), an abduction of 88° (range, 30-160°), and an external rotation of 13° (range, 0°-20°).
Modular endoprostheses have been evaluated as a method for improving bone fixation and restoring soft-tissue tension, while avoiding the complications associated with traditional endoprostheses or allografts (Figures 2A-2D). These systems allow precise adjustments of length using different trial lengths intraoperatively to obtain proper stability and deltoid tension. Of the 12 patients in a 2 center study, 11 had cementless components inserted using a press-fit technique (unpublished data, J. Feldman). At a minimum 2-year follow-up, the patients had an average improvement in forward elevation from 78° to 97°. Excluding 2 patients with loss of the deltoid tuberosity, the forward elevation averaged 109°. There were significant improvements in internal rotation (from 18° to 38°), as well as in the scores of Quick Disabilities of the Arm, Shoulder and Hand (DASH), forward elevation strength, ASES, and VAS pain. However, the overall complication rate was 41%. Therefore, despite these promising early results, longer-term studies are needed.
CONCLUSION
Proximal humeral bone loss remains a significant challenge for the shoulder arthroplasty surgeon. In the setting of a primary or a revision arthroplasty, the bone stock must be thoroughly evaluated during preoperative planning, and a surgical plan for addressing the deficits should be developed. Because proximal humeral bone loss may contribute to prosthetic failure, every effort should be made to reconstitute the bone stock.16 If the bone loss is less extensive, impaction grafting may be considered. Options to address massive proximal humeral bone loss include APCs and endoprosthetic reconstruction. The use of an allograft allows subscapularis repair, which may help stabilize the shoulder and restore the natural lever arm, as well as the tension of the deltoid.1,21-23 In addition, it helps avoid rotational instability and micromotion and provides bone stock for future revisions. However, concern persists regarding allograft resorption over time. More recently, modular endoprosthetic reconstruction systems have been developed to address bone deficiency with metal augmentation. Early clinical results demonstrate a high complication rate in this complex cohort of patients, not unlike those in the series of APCs, but clinical outcomes were improved compared to those in historical series. Nevertheless, longer-term clinical studies are necessary to determine the role of these modular endoprosthetic implant systems.
ABSTRACT
Reconstructing proximal humeral bone loss in the setting of shoulder arthroplasty can be a daunting task. Proposed techniques include long-stemmed humeral components, allograft-prosthesis composites (APCs), and modular endoprosthetic reconstruction. While unsupported long-stemmed components are at high risk for component loosening, APC reconstruction techniques have been reported with success. However, graft resorption and eventual failure are significant concerns. Modular endoprosthetic systems allow bone deficiencies to be reconstructed with metal, which may allow for a more durable reconstruction.
Continue to: Shoulder arthroplasty is an established procedure...
Shoulder arthroplasty is an established procedure with good results for restoring motion and decreasing pain for a variety of indications, including arthritis, fracture, posttraumatic sequelae, and tumor resection.1-4 As the population ages, the incidence of these shoulder disorders increases, with the incidence of total shoulder arthroplasty (TSA) and reverse total shoulder arthroplasty (RTSA) increasing at faster rates than that of hemiarthroplasty.5,6 These expanding indications will, in turn, result in more revisions that would present challenges for surgeons.1,7,8
The glenoid component is much more commonly revised than the humeral component; however, the humeral component may also require revision or removal to allow exposure of the glenoid component.9 Revision of the humeral stem might be required in cases of infection, periprosthetic fracture, dislocation, or aseptic loosening.10 The survival rate of humeral stems is generally >90% at 10 years and >80% at 20-year follow-up.7 Despite these good survival rates, a revision setting the humeral component requires exchange in about half of all cases.11
Humeral bone loss or deficiency is one of the challenges encountered in both primary and revision TSA. The amount of proximal bone loss can be determined by measuring the distance from the top of the prosthesis laterally to the intact lateral cortex.12 Methods for treating bone loss may involve monoblock revision stems to bypass the deficiency, allografts to rebuild the bone stock, or modular components or endoprostheses to restore the length and stability of the extremity.
Proximal humeral bone loss may make component positioning difficult and may create problems with fixation of the humeral stem. Proper sizing and placement of components are important for improving postoperative function, decreasing component wear and instability, and restoring humeral height and offset. Determining the appropriate center of rotation is important for the function and avoidance of impingement on the acromion, as well as for the restoration of the lever arm of the deltoid without overtensioning. The selection of components with the correct size and the accurate intraoperative placement are important to restore humeral height and offset.13,14 Components must be positioned <4 mm from the height of the greater tuberosity and <8 mm of offset to avoid compromising motion.15 De Wilde and Walch16 described about 3 patients who underwent revision reverse shoulder arthroplasty after failure of the humeral implant because of inadequate proximal humeral bone stock. They concluded that treatment of the bone loss was critical to achieve a successful outcome.
LONG-STEMMED HUMERAL COMPONENTS WITHOUT GRAFTING
There is some evidence indicating that humeral bone loss can be managed without allograft or augmentation. Owens and colleagues17 evaluated the use of intermediate- or long-stemmed humeral components for primary shoulder arthroplasty in 17 patients with severe proximal humeral bone loss and in 18 patients with large humeral canals. The stems were fully cemented, cemented distally only with proximal allografting, and uncemented. Indications for fully cemented stems were loss of proximal bone that could be filled with a proximal cement mantle to ensure a secure fit. Distal cement fixation was applied when there was significant proximal bone loss and was often supplemented with cancellous or structural allograft and/or cancellous autograft. Intraoperative complications included cortical perforation or cement extrusion in 16% of patients. Excellent or satisfactory results were obtained in 21 (60%) of the 35 shoulders, 14 (78%) of the 18 shoulders with large humeral canals, and 7 (41%) of the 17 shoulders with bone loss. All the 17 components implanted in patients with proximal humeral bone loss were stable with no gross loosening at an average 6-year follow-up.
Continue to: Budge and colleagues...
Budge and colleagues12 prospectively enrolled 15 patients with substantial proximal humeral bone loss (38.4 mm) who had conversion to RTSA without allografting after a failed TSA. All patients showed improvements in terms of the American Shoulder and Elbow Surgeons (ASES) score, subjective shoulder value, Constant score, and Visual Analog Scale (VAS) pain score, as well as an improved active range of motion (ROM) and good radiographic outcomes at 2-year follow-up. Although the complication rate was high (7 of 15), most of the complications were minor, with only 2 requiring operative intervention. The only component fracture occurred in a patient with a modular prosthesis that was unsupported by bone proximally. Budge and colleagues12 suggested that concerns about prosthetic fracture can be alleviated using a nonmodular monoblock design. No prosthesis-related complications occurred in their series, leading them to recommend monoblock humeral stems in patients with severe proximal humeral bone loss.
Stephens and colleagues18 reported revision to RTSA in 32 patients with hemiarthroplasties, half of whom had proximal humeral bone loss (average 36.3 mm). Of these 16 patients, 10 were treated with monoblock stems and 6 with modular components, with cement fixation of all implants. At an average 4-year follow-up, patients with proximal bone loss had improved motion and outcomes, and decreased pain compared to their preoperative condition; however, they had lower functional and pain ratings, as well as less ROM compared to those of patients with intact proximal bone stock. Complications occurred in 5 (31%) of those with bone loss and in 1 (0.6%) of those without bone loss. Three of the 16 patients with bone loss had humeral stem loosening, with 2 of the 3 having subsidence. Only 1 patient required return to the operating room for the treatment of a periprosthetic fracture sustained in a fall. Of the 16 patients with bone loss, 14 patients demonstrated scapular notching, which was severe in 5 of them. Because patients with altered humeral length and/or standard length stems had worse outcomes, the authors recommended longer stems to improve fixation and advocated the use of a long-stemmed monoblock prosthesis over an allograft-prosthesis composite (APC).18
However, Werner and colleagues19 reported high rates of loosening and distal migration with the use of long-stemmed humeral implants in 50 patients with revision RTSA. They noted periprosthetic lucency on radiographs in 48% of patients, with more than half of them requiring revision. In 6 patients with subsidence of the humeral shaft, revision was done using custom, modular implants, with the anatomic curve being further stabilized using distal screw and cable fixation to provide rotational stability.
Using a biomechanical model, Cuff and colleagues20 compared 3 RTSA humeral designs, 2 modular designs, and 1 monoblock design in 12 intact models and in 12 models simulating 5 cm of proximal humeral bone loss. They observed that proximal humeral bone loss led to increased humeral component micromotion and rotational instability. The bone loss group had 5 failures compared to 2 in the control group. All failures occurred in those with modular components, whereas those with monoblock implants had no failures.
ALLOGRAFT-PROSTHESIS COMPOSITE
Composite treatment with a humeral stem and a metaphyseal allograft was described by Kassab and colleagues21 in 2005 and Levy and colleagues22 in 2007 (Figures 1A-1C) in patients with tumor resections21 or failed hemiarthroplasties.22 Allograft was used when there was insufficient metaphyseal bone to support the implant, and a graft was fashioned and fixed with cerclage wire before the component was cemented in place. In the 29 patients reported by Levy and colleagues,22 subjective and objective measurements trended toward better results in those with an APC than in those with RTSA alone, but this difference did not reach statistical significance. Several authors have identified a lack of proximal humeral bone support as 1 of the 4 possible causes of failure, and suggested that the allograft provides structural support, serves as an attachment for subscapularis repair, and maximizes deltoid function by increasing lateral offset and setting the moment arm of the deltoid.21-23
Continue to: In a prospective study of RTSA...
In a prospective study of RTSA using structural allografts for failed hemiarthroplasty in 25 patients with an average bone loss of 5 cm, 19 patients (76%) reported good or excellent results, 5 reported satisfactory results, and 1 patient reported an unsatisfactory result.1 Patients had significantly improved forward flexion, abduction, and external rotation and improved outcome scores (ASES and SST). Graft incorporation was good, with 88% and 79% incorporation in the metaphysis and diaphysis, respectively. This technique used a fresh-frozen proximal humeral allograft to fashion a custom proximal block with a lateral step-cut, which was fixed around the stem with cables. A long stem and cement were used. If there was no cement mantle remaining or if the medial portion of the graft was longer than 120 mm, the cement mantle was completely excised. The allograft stump of the subscapularis was used to repair the subscapularis tendon either end-to-end or pants-over-vest. The authors noted that the subscapularis repair provided increased stability; the only dislocation not caused by trauma did not have an identifiable tendon to repair. In this manner, APC reconstruction provided structural and rotational support to the humeral stem as well as bone stock for future revision.1,20
One significant concern with APC reconstruction is the potential for graft resorption, which can lead to humeral stem loosening, loss of contour of the tuberosity, or weakening to the point of fracture.24,25 This may be worsened by stress shielding of the allograft by distal stem cement fixation.26 Other concerns include the cost of the allograft, increased risk of de novo infection, donor-to-host infection, increased operative time and complexity, and failure of allograft incorporation.
The use of a proximal femoral allograft has been described when there is a lack of a proximal humeral allograft.1,27 Kelly and colleagues27 described good results in 2 patients in whom proximal femoral allograft was used along with bone morphogenetic protein, cemented long-stemmed revision implants, and locking plate augmentation.
ENDOPROSTHETIC RECONSTRUCTION
Various forms of prosthetic augmentation have been described to compensate for proximal humeral bone loss, with the majority of reports involving the use of endoprosthetic replacement for tumor procedures.28-31 Use of endoprostheses has also been described for revision procedures in patients with rheumatoid arthritis with massive bone loss, demonstrating modest improvements compared to severe preoperative functional limitations.32
Tumor patients, as well as revision arthroplasty patients, may present difficulties with prosthetic fixation due to massive bone loss. Chao and colleagues29 reported about the long-term outcomes after the use of implants with a porous ongrowth surface and extracortical bridging bone graft in multiple anatomic locations, including the proximal humerus, the proximal and distal femur, and the femoral diaphysis. In 3 patients with proximal humeral reconstruction, the measured ongrowth was only 30%. Given the small number of patients with a proximal humerus, no statistical significance was observed in the prosthesis location and the amount of bony ongrowth, but it was far less than that in the lower extremity.
Continue to: Endoprosthetic reconstruction...
Endoprosthetic reconstruction of the proximal humerus is commonly used for tumor resection that resulted in bone loss. Cannon and colleagues28 reported a 97.6% survival rate at a mean follow-up of 30 months in 83 patients with modular and custom reconstruction with a unipolar head. The ROM was limited, but the prosthesis provided adequate stability to allow elbow and hand function. Proximal migration of the prosthetic head was noticed with increasing frequency as the length of follow-up increased.
Use of an endoprosthesis with compressive osteointegration (Zimmer Biomet) has been described in lower extremities and more recently with follow-up on several cases, including 2 proximal humeral replacements for oncology patients to treat severe bone loss. One case was for a primary sarcoma resection, and the other was for the revision of aseptic loosening of a previous endoprosthesis. Follow-up periods for these 2 patients were 54 and 141 months, respectively. Both these patients had complications, but both retained the endoprosthesis. The authors concluded that this is a salvage operation with high risk.30 In another study, Guven and colleagues31 reported about reverse endoprosthetic reconstruction for tumor resection with bone loss. The ROM was improved, with a mean active forward elevation of 96° (range, 30°-160°), an abduction of 88° (range, 30-160°), and an external rotation of 13° (range, 0°-20°).
Modular endoprostheses have been evaluated as a method for improving bone fixation and restoring soft-tissue tension, while avoiding the complications associated with traditional endoprostheses or allografts (Figures 2A-2D). These systems allow precise adjustments of length using different trial lengths intraoperatively to obtain proper stability and deltoid tension. Of the 12 patients in a 2 center study, 11 had cementless components inserted using a press-fit technique (unpublished data, J. Feldman). At a minimum 2-year follow-up, the patients had an average improvement in forward elevation from 78° to 97°. Excluding 2 patients with loss of the deltoid tuberosity, the forward elevation averaged 109°. There were significant improvements in internal rotation (from 18° to 38°), as well as in the scores of Quick Disabilities of the Arm, Shoulder and Hand (DASH), forward elevation strength, ASES, and VAS pain. However, the overall complication rate was 41%. Therefore, despite these promising early results, longer-term studies are needed.
CONCLUSION
Proximal humeral bone loss remains a significant challenge for the shoulder arthroplasty surgeon. In the setting of a primary or a revision arthroplasty, the bone stock must be thoroughly evaluated during preoperative planning, and a surgical plan for addressing the deficits should be developed. Because proximal humeral bone loss may contribute to prosthetic failure, every effort should be made to reconstitute the bone stock.16 If the bone loss is less extensive, impaction grafting may be considered. Options to address massive proximal humeral bone loss include APCs and endoprosthetic reconstruction. The use of an allograft allows subscapularis repair, which may help stabilize the shoulder and restore the natural lever arm, as well as the tension of the deltoid.1,21-23 In addition, it helps avoid rotational instability and micromotion and provides bone stock for future revisions. However, concern persists regarding allograft resorption over time. More recently, modular endoprosthetic reconstruction systems have been developed to address bone deficiency with metal augmentation. Early clinical results demonstrate a high complication rate in this complex cohort of patients, not unlike those in the series of APCs, but clinical outcomes were improved compared to those in historical series. Nevertheless, longer-term clinical studies are necessary to determine the role of these modular endoprosthetic implant systems.
References
1. Chacon A, Virani N, Shannon R, Levy JC, Pupello D, Frankle M. Revision arthroplasty with use of a reverse shoulder prosthesis-allograft composite. J Bone Joint Surg Am. 2009;91(1):119-127. doi:10.2106/JBJS.H.00094.
2. Hattrup SJ, Waldrop R, Sanchez-Sotelo J. Reverse total shoulder arthroplasty for posttraumatic sequelae. J Orthop Trauma. 2016;30(2):e41-e47. doi:10.1097/BOT.0000000000000416.
3. Sewell MD, Kang SN, Al-Hadithy N, et al. Management of peri-prosthetic fracture of the humerus with severe bone loss and loosening of the humeral component after total shoulder replacement. J Bone Joint Surg Br. 2012;94(10):1382-1389. doi:10.1302/0301-620X.94B10.29248.
4. Trompeter AJ, Gupta RR. The management of complex periprosthetic humeral fractures: a case series of strut allograft augmentation, and a review of the literature. Strategies Trauma Limb Reconstr. 2013;8(1):43-51. doi:10.1007/s11751-013-0155-x.
5. Khatib O, Onyekwelu I, Yu S, Zuckerman JD. Shoulder arthroplasty in New York State, 1991 to 2010: changing patterns of utilization. J Shoulder Elbow Surg. 2015;24(10):e286-e291. doi:10.1016/j.jse.2015.05.038.
6. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
7. Cil A, Veillette CJ, Sanchez-Sotelo J, Sperling JW, Schleck CD, Cofield RH. Survivorship of the humeral component in shoulder arthroplasty. J Shoulder Elbow Surg. 2010;19(1):143-150. doi:10.1016/j.jse.2009.04.011.
8. Wright TW. Revision of humeral components in shoulder arthroplasty. Bull Hosp Jt Dis. 2013;71(2 suppl):S77-S81.
9. Duquin TR, Sperling JW. Revision shoulder arthroplasty—how to manage the humerus. Oper Tech Orthop. 2011;21(1):44-51. doi:10.1053/j.oto.2010.09.008.
10. Cil A, Veillette CJ, Sanchez-Sotelo J, Sperling JW, Schleck C, Cofield RH. Revision of the humeral component for aseptic loosening in arthroplasty of the shoulder. J Bone Joint Surg Br. 2009;91(1):75-81. doi:10.1302/0301-620X.91B1.21094.
11. Cofield RH. Revision of hemiarthroplasty to total shoulder arthroplasty. In: Zuckerman JD, ed. Advanced Reconstruction: Shoulder. 1st edition. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2007;613-622.
12. Budge MD, Moravek JE, Zimel MN, Nolan EM, Wiater JM. Reverse total shoulder arthroplasty for the management of failed shoulder arthroplasty with proximal humeral bone loss: is allograft augmentation necessary? J Shoulder Elbow Surg. 2013;22(6):739-744. doi:10.1016/j.jse.2012.08.008.
13. Boileau P, Walch G. The three-dimensional geometry of the proximal humerus. Implications for surgical technique and prosthetic design. J Bone Joint Surg Br. 1997;79(5):857-865.
14. Throckmorton TW. Reconstructive procedures of the shoulder and elbow. In: Azar FM, Beaty JH, Canale ST, eds. Campbell’s Operative Orthopaedics. 13th edition. Philadelphia, PA: Elsevier; 2017;570-622.
15. Williams GR Jr, Wong KL, Pepe MD, et al. The effect of articular malposition after total shoulder arthroplasty on glenohumeral translations, range of motion, and subacromial impingement. J Shoulder Elbow Surg. 2001;10(5):399-409. doi:10.1067/mse.2001.116871.
16. De Wilde L, Walch G. Humeral prosthetic failure of reversed total shoulder arthroplasty: a report of three cases. J Shoulder Elbow Surg. 2006;15(2):260-264. doi:10.1016/j.jse.2005.07.014.
17. Owens CJ, Sperling JW, Cofield RH. Utility and complications of long-stem humeral components in revision shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(7):e7-e12. doi:10.1016/j.jse.2012.10.034.
18. Stephens SP, Paisley KC, Giveans MR, Wirth MA. The effect of proximal humeral bone loss on revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):1519-1526. doi:10.1016/j.jse.2015.02.020.
19. Werner BS, Abdelkawi AF, Boehm D, et al. Long-term analysis of revision reverse shoulder arthroplasty using cemented long stems. J Shoulder Elbow Surg. 2017;26(2):273-278. doi:10.1016/j.jse.2016.05.015.
20. Cuff D, Levy JC, Gutiérrez S, Frankle MA. Torsional stability of modular and non-modular reverse shoulder humeral components in a proximal humeral bone loss model. J Shoulder Elbow Surg. 2011;20(4):646-651. doi:10.1016/j.jse.2010.10.026.
21. Kassab M, Dumaine V, Babinet A, Ouaknine M, Tomeno B, Anract P. Twenty nine shoulder reconstructions after resection of the proximal humerus for neoplasm with mean 7-year follow-up. Rev Chir Orthop Reparatrice Appar Mot. 2005;91(1):15-23.
22. Levy J, Frankle M, Mighell M, Pupello D. The use of the reverse shoulder prosthesis for the treatment of failed hemiarthroplasty for proximal humeral fracture. J Bone Joint Surg. 2007;98(2):292-300. doi:10.2106/JBJS.E.01310.
23. Gagey O, Pourjamasb B, Court C. Revision arthroplasty of the shoulder for painful glenoid loosening: a series of 14 cases with acromial prostheses reviewed at four year follow up. Rev Chir Reparatrice Appar Mot. 2001;87(3):221-228.
24. Abdeen A, Hoang BH, Althanasina EA, Morris CD, Boland PJ, Healey JH. Allograft-prosthesis composite reconstruction of the proximal part of the humerus: functional outcome and survivorship. J Bone Joint Surg Am. 2009;91(10):2406-2415. doi:10.2106/JBJS.H.00815.
25. Getty PJ, Peabody TD. Complications and functional outcomes of reconstruction with an osteoarticular allograft after intra-articular resection of the proximal aspect of the humerus. J Bone Joint Surg Am. 1999;81(8):1138-1146.
26. Chen CF, Chen WM, Cheng YC, Chiang CC, Huang CK, Chen TH. Extracorporeally irradiated autograft-prosthetic composite arthroplasty using AML® extensively porous-coated stem for proximal femur reconstruction: a clinical analysis of 14 patients. J Surg Oncol. 2009;100(5):418-422. doi:10.1002/jso.21351.
27. Kelly JD 2nd, Purchase RJ, Kam G, Norris TR. Alloprosthetic composite reconstruction using the reverse shoulder arthroplasty. Tech Shoulder Elbow Surg. 2009;10(1):5-10.
28. Cannon CP, Paraliticci GU, Lin PP, Lewis VO, Yasko AW. Functional outcome following endoprosthetic reconstruction of the proximal humerus. J Shoulder Elbow Surg. 2009;18(5):705-710. doi:10.1016/j.jse.2008.10.011.
29. Chao EY, Fuchs B, Rowland CM, Ilstrup DM, Pritchard DJ, Sim FH. Long-term results of segmental prosthesis fixation by extracortical bone-bridging and ingrowth. J Bone Joint Surg Am. 2004;86-A(5):948-955.
30. Goulding KA, Schwartz A, Hattrup SJ, et al. Use of compressive osseointegration endoprostheses for massive bone loss from tumor and failed arthroplasty: a viable option in the upper extremity. Clin Orthop Relat Res. 2017;475(6):1702-1711. doi:10.1007/s11999-017-5258-0.
31. Guven MF, Aslan L, Botanlioglu H, Kaynak G, Kesmezacar H, Babacan M. Functional outcome of reverse shoulder tumor prosthesis in the treatment of proximal humeral tumors. J Shoulder Elbow Surg. 2016;25(1):e1-e6. doi:10.1016/j.jse.2015.06.012.
32. Wang ML, Ballard BL, Kulidjian AA, Abrams RA. Upper extremity reconstruction with a humeral tumor endoprosthesis: a novel salvage procedure after multiple revisions of total shoulder and elbow replacement. J Shoulder Elbow Surg. 2011;20(1):e1-e8. doi:10.1016/j.jse.2010.07.018.
References
1. Chacon A, Virani N, Shannon R, Levy JC, Pupello D, Frankle M. Revision arthroplasty with use of a reverse shoulder prosthesis-allograft composite. J Bone Joint Surg Am. 2009;91(1):119-127. doi:10.2106/JBJS.H.00094.
2. Hattrup SJ, Waldrop R, Sanchez-Sotelo J. Reverse total shoulder arthroplasty for posttraumatic sequelae. J Orthop Trauma. 2016;30(2):e41-e47. doi:10.1097/BOT.0000000000000416.
3. Sewell MD, Kang SN, Al-Hadithy N, et al. Management of peri-prosthetic fracture of the humerus with severe bone loss and loosening of the humeral component after total shoulder replacement. J Bone Joint Surg Br. 2012;94(10):1382-1389. doi:10.1302/0301-620X.94B10.29248.
4. Trompeter AJ, Gupta RR. The management of complex periprosthetic humeral fractures: a case series of strut allograft augmentation, and a review of the literature. Strategies Trauma Limb Reconstr. 2013;8(1):43-51. doi:10.1007/s11751-013-0155-x.
5. Khatib O, Onyekwelu I, Yu S, Zuckerman JD. Shoulder arthroplasty in New York State, 1991 to 2010: changing patterns of utilization. J Shoulder Elbow Surg. 2015;24(10):e286-e291. doi:10.1016/j.jse.2015.05.038.
6. Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011;93(24):2249-2254. doi:10.2106/JBJS.J.01994.
7. Cil A, Veillette CJ, Sanchez-Sotelo J, Sperling JW, Schleck CD, Cofield RH. Survivorship of the humeral component in shoulder arthroplasty. J Shoulder Elbow Surg. 2010;19(1):143-150. doi:10.1016/j.jse.2009.04.011.
8. Wright TW. Revision of humeral components in shoulder arthroplasty. Bull Hosp Jt Dis. 2013;71(2 suppl):S77-S81.
9. Duquin TR, Sperling JW. Revision shoulder arthroplasty—how to manage the humerus. Oper Tech Orthop. 2011;21(1):44-51. doi:10.1053/j.oto.2010.09.008.
10. Cil A, Veillette CJ, Sanchez-Sotelo J, Sperling JW, Schleck C, Cofield RH. Revision of the humeral component for aseptic loosening in arthroplasty of the shoulder. J Bone Joint Surg Br. 2009;91(1):75-81. doi:10.1302/0301-620X.91B1.21094.
11. Cofield RH. Revision of hemiarthroplasty to total shoulder arthroplasty. In: Zuckerman JD, ed. Advanced Reconstruction: Shoulder. 1st edition. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2007;613-622.
12. Budge MD, Moravek JE, Zimel MN, Nolan EM, Wiater JM. Reverse total shoulder arthroplasty for the management of failed shoulder arthroplasty with proximal humeral bone loss: is allograft augmentation necessary? J Shoulder Elbow Surg. 2013;22(6):739-744. doi:10.1016/j.jse.2012.08.008.
13. Boileau P, Walch G. The three-dimensional geometry of the proximal humerus. Implications for surgical technique and prosthetic design. J Bone Joint Surg Br. 1997;79(5):857-865.
14. Throckmorton TW. Reconstructive procedures of the shoulder and elbow. In: Azar FM, Beaty JH, Canale ST, eds. Campbell’s Operative Orthopaedics. 13th edition. Philadelphia, PA: Elsevier; 2017;570-622.
15. Williams GR Jr, Wong KL, Pepe MD, et al. The effect of articular malposition after total shoulder arthroplasty on glenohumeral translations, range of motion, and subacromial impingement. J Shoulder Elbow Surg. 2001;10(5):399-409. doi:10.1067/mse.2001.116871.
16. De Wilde L, Walch G. Humeral prosthetic failure of reversed total shoulder arthroplasty: a report of three cases. J Shoulder Elbow Surg. 2006;15(2):260-264. doi:10.1016/j.jse.2005.07.014.
17. Owens CJ, Sperling JW, Cofield RH. Utility and complications of long-stem humeral components in revision shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(7):e7-e12. doi:10.1016/j.jse.2012.10.034.
18. Stephens SP, Paisley KC, Giveans MR, Wirth MA. The effect of proximal humeral bone loss on revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(10):1519-1526. doi:10.1016/j.jse.2015.02.020.
19. Werner BS, Abdelkawi AF, Boehm D, et al. Long-term analysis of revision reverse shoulder arthroplasty using cemented long stems. J Shoulder Elbow Surg. 2017;26(2):273-278. doi:10.1016/j.jse.2016.05.015.
20. Cuff D, Levy JC, Gutiérrez S, Frankle MA. Torsional stability of modular and non-modular reverse shoulder humeral components in a proximal humeral bone loss model. J Shoulder Elbow Surg. 2011;20(4):646-651. doi:10.1016/j.jse.2010.10.026.
21. Kassab M, Dumaine V, Babinet A, Ouaknine M, Tomeno B, Anract P. Twenty nine shoulder reconstructions after resection of the proximal humerus for neoplasm with mean 7-year follow-up. Rev Chir Orthop Reparatrice Appar Mot. 2005;91(1):15-23.
22. Levy J, Frankle M, Mighell M, Pupello D. The use of the reverse shoulder prosthesis for the treatment of failed hemiarthroplasty for proximal humeral fracture. J Bone Joint Surg. 2007;98(2):292-300. doi:10.2106/JBJS.E.01310.
23. Gagey O, Pourjamasb B, Court C. Revision arthroplasty of the shoulder for painful glenoid loosening: a series of 14 cases with acromial prostheses reviewed at four year follow up. Rev Chir Reparatrice Appar Mot. 2001;87(3):221-228.
24. Abdeen A, Hoang BH, Althanasina EA, Morris CD, Boland PJ, Healey JH. Allograft-prosthesis composite reconstruction of the proximal part of the humerus: functional outcome and survivorship. J Bone Joint Surg Am. 2009;91(10):2406-2415. doi:10.2106/JBJS.H.00815.
25. Getty PJ, Peabody TD. Complications and functional outcomes of reconstruction with an osteoarticular allograft after intra-articular resection of the proximal aspect of the humerus. J Bone Joint Surg Am. 1999;81(8):1138-1146.
26. Chen CF, Chen WM, Cheng YC, Chiang CC, Huang CK, Chen TH. Extracorporeally irradiated autograft-prosthetic composite arthroplasty using AML® extensively porous-coated stem for proximal femur reconstruction: a clinical analysis of 14 patients. J Surg Oncol. 2009;100(5):418-422. doi:10.1002/jso.21351.
27. Kelly JD 2nd, Purchase RJ, Kam G, Norris TR. Alloprosthetic composite reconstruction using the reverse shoulder arthroplasty. Tech Shoulder Elbow Surg. 2009;10(1):5-10.
28. Cannon CP, Paraliticci GU, Lin PP, Lewis VO, Yasko AW. Functional outcome following endoprosthetic reconstruction of the proximal humerus. J Shoulder Elbow Surg. 2009;18(5):705-710. doi:10.1016/j.jse.2008.10.011.
29. Chao EY, Fuchs B, Rowland CM, Ilstrup DM, Pritchard DJ, Sim FH. Long-term results of segmental prosthesis fixation by extracortical bone-bridging and ingrowth. J Bone Joint Surg Am. 2004;86-A(5):948-955.
30. Goulding KA, Schwartz A, Hattrup SJ, et al. Use of compressive osseointegration endoprostheses for massive bone loss from tumor and failed arthroplasty: a viable option in the upper extremity. Clin Orthop Relat Res. 2017;475(6):1702-1711. doi:10.1007/s11999-017-5258-0.
31. Guven MF, Aslan L, Botanlioglu H, Kaynak G, Kesmezacar H, Babacan M. Functional outcome of reverse shoulder tumor prosthesis in the treatment of proximal humeral tumors. J Shoulder Elbow Surg. 2016;25(1):e1-e6. doi:10.1016/j.jse.2015.06.012.
32. Wang ML, Ballard BL, Kulidjian AA, Abrams RA. Upper extremity reconstruction with a humeral tumor endoprosthesis: a novel salvage procedure after multiple revisions of total shoulder and elbow replacement. J Shoulder Elbow Surg. 2011;20(1):e1-e8. doi:10.1016/j.jse.2010.07.018.
Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be encountered in the primary setting (degenerative, congenital, post-traumatic), severe glenoid bone loss is encountered in most revision total shoulder arthroplasties. Severe glenoid bone loss is treated with various techniques including hemiarthroplasty, eccentric reaming, and glenoid reconstruction with bone autografts and allografts. Despite encouraging short- to mid-term results reported with these reconstruction techniques, the clinical and radiographic outcomes remain inconsistent and the high number of complications is a concern. To overcome this problem, more recently augmented components and patient specific implants were introduced. Using the computer-aided design and computer-aided manufacturing technology patient-specific implants have been created to reconstruct the glenoid vault in cases of severe glenoid bone loss.
In this article we describe a patient specific glenoid implant, its indication, technical aspects and surgical technique, based on the author's experience as well as a review of the current literature on custom glenoid implants.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) is an effective operation for providing pain relief and improving function in patients with end-stage degenerative shoulder disease that is nonresponsive to nonoperative treatments.1-4 With the increasing number of arthroplasties performed, and the expanding indication for shoulder arthroplasty, the number of revision shoulder arthroplasties is also increasing.5-14 Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered mostly in revision TSAs.
Historically, patients with severe glenoid bone loss were treated with a hemiarthroplasty.15-17 However, due to inferior outcomes associated with the use of shoulder hemiarthroplasties compared with TSA in these cases,18-20 various techniques were developed with the aim of realigning the glenoid axis and securing the implants into the deficient glenoid vault.21-25 Options have included eccentric reaming, glenoid reconstruction with bone autografts and allografts, and more recently augmented components and patient-specific implants. Studies with eccentric reaming and reconstruction with bone graft during complex shoulder arthroplasty have reported encouraging short- to mid-term results, but the clinical and radiographic outcomes remain inconsistent, and the high number of complications is a concern.25-28
Complications with these techniques include component loosening, graft resorption, nonunion, failure of graft incorporation, infection, and instability.25-28
Computer-aided design and computer-aided manufacturing (CAD/CAM) of patient-specific implants have been used successfully by hip arthroplasty surgeons to deal with complex acetabular reconstructions in the setting of severe bone loss. More recently, the same technology has been used to reconstruct the glenoid vault in cases of severe glenoid bone loss.
In this article, we describe a patient-specific glenoid implant, its indication, and both technical aspects and the surgical technique, based on the authors’ experience as well as a review of the current literature on custom glenoid implants.
Continue to: PATIENT-SPECIFIC GLENOID COMPONENT
PATIENT-SPECIFIC GLENOID COMPONENT
The Vault Reconstruction System ([VRS], Zimmer Biomet) is a patient-specific glenoid vault reconstruction system developed with the use of CAD/CAM to address severe glenoid bone loss encountered during shoulder arthroplasty. For several years, the VRS was available only as a custom implant according to the US Food and Drug Administration rules, and therefore its use was limited to a few cases per year. Recently, a 510(k) envelope clearance was granted to use the VRS in reverse TSA to address significant glenoid bone defects.
The VRS is made of porous plasma spray titanium to provide high strength and flexibility, and allows for biologic fixation. This system can accommodate a restricted bone loss envelope of about 50 mm × 50 mm × 35 mm according to the previous experience of the manufacturer in the custom scenario, covering 96% of defects previously addressed. One 6.5-mm nonlocking central screw and a minimum of four 4.75-mm nonlocking or locking peripheral screws are required for optimal fixation of the implant in the native scapula. A custom boss can be added in to enhance fixation in the native scapula when the bone is sufficient. To facilitate the surgical procedure, a trial implant, a bone model of the scapula, and a custom boss reaming guide are 3-dimensional (3-D) and printed in sterilizable material. These are all provided as single-use disposable instruments and can be available for surgeons during both the initial plan review and surgery.
PREOPERATIVE PLANNING
Patients undergo a preoperative fine-cut 2-dimensional computed tomography scan of the scapula and adjacent humerus following a predefined protocol with a slice thickness of 2 mm to 3 mm. An accurate 3-D bone model of the scapula is obtained using a 3-D image processing software system (Figure 1). The 3-D scapular model is used to create a patient-specific glenoid implant proposal that is approved by the surgeon (Figure 2). Implant position, orientation, size, screw trajectory, and recommended bone removal, if necessary, are determined to create a more normal glenohumeral center of rotation and to secure a glenoid implant in severely deficient glenoid bone (Figure 3). Once the implant design is approved by the surgeon, the final patient-specific implant is manufactured.
SURGICAL TECHNIQUE
The exposure of the glenoid is a critical step for the successful implantation of the patient-specific glenoid implant. Soft tissue and scar tissue around the glenoid must be removed to allow for optimal fit of the custom-made reaming guide. Also, removal of the entire capsulolabral complex on the anteroinferior rim of the glenoid is essential to both enhance glenoid exposure and to allow a perfect fit of the guide to the pathologic bone stock. Attention should be paid during débridement and/or implant removal in case of revision, to make sure that no excessive bone is removed because the patient-specific guide is referenced to this anatomy. Excessive bone removal can change the orientation of the patient-specific guide and ultimately the fixation of the implant. Once the custom-made patient-specific guide is positioned, a 3.2-mm Steinmann pin is placed through the inserter for temporary fixation. The pin should engage or perforate the medial cortical wall to ensure that the subsequent reamer has a stable cannula over which to ream. After the glenoid is reamed, the final implant can be placed in the ideal position according to the preoperative planning. A central 6.5-mm nonlocking central screw and 4.75-mm nonlocking or locking peripheral screws are required to complete the fixation of the implant in the native scapula. Once the patient-specific glenoid component is positioned and strongly fixed to the bone, the glenosphere can be positioned according to the preoperative planning, and the reverse shoulder arthroplasty can be completed in the usual fashion.
CASE EXAMPLES
A 68-year-old woman underwent a TSA for end-stage osteoarthritis in 2000. The implant failed due to a cuff failure. The patient underwent several surgeries, including an open cuff repair, with no success. She had no active elevation preoperatively. Because of the significant glenoid bone loss, a patient-specific glenoid reconstruction was planned. Within 24 months after this surgery, the patient was able to get her hand to her head and elevate to 90º (Figures 4A-4F).
Continue to: In October 2013...
In October 2013, a 68-year-old man underwent a TSA for end-stage osteoarthritis. After 18 months, the implant failed due to active Propionibacterium acnes infection, which required excisional arthroplasty with insertion of an antibiotic spacer. Significant glenoid bone loss (Figure 5) and global soft-tissue deficiency caused substantial disability and led to an indication for a reverse TSA with a patient-specific glenoid vault reconstruction (Figures 6A-6D) after infection eradication. Within 20 months after this surgery, the patient had resumed a satisfactory range of motion (130º forward elevation, 20º external rotation) and outcome.
DISCUSSION
Although glenoid bone loss is often seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered in most revision TSAs. The best treatment method for massive glenoid bone defects during complex shoulder arthroplasty remains uncertain. Options have included eccentric reaming, glenoid reconstruction with bone allograft and autograft, and more recently augmented components and patient-specific implants.21-25 The advent and availability of CAD/CAM technology have enabled shoulder surgeons to create patient-specific metal solutions to these challenging cases. Currently, only a few reports exist in the literature on patient-specific glenoid components in the setting of severe bone loss.29-32
Chammaa and colleagues29 reported the outcomes of 37 patients with a hip-inspired glenoid component (Total Shoulder Replacement, Stanmore Implants Worldwide). The 5-year results with this implant were promising, with a 16% revision rate and only 1 case of glenoid loosening.
Stoffelen and colleagues30 recently described the successful use of a patient-specific anatomic metal-backed glenoid component for the management of severe glenoid bone loss with excellent results at 2.5 years of follow-up. A different approach was pursued by Gunther and Lynch,31 who reported on 7 patients with a custom inset glenoid implant for deficient glenoid vaults. These circular anatomic, custom-made glenoid components were created with the intention of placing the implants partially inside the glenoid vault and relying partially on sclerotic cortical bone. Despite excellent results at 3 years of follow-up, their use is limited to specific defect geometries and cannot be used in cases of extreme bone loss.
CONCLUSION
We have described the use of a patient-specific glenoid component in 2 patients with severe glenoid bone loss. Despite the satisfactory clinical and short-term radiographic results, we acknowledge that longer-term follow-up is needed to confirm the efficacy of this type of reconstruction. We believe that patient-specific glenoid components represent a valuable addition to the armamentarium of shoulder surgeons who address complex glenoid bone deformities.
References
1. Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014;29(4):856-860. doi:10.1016/j.arth.2013.07.002.
2. Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479. doi:10.1016/j.jse.2005.02.009.
3. Montoya F, Magosch P, Scheiderer B, Lichtenberg S, Melean P, Habermeyer P. Midterm results of a total shoulder prosthesis fixed with a cementless glenoid component. J Shoulder Elbow Surg. 2013;22(5):628-635. doi:10.1016/j.jse.2012.07.005.
4. Torchia ME, Cofield RH, Settergren CR. Total shoulder arthroplasty with the Neer prosthesis: long-term results. J Shoulder Elbow Surg. 1997;6(6):495-505.
5. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224. doi:10.1067/mse.2001.113961.
6. Chalmers PN, Rahman Z, Romeo AA, Nicholson GP. Early dislocation after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(5):737-744. doi:10.1016/j.jse.2013.08.015.
8. Farshad M, Grogli M, Catanzaro S, Gerber C. Revision of reversed total shoulder arthroplasty. Indications and outcome. BMC Musculoskelet Disord. 2012;13(1):160. doi:10.1186/1471-2474-13-160.
9. Fevang BT, Lie SA, Havelin LI, Skredderstuen A, Furnes O. Risk factors for revision after shoulder arthroplasty: 1,825 shoulder arthroplasties from the Norwegian Arthroplasty Register. Acta Orthop. 2009;80(1):83-91.
10. Fox TJ, Cil A, Sperling JW, Sanchez-Sotelo J, Schleck CD, Cofield RH. Survival of the glenoid component in shoulder arthroplasty. J Shoulder Elbow Surg. 2009;18(6):859-863. doi:10.1016/j.jse.2008.11.020.
11. Rasmussen JV. Outcome and risk of revision following shoulder replacement in patients with glenohumeral osteoarthritis. Acta Orthop Suppl. 2014;85(355 suppl):1-23. doi:10.3109/17453674.2014.922007.
12. Rasmussen JV, Polk A, Brorson S, Sorensen AK, Olsen BS. Patient-reported outcome and risk of revision after shoulder replacement for osteoarthritis. 1,209 cases from the Danish Shoulder Arthroplasty Registry, 2006-2010. Acta Orthop. 2014;85(2):117-122. doi:10.3109/17453674.2014.893497.
13. Sajadi KR, Kwon YW, Zuckerman JD. Revision shoulder arthroplasty: an analysis of indications and outcomes. J Shoulder Elbow Surg. 2010;19(2):308-313. doi:10.1016/j.jse.2009.05.016.
14. Singh JA, Sperling JW, Cofield RH. Revision surgery following total shoulder arthroplasty: analysis of 2588 shoulders over three decades (1976 to 2008). J Bone Joint Surg Br. 2011;93(11):1513-1517. doi:10.1302/0301-620X.93B11.26938.
15. Levine WN, Djurasovic M, Glasson JM, Pollock RG, Flatow EL, Bigliani LU. Hemiarthroplasty for glenohumeral osteoarthritis: results correlated to degree of glenoid wear. J Shoulder Elbow Surg. 1997;6(5):449-454.
16. Levine WN, Fischer CR, Nguyen D, Flatow EL, Ahmad CS, Bigliani LU. Long-term follow-up of shoulder hemiarthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 2012;94(22):e164. doi:10.2106/JBJS.K.00603.
17. Lynch JR, Franta AK, Montgomery WH, Lenters TR, Mounce D, Matsen FA. Self-assessed outcome at two to four years after shoulder hemiarthroplasty with concentric glenoid reaming. J Bone Joint Surg Am. 2007;89(6):1284-1292. doi:10.2106/JBJS.E.00942.
18. Iannotti JP, Norris TR. Influence of preoperative factors on outcome of shoulder arthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 2003;85-A(2):251-258.
19. Sperling JW, Cofield RH, Rowland CM. Neer hemiarthroplasty and Neer total shoulder arthroplasty in patients fifty years old or less. Long-term results. J Bone Joint Surg Am. 1998;80(4):464-473.
21. Cil A, Sperling JW, Cofield RH. Nonstandard glenoid components for bone deficiencies in shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(7):e149-e157. doi:10.1016/j.jse.2013.09.023.
22. Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013;22(11):1589-1598. doi:10.1016/j.jse.2013.06.017.
23. Gunther SB, Lynch TL. Total shoulder replacement surgery with custom glenoid implants for severe bone deficiency. J Shoulder Elbow Surg. 2012;21(5):675-684. doi:10.1016/j.jse.2011.03.023.
24. Neer CS, Morrison DS. Glenoid bone-grafting in total shoulder arthroplasty. J Bone Joint Surg Am. 1988;70(8):1154-1162.
25. Steinmann SP, Cofield RH. Bone grafting for glenoid deficiency in total shoulder replacement. J Shoulder Elbow Surg. 2000;9(5):361-367. doi:10.1067/mse.2000.106921.
26. Iannotti JP, Frangiamore SJ. Fate of large structural allograft for treatment of severe uncontained glenoid bone deficiency. J Shoulder Elbow Surg. 2012:21(6):765-771. doi:10.1016/j.jse.2011.08.069.
27. Hill JM, Norris TR. Long-term results of total shoulder arthroplasty following bone-grafting of the glenoid. J Bone Joint Surg Am. 2001;83-A(6):877-883.
28. Hsu JE, Ricchetti ET, Huffman GR, Iannotti JP, Glaser DL. Addressing glenoid bone deficiency and asymptomatic posterior erosion in shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(9):1298-1308.
29. Chammaa R, Uri O, Lambert S. Primary shoulder arthroplasty using a custom-made hip-inspired implant for the treatment of advanced glenohumeral arthritis in the presence of severe glenoid bone loss. J Shoulder Elbow Surg. 2017;26(1):101-107. doi:10.1016/j.jse.2016.05.027.
30. Stoffelen DV, Eraly K, Debeer P. The use of 3D printing technology in reconstruction of a severe glenoid defect: a case report with 2.5 years of follow-up. J Shoulder Elbow Surg. 2015;24(8):e218-e222. doi:10.1016/j.jse.2015.04.006.
31. Gunther SB, Lynch TL. Total shoulder replacement surgery with custom glenoid implants for severe bone deficiency. J Shoulder Elbow Surg. 2012;21(5):675-684. doi:10.1016/j.jse.2011.03.023.
32. Dines DM, Gulotta L, Craig EV, Dines JS. Novel solution for massive glenoid defects in shoulder arthroplasty: a patient-specific glenoid vault reconstruction system. Am J Orthop. 2017;46(2):104-108.
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. De Martino reports that he is a consultant to Lima Corporate. Dr. Dines and Dr. Craig report that they receive royalties from Zimmer Biomet for the development of the product (Comprehensive Shoulder VRS) discussed in this article. Dr. Gulotta reports that he is a consultant to Zimmer Biomet. Dr. Warren reports no actual or potential conflict of interest in relation to this article.
Dr. De Martino is a Clinical Fellow, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York. Dr. Dines is an Attending Orthopaedic Surgeon, Hospital for Special Surgery, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York, Professor, Weill Cornell Medical College, as well as Chairman and Professor of Orthopedic Surgery, Albert Einstein College of Medicine at LIJ, Bronx, New York. Dr. Warren is Professor of Orthopedic Surgery, Weill Cornell Medical College, and Attending Orthopedic Surgeon, Hospital for Special Surgery, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York. Dr. Craig is Chief Executive Officer, TRIA Orthopaedic Center Professor of Orthopaedic Surgery, University of Minnesota TRIA Orthopaedic Center, Bloomington, Minnesota. Dr. Gulotta is an Assistant Attending Orthopaedic Surgeon, Hospital for Special Surgery, and Assistant Professor of Orthopaedic Surgery, Weill Cornell Medical College, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York.
Address correspondence to: Lawrence V. Gulotta, MD, Sports Medicine and Shoulder Service, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021 (tel, 646-797-8735; fax, 646-797-8726; email, gulottal@hss.edu).
Ivan De Martino, MD David M. Dines, MD Russell F. Warren, MD Edward V. Craig, MD, MPH Lawrence V. Gulotta, MD . Patient-Specific Implants in Severe Glenoid Bone Loss. Am J Orthop. February 8, 2018
Authors’ Disclosure Statement: Dr. De Martino reports that he is a consultant to Lima Corporate. Dr. Dines and Dr. Craig report that they receive royalties from Zimmer Biomet for the development of the product (Comprehensive Shoulder VRS) discussed in this article. Dr. Gulotta reports that he is a consultant to Zimmer Biomet. Dr. Warren reports no actual or potential conflict of interest in relation to this article.
Dr. De Martino is a Clinical Fellow, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York. Dr. Dines is an Attending Orthopaedic Surgeon, Hospital for Special Surgery, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York, Professor, Weill Cornell Medical College, as well as Chairman and Professor of Orthopedic Surgery, Albert Einstein College of Medicine at LIJ, Bronx, New York. Dr. Warren is Professor of Orthopedic Surgery, Weill Cornell Medical College, and Attending Orthopedic Surgeon, Hospital for Special Surgery, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York. Dr. Craig is Chief Executive Officer, TRIA Orthopaedic Center Professor of Orthopaedic Surgery, University of Minnesota TRIA Orthopaedic Center, Bloomington, Minnesota. Dr. Gulotta is an Assistant Attending Orthopaedic Surgeon, Hospital for Special Surgery, and Assistant Professor of Orthopaedic Surgery, Weill Cornell Medical College, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York.
Address correspondence to: Lawrence V. Gulotta, MD, Sports Medicine and Shoulder Service, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021 (tel, 646-797-8735; fax, 646-797-8726; email, gulottal@hss.edu).
Ivan De Martino, MD David M. Dines, MD Russell F. Warren, MD Edward V. Craig, MD, MPH Lawrence V. Gulotta, MD . Patient-Specific Implants in Severe Glenoid Bone Loss. Am J Orthop. February 8, 2018
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. De Martino reports that he is a consultant to Lima Corporate. Dr. Dines and Dr. Craig report that they receive royalties from Zimmer Biomet for the development of the product (Comprehensive Shoulder VRS) discussed in this article. Dr. Gulotta reports that he is a consultant to Zimmer Biomet. Dr. Warren reports no actual or potential conflict of interest in relation to this article.
Dr. De Martino is a Clinical Fellow, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York. Dr. Dines is an Attending Orthopaedic Surgeon, Hospital for Special Surgery, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York, Professor, Weill Cornell Medical College, as well as Chairman and Professor of Orthopedic Surgery, Albert Einstein College of Medicine at LIJ, Bronx, New York. Dr. Warren is Professor of Orthopedic Surgery, Weill Cornell Medical College, and Attending Orthopedic Surgeon, Hospital for Special Surgery, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York. Dr. Craig is Chief Executive Officer, TRIA Orthopaedic Center Professor of Orthopaedic Surgery, University of Minnesota TRIA Orthopaedic Center, Bloomington, Minnesota. Dr. Gulotta is an Assistant Attending Orthopaedic Surgeon, Hospital for Special Surgery, and Assistant Professor of Orthopaedic Surgery, Weill Cornell Medical College, Sports Medicine and Shoulder Service Division, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York.
Address correspondence to: Lawrence V. Gulotta, MD, Sports Medicine and Shoulder Service, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021 (tel, 646-797-8735; fax, 646-797-8726; email, gulottal@hss.edu).
Ivan De Martino, MD David M. Dines, MD Russell F. Warren, MD Edward V. Craig, MD, MPH Lawrence V. Gulotta, MD . Patient-Specific Implants in Severe Glenoid Bone Loss. Am J Orthop. February 8, 2018
ABSTRACT
Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be encountered in the primary setting (degenerative, congenital, post-traumatic), severe glenoid bone loss is encountered in most revision total shoulder arthroplasties. Severe glenoid bone loss is treated with various techniques including hemiarthroplasty, eccentric reaming, and glenoid reconstruction with bone autografts and allografts. Despite encouraging short- to mid-term results reported with these reconstruction techniques, the clinical and radiographic outcomes remain inconsistent and the high number of complications is a concern. To overcome this problem, more recently augmented components and patient specific implants were introduced. Using the computer-aided design and computer-aided manufacturing technology patient-specific implants have been created to reconstruct the glenoid vault in cases of severe glenoid bone loss.
In this article we describe a patient specific glenoid implant, its indication, technical aspects and surgical technique, based on the author's experience as well as a review of the current literature on custom glenoid implants.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) is an effective operation for providing pain relief and improving function in patients with end-stage degenerative shoulder disease that is nonresponsive to nonoperative treatments.1-4 With the increasing number of arthroplasties performed, and the expanding indication for shoulder arthroplasty, the number of revision shoulder arthroplasties is also increasing.5-14 Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered mostly in revision TSAs.
Historically, patients with severe glenoid bone loss were treated with a hemiarthroplasty.15-17 However, due to inferior outcomes associated with the use of shoulder hemiarthroplasties compared with TSA in these cases,18-20 various techniques were developed with the aim of realigning the glenoid axis and securing the implants into the deficient glenoid vault.21-25 Options have included eccentric reaming, glenoid reconstruction with bone autografts and allografts, and more recently augmented components and patient-specific implants. Studies with eccentric reaming and reconstruction with bone graft during complex shoulder arthroplasty have reported encouraging short- to mid-term results, but the clinical and radiographic outcomes remain inconsistent, and the high number of complications is a concern.25-28
Complications with these techniques include component loosening, graft resorption, nonunion, failure of graft incorporation, infection, and instability.25-28
Computer-aided design and computer-aided manufacturing (CAD/CAM) of patient-specific implants have been used successfully by hip arthroplasty surgeons to deal with complex acetabular reconstructions in the setting of severe bone loss. More recently, the same technology has been used to reconstruct the glenoid vault in cases of severe glenoid bone loss.
In this article, we describe a patient-specific glenoid implant, its indication, and both technical aspects and the surgical technique, based on the authors’ experience as well as a review of the current literature on custom glenoid implants.
Continue to: PATIENT-SPECIFIC GLENOID COMPONENT
PATIENT-SPECIFIC GLENOID COMPONENT
The Vault Reconstruction System ([VRS], Zimmer Biomet) is a patient-specific glenoid vault reconstruction system developed with the use of CAD/CAM to address severe glenoid bone loss encountered during shoulder arthroplasty. For several years, the VRS was available only as a custom implant according to the US Food and Drug Administration rules, and therefore its use was limited to a few cases per year. Recently, a 510(k) envelope clearance was granted to use the VRS in reverse TSA to address significant glenoid bone defects.
The VRS is made of porous plasma spray titanium to provide high strength and flexibility, and allows for biologic fixation. This system can accommodate a restricted bone loss envelope of about 50 mm × 50 mm × 35 mm according to the previous experience of the manufacturer in the custom scenario, covering 96% of defects previously addressed. One 6.5-mm nonlocking central screw and a minimum of four 4.75-mm nonlocking or locking peripheral screws are required for optimal fixation of the implant in the native scapula. A custom boss can be added in to enhance fixation in the native scapula when the bone is sufficient. To facilitate the surgical procedure, a trial implant, a bone model of the scapula, and a custom boss reaming guide are 3-dimensional (3-D) and printed in sterilizable material. These are all provided as single-use disposable instruments and can be available for surgeons during both the initial plan review and surgery.
PREOPERATIVE PLANNING
Patients undergo a preoperative fine-cut 2-dimensional computed tomography scan of the scapula and adjacent humerus following a predefined protocol with a slice thickness of 2 mm to 3 mm. An accurate 3-D bone model of the scapula is obtained using a 3-D image processing software system (Figure 1). The 3-D scapular model is used to create a patient-specific glenoid implant proposal that is approved by the surgeon (Figure 2). Implant position, orientation, size, screw trajectory, and recommended bone removal, if necessary, are determined to create a more normal glenohumeral center of rotation and to secure a glenoid implant in severely deficient glenoid bone (Figure 3). Once the implant design is approved by the surgeon, the final patient-specific implant is manufactured.
SURGICAL TECHNIQUE
The exposure of the glenoid is a critical step for the successful implantation of the patient-specific glenoid implant. Soft tissue and scar tissue around the glenoid must be removed to allow for optimal fit of the custom-made reaming guide. Also, removal of the entire capsulolabral complex on the anteroinferior rim of the glenoid is essential to both enhance glenoid exposure and to allow a perfect fit of the guide to the pathologic bone stock. Attention should be paid during débridement and/or implant removal in case of revision, to make sure that no excessive bone is removed because the patient-specific guide is referenced to this anatomy. Excessive bone removal can change the orientation of the patient-specific guide and ultimately the fixation of the implant. Once the custom-made patient-specific guide is positioned, a 3.2-mm Steinmann pin is placed through the inserter for temporary fixation. The pin should engage or perforate the medial cortical wall to ensure that the subsequent reamer has a stable cannula over which to ream. After the glenoid is reamed, the final implant can be placed in the ideal position according to the preoperative planning. A central 6.5-mm nonlocking central screw and 4.75-mm nonlocking or locking peripheral screws are required to complete the fixation of the implant in the native scapula. Once the patient-specific glenoid component is positioned and strongly fixed to the bone, the glenosphere can be positioned according to the preoperative planning, and the reverse shoulder arthroplasty can be completed in the usual fashion.
CASE EXAMPLES
A 68-year-old woman underwent a TSA for end-stage osteoarthritis in 2000. The implant failed due to a cuff failure. The patient underwent several surgeries, including an open cuff repair, with no success. She had no active elevation preoperatively. Because of the significant glenoid bone loss, a patient-specific glenoid reconstruction was planned. Within 24 months after this surgery, the patient was able to get her hand to her head and elevate to 90º (Figures 4A-4F).
Continue to: In October 2013...
In October 2013, a 68-year-old man underwent a TSA for end-stage osteoarthritis. After 18 months, the implant failed due to active Propionibacterium acnes infection, which required excisional arthroplasty with insertion of an antibiotic spacer. Significant glenoid bone loss (Figure 5) and global soft-tissue deficiency caused substantial disability and led to an indication for a reverse TSA with a patient-specific glenoid vault reconstruction (Figures 6A-6D) after infection eradication. Within 20 months after this surgery, the patient had resumed a satisfactory range of motion (130º forward elevation, 20º external rotation) and outcome.
DISCUSSION
Although glenoid bone loss is often seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered in most revision TSAs. The best treatment method for massive glenoid bone defects during complex shoulder arthroplasty remains uncertain. Options have included eccentric reaming, glenoid reconstruction with bone allograft and autograft, and more recently augmented components and patient-specific implants.21-25 The advent and availability of CAD/CAM technology have enabled shoulder surgeons to create patient-specific metal solutions to these challenging cases. Currently, only a few reports exist in the literature on patient-specific glenoid components in the setting of severe bone loss.29-32
Chammaa and colleagues29 reported the outcomes of 37 patients with a hip-inspired glenoid component (Total Shoulder Replacement, Stanmore Implants Worldwide). The 5-year results with this implant were promising, with a 16% revision rate and only 1 case of glenoid loosening.
Stoffelen and colleagues30 recently described the successful use of a patient-specific anatomic metal-backed glenoid component for the management of severe glenoid bone loss with excellent results at 2.5 years of follow-up. A different approach was pursued by Gunther and Lynch,31 who reported on 7 patients with a custom inset glenoid implant for deficient glenoid vaults. These circular anatomic, custom-made glenoid components were created with the intention of placing the implants partially inside the glenoid vault and relying partially on sclerotic cortical bone. Despite excellent results at 3 years of follow-up, their use is limited to specific defect geometries and cannot be used in cases of extreme bone loss.
CONCLUSION
We have described the use of a patient-specific glenoid component in 2 patients with severe glenoid bone loss. Despite the satisfactory clinical and short-term radiographic results, we acknowledge that longer-term follow-up is needed to confirm the efficacy of this type of reconstruction. We believe that patient-specific glenoid components represent a valuable addition to the armamentarium of shoulder surgeons who address complex glenoid bone deformities.
ABSTRACT
Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be encountered in the primary setting (degenerative, congenital, post-traumatic), severe glenoid bone loss is encountered in most revision total shoulder arthroplasties. Severe glenoid bone loss is treated with various techniques including hemiarthroplasty, eccentric reaming, and glenoid reconstruction with bone autografts and allografts. Despite encouraging short- to mid-term results reported with these reconstruction techniques, the clinical and radiographic outcomes remain inconsistent and the high number of complications is a concern. To overcome this problem, more recently augmented components and patient specific implants were introduced. Using the computer-aided design and computer-aided manufacturing technology patient-specific implants have been created to reconstruct the glenoid vault in cases of severe glenoid bone loss.
In this article we describe a patient specific glenoid implant, its indication, technical aspects and surgical technique, based on the author's experience as well as a review of the current literature on custom glenoid implants.
Continue to: Total shoulder arthroplasty...
Total shoulder arthroplasty (TSA) is an effective operation for providing pain relief and improving function in patients with end-stage degenerative shoulder disease that is nonresponsive to nonoperative treatments.1-4 With the increasing number of arthroplasties performed, and the expanding indication for shoulder arthroplasty, the number of revision shoulder arthroplasties is also increasing.5-14 Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered mostly in revision TSAs.
Historically, patients with severe glenoid bone loss were treated with a hemiarthroplasty.15-17 However, due to inferior outcomes associated with the use of shoulder hemiarthroplasties compared with TSA in these cases,18-20 various techniques were developed with the aim of realigning the glenoid axis and securing the implants into the deficient glenoid vault.21-25 Options have included eccentric reaming, glenoid reconstruction with bone autografts and allografts, and more recently augmented components and patient-specific implants. Studies with eccentric reaming and reconstruction with bone graft during complex shoulder arthroplasty have reported encouraging short- to mid-term results, but the clinical and radiographic outcomes remain inconsistent, and the high number of complications is a concern.25-28
Complications with these techniques include component loosening, graft resorption, nonunion, failure of graft incorporation, infection, and instability.25-28
Computer-aided design and computer-aided manufacturing (CAD/CAM) of patient-specific implants have been used successfully by hip arthroplasty surgeons to deal with complex acetabular reconstructions in the setting of severe bone loss. More recently, the same technology has been used to reconstruct the glenoid vault in cases of severe glenoid bone loss.
In this article, we describe a patient-specific glenoid implant, its indication, and both technical aspects and the surgical technique, based on the authors’ experience as well as a review of the current literature on custom glenoid implants.
Continue to: PATIENT-SPECIFIC GLENOID COMPONENT
PATIENT-SPECIFIC GLENOID COMPONENT
The Vault Reconstruction System ([VRS], Zimmer Biomet) is a patient-specific glenoid vault reconstruction system developed with the use of CAD/CAM to address severe glenoid bone loss encountered during shoulder arthroplasty. For several years, the VRS was available only as a custom implant according to the US Food and Drug Administration rules, and therefore its use was limited to a few cases per year. Recently, a 510(k) envelope clearance was granted to use the VRS in reverse TSA to address significant glenoid bone defects.
The VRS is made of porous plasma spray titanium to provide high strength and flexibility, and allows for biologic fixation. This system can accommodate a restricted bone loss envelope of about 50 mm × 50 mm × 35 mm according to the previous experience of the manufacturer in the custom scenario, covering 96% of defects previously addressed. One 6.5-mm nonlocking central screw and a minimum of four 4.75-mm nonlocking or locking peripheral screws are required for optimal fixation of the implant in the native scapula. A custom boss can be added in to enhance fixation in the native scapula when the bone is sufficient. To facilitate the surgical procedure, a trial implant, a bone model of the scapula, and a custom boss reaming guide are 3-dimensional (3-D) and printed in sterilizable material. These are all provided as single-use disposable instruments and can be available for surgeons during both the initial plan review and surgery.
PREOPERATIVE PLANNING
Patients undergo a preoperative fine-cut 2-dimensional computed tomography scan of the scapula and adjacent humerus following a predefined protocol with a slice thickness of 2 mm to 3 mm. An accurate 3-D bone model of the scapula is obtained using a 3-D image processing software system (Figure 1). The 3-D scapular model is used to create a patient-specific glenoid implant proposal that is approved by the surgeon (Figure 2). Implant position, orientation, size, screw trajectory, and recommended bone removal, if necessary, are determined to create a more normal glenohumeral center of rotation and to secure a glenoid implant in severely deficient glenoid bone (Figure 3). Once the implant design is approved by the surgeon, the final patient-specific implant is manufactured.
SURGICAL TECHNIQUE
The exposure of the glenoid is a critical step for the successful implantation of the patient-specific glenoid implant. Soft tissue and scar tissue around the glenoid must be removed to allow for optimal fit of the custom-made reaming guide. Also, removal of the entire capsulolabral complex on the anteroinferior rim of the glenoid is essential to both enhance glenoid exposure and to allow a perfect fit of the guide to the pathologic bone stock. Attention should be paid during débridement and/or implant removal in case of revision, to make sure that no excessive bone is removed because the patient-specific guide is referenced to this anatomy. Excessive bone removal can change the orientation of the patient-specific guide and ultimately the fixation of the implant. Once the custom-made patient-specific guide is positioned, a 3.2-mm Steinmann pin is placed through the inserter for temporary fixation. The pin should engage or perforate the medial cortical wall to ensure that the subsequent reamer has a stable cannula over which to ream. After the glenoid is reamed, the final implant can be placed in the ideal position according to the preoperative planning. A central 6.5-mm nonlocking central screw and 4.75-mm nonlocking or locking peripheral screws are required to complete the fixation of the implant in the native scapula. Once the patient-specific glenoid component is positioned and strongly fixed to the bone, the glenosphere can be positioned according to the preoperative planning, and the reverse shoulder arthroplasty can be completed in the usual fashion.
CASE EXAMPLES
A 68-year-old woman underwent a TSA for end-stage osteoarthritis in 2000. The implant failed due to a cuff failure. The patient underwent several surgeries, including an open cuff repair, with no success. She had no active elevation preoperatively. Because of the significant glenoid bone loss, a patient-specific glenoid reconstruction was planned. Within 24 months after this surgery, the patient was able to get her hand to her head and elevate to 90º (Figures 4A-4F).
Continue to: In October 2013...
In October 2013, a 68-year-old man underwent a TSA for end-stage osteoarthritis. After 18 months, the implant failed due to active Propionibacterium acnes infection, which required excisional arthroplasty with insertion of an antibiotic spacer. Significant glenoid bone loss (Figure 5) and global soft-tissue deficiency caused substantial disability and led to an indication for a reverse TSA with a patient-specific glenoid vault reconstruction (Figures 6A-6D) after infection eradication. Within 20 months after this surgery, the patient had resumed a satisfactory range of motion (130º forward elevation, 20º external rotation) and outcome.
DISCUSSION
Although glenoid bone loss is often seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered in most revision TSAs. The best treatment method for massive glenoid bone defects during complex shoulder arthroplasty remains uncertain. Options have included eccentric reaming, glenoid reconstruction with bone allograft and autograft, and more recently augmented components and patient-specific implants.21-25 The advent and availability of CAD/CAM technology have enabled shoulder surgeons to create patient-specific metal solutions to these challenging cases. Currently, only a few reports exist in the literature on patient-specific glenoid components in the setting of severe bone loss.29-32
Chammaa and colleagues29 reported the outcomes of 37 patients with a hip-inspired glenoid component (Total Shoulder Replacement, Stanmore Implants Worldwide). The 5-year results with this implant were promising, with a 16% revision rate and only 1 case of glenoid loosening.
Stoffelen and colleagues30 recently described the successful use of a patient-specific anatomic metal-backed glenoid component for the management of severe glenoid bone loss with excellent results at 2.5 years of follow-up. A different approach was pursued by Gunther and Lynch,31 who reported on 7 patients with a custom inset glenoid implant for deficient glenoid vaults. These circular anatomic, custom-made glenoid components were created with the intention of placing the implants partially inside the glenoid vault and relying partially on sclerotic cortical bone. Despite excellent results at 3 years of follow-up, their use is limited to specific defect geometries and cannot be used in cases of extreme bone loss.
CONCLUSION
We have described the use of a patient-specific glenoid component in 2 patients with severe glenoid bone loss. Despite the satisfactory clinical and short-term radiographic results, we acknowledge that longer-term follow-up is needed to confirm the efficacy of this type of reconstruction. We believe that patient-specific glenoid components represent a valuable addition to the armamentarium of shoulder surgeons who address complex glenoid bone deformities.
References
1. Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014;29(4):856-860. doi:10.1016/j.arth.2013.07.002.
2. Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479. doi:10.1016/j.jse.2005.02.009.
3. Montoya F, Magosch P, Scheiderer B, Lichtenberg S, Melean P, Habermeyer P. Midterm results of a total shoulder prosthesis fixed with a cementless glenoid component. J Shoulder Elbow Surg. 2013;22(5):628-635. doi:10.1016/j.jse.2012.07.005.
4. Torchia ME, Cofield RH, Settergren CR. Total shoulder arthroplasty with the Neer prosthesis: long-term results. J Shoulder Elbow Surg. 1997;6(6):495-505.
5. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224. doi:10.1067/mse.2001.113961.
6. Chalmers PN, Rahman Z, Romeo AA, Nicholson GP. Early dislocation after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(5):737-744. doi:10.1016/j.jse.2013.08.015.
8. Farshad M, Grogli M, Catanzaro S, Gerber C. Revision of reversed total shoulder arthroplasty. Indications and outcome. BMC Musculoskelet Disord. 2012;13(1):160. doi:10.1186/1471-2474-13-160.
9. Fevang BT, Lie SA, Havelin LI, Skredderstuen A, Furnes O. Risk factors for revision after shoulder arthroplasty: 1,825 shoulder arthroplasties from the Norwegian Arthroplasty Register. Acta Orthop. 2009;80(1):83-91.
10. Fox TJ, Cil A, Sperling JW, Sanchez-Sotelo J, Schleck CD, Cofield RH. Survival of the glenoid component in shoulder arthroplasty. J Shoulder Elbow Surg. 2009;18(6):859-863. doi:10.1016/j.jse.2008.11.020.
11. Rasmussen JV. Outcome and risk of revision following shoulder replacement in patients with glenohumeral osteoarthritis. Acta Orthop Suppl. 2014;85(355 suppl):1-23. doi:10.3109/17453674.2014.922007.
12. Rasmussen JV, Polk A, Brorson S, Sorensen AK, Olsen BS. Patient-reported outcome and risk of revision after shoulder replacement for osteoarthritis. 1,209 cases from the Danish Shoulder Arthroplasty Registry, 2006-2010. Acta Orthop. 2014;85(2):117-122. doi:10.3109/17453674.2014.893497.
13. Sajadi KR, Kwon YW, Zuckerman JD. Revision shoulder arthroplasty: an analysis of indications and outcomes. J Shoulder Elbow Surg. 2010;19(2):308-313. doi:10.1016/j.jse.2009.05.016.
14. Singh JA, Sperling JW, Cofield RH. Revision surgery following total shoulder arthroplasty: analysis of 2588 shoulders over three decades (1976 to 2008). J Bone Joint Surg Br. 2011;93(11):1513-1517. doi:10.1302/0301-620X.93B11.26938.
15. Levine WN, Djurasovic M, Glasson JM, Pollock RG, Flatow EL, Bigliani LU. Hemiarthroplasty for glenohumeral osteoarthritis: results correlated to degree of glenoid wear. J Shoulder Elbow Surg. 1997;6(5):449-454.
16. Levine WN, Fischer CR, Nguyen D, Flatow EL, Ahmad CS, Bigliani LU. Long-term follow-up of shoulder hemiarthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 2012;94(22):e164. doi:10.2106/JBJS.K.00603.
17. Lynch JR, Franta AK, Montgomery WH, Lenters TR, Mounce D, Matsen FA. Self-assessed outcome at two to four years after shoulder hemiarthroplasty with concentric glenoid reaming. J Bone Joint Surg Am. 2007;89(6):1284-1292. doi:10.2106/JBJS.E.00942.
18. Iannotti JP, Norris TR. Influence of preoperative factors on outcome of shoulder arthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 2003;85-A(2):251-258.
19. Sperling JW, Cofield RH, Rowland CM. Neer hemiarthroplasty and Neer total shoulder arthroplasty in patients fifty years old or less. Long-term results. J Bone Joint Surg Am. 1998;80(4):464-473.
21. Cil A, Sperling JW, Cofield RH. Nonstandard glenoid components for bone deficiencies in shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(7):e149-e157. doi:10.1016/j.jse.2013.09.023.
22. Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013;22(11):1589-1598. doi:10.1016/j.jse.2013.06.017.
23. Gunther SB, Lynch TL. Total shoulder replacement surgery with custom glenoid implants for severe bone deficiency. J Shoulder Elbow Surg. 2012;21(5):675-684. doi:10.1016/j.jse.2011.03.023.
24. Neer CS, Morrison DS. Glenoid bone-grafting in total shoulder arthroplasty. J Bone Joint Surg Am. 1988;70(8):1154-1162.
25. Steinmann SP, Cofield RH. Bone grafting for glenoid deficiency in total shoulder replacement. J Shoulder Elbow Surg. 2000;9(5):361-367. doi:10.1067/mse.2000.106921.
26. Iannotti JP, Frangiamore SJ. Fate of large structural allograft for treatment of severe uncontained glenoid bone deficiency. J Shoulder Elbow Surg. 2012:21(6):765-771. doi:10.1016/j.jse.2011.08.069.
27. Hill JM, Norris TR. Long-term results of total shoulder arthroplasty following bone-grafting of the glenoid. J Bone Joint Surg Am. 2001;83-A(6):877-883.
28. Hsu JE, Ricchetti ET, Huffman GR, Iannotti JP, Glaser DL. Addressing glenoid bone deficiency and asymptomatic posterior erosion in shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(9):1298-1308.
29. Chammaa R, Uri O, Lambert S. Primary shoulder arthroplasty using a custom-made hip-inspired implant for the treatment of advanced glenohumeral arthritis in the presence of severe glenoid bone loss. J Shoulder Elbow Surg. 2017;26(1):101-107. doi:10.1016/j.jse.2016.05.027.
30. Stoffelen DV, Eraly K, Debeer P. The use of 3D printing technology in reconstruction of a severe glenoid defect: a case report with 2.5 years of follow-up. J Shoulder Elbow Surg. 2015;24(8):e218-e222. doi:10.1016/j.jse.2015.04.006.
31. Gunther SB, Lynch TL. Total shoulder replacement surgery with custom glenoid implants for severe bone deficiency. J Shoulder Elbow Surg. 2012;21(5):675-684. doi:10.1016/j.jse.2011.03.023.
32. Dines DM, Gulotta L, Craig EV, Dines JS. Novel solution for massive glenoid defects in shoulder arthroplasty: a patient-specific glenoid vault reconstruction system. Am J Orthop. 2017;46(2):104-108.
References
1. Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014;29(4):856-860. doi:10.1016/j.arth.2013.07.002.
2. Deshmukh AV, Koris M, Zurakowski D, Thornhill TS. Total shoulder arthroplasty: long-term survivorship, functional outcome, and quality of life. J Shoulder Elbow Surg. 2005;14(5):471-479. doi:10.1016/j.jse.2005.02.009.
3. Montoya F, Magosch P, Scheiderer B, Lichtenberg S, Melean P, Habermeyer P. Midterm results of a total shoulder prosthesis fixed with a cementless glenoid component. J Shoulder Elbow Surg. 2013;22(5):628-635. doi:10.1016/j.jse.2012.07.005.
4. Torchia ME, Cofield RH, Settergren CR. Total shoulder arthroplasty with the Neer prosthesis: long-term results. J Shoulder Elbow Surg. 1997;6(6):495-505.
5. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224. doi:10.1067/mse.2001.113961.
6. Chalmers PN, Rahman Z, Romeo AA, Nicholson GP. Early dislocation after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(5):737-744. doi:10.1016/j.jse.2013.08.015.
8. Farshad M, Grogli M, Catanzaro S, Gerber C. Revision of reversed total shoulder arthroplasty. Indications and outcome. BMC Musculoskelet Disord. 2012;13(1):160. doi:10.1186/1471-2474-13-160.
9. Fevang BT, Lie SA, Havelin LI, Skredderstuen A, Furnes O. Risk factors for revision after shoulder arthroplasty: 1,825 shoulder arthroplasties from the Norwegian Arthroplasty Register. Acta Orthop. 2009;80(1):83-91.
10. Fox TJ, Cil A, Sperling JW, Sanchez-Sotelo J, Schleck CD, Cofield RH. Survival of the glenoid component in shoulder arthroplasty. J Shoulder Elbow Surg. 2009;18(6):859-863. doi:10.1016/j.jse.2008.11.020.
11. Rasmussen JV. Outcome and risk of revision following shoulder replacement in patients with glenohumeral osteoarthritis. Acta Orthop Suppl. 2014;85(355 suppl):1-23. doi:10.3109/17453674.2014.922007.
12. Rasmussen JV, Polk A, Brorson S, Sorensen AK, Olsen BS. Patient-reported outcome and risk of revision after shoulder replacement for osteoarthritis. 1,209 cases from the Danish Shoulder Arthroplasty Registry, 2006-2010. Acta Orthop. 2014;85(2):117-122. doi:10.3109/17453674.2014.893497.
13. Sajadi KR, Kwon YW, Zuckerman JD. Revision shoulder arthroplasty: an analysis of indications and outcomes. J Shoulder Elbow Surg. 2010;19(2):308-313. doi:10.1016/j.jse.2009.05.016.
14. Singh JA, Sperling JW, Cofield RH. Revision surgery following total shoulder arthroplasty: analysis of 2588 shoulders over three decades (1976 to 2008). J Bone Joint Surg Br. 2011;93(11):1513-1517. doi:10.1302/0301-620X.93B11.26938.
15. Levine WN, Djurasovic M, Glasson JM, Pollock RG, Flatow EL, Bigliani LU. Hemiarthroplasty for glenohumeral osteoarthritis: results correlated to degree of glenoid wear. J Shoulder Elbow Surg. 1997;6(5):449-454.
16. Levine WN, Fischer CR, Nguyen D, Flatow EL, Ahmad CS, Bigliani LU. Long-term follow-up of shoulder hemiarthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 2012;94(22):e164. doi:10.2106/JBJS.K.00603.
17. Lynch JR, Franta AK, Montgomery WH, Lenters TR, Mounce D, Matsen FA. Self-assessed outcome at two to four years after shoulder hemiarthroplasty with concentric glenoid reaming. J Bone Joint Surg Am. 2007;89(6):1284-1292. doi:10.2106/JBJS.E.00942.
18. Iannotti JP, Norris TR. Influence of preoperative factors on outcome of shoulder arthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 2003;85-A(2):251-258.
19. Sperling JW, Cofield RH, Rowland CM. Neer hemiarthroplasty and Neer total shoulder arthroplasty in patients fifty years old or less. Long-term results. J Bone Joint Surg Am. 1998;80(4):464-473.
21. Cil A, Sperling JW, Cofield RH. Nonstandard glenoid components for bone deficiencies in shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(7):e149-e157. doi:10.1016/j.jse.2013.09.023.
22. Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013;22(11):1589-1598. doi:10.1016/j.jse.2013.06.017.
23. Gunther SB, Lynch TL. Total shoulder replacement surgery with custom glenoid implants for severe bone deficiency. J Shoulder Elbow Surg. 2012;21(5):675-684. doi:10.1016/j.jse.2011.03.023.
24. Neer CS, Morrison DS. Glenoid bone-grafting in total shoulder arthroplasty. J Bone Joint Surg Am. 1988;70(8):1154-1162.
25. Steinmann SP, Cofield RH. Bone grafting for glenoid deficiency in total shoulder replacement. J Shoulder Elbow Surg. 2000;9(5):361-367. doi:10.1067/mse.2000.106921.
26. Iannotti JP, Frangiamore SJ. Fate of large structural allograft for treatment of severe uncontained glenoid bone deficiency. J Shoulder Elbow Surg. 2012:21(6):765-771. doi:10.1016/j.jse.2011.08.069.
27. Hill JM, Norris TR. Long-term results of total shoulder arthroplasty following bone-grafting of the glenoid. J Bone Joint Surg Am. 2001;83-A(6):877-883.
28. Hsu JE, Ricchetti ET, Huffman GR, Iannotti JP, Glaser DL. Addressing glenoid bone deficiency and asymptomatic posterior erosion in shoulder arthroplasty. J Shoulder Elbow Surg. 2013;22(9):1298-1308.
29. Chammaa R, Uri O, Lambert S. Primary shoulder arthroplasty using a custom-made hip-inspired implant for the treatment of advanced glenohumeral arthritis in the presence of severe glenoid bone loss. J Shoulder Elbow Surg. 2017;26(1):101-107. doi:10.1016/j.jse.2016.05.027.
30. Stoffelen DV, Eraly K, Debeer P. The use of 3D printing technology in reconstruction of a severe glenoid defect: a case report with 2.5 years of follow-up. J Shoulder Elbow Surg. 2015;24(8):e218-e222. doi:10.1016/j.jse.2015.04.006.
31. Gunther SB, Lynch TL. Total shoulder replacement surgery with custom glenoid implants for severe bone deficiency. J Shoulder Elbow Surg. 2012;21(5):675-684. doi:10.1016/j.jse.2011.03.023.
32. Dines DM, Gulotta L, Craig EV, Dines JS. Novel solution for massive glenoid defects in shoulder arthroplasty: a patient-specific glenoid vault reconstruction system. Am J Orthop. 2017;46(2):104-108.
With the increasing number of arthroplasties performed, and the expanding indication for shoulder arthroplasty, the number of revision shoulder arthroplasties is also increasing.
Complex glenoid bone defects are sometimes encountered in revision shoulder arthroplasties.
Glenoid reconstructions with bone graft have reported encouraging short- to mid-term results, but the high number of complications is a concern.
Using the CAD/CAM technology patient-specific glenoid components have been created to reconstruct the glenoid vault in cases of severe glenoid bone loss.
Short-term clinical and radiographic results of patient-specific glenoid components are encouraging, however longer-term follow-up are needed to confirm the efficacy of this type of reconstruction.
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Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. The purpose of this study was to demonstrate the feasibility of revisions with a completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.
Between 2003 and 2011, 104 primary total shoulder arthroplasties (TSAs) were performed with an uncemented glenoid component in our group. Of these patients, 13 (average age, 64 years) were revised to reverse shoulder arthroplasty (RSA) using a modular convertible platform system and were included in this study. Average follow-up after revision was 22 months. Outcome measures included pain, range of motion, Constant-Murley scores, Simple Shoulder Tests, and subjective shoulder values. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021), and active external rotation increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°). Mean pain scores significantly improved from 4.2 to 13.3 points. The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90). Subjectively, 12 patients rated their shoulder as better or much better than preoperatively. This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function.
Continue to: Polyethylene glenoid components...
Polyethylene glenoid components are the gold standard in anatomic total shoulder arthroplasty (TSA). However, even though TSA survivorship exceeds 95% at 10-year follow-up,1 glenoid component loosening remains the main complication and the weak link in these implants. This complication accounts for 25% of all complications related to TSA in the literature.2 In most cases, glenoid component loosening is not isolated but combined with a rotator cuff tear, glenohumeral instability, or component malposition.3-5 Therefore, revision of TSA to reverse shoulder arthroplasty (RSA) often requires the removal of both the humeral stem and glenoid component. Removal of the humeral stem can be challenging and can necessitate removal of the cement and osteotomy of the diaphysis, risking fracture and extensive damage to the soft tissue (Figures 1A, 1B).6-8 Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. Allografts and specific designs with a longer post can be mandatory to obtain a stable fixation of the new baseplate.9-12
We hypothesized that a completely convertible platform system on both the humeral and the glenoid side could facilitate the revision of a failed TSA to a RSA. This would enable the surgeon to leave the humeral stem and the glenoid baseplate in place, avoiding the difficulty of stem removal and the reimplantation of a glenoid component, especially in osteoporotic glenoid bone and elderly patients. The revision procedure would then only consist of replacing the humeral head by a metallic tray and polyethylene bearing on the humeral side and by impacting a glenosphere on the glenoid baseplate (Figures 2A, 2B).
The purpose of this study was to demonstrate the feasibility of revisions with this completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.
MATERIALS AND METHODS
PATIENT SELECTION
Between 2003 and 2011, 104 primary TSAs were performed with an uncemented glenoid component in our group. Of these patients, 18 underwent revision (17.3%). Among these 18 patients, 13 were revised to RSA using a modular convertible platform system and were included in this study, while 5 patients were revised to another TSA (2 dissociations of the polyethylene glenoid implant, 2 excessively low implantations of the glenoid baseplate, and 1 glenoid loosening). The mean age of the 13 patients (9 women, 4 men) included in this retrospective study at the time of revision was 64 years (range, 50-75 years). The reasons for revision surgery were rotator cuff tear (5, among which 2 were posterosuperior tears, and 3 were tears of the subscapularis), dislocations (5 posterior and 1 anterior, among which 4 had a B2 or C glenoid), suprascapular nerve paralysis (1), and dissociation of the polyethylene (1). The initial TSA was indicated for primary osteoarthritis with a normal cuff (9), primary osteoarthritis with a reparable cuff tear (2), posttraumatic osteoarthritis (1), and chronic dislocation (1). The right dominant shoulder was involved in 10 cases. The mean time interval between the primary TSA and the revision was 15 months (range, 1-61 months).
OPERATIVE TECHNIQUE
PREOPERATIVE PLANNING
Revision of a failed TSA is always a difficult challenge, and evaluation of bone loss on both the humeral and the glenoid sides, as well as the status of the cuff, is mandatory, even with a completely convertible arthroplasty system. The surgeon must be prepared to remove the humeral stem in case reduction of the joint is impossible. We systematically performed standard radiographs (anteroposterior, axillary, and outlet views) and computed tomography (CT) scans in order to assess both the version and positioning, as well as potential signs of loosening of the implants and the status of the cuff (continuity, degree of muscle trophicity, and fatty infiltration). A preoperative leucocyte count, sedimentation rate, and C-reactive protein rates were requested in every revision case, even if a mechanical etiology was strongly suspected.
Continue to: REVISION PROCEDURE
REVISION PROCEDURE
All the implants that had been used in the primary TSAs were Arrow Universal Shoulder Prostheses (FH Orthopedics). All revisions were performed through the previous deltopectoral approach in the beach chair position under general anesthesia with an interscalene block. Adhesions of the deep part of the deltoid were carefully released. The conjoint tendon was released, and the location of the musculocutaneous and axillary nerves was identified before any retractor was placed. In the 10 cases where the subscapularis was intact, it was peeled off the medial border of the bicipital groove to obtain sufficient length for a tension-free reinsertion.
The anatomical head of the humeral implant was disconnected from the stem and removed. All stems were found to be well fixed; there were no cases of loosening or evidence of infection. A circumferential capsular release was systematically carried out. The polyethylene glenoid onlay was then unlocked from the baseplate.
The quality of the fixation of the glenoid baseplate was systematically evaluated; no screw was found to be loose, and the fixation of all baseplates was stable. Therefore, there was no need to revise the glenoid baseplate, even when its position was considered excessively retroverted (Glenoid B2) or high. A glenosphere was impacted on the baseplate, and a polyethylene humeral bearing was then implanted on the humeral stem. The thinnest polyethylene bearing available (number 0) was chosen in all cases, and a size 36 glenosphere was chosen in 12 out of 13 cases. Intraoperative stability of the implant was satisfactory, and no impingement was found posteriorly, anteriorly, or inferiorly.
In one case, the humeral stem was a first-generation humeral implant which was not compatible with the new-generation humeral bearing, and the humeral stem had to be replaced.
In 2 cases, reduction of the RSA was either impossible or felt to be too tight, even after extensive soft-tissue release and resection of the remaining supraspinatus. The main reason for this was an excessively proud humeral stem because of an onlay polyethylene humeral bearing instead of an inlay design. However, removal of the uncemented humeral stem was always possible with no osteotomy or cortical window of the humeral shaft as the humeral stem has been designed with a bone ingrowth surface only on the metaphyseal part with a smooth surface on diaphyseal part. After removal of the stem, a small amount of humeral metaphysis was cut, and a new humeral stem was press-fit in a lower position. This allowed restoration of an appropriate tension of the soft tissue and, therefore, an easier reduction. The subscapularis was medialized and reinserted transosseously when possible with a double-row repair. In 3 cases, the subscapularis was torn and retracted at the level of the glenoid, or impossible to identify to allow its reinsertion.
Continue to: According to our infectious disease department...
According to our infectious disease department, we made a minimum of 5 cultures for each revision case looking for a possible low-grade infection. All cultures in our group are held for 14 days to assess for Propionibacterium acnes.
POSTOPERATIVE MANAGEMENT
A shoulder splint in neutral rotation was used for the first 4 weeks. Passive range of motion (ROM) was started immediately with pendulum exercises and passive anterior elevation. Active assisted and active ROM were allowed after 4 weeks, and physiotherapy was continued for 6 months. Elderly patients were referred to a center of rehabilitation. We found only 1 or 2 positive cultures (Propionibacterium acnes) for 4 patients, and we decided to consider them as a contamination. None of the patients were treated with antibiotics.
CLINICAL AND RADIOLOGICAL ASSESSMENT
Clinical evaluation included pre- and postoperative pain scores (visual analog scale [VAS]), ROM, the Constant-Murley13 score, the Simple Shoulder Test (SST),14 and the subjective shoulder value.15 Subjective satisfaction was assessed by asking the patients at follow-up how they felt compared with before surgery and was graded using a 4-point scale: 1, much better; 2, better; 3, the same; and 4, worse. Radiographic evaluation was performed on pre- and postoperative standard anteroposterior, outlet, and axillary views. Radiographs were reviewed to determine the presence of glenohumeral subluxation, periprosthetic lucency, component shift in position, and scapular notching.
STATISTICAL ANALYSIS
Descriptive statistics are reported as mean (range) for continuous measures and number (percentage) for discrete variables. The Wilcoxon signed-rank test was used for preoperative vs postoperative changes. The alpha level for all tests was set at 0.05 for statistical significance.
RESULTS
CLINICAL OUTCOME
At a mean of 22 months (range, 7-38 months) follow-up after revision, active ROM was significantly improved. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021). Active external rotation with the elbow on the side increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°) (P = 0.034), and increased with the arm held at 90° abduction from 13° (range, 0°-20°) to 49° (range, 0°-80°) (P = 0.025). Mean pain scores improved from 4.2 to 13.3 points (P < 0.001). VAS improved significantly from 9 to 1 (P < 0.0001). The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90) (P = 0.006). The final SST was 7 per 12. Subjectively, 4 patients rated their shoulder as much better, 8 as better, and 1 as the same as preoperatively. No intra- or postoperative complications, including infections, were observed. The mean duration of the procedure was 60 minutes (range, 30-75 minutes).
Continue to: RADIOLOGICAL OUTCOME
RADIOLOGICAL OUTCOME
No periprosthetic lucency or shift in component was observed at the last follow-up. There was no scapular notching. No resorption of the tuberosities, and no fractures of the acromion or the scapular spine were observed.
DISCUSSION
In this retrospective study, failure of TSA with a metal-backed glenoid implant was successfully revised to RSA. In 10 patients, the use of a universal platform system allowed an easier conversion without removal of the humeral stem or the glenoid component (Figures 3A-3D). Twelve of the 13 patients were satisfied or very satisfied at the last follow-up. None of the patients were in pain, and the mean Constant score was 63. In all the cases, the glenoid baseplate was not changed. In 3 cases the humeral stem was changed without any fracture of the tuberosities of need for an osteotomy. This greatly simplified the revision procedure, as glenoid revisions can be very challenging. Indeed, it is often difficult to assess precisely preoperatively the remaining glenoid bone stock after removal of the glenoid component and the cement. Many therapeutic options to deal with glenoid loosening have been reported in the literature: glenoid bone reconstruction after glenoid component removal and revision to a hemiarthroplasty (HA),10,16-18 glenoid bone reconstruction after glenoid component removal and revision to a new TSA with a cemented glenoid implant,16,17,19,20 and glenoid reconstruction after glenoid component removal and revision to a RSA.12,21 These authors reported that glenoid reconstruction frequently necessitates an iliac bone graft associated with a special design of the baseplate with a long post fixed into the native glenoid bone. However, sometimes implantation of an uncemented glenoid component can be unstable with a high risk of early mobilization of the implant, and 2 steps may be necessary. Conversion to a HA,10,16-18 or a TSA16,17,19,20 with a new cemented implant have both been associated with poor clinical outcome, with a high rate of recurrent glenoid loosening for the TSAs.
In our retrospective study, we reported no intra- or postoperative complications. Flury and colleagues22 reported a complication rate of 38% in 21 patients after conversion from a TSA to a RSA with a mean follow-up of 46 months. They removed all the components of the prosthesis with a crack or fracture of the humerus and/or the glenoid. Ortmaier and colleagues23 reported a rate of complication of 22.7% during the conversion of TSA to RSA. They did an osteotomy of the humeral diaphysis to extract the stem in 40% of cases and had to remove the glenoid cement in 86% of cases with severe damage of the glenoid bone in 10% of cases. Fewer complications were found in our study, as we did not need any procedure such as humeral osteotomy, cerclage, bone grafting, and/or reconstruction of the glenoid. The short operative time and the absence of extensive soft-tissue dissection, thanks to a standard deltopectoral approach, could explain the absence of infection in our series.
Other authors shared our strategy of a universal convertible system and reported their results in the literature. Castagna and colleagues24 in 2013 reported the clinical and radiological results of conversions of HA or TSA to RSA using a modular, convertible system (SMR Shoulder System, Lima Corporate). In their series, only 8 cases of TSAs were converted to RSA. They preserved, in each case, the humeral stem and the glenoid baseplate. There were no intra- or postoperative complications. The mean VAS score decreased from 8 to 2. Weber-Spickschen and colleague25 reported recently in 2015 the same experience with the same system (SMR Shoulder System). They reviewed 15 conversions of TSAs to RSAs without any removal of the implants at a mean 43-month follow-up. They reported excellent pain relief (VAS decreased from 8 to 1) and improvement in shoulder function with a low rate of complications.
Kany and colleagues26 in 2015 had already reported the advantages of a shoulder platform system for revisions. In their series, the authors included cases of failure of HAs and TSAs with loose cemented glenoids and metal-backed glenoids. The clinical and radiological results were similar, with a final Constant score of 60 (range, 42-85) and a similar rate of humeral stems which had to be changed (24%). These stems were replaced either because they were too proud or because there was not enough space to add an onlay polyethylene socket.
Continue to: Despite the encouraging results...
Despite the encouraging results reported in this study, there are some limitations. Firstly, no control group was used. Attempting to address this issue, we compared our results with the literature. Secondly, the number of patients in our study was small. Finally, the follow-up duration (mean 22 months) did not provide long-term outcomes.
CONCLUSION
This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function. A platform system on both the humeral and the glenoid side reduces the operative time of the conversion with a low risk of complications.
References
1. Brenner BC, Ferlic DC, Clayton ML, Dennis DA. Survivorship of unconstrained total shoulder arthroplasty. J Bone Joint Surg Am. 1989;71(9):1289-1296.
2. Budge MD, Nolan EM, Heisey MH, Baker K, Wiater JM. Results of total shoulder arthroplasty with a monoblock porous tantalum glenoid component: a prospective minimum 2-year follow-up study. J Shoulder Elbow Surg. 2013;22(4):535-541. doi:10.1016/j.jse.2012.06.001.
3. Chin PY, Sperling JW, Cofield RH, Schleck C. Complications of total shoulder arthroplasty: are they fewer or different? J Shoulder Elbow Surg. 2006;15(1):19-22. doi:10.1016/j.jse.2005.05.005.
4. Torchia ME, Cofield RH, Settergren CR. Total shoulder arthroplasty with the Neer prosthesis: long-term results. J Shoulder Elbow Surg. 1997;6(6):495-505.
5. Wirth MA, Rockwood CA Jr. Complications of total shoulder-replacement surgery. J Bone Joint Surg Am. 1996;78(4):603-616.
6. Gohlke F, Rolf O. Revision of failed fracture hemiarthroplasties to reverse total shoulder prosthesis through the transhumeral approach: method incorporating a pectoralis-major-pedicled bone window. Oper Orthop Traumatol. 2007;19(2):185-208. doi:10.1007/s00064-007-1202-x.
7. Goldberg SH, Cohen MS, Young M, Bradnock B. Thermal tissue damage caused by ultrasonic cement removal from the humerus. J Bone Joint Surg Am. 2005;87(3):583-591. doi:10.2106/JBJS.D.01966.
8. Sperling JW, Cofield RH. Humeral windows in revision shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(3):258-263. doi:10.1016/j.jse.2004.09.004.
9. Chacon A, Virani N, Shannon R, Levy JC, Pupello D, Frankle M. Revision arthroplasty with use of a reverse shoulder prosthesis-allograft composite. J Bone Joint Surg Am. 2009;91(1):119-127. doi:10.2106/JBJS.H.00094.
10. Iannotti JP, Frangiamore SJ. Fate of large structural allograft for treatment of severe uncontained glenoid bone deficiency. J Shoulder Elbow Surg. 2012;21(6):765-771. doi:10.1016/j.jse.2011.08.069.
11. Kelly JD 2nd, Zhao JX, Hobgood ER, Norris TR. Clinical results of revision shoulder arthroplasty using the reverse prosthesis. J Shoulder Elbow Surg. 2012;21(11):1516-1525. doi:10.1016/j.jse.2011.11.021.
12. Melis B, Bonnevialle N, Neyton L, et al. Glenoid loosening and failure in anatomical total shoulder arthroplasty: is revision with a reverse shoulder arthroplasty a reliable option? J Shoulder Elbow Surg. 2012;21(3):342-349. doi:10.1016/j.jse.2011.05.021.
13. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;(214):160-164.
14. Matsen FA 3rd, Ziegler DW, DeBartolo SE. Patient self-assessment of health status and function in glenohumeral degenerative joint disease. J Shoulder Elbow Surg. 1995;4(5):345-351.
15. Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007;16(6):717-721. doi:10.1016/j.jse.2007.02.123.
16. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224. doi:10.1067/mse.2001.113961.
17. Cofield RH, Edgerton BC. Total shoulder arthroplasty: complications and revision surgery. Instr Course Lect. 1990;39:449-462.
18. Neyton L, Walch G, Nove-Josserand L, Edwards TB. Glenoid corticocancellous bone grafting after glenoid component removal in the treatment of glenoid loosening. J Shoulder Elbow Surg. 2006;15(2):173-179. doi:10.1016/j.jse.2005.07.010.
19. Bonnevialle N, Melis B, Neyton L, et al. Aseptic glenoid loosening or failure in total shoulder arthroplasty: revision with glenoid reimplantation. J Shoulder Elbow Surg. 2013;22(6):745-751. doi:10.1016/j.jse.2012.08.009.
20. Rodosky MW, Bigliani LU. Indications for glenoid resurfacing in shoulder arthroplasty. J Shoulder Elbow Surg. 1996;5(3):231-248.
21. Bateman E, Donald SM. Reconstruction of massive uncontained glenoid defects using a combined autograft-allograft construct with reverse shoulder arthroplasty: preliminary results. J Shoulder Elbow Surg. 2012;21(7):925-934. doi:10.1016/j.jse.2011.07.009.
22. Flury MP, Frey P, Goldhahn J, Schwyzer HK, Simmen BR. Reverse shoulder arthroplasty as a salvage procedure for failed conventional shoulder replacement due to cuff failure--midterm results. Int Orthop. 2011;35(1):53-60. doi:10.1007/s00264-010-0990-z.
23. Ortmaier R, Resch H, Hitzl W, et al. Reverse shoulder arthroplasty combined with latissimus dorsi transfer using the bone-chip technique. Int Orthop. 2013;38(3):1-7. doi:10.1007/s00264-013-2139-3.
24. Castagna A, Delcogliano M, de Caro F, et al. Conversion of shoulder arthroplasty to reverse implants: clinical and radiological results using a modular system. Int Orthop. 2013;37(7):1297-1305. doi:10.1007/s00264-013-1907-4.
25. Weber-Spickschen TS, Alfke D, Agneskirchner JD. The use of a modular system to convert an anatomical total shoulder arthroplasty to a reverse shoulder arthroplasty: Clinical and radiological results. Bone Joint J. 2015;97-B(12):1662-1667. doi:10.1302/0301-620X.97B12.35176.
26. Kany J, Amouyel T, Flamand O, Katz D, Valenti P. A convertible shoulder system: is it useful in total shoulder arthroplasty revisions? Int Orthop. 2015;39(2):299-304. doi:10.1007/s00264-014-2563-z.
Author and Disclosure Information
Authors’ Disclosure Statement: All authors report that they receive royalties for a shoulder prosthesis design from FH Orthopedics.
Dr. Valenti is an Orthopedic Surgeon, and Dr. Werthel is an Assistant, Paris Shoulder Unit, Clinique Bizet, Paris, France. Dr. Katz is an Orthopedic Surgeon, Douar Gwen, Ploemeur, France. Dr. Kany is an Orthopedic Surgeon, Clinique de l’Union, Saint-Jean, France.
Address correspondence to: Philippe Valenti, MD, Paris Shoulder Unit, Clinique Bizet, 21 rue Georges Bizet, 75116 Paris, France (email, Philippe.valenti@wanadoo.fr).
Philippe Valenti, MD Denis Katz, MD Jean Kany, MD Jean-David Werthel, MD, MS . Convertible Glenoid Components Facilitate Revisions to Reverse Shoulder Arthroplasty Easier: Retrospective Review of 13 Cases . Am J Orthop. February 8, 2018
Authors’ Disclosure Statement: All authors report that they receive royalties for a shoulder prosthesis design from FH Orthopedics.
Dr. Valenti is an Orthopedic Surgeon, and Dr. Werthel is an Assistant, Paris Shoulder Unit, Clinique Bizet, Paris, France. Dr. Katz is an Orthopedic Surgeon, Douar Gwen, Ploemeur, France. Dr. Kany is an Orthopedic Surgeon, Clinique de l’Union, Saint-Jean, France.
Address correspondence to: Philippe Valenti, MD, Paris Shoulder Unit, Clinique Bizet, 21 rue Georges Bizet, 75116 Paris, France (email, Philippe.valenti@wanadoo.fr).
Philippe Valenti, MD Denis Katz, MD Jean Kany, MD Jean-David Werthel, MD, MS . Convertible Glenoid Components Facilitate Revisions to Reverse Shoulder Arthroplasty Easier: Retrospective Review of 13 Cases . Am J Orthop. February 8, 2018
Author and Disclosure Information
Authors’ Disclosure Statement: All authors report that they receive royalties for a shoulder prosthesis design from FH Orthopedics.
Dr. Valenti is an Orthopedic Surgeon, and Dr. Werthel is an Assistant, Paris Shoulder Unit, Clinique Bizet, Paris, France. Dr. Katz is an Orthopedic Surgeon, Douar Gwen, Ploemeur, France. Dr. Kany is an Orthopedic Surgeon, Clinique de l’Union, Saint-Jean, France.
Address correspondence to: Philippe Valenti, MD, Paris Shoulder Unit, Clinique Bizet, 21 rue Georges Bizet, 75116 Paris, France (email, Philippe.valenti@wanadoo.fr).
Philippe Valenti, MD Denis Katz, MD Jean Kany, MD Jean-David Werthel, MD, MS . Convertible Glenoid Components Facilitate Revisions to Reverse Shoulder Arthroplasty Easier: Retrospective Review of 13 Cases . Am J Orthop. February 8, 2018
ABSTRACT
Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. The purpose of this study was to demonstrate the feasibility of revisions with a completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.
Between 2003 and 2011, 104 primary total shoulder arthroplasties (TSAs) were performed with an uncemented glenoid component in our group. Of these patients, 13 (average age, 64 years) were revised to reverse shoulder arthroplasty (RSA) using a modular convertible platform system and were included in this study. Average follow-up after revision was 22 months. Outcome measures included pain, range of motion, Constant-Murley scores, Simple Shoulder Tests, and subjective shoulder values. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021), and active external rotation increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°). Mean pain scores significantly improved from 4.2 to 13.3 points. The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90). Subjectively, 12 patients rated their shoulder as better or much better than preoperatively. This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function.
Continue to: Polyethylene glenoid components...
Polyethylene glenoid components are the gold standard in anatomic total shoulder arthroplasty (TSA). However, even though TSA survivorship exceeds 95% at 10-year follow-up,1 glenoid component loosening remains the main complication and the weak link in these implants. This complication accounts for 25% of all complications related to TSA in the literature.2 In most cases, glenoid component loosening is not isolated but combined with a rotator cuff tear, glenohumeral instability, or component malposition.3-5 Therefore, revision of TSA to reverse shoulder arthroplasty (RSA) often requires the removal of both the humeral stem and glenoid component. Removal of the humeral stem can be challenging and can necessitate removal of the cement and osteotomy of the diaphysis, risking fracture and extensive damage to the soft tissue (Figures 1A, 1B).6-8 Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. Allografts and specific designs with a longer post can be mandatory to obtain a stable fixation of the new baseplate.9-12
We hypothesized that a completely convertible platform system on both the humeral and the glenoid side could facilitate the revision of a failed TSA to a RSA. This would enable the surgeon to leave the humeral stem and the glenoid baseplate in place, avoiding the difficulty of stem removal and the reimplantation of a glenoid component, especially in osteoporotic glenoid bone and elderly patients. The revision procedure would then only consist of replacing the humeral head by a metallic tray and polyethylene bearing on the humeral side and by impacting a glenosphere on the glenoid baseplate (Figures 2A, 2B).
The purpose of this study was to demonstrate the feasibility of revisions with this completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.
MATERIALS AND METHODS
PATIENT SELECTION
Between 2003 and 2011, 104 primary TSAs were performed with an uncemented glenoid component in our group. Of these patients, 18 underwent revision (17.3%). Among these 18 patients, 13 were revised to RSA using a modular convertible platform system and were included in this study, while 5 patients were revised to another TSA (2 dissociations of the polyethylene glenoid implant, 2 excessively low implantations of the glenoid baseplate, and 1 glenoid loosening). The mean age of the 13 patients (9 women, 4 men) included in this retrospective study at the time of revision was 64 years (range, 50-75 years). The reasons for revision surgery were rotator cuff tear (5, among which 2 were posterosuperior tears, and 3 were tears of the subscapularis), dislocations (5 posterior and 1 anterior, among which 4 had a B2 or C glenoid), suprascapular nerve paralysis (1), and dissociation of the polyethylene (1). The initial TSA was indicated for primary osteoarthritis with a normal cuff (9), primary osteoarthritis with a reparable cuff tear (2), posttraumatic osteoarthritis (1), and chronic dislocation (1). The right dominant shoulder was involved in 10 cases. The mean time interval between the primary TSA and the revision was 15 months (range, 1-61 months).
OPERATIVE TECHNIQUE
PREOPERATIVE PLANNING
Revision of a failed TSA is always a difficult challenge, and evaluation of bone loss on both the humeral and the glenoid sides, as well as the status of the cuff, is mandatory, even with a completely convertible arthroplasty system. The surgeon must be prepared to remove the humeral stem in case reduction of the joint is impossible. We systematically performed standard radiographs (anteroposterior, axillary, and outlet views) and computed tomography (CT) scans in order to assess both the version and positioning, as well as potential signs of loosening of the implants and the status of the cuff (continuity, degree of muscle trophicity, and fatty infiltration). A preoperative leucocyte count, sedimentation rate, and C-reactive protein rates were requested in every revision case, even if a mechanical etiology was strongly suspected.
Continue to: REVISION PROCEDURE
REVISION PROCEDURE
All the implants that had been used in the primary TSAs were Arrow Universal Shoulder Prostheses (FH Orthopedics). All revisions were performed through the previous deltopectoral approach in the beach chair position under general anesthesia with an interscalene block. Adhesions of the deep part of the deltoid were carefully released. The conjoint tendon was released, and the location of the musculocutaneous and axillary nerves was identified before any retractor was placed. In the 10 cases where the subscapularis was intact, it was peeled off the medial border of the bicipital groove to obtain sufficient length for a tension-free reinsertion.
The anatomical head of the humeral implant was disconnected from the stem and removed. All stems were found to be well fixed; there were no cases of loosening or evidence of infection. A circumferential capsular release was systematically carried out. The polyethylene glenoid onlay was then unlocked from the baseplate.
The quality of the fixation of the glenoid baseplate was systematically evaluated; no screw was found to be loose, and the fixation of all baseplates was stable. Therefore, there was no need to revise the glenoid baseplate, even when its position was considered excessively retroverted (Glenoid B2) or high. A glenosphere was impacted on the baseplate, and a polyethylene humeral bearing was then implanted on the humeral stem. The thinnest polyethylene bearing available (number 0) was chosen in all cases, and a size 36 glenosphere was chosen in 12 out of 13 cases. Intraoperative stability of the implant was satisfactory, and no impingement was found posteriorly, anteriorly, or inferiorly.
In one case, the humeral stem was a first-generation humeral implant which was not compatible with the new-generation humeral bearing, and the humeral stem had to be replaced.
In 2 cases, reduction of the RSA was either impossible or felt to be too tight, even after extensive soft-tissue release and resection of the remaining supraspinatus. The main reason for this was an excessively proud humeral stem because of an onlay polyethylene humeral bearing instead of an inlay design. However, removal of the uncemented humeral stem was always possible with no osteotomy or cortical window of the humeral shaft as the humeral stem has been designed with a bone ingrowth surface only on the metaphyseal part with a smooth surface on diaphyseal part. After removal of the stem, a small amount of humeral metaphysis was cut, and a new humeral stem was press-fit in a lower position. This allowed restoration of an appropriate tension of the soft tissue and, therefore, an easier reduction. The subscapularis was medialized and reinserted transosseously when possible with a double-row repair. In 3 cases, the subscapularis was torn and retracted at the level of the glenoid, or impossible to identify to allow its reinsertion.
Continue to: According to our infectious disease department...
According to our infectious disease department, we made a minimum of 5 cultures for each revision case looking for a possible low-grade infection. All cultures in our group are held for 14 days to assess for Propionibacterium acnes.
POSTOPERATIVE MANAGEMENT
A shoulder splint in neutral rotation was used for the first 4 weeks. Passive range of motion (ROM) was started immediately with pendulum exercises and passive anterior elevation. Active assisted and active ROM were allowed after 4 weeks, and physiotherapy was continued for 6 months. Elderly patients were referred to a center of rehabilitation. We found only 1 or 2 positive cultures (Propionibacterium acnes) for 4 patients, and we decided to consider them as a contamination. None of the patients were treated with antibiotics.
CLINICAL AND RADIOLOGICAL ASSESSMENT
Clinical evaluation included pre- and postoperative pain scores (visual analog scale [VAS]), ROM, the Constant-Murley13 score, the Simple Shoulder Test (SST),14 and the subjective shoulder value.15 Subjective satisfaction was assessed by asking the patients at follow-up how they felt compared with before surgery and was graded using a 4-point scale: 1, much better; 2, better; 3, the same; and 4, worse. Radiographic evaluation was performed on pre- and postoperative standard anteroposterior, outlet, and axillary views. Radiographs were reviewed to determine the presence of glenohumeral subluxation, periprosthetic lucency, component shift in position, and scapular notching.
STATISTICAL ANALYSIS
Descriptive statistics are reported as mean (range) for continuous measures and number (percentage) for discrete variables. The Wilcoxon signed-rank test was used for preoperative vs postoperative changes. The alpha level for all tests was set at 0.05 for statistical significance.
RESULTS
CLINICAL OUTCOME
At a mean of 22 months (range, 7-38 months) follow-up after revision, active ROM was significantly improved. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021). Active external rotation with the elbow on the side increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°) (P = 0.034), and increased with the arm held at 90° abduction from 13° (range, 0°-20°) to 49° (range, 0°-80°) (P = 0.025). Mean pain scores improved from 4.2 to 13.3 points (P < 0.001). VAS improved significantly from 9 to 1 (P < 0.0001). The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90) (P = 0.006). The final SST was 7 per 12. Subjectively, 4 patients rated their shoulder as much better, 8 as better, and 1 as the same as preoperatively. No intra- or postoperative complications, including infections, were observed. The mean duration of the procedure was 60 minutes (range, 30-75 minutes).
Continue to: RADIOLOGICAL OUTCOME
RADIOLOGICAL OUTCOME
No periprosthetic lucency or shift in component was observed at the last follow-up. There was no scapular notching. No resorption of the tuberosities, and no fractures of the acromion or the scapular spine were observed.
DISCUSSION
In this retrospective study, failure of TSA with a metal-backed glenoid implant was successfully revised to RSA. In 10 patients, the use of a universal platform system allowed an easier conversion without removal of the humeral stem or the glenoid component (Figures 3A-3D). Twelve of the 13 patients were satisfied or very satisfied at the last follow-up. None of the patients were in pain, and the mean Constant score was 63. In all the cases, the glenoid baseplate was not changed. In 3 cases the humeral stem was changed without any fracture of the tuberosities of need for an osteotomy. This greatly simplified the revision procedure, as glenoid revisions can be very challenging. Indeed, it is often difficult to assess precisely preoperatively the remaining glenoid bone stock after removal of the glenoid component and the cement. Many therapeutic options to deal with glenoid loosening have been reported in the literature: glenoid bone reconstruction after glenoid component removal and revision to a hemiarthroplasty (HA),10,16-18 glenoid bone reconstruction after glenoid component removal and revision to a new TSA with a cemented glenoid implant,16,17,19,20 and glenoid reconstruction after glenoid component removal and revision to a RSA.12,21 These authors reported that glenoid reconstruction frequently necessitates an iliac bone graft associated with a special design of the baseplate with a long post fixed into the native glenoid bone. However, sometimes implantation of an uncemented glenoid component can be unstable with a high risk of early mobilization of the implant, and 2 steps may be necessary. Conversion to a HA,10,16-18 or a TSA16,17,19,20 with a new cemented implant have both been associated with poor clinical outcome, with a high rate of recurrent glenoid loosening for the TSAs.
In our retrospective study, we reported no intra- or postoperative complications. Flury and colleagues22 reported a complication rate of 38% in 21 patients after conversion from a TSA to a RSA with a mean follow-up of 46 months. They removed all the components of the prosthesis with a crack or fracture of the humerus and/or the glenoid. Ortmaier and colleagues23 reported a rate of complication of 22.7% during the conversion of TSA to RSA. They did an osteotomy of the humeral diaphysis to extract the stem in 40% of cases and had to remove the glenoid cement in 86% of cases with severe damage of the glenoid bone in 10% of cases. Fewer complications were found in our study, as we did not need any procedure such as humeral osteotomy, cerclage, bone grafting, and/or reconstruction of the glenoid. The short operative time and the absence of extensive soft-tissue dissection, thanks to a standard deltopectoral approach, could explain the absence of infection in our series.
Other authors shared our strategy of a universal convertible system and reported their results in the literature. Castagna and colleagues24 in 2013 reported the clinical and radiological results of conversions of HA or TSA to RSA using a modular, convertible system (SMR Shoulder System, Lima Corporate). In their series, only 8 cases of TSAs were converted to RSA. They preserved, in each case, the humeral stem and the glenoid baseplate. There were no intra- or postoperative complications. The mean VAS score decreased from 8 to 2. Weber-Spickschen and colleague25 reported recently in 2015 the same experience with the same system (SMR Shoulder System). They reviewed 15 conversions of TSAs to RSAs without any removal of the implants at a mean 43-month follow-up. They reported excellent pain relief (VAS decreased from 8 to 1) and improvement in shoulder function with a low rate of complications.
Kany and colleagues26 in 2015 had already reported the advantages of a shoulder platform system for revisions. In their series, the authors included cases of failure of HAs and TSAs with loose cemented glenoids and metal-backed glenoids. The clinical and radiological results were similar, with a final Constant score of 60 (range, 42-85) and a similar rate of humeral stems which had to be changed (24%). These stems were replaced either because they were too proud or because there was not enough space to add an onlay polyethylene socket.
Continue to: Despite the encouraging results...
Despite the encouraging results reported in this study, there are some limitations. Firstly, no control group was used. Attempting to address this issue, we compared our results with the literature. Secondly, the number of patients in our study was small. Finally, the follow-up duration (mean 22 months) did not provide long-term outcomes.
CONCLUSION
This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function. A platform system on both the humeral and the glenoid side reduces the operative time of the conversion with a low risk of complications.
ABSTRACT
Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. The purpose of this study was to demonstrate the feasibility of revisions with a completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.
Between 2003 and 2011, 104 primary total shoulder arthroplasties (TSAs) were performed with an uncemented glenoid component in our group. Of these patients, 13 (average age, 64 years) were revised to reverse shoulder arthroplasty (RSA) using a modular convertible platform system and were included in this study. Average follow-up after revision was 22 months. Outcome measures included pain, range of motion, Constant-Murley scores, Simple Shoulder Tests, and subjective shoulder values. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021), and active external rotation increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°). Mean pain scores significantly improved from 4.2 to 13.3 points. The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90). Subjectively, 12 patients rated their shoulder as better or much better than preoperatively. This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function.
Continue to: Polyethylene glenoid components...
Polyethylene glenoid components are the gold standard in anatomic total shoulder arthroplasty (TSA). However, even though TSA survivorship exceeds 95% at 10-year follow-up,1 glenoid component loosening remains the main complication and the weak link in these implants. This complication accounts for 25% of all complications related to TSA in the literature.2 In most cases, glenoid component loosening is not isolated but combined with a rotator cuff tear, glenohumeral instability, or component malposition.3-5 Therefore, revision of TSA to reverse shoulder arthroplasty (RSA) often requires the removal of both the humeral stem and glenoid component. Removal of the humeral stem can be challenging and can necessitate removal of the cement and osteotomy of the diaphysis, risking fracture and extensive damage to the soft tissue (Figures 1A, 1B).6-8 Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. Allografts and specific designs with a longer post can be mandatory to obtain a stable fixation of the new baseplate.9-12
We hypothesized that a completely convertible platform system on both the humeral and the glenoid side could facilitate the revision of a failed TSA to a RSA. This would enable the surgeon to leave the humeral stem and the glenoid baseplate in place, avoiding the difficulty of stem removal and the reimplantation of a glenoid component, especially in osteoporotic glenoid bone and elderly patients. The revision procedure would then only consist of replacing the humeral head by a metallic tray and polyethylene bearing on the humeral side and by impacting a glenosphere on the glenoid baseplate (Figures 2A, 2B).
The purpose of this study was to demonstrate the feasibility of revisions with this completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.
MATERIALS AND METHODS
PATIENT SELECTION
Between 2003 and 2011, 104 primary TSAs were performed with an uncemented glenoid component in our group. Of these patients, 18 underwent revision (17.3%). Among these 18 patients, 13 were revised to RSA using a modular convertible platform system and were included in this study, while 5 patients were revised to another TSA (2 dissociations of the polyethylene glenoid implant, 2 excessively low implantations of the glenoid baseplate, and 1 glenoid loosening). The mean age of the 13 patients (9 women, 4 men) included in this retrospective study at the time of revision was 64 years (range, 50-75 years). The reasons for revision surgery were rotator cuff tear (5, among which 2 were posterosuperior tears, and 3 were tears of the subscapularis), dislocations (5 posterior and 1 anterior, among which 4 had a B2 or C glenoid), suprascapular nerve paralysis (1), and dissociation of the polyethylene (1). The initial TSA was indicated for primary osteoarthritis with a normal cuff (9), primary osteoarthritis with a reparable cuff tear (2), posttraumatic osteoarthritis (1), and chronic dislocation (1). The right dominant shoulder was involved in 10 cases. The mean time interval between the primary TSA and the revision was 15 months (range, 1-61 months).
OPERATIVE TECHNIQUE
PREOPERATIVE PLANNING
Revision of a failed TSA is always a difficult challenge, and evaluation of bone loss on both the humeral and the glenoid sides, as well as the status of the cuff, is mandatory, even with a completely convertible arthroplasty system. The surgeon must be prepared to remove the humeral stem in case reduction of the joint is impossible. We systematically performed standard radiographs (anteroposterior, axillary, and outlet views) and computed tomography (CT) scans in order to assess both the version and positioning, as well as potential signs of loosening of the implants and the status of the cuff (continuity, degree of muscle trophicity, and fatty infiltration). A preoperative leucocyte count, sedimentation rate, and C-reactive protein rates were requested in every revision case, even if a mechanical etiology was strongly suspected.
Continue to: REVISION PROCEDURE
REVISION PROCEDURE
All the implants that had been used in the primary TSAs were Arrow Universal Shoulder Prostheses (FH Orthopedics). All revisions were performed through the previous deltopectoral approach in the beach chair position under general anesthesia with an interscalene block. Adhesions of the deep part of the deltoid were carefully released. The conjoint tendon was released, and the location of the musculocutaneous and axillary nerves was identified before any retractor was placed. In the 10 cases where the subscapularis was intact, it was peeled off the medial border of the bicipital groove to obtain sufficient length for a tension-free reinsertion.
The anatomical head of the humeral implant was disconnected from the stem and removed. All stems were found to be well fixed; there were no cases of loosening or evidence of infection. A circumferential capsular release was systematically carried out. The polyethylene glenoid onlay was then unlocked from the baseplate.
The quality of the fixation of the glenoid baseplate was systematically evaluated; no screw was found to be loose, and the fixation of all baseplates was stable. Therefore, there was no need to revise the glenoid baseplate, even when its position was considered excessively retroverted (Glenoid B2) or high. A glenosphere was impacted on the baseplate, and a polyethylene humeral bearing was then implanted on the humeral stem. The thinnest polyethylene bearing available (number 0) was chosen in all cases, and a size 36 glenosphere was chosen in 12 out of 13 cases. Intraoperative stability of the implant was satisfactory, and no impingement was found posteriorly, anteriorly, or inferiorly.
In one case, the humeral stem was a first-generation humeral implant which was not compatible with the new-generation humeral bearing, and the humeral stem had to be replaced.
In 2 cases, reduction of the RSA was either impossible or felt to be too tight, even after extensive soft-tissue release and resection of the remaining supraspinatus. The main reason for this was an excessively proud humeral stem because of an onlay polyethylene humeral bearing instead of an inlay design. However, removal of the uncemented humeral stem was always possible with no osteotomy or cortical window of the humeral shaft as the humeral stem has been designed with a bone ingrowth surface only on the metaphyseal part with a smooth surface on diaphyseal part. After removal of the stem, a small amount of humeral metaphysis was cut, and a new humeral stem was press-fit in a lower position. This allowed restoration of an appropriate tension of the soft tissue and, therefore, an easier reduction. The subscapularis was medialized and reinserted transosseously when possible with a double-row repair. In 3 cases, the subscapularis was torn and retracted at the level of the glenoid, or impossible to identify to allow its reinsertion.
Continue to: According to our infectious disease department...
According to our infectious disease department, we made a minimum of 5 cultures for each revision case looking for a possible low-grade infection. All cultures in our group are held for 14 days to assess for Propionibacterium acnes.
POSTOPERATIVE MANAGEMENT
A shoulder splint in neutral rotation was used for the first 4 weeks. Passive range of motion (ROM) was started immediately with pendulum exercises and passive anterior elevation. Active assisted and active ROM were allowed after 4 weeks, and physiotherapy was continued for 6 months. Elderly patients were referred to a center of rehabilitation. We found only 1 or 2 positive cultures (Propionibacterium acnes) for 4 patients, and we decided to consider them as a contamination. None of the patients were treated with antibiotics.
CLINICAL AND RADIOLOGICAL ASSESSMENT
Clinical evaluation included pre- and postoperative pain scores (visual analog scale [VAS]), ROM, the Constant-Murley13 score, the Simple Shoulder Test (SST),14 and the subjective shoulder value.15 Subjective satisfaction was assessed by asking the patients at follow-up how they felt compared with before surgery and was graded using a 4-point scale: 1, much better; 2, better; 3, the same; and 4, worse. Radiographic evaluation was performed on pre- and postoperative standard anteroposterior, outlet, and axillary views. Radiographs were reviewed to determine the presence of glenohumeral subluxation, periprosthetic lucency, component shift in position, and scapular notching.
STATISTICAL ANALYSIS
Descriptive statistics are reported as mean (range) for continuous measures and number (percentage) for discrete variables. The Wilcoxon signed-rank test was used for preoperative vs postoperative changes. The alpha level for all tests was set at 0.05 for statistical significance.
RESULTS
CLINICAL OUTCOME
At a mean of 22 months (range, 7-38 months) follow-up after revision, active ROM was significantly improved. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021). Active external rotation with the elbow on the side increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°) (P = 0.034), and increased with the arm held at 90° abduction from 13° (range, 0°-20°) to 49° (range, 0°-80°) (P = 0.025). Mean pain scores improved from 4.2 to 13.3 points (P < 0.001). VAS improved significantly from 9 to 1 (P < 0.0001). The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90) (P = 0.006). The final SST was 7 per 12. Subjectively, 4 patients rated their shoulder as much better, 8 as better, and 1 as the same as preoperatively. No intra- or postoperative complications, including infections, were observed. The mean duration of the procedure was 60 minutes (range, 30-75 minutes).
Continue to: RADIOLOGICAL OUTCOME
RADIOLOGICAL OUTCOME
No periprosthetic lucency or shift in component was observed at the last follow-up. There was no scapular notching. No resorption of the tuberosities, and no fractures of the acromion or the scapular spine were observed.
DISCUSSION
In this retrospective study, failure of TSA with a metal-backed glenoid implant was successfully revised to RSA. In 10 patients, the use of a universal platform system allowed an easier conversion without removal of the humeral stem or the glenoid component (Figures 3A-3D). Twelve of the 13 patients were satisfied or very satisfied at the last follow-up. None of the patients were in pain, and the mean Constant score was 63. In all the cases, the glenoid baseplate was not changed. In 3 cases the humeral stem was changed without any fracture of the tuberosities of need for an osteotomy. This greatly simplified the revision procedure, as glenoid revisions can be very challenging. Indeed, it is often difficult to assess precisely preoperatively the remaining glenoid bone stock after removal of the glenoid component and the cement. Many therapeutic options to deal with glenoid loosening have been reported in the literature: glenoid bone reconstruction after glenoid component removal and revision to a hemiarthroplasty (HA),10,16-18 glenoid bone reconstruction after glenoid component removal and revision to a new TSA with a cemented glenoid implant,16,17,19,20 and glenoid reconstruction after glenoid component removal and revision to a RSA.12,21 These authors reported that glenoid reconstruction frequently necessitates an iliac bone graft associated with a special design of the baseplate with a long post fixed into the native glenoid bone. However, sometimes implantation of an uncemented glenoid component can be unstable with a high risk of early mobilization of the implant, and 2 steps may be necessary. Conversion to a HA,10,16-18 or a TSA16,17,19,20 with a new cemented implant have both been associated with poor clinical outcome, with a high rate of recurrent glenoid loosening for the TSAs.
In our retrospective study, we reported no intra- or postoperative complications. Flury and colleagues22 reported a complication rate of 38% in 21 patients after conversion from a TSA to a RSA with a mean follow-up of 46 months. They removed all the components of the prosthesis with a crack or fracture of the humerus and/or the glenoid. Ortmaier and colleagues23 reported a rate of complication of 22.7% during the conversion of TSA to RSA. They did an osteotomy of the humeral diaphysis to extract the stem in 40% of cases and had to remove the glenoid cement in 86% of cases with severe damage of the glenoid bone in 10% of cases. Fewer complications were found in our study, as we did not need any procedure such as humeral osteotomy, cerclage, bone grafting, and/or reconstruction of the glenoid. The short operative time and the absence of extensive soft-tissue dissection, thanks to a standard deltopectoral approach, could explain the absence of infection in our series.
Other authors shared our strategy of a universal convertible system and reported their results in the literature. Castagna and colleagues24 in 2013 reported the clinical and radiological results of conversions of HA or TSA to RSA using a modular, convertible system (SMR Shoulder System, Lima Corporate). In their series, only 8 cases of TSAs were converted to RSA. They preserved, in each case, the humeral stem and the glenoid baseplate. There were no intra- or postoperative complications. The mean VAS score decreased from 8 to 2. Weber-Spickschen and colleague25 reported recently in 2015 the same experience with the same system (SMR Shoulder System). They reviewed 15 conversions of TSAs to RSAs without any removal of the implants at a mean 43-month follow-up. They reported excellent pain relief (VAS decreased from 8 to 1) and improvement in shoulder function with a low rate of complications.
Kany and colleagues26 in 2015 had already reported the advantages of a shoulder platform system for revisions. In their series, the authors included cases of failure of HAs and TSAs with loose cemented glenoids and metal-backed glenoids. The clinical and radiological results were similar, with a final Constant score of 60 (range, 42-85) and a similar rate of humeral stems which had to be changed (24%). These stems were replaced either because they were too proud or because there was not enough space to add an onlay polyethylene socket.
Continue to: Despite the encouraging results...
Despite the encouraging results reported in this study, there are some limitations. Firstly, no control group was used. Attempting to address this issue, we compared our results with the literature. Secondly, the number of patients in our study was small. Finally, the follow-up duration (mean 22 months) did not provide long-term outcomes.
CONCLUSION
This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function. A platform system on both the humeral and the glenoid side reduces the operative time of the conversion with a low risk of complications.
References
1. Brenner BC, Ferlic DC, Clayton ML, Dennis DA. Survivorship of unconstrained total shoulder arthroplasty. J Bone Joint Surg Am. 1989;71(9):1289-1296.
2. Budge MD, Nolan EM, Heisey MH, Baker K, Wiater JM. Results of total shoulder arthroplasty with a monoblock porous tantalum glenoid component: a prospective minimum 2-year follow-up study. J Shoulder Elbow Surg. 2013;22(4):535-541. doi:10.1016/j.jse.2012.06.001.
3. Chin PY, Sperling JW, Cofield RH, Schleck C. Complications of total shoulder arthroplasty: are they fewer or different? J Shoulder Elbow Surg. 2006;15(1):19-22. doi:10.1016/j.jse.2005.05.005.
4. Torchia ME, Cofield RH, Settergren CR. Total shoulder arthroplasty with the Neer prosthesis: long-term results. J Shoulder Elbow Surg. 1997;6(6):495-505.
5. Wirth MA, Rockwood CA Jr. Complications of total shoulder-replacement surgery. J Bone Joint Surg Am. 1996;78(4):603-616.
6. Gohlke F, Rolf O. Revision of failed fracture hemiarthroplasties to reverse total shoulder prosthesis through the transhumeral approach: method incorporating a pectoralis-major-pedicled bone window. Oper Orthop Traumatol. 2007;19(2):185-208. doi:10.1007/s00064-007-1202-x.
7. Goldberg SH, Cohen MS, Young M, Bradnock B. Thermal tissue damage caused by ultrasonic cement removal from the humerus. J Bone Joint Surg Am. 2005;87(3):583-591. doi:10.2106/JBJS.D.01966.
8. Sperling JW, Cofield RH. Humeral windows in revision shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(3):258-263. doi:10.1016/j.jse.2004.09.004.
9. Chacon A, Virani N, Shannon R, Levy JC, Pupello D, Frankle M. Revision arthroplasty with use of a reverse shoulder prosthesis-allograft composite. J Bone Joint Surg Am. 2009;91(1):119-127. doi:10.2106/JBJS.H.00094.
10. Iannotti JP, Frangiamore SJ. Fate of large structural allograft for treatment of severe uncontained glenoid bone deficiency. J Shoulder Elbow Surg. 2012;21(6):765-771. doi:10.1016/j.jse.2011.08.069.
11. Kelly JD 2nd, Zhao JX, Hobgood ER, Norris TR. Clinical results of revision shoulder arthroplasty using the reverse prosthesis. J Shoulder Elbow Surg. 2012;21(11):1516-1525. doi:10.1016/j.jse.2011.11.021.
12. Melis B, Bonnevialle N, Neyton L, et al. Glenoid loosening and failure in anatomical total shoulder arthroplasty: is revision with a reverse shoulder arthroplasty a reliable option? J Shoulder Elbow Surg. 2012;21(3):342-349. doi:10.1016/j.jse.2011.05.021.
13. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;(214):160-164.
14. Matsen FA 3rd, Ziegler DW, DeBartolo SE. Patient self-assessment of health status and function in glenohumeral degenerative joint disease. J Shoulder Elbow Surg. 1995;4(5):345-351.
15. Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007;16(6):717-721. doi:10.1016/j.jse.2007.02.123.
16. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224. doi:10.1067/mse.2001.113961.
17. Cofield RH, Edgerton BC. Total shoulder arthroplasty: complications and revision surgery. Instr Course Lect. 1990;39:449-462.
18. Neyton L, Walch G, Nove-Josserand L, Edwards TB. Glenoid corticocancellous bone grafting after glenoid component removal in the treatment of glenoid loosening. J Shoulder Elbow Surg. 2006;15(2):173-179. doi:10.1016/j.jse.2005.07.010.
19. Bonnevialle N, Melis B, Neyton L, et al. Aseptic glenoid loosening or failure in total shoulder arthroplasty: revision with glenoid reimplantation. J Shoulder Elbow Surg. 2013;22(6):745-751. doi:10.1016/j.jse.2012.08.009.
20. Rodosky MW, Bigliani LU. Indications for glenoid resurfacing in shoulder arthroplasty. J Shoulder Elbow Surg. 1996;5(3):231-248.
21. Bateman E, Donald SM. Reconstruction of massive uncontained glenoid defects using a combined autograft-allograft construct with reverse shoulder arthroplasty: preliminary results. J Shoulder Elbow Surg. 2012;21(7):925-934. doi:10.1016/j.jse.2011.07.009.
22. Flury MP, Frey P, Goldhahn J, Schwyzer HK, Simmen BR. Reverse shoulder arthroplasty as a salvage procedure for failed conventional shoulder replacement due to cuff failure--midterm results. Int Orthop. 2011;35(1):53-60. doi:10.1007/s00264-010-0990-z.
23. Ortmaier R, Resch H, Hitzl W, et al. Reverse shoulder arthroplasty combined with latissimus dorsi transfer using the bone-chip technique. Int Orthop. 2013;38(3):1-7. doi:10.1007/s00264-013-2139-3.
24. Castagna A, Delcogliano M, de Caro F, et al. Conversion of shoulder arthroplasty to reverse implants: clinical and radiological results using a modular system. Int Orthop. 2013;37(7):1297-1305. doi:10.1007/s00264-013-1907-4.
25. Weber-Spickschen TS, Alfke D, Agneskirchner JD. The use of a modular system to convert an anatomical total shoulder arthroplasty to a reverse shoulder arthroplasty: Clinical and radiological results. Bone Joint J. 2015;97-B(12):1662-1667. doi:10.1302/0301-620X.97B12.35176.
26. Kany J, Amouyel T, Flamand O, Katz D, Valenti P. A convertible shoulder system: is it useful in total shoulder arthroplasty revisions? Int Orthop. 2015;39(2):299-304. doi:10.1007/s00264-014-2563-z.
References
1. Brenner BC, Ferlic DC, Clayton ML, Dennis DA. Survivorship of unconstrained total shoulder arthroplasty. J Bone Joint Surg Am. 1989;71(9):1289-1296.
2. Budge MD, Nolan EM, Heisey MH, Baker K, Wiater JM. Results of total shoulder arthroplasty with a monoblock porous tantalum glenoid component: a prospective minimum 2-year follow-up study. J Shoulder Elbow Surg. 2013;22(4):535-541. doi:10.1016/j.jse.2012.06.001.
3. Chin PY, Sperling JW, Cofield RH, Schleck C. Complications of total shoulder arthroplasty: are they fewer or different? J Shoulder Elbow Surg. 2006;15(1):19-22. doi:10.1016/j.jse.2005.05.005.
4. Torchia ME, Cofield RH, Settergren CR. Total shoulder arthroplasty with the Neer prosthesis: long-term results. J Shoulder Elbow Surg. 1997;6(6):495-505.
5. Wirth MA, Rockwood CA Jr. Complications of total shoulder-replacement surgery. J Bone Joint Surg Am. 1996;78(4):603-616.
6. Gohlke F, Rolf O. Revision of failed fracture hemiarthroplasties to reverse total shoulder prosthesis through the transhumeral approach: method incorporating a pectoralis-major-pedicled bone window. Oper Orthop Traumatol. 2007;19(2):185-208. doi:10.1007/s00064-007-1202-x.
7. Goldberg SH, Cohen MS, Young M, Bradnock B. Thermal tissue damage caused by ultrasonic cement removal from the humerus. J Bone Joint Surg Am. 2005;87(3):583-591. doi:10.2106/JBJS.D.01966.
8. Sperling JW, Cofield RH. Humeral windows in revision shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(3):258-263. doi:10.1016/j.jse.2004.09.004.
9. Chacon A, Virani N, Shannon R, Levy JC, Pupello D, Frankle M. Revision arthroplasty with use of a reverse shoulder prosthesis-allograft composite. J Bone Joint Surg Am. 2009;91(1):119-127. doi:10.2106/JBJS.H.00094.
10. Iannotti JP, Frangiamore SJ. Fate of large structural allograft for treatment of severe uncontained glenoid bone deficiency. J Shoulder Elbow Surg. 2012;21(6):765-771. doi:10.1016/j.jse.2011.08.069.
11. Kelly JD 2nd, Zhao JX, Hobgood ER, Norris TR. Clinical results of revision shoulder arthroplasty using the reverse prosthesis. J Shoulder Elbow Surg. 2012;21(11):1516-1525. doi:10.1016/j.jse.2011.11.021.
12. Melis B, Bonnevialle N, Neyton L, et al. Glenoid loosening and failure in anatomical total shoulder arthroplasty: is revision with a reverse shoulder arthroplasty a reliable option? J Shoulder Elbow Surg. 2012;21(3):342-349. doi:10.1016/j.jse.2011.05.021.
13. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;(214):160-164.
14. Matsen FA 3rd, Ziegler DW, DeBartolo SE. Patient self-assessment of health status and function in glenohumeral degenerative joint disease. J Shoulder Elbow Surg. 1995;4(5):345-351.
15. Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007;16(6):717-721. doi:10.1016/j.jse.2007.02.123.
16. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224. doi:10.1067/mse.2001.113961.
17. Cofield RH, Edgerton BC. Total shoulder arthroplasty: complications and revision surgery. Instr Course Lect. 1990;39:449-462.
18. Neyton L, Walch G, Nove-Josserand L, Edwards TB. Glenoid corticocancellous bone grafting after glenoid component removal in the treatment of glenoid loosening. J Shoulder Elbow Surg. 2006;15(2):173-179. doi:10.1016/j.jse.2005.07.010.
19. Bonnevialle N, Melis B, Neyton L, et al. Aseptic glenoid loosening or failure in total shoulder arthroplasty: revision with glenoid reimplantation. J Shoulder Elbow Surg. 2013;22(6):745-751. doi:10.1016/j.jse.2012.08.009.
20. Rodosky MW, Bigliani LU. Indications for glenoid resurfacing in shoulder arthroplasty. J Shoulder Elbow Surg. 1996;5(3):231-248.
21. Bateman E, Donald SM. Reconstruction of massive uncontained glenoid defects using a combined autograft-allograft construct with reverse shoulder arthroplasty: preliminary results. J Shoulder Elbow Surg. 2012;21(7):925-934. doi:10.1016/j.jse.2011.07.009.
22. Flury MP, Frey P, Goldhahn J, Schwyzer HK, Simmen BR. Reverse shoulder arthroplasty as a salvage procedure for failed conventional shoulder replacement due to cuff failure--midterm results. Int Orthop. 2011;35(1):53-60. doi:10.1007/s00264-010-0990-z.
23. Ortmaier R, Resch H, Hitzl W, et al. Reverse shoulder arthroplasty combined with latissimus dorsi transfer using the bone-chip technique. Int Orthop. 2013;38(3):1-7. doi:10.1007/s00264-013-2139-3.
24. Castagna A, Delcogliano M, de Caro F, et al. Conversion of shoulder arthroplasty to reverse implants: clinical and radiological results using a modular system. Int Orthop. 2013;37(7):1297-1305. doi:10.1007/s00264-013-1907-4.
25. Weber-Spickschen TS, Alfke D, Agneskirchner JD. The use of a modular system to convert an anatomical total shoulder arthroplasty to a reverse shoulder arthroplasty: Clinical and radiological results. Bone Joint J. 2015;97-B(12):1662-1667. doi:10.1302/0301-620X.97B12.35176.
26. Kany J, Amouyel T, Flamand O, Katz D, Valenti P. A convertible shoulder system: is it useful in total shoulder arthroplasty revisions? Int Orthop. 2015;39(2):299-304. doi:10.1007/s00264-014-2563-z.
Proper reconstruction of proximal humeral anatomy is of primary importance to maximize patient outcomes after total shoulder arthroplasty. This article describes a new arthroplasty technique, where a fixed multiplanar bone resection is made and a novel implant, which is designed to precisely match the bone resection, is inserted.
Continue to: The success of total shoulder arthroplasty...
The success of total shoulder arthroplasty (TSA) is largely dependent on how accurate the proximal humeral anatomy is reconstructed and the glenohumeral relationships are restored.1-4 Numerous studies have demonstrated a relationship of worse clinical outcomes and implant failure with nonanatomic implant placement.5-8 The majority of arthroplasty systems rely on surgeon-dependent decision-making to determine the location of the border of the articular surface and, ultimately, the amount and location of bone to be resected. Even in experienced hands, the ability to reproducibly restore the joint line is inconsistent.3
In contrast, the majority of total knee arthroplasty (TKA) systems have been designed with instrumentation that guides the surgeon precisely regarding where and how much femoral bone must be resected, and the corresponding implant is designed with the same thickness to preserve the location of the joint line. Cutting block instrumentation rather than freehand cuts enables reproducibility of TKA while being performed for an estimated 700,000 times annually in the US.9
To achieve similar high levels of reproducibility in shoulder arthroplasty, a new technique was developed based on the principle of providing instrumentation to assist the surgeon in accurately restoring the proximal humeral joint line. This technical article describes the technique of using a multiplanar instrumented cutting system and matching implants to perform TSA. The technique shown was previously studied and was found to allow surgeons to recreate the original anatomy of the humerus with very high precision.10
The humeral prosthesis described in this article has an articular surface that is slightly elliptical to more closely match the actual shape of the humerus bone.11 Biomechanical studies have demonstrated that implants designed with a nonspherical shape have more similar motion and kinematics to those of the native humeral head.12 The undersurface of the implant has a concave four-plane geometry that matches with the bone cuts created by the cutting guides (Figures 1, 2).
This provides rotation stability, and the implant rests on the strong subchondral bone of the proximal humerus proximal to the anatomic neck rather than relying on metaphyseal bone or canal fixation, as recommended by Aldoiusti.13 It also allows optimal implant placement with complete freedom with respect to inclination, version, and medial/posterior offset from the humeral canal.
Continue to: The implant respects the relationship...
The implant respects the relationship of the rotator cuff insertion and has a recessed superior margin to keep both the implant and the saw blade 3 mm to 5 mm away from the supraspinatus fibers to protect the rotator cuff from iatrogenic injury.
TECHNIQUE
The technique described in this article uses the Catalyst CSR Total Shoulder System (Catalyst OrthoScience), which was cleared to treat arthritis of the shoulder by the US Food and Drug Administration in May 2016.
A standard deltopectoral incision is made, and the surgeon dissects the interval between the pectoralis major medially and the deltoid laterally. The subscapularis can be incised by tenotomy; alternatively, the surgeon can perform a subscapularis peel or a lesser tuberosity osteotomy using this technique.
Once the glenohumeral joint is exposed, the surgeon delivers the humeral head anteriorly. A preferred method is to place a Darrach retractor between the humeral head and the glenoid, and a cobra or a second Darrach retractor behind the superolateral humeral head superficial to the supraspinatus tendon. By simultaneously pressing on both retractors and externally rotating the patient’s arm, the humeral head is delivered anteriorly. Osteophytes on the anterior and inferior edge of the humeral head are generously removed at this time using a rongeur.
Using a pin guide, the long 3.2-mm guidewire pin is drilled under power into the center of the articular surface. The pin guide is then removed, leaving the pin in the center of the humerus (Figure 3).
Continue to: Next, the surgeon...
Next, the surgeon slides the cannulated reamer over the long guidewire pin and under power removes a small portion of the humeral head subchondral bone until the surgeon feels and observes that the reamer is no longer removing bone (Figure 4). The patent-pending reamer design prevents the surgeon from removing more than a few millimeters of bone, after which point the reamer spins on the surface of the bone without resecting further.
The surgeon is aware that the reamer has achieved its desired depth when it is no longer creating new bone shavings, and the surgeon can hear and feel that the reamer is spinning and no longer cutting. Then the surgeon removes the reamer.
The surgeon places the first humeral cut guide over the long guidewire pin, oriented superiorly-inferiorly and secures the guide using 4 short pins, and the long pin is removed. The surgeon uses an oscillating saw to cut the anterior and posterior plane cuts through the saw captures in the cut guide (Figure 5). The humeral cut guide and short pins are removed (Figure 6).
The surgeon then applies the second humeral cut guide to the proximal humerus and secures it using 2 short pins. The surgeon then uses the 6-mm drill to drill the 4 holes for the pegs of the implant. The top portion of the guide is removed, and the surgeon makes the superior and inferior cuts along the top and bottom surfaces of the guide using an oscillating saw (Figure 7).
The surgeon then uses a rongeur to slightly round the edges of the 4 corners at the periphery of the humerus. The second humeral cut guide and short pins are removed (Figure 8).
Continue to: Next, the surgeon trials...
Next, the surgeon trials humeral implants to determine the correct implant size (Figure 9). Once the proper humeral size is chosen, the trial is removed and the humeral cover is placed over the prepared humeral head. The surgeon then proceeds to glenoid preparation (Figure 10), which is easily accessible and facilitated by angled planar cuts on the humeral head. Glenoid technique will be discussed in a subsequent article.
After glenoid preparation and insertion, the humerus is delivered anteriorly. The proximal humerus is washed and dried, and cement is applied to the peg holes in the humerus bone and the underside of the humeral implant. The implant is then inserted using the humeral impactor to apply pressure and assure that the implant is fully seated. Once the humeral cement is hardened, the glenohumeral joint is irrigated and closure begins. Postoperative radiograph is shown in Figure 11.
DISCUSSION
Numerous authors have demonstrated that accurate implant placement is crucial for restoring normal glenoid kinematics and motion,1-4 while some authors have reported worsening clinical outcomes and higher rates of pain and implant loosening when the implants were not placed anatomically.5-8 This is such an important concept that it essentially was the primary inspiration for creating this TSA system. In addition, the system utilizes a nonspherical, elliptical humeral head that more closely matches the anatomy of the proximal humerus,14,15 and this type of shape has shown improved biomechanics in laboratory testing.12
Good results have been demonstrated in restoring the normal anatomy using stemmed devices on the radiographic analysis of cadavers.16 The creation of stemmed implants with variable inclination and offset has improved computer models17 compared with previous studies,18 with the exception of scenarios with extreme offset.
In theory, resurfacing implants and implants without a canal stem should have a better implant placement than that with stemmed implants; however, the ability to restore the center of rotation was even worse for resurfacing prostheses, with 65% of all implants being measured as outliers postoperatively in one study.19 Most of the resurfacing implants and their instrumentation techniques offer little to help the surgeon control for implant height. The depth of the reaming is variable, not calibrated, and not correlated with the implant size, frequently leading to overstuffing after surgery. Second, the use of spherical prostheses forces the surgeon to choose between matching the superior-inferior humeral size, leading to overhang of the implant, or matching the anteroposterior, leading to frequent undersizing in the coronal plane. The nonspherical, elliptical head shape can potentially simplify implant selection.
In summary, new techniques have been developed in an attempt to achieve increased consistency and precision in TSA. By more accurately reproducing the proximal humeral anatomy, it is proposed that clinical outcomes in terms of the range of motion and patient satisfaction may also be improved through newer techniques. Cadaver studies have validated the anatomic precision of this technique.10 Clinical data comprising of patient-reported outcome measures and radiographic outcome studies are currently underway for this arthroplasty system.
References
1. Williams GR Jr, Wong KL, Pepe MD, et al. The effect of articular malposition after total shoulder arthroplasty on glenohumeral translations, range of motion, and subacromial impingement. J Shoulder Elbow Surg. 2001;10(5):399-409.
2. Nyffeler RW, Sheikh R, Jacob HA, Gerber C. Influence of humeral prosthesis height on biomechanics of glenohumeral abduction. An in vitro study. J Bone Joint Surg Am. 2004;86-A(3):575-580.
3. Iannotti JP, Spencer EE, Winter U, Deffenbaugh D, Williams G. Prosthetic positioning in total shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(1 Supple S):111S-121S.
4. Terrier A, Ramondetti S, Merlini F, Pioletti DD, Farron A. Biomechanical consequences of humeral component malpositioning after anatomical total shoulder arthroplasty. J Shoulder Elbow Surg. 2010;19(8):1184-1190.
5. Denard PJ, Raiss P, Sowa B, Walch G. Mid- to long-term follow-up of total shoulder arthroplasty using a keeled glenoid in young adults with primary glenohumeral arthritis. J Shoulder Elbow Surg. 2013;22(7):894-900.
6. Figgie HE 3rd, Inglis AE, Goldberg VM, Ranawat CS, Figgie MP, Wile JM. An analysis of factors affecting the long-term results of total shoulder arthroplasty in inflammatory arthritis. J Arthroplasty. 1988;3(2):123-130.
7. Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA 3rd. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007;16(5):555-562.
8. Flurin PH, Roche CP, Wright TW, Zuckerman JD. Correlation between clinical outcomes and anatomic reconstruction with anatomic total shoulder arthroplasty. Bull Hosp Jt Dis(2013). 2015;73 Suppl 1:S92-S98.
9. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785.
10. Goldberg SS, Akyuz E, Murthi AM, Blaine T. Accuracy of humeral articular surface restoration in a novel anatomic shoulder arthroplasty technique and design: a cadaveric study. Journal of Shoulder and Elbow Arthroplasty. 2018;2:2471549217750791.
11. Iannotti JP, Gabriel JP, Schneck SL, Evans BG, Misra S. The normal glenohumeral relationships. An anatomical study of one hundred and forty shoulders. J Bone Joint Surg Am. 1992;74(4):491-500.
12. Jun BJ, Lee TQ, McGarry MH, Quigley RJ, Shin SJ, Iannotti JP. The effects of prosthetic humeral head shape on glenohumeral joint kinematics during humeral axial rotation in total shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(7):1084-1093.
13. Alidousti H, Giles JW, Emery RJH, Jeffers J. Spatial mapping of humeral head bone density. J Shoulder Elbow Surg. 2017;26(9):1653-1661.
14. Harrold F, Wigderowitz C. Humeral head arthroplasty and its ability to restore original humeral head geometry. J Shoulder Elbow Surg. 2013;22(1):115-121.
15. Hertel R, Knothe U, Ballmer FT. Geometry of the proximal humerus and implications for prosthetic design. J Shoulder Elbow Surg. 2002;11(4):331-338.
16. Wirth MA, Ondrla J, Southworth C, Kaar K, Anderson BC, Rockwood CA 3rd. Replicating proximal humeral articular geometry with a third-generation implant: a radiographic study in cadaveric shoulders. J Shoulder Elbow Surg. 2007;16(3 Suppl):S111-S116.
17. Pearl ML, Kurutz S, Postacchini R. Geometric variables in anatomic replacement of the proximal humerus: How much prosthetic geometry is necessary? J Shoulder Elbow Surg. 2009;18(3):366-370.
18. Pearl ML, Volk AG. Coronal plane geometry of the proximal humerus relevant to prosthetic arthroplasty. J Shoulder Elbow Surg. 1996;5(4):320-326.
19. Alolabi B, Youderian AR, Napolitano L, et al. Radiographic assessment of prosthetic humeral head size after anatomic shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(11):1740-1746.
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. Goldberg reports that he is a paid consultant and has intellectual property assigned to, and stock and stock options in, Catalyst OrthoScience, the manufacturer of the implant and instruments shown in this article. Dr. Baranek reports no actual or potential conflict of interest in relation to this article.
Dr. Goldberg is Chief of Orthopedic Surgery, Physicians Regional Medical Center, Naples, Florida. Dr. Baranek is a Resident Physician, Department of Orthopedic Surgery, Columbia University-New York Presbyterian Medical Center, New York, New York.
Address correspondence to: Steven S. Goldberg, MD, Physicians Regional Medical Center–Pine Ridge, 6101 Pine Ridge Road, Naples, FL 34119 (tel, 239-348-4253; fax, 239-304-4929; email, Drstevengoldberg@gmail.com).
Steven S. Goldberg MD Eric S. Baranek MD . Total Shoulder Arthroplasty Using a Bone-Sparing, Precision Multiplanar Humeral Prosthesis. Am J Orthop. February 1, 2018
Authors’ Disclosure Statement: Dr. Goldberg reports that he is a paid consultant and has intellectual property assigned to, and stock and stock options in, Catalyst OrthoScience, the manufacturer of the implant and instruments shown in this article. Dr. Baranek reports no actual or potential conflict of interest in relation to this article.
Dr. Goldberg is Chief of Orthopedic Surgery, Physicians Regional Medical Center, Naples, Florida. Dr. Baranek is a Resident Physician, Department of Orthopedic Surgery, Columbia University-New York Presbyterian Medical Center, New York, New York.
Address correspondence to: Steven S. Goldberg, MD, Physicians Regional Medical Center–Pine Ridge, 6101 Pine Ridge Road, Naples, FL 34119 (tel, 239-348-4253; fax, 239-304-4929; email, Drstevengoldberg@gmail.com).
Steven S. Goldberg MD Eric S. Baranek MD . Total Shoulder Arthroplasty Using a Bone-Sparing, Precision Multiplanar Humeral Prosthesis. Am J Orthop. February 1, 2018
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. Goldberg reports that he is a paid consultant and has intellectual property assigned to, and stock and stock options in, Catalyst OrthoScience, the manufacturer of the implant and instruments shown in this article. Dr. Baranek reports no actual or potential conflict of interest in relation to this article.
Dr. Goldberg is Chief of Orthopedic Surgery, Physicians Regional Medical Center, Naples, Florida. Dr. Baranek is a Resident Physician, Department of Orthopedic Surgery, Columbia University-New York Presbyterian Medical Center, New York, New York.
Address correspondence to: Steven S. Goldberg, MD, Physicians Regional Medical Center–Pine Ridge, 6101 Pine Ridge Road, Naples, FL 34119 (tel, 239-348-4253; fax, 239-304-4929; email, Drstevengoldberg@gmail.com).
Steven S. Goldberg MD Eric S. Baranek MD . Total Shoulder Arthroplasty Using a Bone-Sparing, Precision Multiplanar Humeral Prosthesis. Am J Orthop. February 1, 2018
ABSTRACT
Proper reconstruction of proximal humeral anatomy is of primary importance to maximize patient outcomes after total shoulder arthroplasty. This article describes a new arthroplasty technique, where a fixed multiplanar bone resection is made and a novel implant, which is designed to precisely match the bone resection, is inserted.
Continue to: The success of total shoulder arthroplasty...
The success of total shoulder arthroplasty (TSA) is largely dependent on how accurate the proximal humeral anatomy is reconstructed and the glenohumeral relationships are restored.1-4 Numerous studies have demonstrated a relationship of worse clinical outcomes and implant failure with nonanatomic implant placement.5-8 The majority of arthroplasty systems rely on surgeon-dependent decision-making to determine the location of the border of the articular surface and, ultimately, the amount and location of bone to be resected. Even in experienced hands, the ability to reproducibly restore the joint line is inconsistent.3
In contrast, the majority of total knee arthroplasty (TKA) systems have been designed with instrumentation that guides the surgeon precisely regarding where and how much femoral bone must be resected, and the corresponding implant is designed with the same thickness to preserve the location of the joint line. Cutting block instrumentation rather than freehand cuts enables reproducibility of TKA while being performed for an estimated 700,000 times annually in the US.9
To achieve similar high levels of reproducibility in shoulder arthroplasty, a new technique was developed based on the principle of providing instrumentation to assist the surgeon in accurately restoring the proximal humeral joint line. This technical article describes the technique of using a multiplanar instrumented cutting system and matching implants to perform TSA. The technique shown was previously studied and was found to allow surgeons to recreate the original anatomy of the humerus with very high precision.10
The humeral prosthesis described in this article has an articular surface that is slightly elliptical to more closely match the actual shape of the humerus bone.11 Biomechanical studies have demonstrated that implants designed with a nonspherical shape have more similar motion and kinematics to those of the native humeral head.12 The undersurface of the implant has a concave four-plane geometry that matches with the bone cuts created by the cutting guides (Figures 1, 2).
This provides rotation stability, and the implant rests on the strong subchondral bone of the proximal humerus proximal to the anatomic neck rather than relying on metaphyseal bone or canal fixation, as recommended by Aldoiusti.13 It also allows optimal implant placement with complete freedom with respect to inclination, version, and medial/posterior offset from the humeral canal.
Continue to: The implant respects the relationship...
The implant respects the relationship of the rotator cuff insertion and has a recessed superior margin to keep both the implant and the saw blade 3 mm to 5 mm away from the supraspinatus fibers to protect the rotator cuff from iatrogenic injury.
TECHNIQUE
The technique described in this article uses the Catalyst CSR Total Shoulder System (Catalyst OrthoScience), which was cleared to treat arthritis of the shoulder by the US Food and Drug Administration in May 2016.
A standard deltopectoral incision is made, and the surgeon dissects the interval between the pectoralis major medially and the deltoid laterally. The subscapularis can be incised by tenotomy; alternatively, the surgeon can perform a subscapularis peel or a lesser tuberosity osteotomy using this technique.
Once the glenohumeral joint is exposed, the surgeon delivers the humeral head anteriorly. A preferred method is to place a Darrach retractor between the humeral head and the glenoid, and a cobra or a second Darrach retractor behind the superolateral humeral head superficial to the supraspinatus tendon. By simultaneously pressing on both retractors and externally rotating the patient’s arm, the humeral head is delivered anteriorly. Osteophytes on the anterior and inferior edge of the humeral head are generously removed at this time using a rongeur.
Using a pin guide, the long 3.2-mm guidewire pin is drilled under power into the center of the articular surface. The pin guide is then removed, leaving the pin in the center of the humerus (Figure 3).
Continue to: Next, the surgeon...
Next, the surgeon slides the cannulated reamer over the long guidewire pin and under power removes a small portion of the humeral head subchondral bone until the surgeon feels and observes that the reamer is no longer removing bone (Figure 4). The patent-pending reamer design prevents the surgeon from removing more than a few millimeters of bone, after which point the reamer spins on the surface of the bone without resecting further.
The surgeon is aware that the reamer has achieved its desired depth when it is no longer creating new bone shavings, and the surgeon can hear and feel that the reamer is spinning and no longer cutting. Then the surgeon removes the reamer.
The surgeon places the first humeral cut guide over the long guidewire pin, oriented superiorly-inferiorly and secures the guide using 4 short pins, and the long pin is removed. The surgeon uses an oscillating saw to cut the anterior and posterior plane cuts through the saw captures in the cut guide (Figure 5). The humeral cut guide and short pins are removed (Figure 6).
The surgeon then applies the second humeral cut guide to the proximal humerus and secures it using 2 short pins. The surgeon then uses the 6-mm drill to drill the 4 holes for the pegs of the implant. The top portion of the guide is removed, and the surgeon makes the superior and inferior cuts along the top and bottom surfaces of the guide using an oscillating saw (Figure 7).
The surgeon then uses a rongeur to slightly round the edges of the 4 corners at the periphery of the humerus. The second humeral cut guide and short pins are removed (Figure 8).
Continue to: Next, the surgeon trials...
Next, the surgeon trials humeral implants to determine the correct implant size (Figure 9). Once the proper humeral size is chosen, the trial is removed and the humeral cover is placed over the prepared humeral head. The surgeon then proceeds to glenoid preparation (Figure 10), which is easily accessible and facilitated by angled planar cuts on the humeral head. Glenoid technique will be discussed in a subsequent article.
After glenoid preparation and insertion, the humerus is delivered anteriorly. The proximal humerus is washed and dried, and cement is applied to the peg holes in the humerus bone and the underside of the humeral implant. The implant is then inserted using the humeral impactor to apply pressure and assure that the implant is fully seated. Once the humeral cement is hardened, the glenohumeral joint is irrigated and closure begins. Postoperative radiograph is shown in Figure 11.
DISCUSSION
Numerous authors have demonstrated that accurate implant placement is crucial for restoring normal glenoid kinematics and motion,1-4 while some authors have reported worsening clinical outcomes and higher rates of pain and implant loosening when the implants were not placed anatomically.5-8 This is such an important concept that it essentially was the primary inspiration for creating this TSA system. In addition, the system utilizes a nonspherical, elliptical humeral head that more closely matches the anatomy of the proximal humerus,14,15 and this type of shape has shown improved biomechanics in laboratory testing.12
Good results have been demonstrated in restoring the normal anatomy using stemmed devices on the radiographic analysis of cadavers.16 The creation of stemmed implants with variable inclination and offset has improved computer models17 compared with previous studies,18 with the exception of scenarios with extreme offset.
In theory, resurfacing implants and implants without a canal stem should have a better implant placement than that with stemmed implants; however, the ability to restore the center of rotation was even worse for resurfacing prostheses, with 65% of all implants being measured as outliers postoperatively in one study.19 Most of the resurfacing implants and their instrumentation techniques offer little to help the surgeon control for implant height. The depth of the reaming is variable, not calibrated, and not correlated with the implant size, frequently leading to overstuffing after surgery. Second, the use of spherical prostheses forces the surgeon to choose between matching the superior-inferior humeral size, leading to overhang of the implant, or matching the anteroposterior, leading to frequent undersizing in the coronal plane. The nonspherical, elliptical head shape can potentially simplify implant selection.
In summary, new techniques have been developed in an attempt to achieve increased consistency and precision in TSA. By more accurately reproducing the proximal humeral anatomy, it is proposed that clinical outcomes in terms of the range of motion and patient satisfaction may also be improved through newer techniques. Cadaver studies have validated the anatomic precision of this technique.10 Clinical data comprising of patient-reported outcome measures and radiographic outcome studies are currently underway for this arthroplasty system.
ABSTRACT
Proper reconstruction of proximal humeral anatomy is of primary importance to maximize patient outcomes after total shoulder arthroplasty. This article describes a new arthroplasty technique, where a fixed multiplanar bone resection is made and a novel implant, which is designed to precisely match the bone resection, is inserted.
Continue to: The success of total shoulder arthroplasty...
The success of total shoulder arthroplasty (TSA) is largely dependent on how accurate the proximal humeral anatomy is reconstructed and the glenohumeral relationships are restored.1-4 Numerous studies have demonstrated a relationship of worse clinical outcomes and implant failure with nonanatomic implant placement.5-8 The majority of arthroplasty systems rely on surgeon-dependent decision-making to determine the location of the border of the articular surface and, ultimately, the amount and location of bone to be resected. Even in experienced hands, the ability to reproducibly restore the joint line is inconsistent.3
In contrast, the majority of total knee arthroplasty (TKA) systems have been designed with instrumentation that guides the surgeon precisely regarding where and how much femoral bone must be resected, and the corresponding implant is designed with the same thickness to preserve the location of the joint line. Cutting block instrumentation rather than freehand cuts enables reproducibility of TKA while being performed for an estimated 700,000 times annually in the US.9
To achieve similar high levels of reproducibility in shoulder arthroplasty, a new technique was developed based on the principle of providing instrumentation to assist the surgeon in accurately restoring the proximal humeral joint line. This technical article describes the technique of using a multiplanar instrumented cutting system and matching implants to perform TSA. The technique shown was previously studied and was found to allow surgeons to recreate the original anatomy of the humerus with very high precision.10
The humeral prosthesis described in this article has an articular surface that is slightly elliptical to more closely match the actual shape of the humerus bone.11 Biomechanical studies have demonstrated that implants designed with a nonspherical shape have more similar motion and kinematics to those of the native humeral head.12 The undersurface of the implant has a concave four-plane geometry that matches with the bone cuts created by the cutting guides (Figures 1, 2).
This provides rotation stability, and the implant rests on the strong subchondral bone of the proximal humerus proximal to the anatomic neck rather than relying on metaphyseal bone or canal fixation, as recommended by Aldoiusti.13 It also allows optimal implant placement with complete freedom with respect to inclination, version, and medial/posterior offset from the humeral canal.
Continue to: The implant respects the relationship...
The implant respects the relationship of the rotator cuff insertion and has a recessed superior margin to keep both the implant and the saw blade 3 mm to 5 mm away from the supraspinatus fibers to protect the rotator cuff from iatrogenic injury.
TECHNIQUE
The technique described in this article uses the Catalyst CSR Total Shoulder System (Catalyst OrthoScience), which was cleared to treat arthritis of the shoulder by the US Food and Drug Administration in May 2016.
A standard deltopectoral incision is made, and the surgeon dissects the interval between the pectoralis major medially and the deltoid laterally. The subscapularis can be incised by tenotomy; alternatively, the surgeon can perform a subscapularis peel or a lesser tuberosity osteotomy using this technique.
Once the glenohumeral joint is exposed, the surgeon delivers the humeral head anteriorly. A preferred method is to place a Darrach retractor between the humeral head and the glenoid, and a cobra or a second Darrach retractor behind the superolateral humeral head superficial to the supraspinatus tendon. By simultaneously pressing on both retractors and externally rotating the patient’s arm, the humeral head is delivered anteriorly. Osteophytes on the anterior and inferior edge of the humeral head are generously removed at this time using a rongeur.
Using a pin guide, the long 3.2-mm guidewire pin is drilled under power into the center of the articular surface. The pin guide is then removed, leaving the pin in the center of the humerus (Figure 3).
Continue to: Next, the surgeon...
Next, the surgeon slides the cannulated reamer over the long guidewire pin and under power removes a small portion of the humeral head subchondral bone until the surgeon feels and observes that the reamer is no longer removing bone (Figure 4). The patent-pending reamer design prevents the surgeon from removing more than a few millimeters of bone, after which point the reamer spins on the surface of the bone without resecting further.
The surgeon is aware that the reamer has achieved its desired depth when it is no longer creating new bone shavings, and the surgeon can hear and feel that the reamer is spinning and no longer cutting. Then the surgeon removes the reamer.
The surgeon places the first humeral cut guide over the long guidewire pin, oriented superiorly-inferiorly and secures the guide using 4 short pins, and the long pin is removed. The surgeon uses an oscillating saw to cut the anterior and posterior plane cuts through the saw captures in the cut guide (Figure 5). The humeral cut guide and short pins are removed (Figure 6).
The surgeon then applies the second humeral cut guide to the proximal humerus and secures it using 2 short pins. The surgeon then uses the 6-mm drill to drill the 4 holes for the pegs of the implant. The top portion of the guide is removed, and the surgeon makes the superior and inferior cuts along the top and bottom surfaces of the guide using an oscillating saw (Figure 7).
The surgeon then uses a rongeur to slightly round the edges of the 4 corners at the periphery of the humerus. The second humeral cut guide and short pins are removed (Figure 8).
Continue to: Next, the surgeon trials...
Next, the surgeon trials humeral implants to determine the correct implant size (Figure 9). Once the proper humeral size is chosen, the trial is removed and the humeral cover is placed over the prepared humeral head. The surgeon then proceeds to glenoid preparation (Figure 10), which is easily accessible and facilitated by angled planar cuts on the humeral head. Glenoid technique will be discussed in a subsequent article.
After glenoid preparation and insertion, the humerus is delivered anteriorly. The proximal humerus is washed and dried, and cement is applied to the peg holes in the humerus bone and the underside of the humeral implant. The implant is then inserted using the humeral impactor to apply pressure and assure that the implant is fully seated. Once the humeral cement is hardened, the glenohumeral joint is irrigated and closure begins. Postoperative radiograph is shown in Figure 11.
DISCUSSION
Numerous authors have demonstrated that accurate implant placement is crucial for restoring normal glenoid kinematics and motion,1-4 while some authors have reported worsening clinical outcomes and higher rates of pain and implant loosening when the implants were not placed anatomically.5-8 This is such an important concept that it essentially was the primary inspiration for creating this TSA system. In addition, the system utilizes a nonspherical, elliptical humeral head that more closely matches the anatomy of the proximal humerus,14,15 and this type of shape has shown improved biomechanics in laboratory testing.12
Good results have been demonstrated in restoring the normal anatomy using stemmed devices on the radiographic analysis of cadavers.16 The creation of stemmed implants with variable inclination and offset has improved computer models17 compared with previous studies,18 with the exception of scenarios with extreme offset.
In theory, resurfacing implants and implants without a canal stem should have a better implant placement than that with stemmed implants; however, the ability to restore the center of rotation was even worse for resurfacing prostheses, with 65% of all implants being measured as outliers postoperatively in one study.19 Most of the resurfacing implants and their instrumentation techniques offer little to help the surgeon control for implant height. The depth of the reaming is variable, not calibrated, and not correlated with the implant size, frequently leading to overstuffing after surgery. Second, the use of spherical prostheses forces the surgeon to choose between matching the superior-inferior humeral size, leading to overhang of the implant, or matching the anteroposterior, leading to frequent undersizing in the coronal plane. The nonspherical, elliptical head shape can potentially simplify implant selection.
In summary, new techniques have been developed in an attempt to achieve increased consistency and precision in TSA. By more accurately reproducing the proximal humeral anatomy, it is proposed that clinical outcomes in terms of the range of motion and patient satisfaction may also be improved through newer techniques. Cadaver studies have validated the anatomic precision of this technique.10 Clinical data comprising of patient-reported outcome measures and radiographic outcome studies are currently underway for this arthroplasty system.
References
1. Williams GR Jr, Wong KL, Pepe MD, et al. The effect of articular malposition after total shoulder arthroplasty on glenohumeral translations, range of motion, and subacromial impingement. J Shoulder Elbow Surg. 2001;10(5):399-409.
2. Nyffeler RW, Sheikh R, Jacob HA, Gerber C. Influence of humeral prosthesis height on biomechanics of glenohumeral abduction. An in vitro study. J Bone Joint Surg Am. 2004;86-A(3):575-580.
3. Iannotti JP, Spencer EE, Winter U, Deffenbaugh D, Williams G. Prosthetic positioning in total shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(1 Supple S):111S-121S.
4. Terrier A, Ramondetti S, Merlini F, Pioletti DD, Farron A. Biomechanical consequences of humeral component malpositioning after anatomical total shoulder arthroplasty. J Shoulder Elbow Surg. 2010;19(8):1184-1190.
5. Denard PJ, Raiss P, Sowa B, Walch G. Mid- to long-term follow-up of total shoulder arthroplasty using a keeled glenoid in young adults with primary glenohumeral arthritis. J Shoulder Elbow Surg. 2013;22(7):894-900.
6. Figgie HE 3rd, Inglis AE, Goldberg VM, Ranawat CS, Figgie MP, Wile JM. An analysis of factors affecting the long-term results of total shoulder arthroplasty in inflammatory arthritis. J Arthroplasty. 1988;3(2):123-130.
7. Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA 3rd. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007;16(5):555-562.
8. Flurin PH, Roche CP, Wright TW, Zuckerman JD. Correlation between clinical outcomes and anatomic reconstruction with anatomic total shoulder arthroplasty. Bull Hosp Jt Dis(2013). 2015;73 Suppl 1:S92-S98.
9. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785.
10. Goldberg SS, Akyuz E, Murthi AM, Blaine T. Accuracy of humeral articular surface restoration in a novel anatomic shoulder arthroplasty technique and design: a cadaveric study. Journal of Shoulder and Elbow Arthroplasty. 2018;2:2471549217750791.
11. Iannotti JP, Gabriel JP, Schneck SL, Evans BG, Misra S. The normal glenohumeral relationships. An anatomical study of one hundred and forty shoulders. J Bone Joint Surg Am. 1992;74(4):491-500.
12. Jun BJ, Lee TQ, McGarry MH, Quigley RJ, Shin SJ, Iannotti JP. The effects of prosthetic humeral head shape on glenohumeral joint kinematics during humeral axial rotation in total shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(7):1084-1093.
13. Alidousti H, Giles JW, Emery RJH, Jeffers J. Spatial mapping of humeral head bone density. J Shoulder Elbow Surg. 2017;26(9):1653-1661.
14. Harrold F, Wigderowitz C. Humeral head arthroplasty and its ability to restore original humeral head geometry. J Shoulder Elbow Surg. 2013;22(1):115-121.
15. Hertel R, Knothe U, Ballmer FT. Geometry of the proximal humerus and implications for prosthetic design. J Shoulder Elbow Surg. 2002;11(4):331-338.
16. Wirth MA, Ondrla J, Southworth C, Kaar K, Anderson BC, Rockwood CA 3rd. Replicating proximal humeral articular geometry with a third-generation implant: a radiographic study in cadaveric shoulders. J Shoulder Elbow Surg. 2007;16(3 Suppl):S111-S116.
17. Pearl ML, Kurutz S, Postacchini R. Geometric variables in anatomic replacement of the proximal humerus: How much prosthetic geometry is necessary? J Shoulder Elbow Surg. 2009;18(3):366-370.
18. Pearl ML, Volk AG. Coronal plane geometry of the proximal humerus relevant to prosthetic arthroplasty. J Shoulder Elbow Surg. 1996;5(4):320-326.
19. Alolabi B, Youderian AR, Napolitano L, et al. Radiographic assessment of prosthetic humeral head size after anatomic shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(11):1740-1746.
References
1. Williams GR Jr, Wong KL, Pepe MD, et al. The effect of articular malposition after total shoulder arthroplasty on glenohumeral translations, range of motion, and subacromial impingement. J Shoulder Elbow Surg. 2001;10(5):399-409.
2. Nyffeler RW, Sheikh R, Jacob HA, Gerber C. Influence of humeral prosthesis height on biomechanics of glenohumeral abduction. An in vitro study. J Bone Joint Surg Am. 2004;86-A(3):575-580.
3. Iannotti JP, Spencer EE, Winter U, Deffenbaugh D, Williams G. Prosthetic positioning in total shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(1 Supple S):111S-121S.
4. Terrier A, Ramondetti S, Merlini F, Pioletti DD, Farron A. Biomechanical consequences of humeral component malpositioning after anatomical total shoulder arthroplasty. J Shoulder Elbow Surg. 2010;19(8):1184-1190.
5. Denard PJ, Raiss P, Sowa B, Walch G. Mid- to long-term follow-up of total shoulder arthroplasty using a keeled glenoid in young adults with primary glenohumeral arthritis. J Shoulder Elbow Surg. 2013;22(7):894-900.
6. Figgie HE 3rd, Inglis AE, Goldberg VM, Ranawat CS, Figgie MP, Wile JM. An analysis of factors affecting the long-term results of total shoulder arthroplasty in inflammatory arthritis. J Arthroplasty. 1988;3(2):123-130.
7. Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA 3rd. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007;16(5):555-562.
8. Flurin PH, Roche CP, Wright TW, Zuckerman JD. Correlation between clinical outcomes and anatomic reconstruction with anatomic total shoulder arthroplasty. Bull Hosp Jt Dis(2013). 2015;73 Suppl 1:S92-S98.
9. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785.
10. Goldberg SS, Akyuz E, Murthi AM, Blaine T. Accuracy of humeral articular surface restoration in a novel anatomic shoulder arthroplasty technique and design: a cadaveric study. Journal of Shoulder and Elbow Arthroplasty. 2018;2:2471549217750791.
11. Iannotti JP, Gabriel JP, Schneck SL, Evans BG, Misra S. The normal glenohumeral relationships. An anatomical study of one hundred and forty shoulders. J Bone Joint Surg Am. 1992;74(4):491-500.
12. Jun BJ, Lee TQ, McGarry MH, Quigley RJ, Shin SJ, Iannotti JP. The effects of prosthetic humeral head shape on glenohumeral joint kinematics during humeral axial rotation in total shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(7):1084-1093.
13. Alidousti H, Giles JW, Emery RJH, Jeffers J. Spatial mapping of humeral head bone density. J Shoulder Elbow Surg. 2017;26(9):1653-1661.
14. Harrold F, Wigderowitz C. Humeral head arthroplasty and its ability to restore original humeral head geometry. J Shoulder Elbow Surg. 2013;22(1):115-121.
15. Hertel R, Knothe U, Ballmer FT. Geometry of the proximal humerus and implications for prosthetic design. J Shoulder Elbow Surg. 2002;11(4):331-338.
16. Wirth MA, Ondrla J, Southworth C, Kaar K, Anderson BC, Rockwood CA 3rd. Replicating proximal humeral articular geometry with a third-generation implant: a radiographic study in cadaveric shoulders. J Shoulder Elbow Surg. 2007;16(3 Suppl):S111-S116.
17. Pearl ML, Kurutz S, Postacchini R. Geometric variables in anatomic replacement of the proximal humerus: How much prosthetic geometry is necessary? J Shoulder Elbow Surg. 2009;18(3):366-370.
18. Pearl ML, Volk AG. Coronal plane geometry of the proximal humerus relevant to prosthetic arthroplasty. J Shoulder Elbow Surg. 1996;5(4):320-326.
19. Alolabi B, Youderian AR, Napolitano L, et al. Radiographic assessment of prosthetic humeral head size after anatomic shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(11):1740-1746.
Over the past few decades, there has been a dramatic increase in the number of shoulder arthroplasties performed around the world. This increase is the result of an aging and increasingly more active population, better implant technology, and the advent of reverse shoulder arthroplasty (RSA) for rotator cuff arthropathy. Additionally, as the indications for RSA have expanded to include pathologies such as rotator cuff insufficiency, chronic instabilities, trauma, and tumors, the number of arthroplasties will continue to increase. Although the results of most arthroplasties are good and predictable, any glenoid and/or humeral bone deficiencies can have detrimental effects on the clinical outcomes of these procedures. Bone loss becomes more of a problem in revision cases, and, as the number of primary arthroplasties increases, it follows that the number of revision procedures will also increase.
Many of the disease- or procedure-specific processes indicated for shoulder arthroplasty have predictable patterns of bone loss, especially on the glenoid side. Walch and colleagues1 and Bercik and colleagues2 made us aware that many patients with primary osteoarthritis have significant glenoid bone deformity. Similarly, there have been a number of first- and second-generation classification systems for delineating glenoid deformity in rotator cuff tear arthropathy and in revision settings. In revision settings, both glenoid and humeral bone deficiencies can occur as a result of implant removal, iatrogenic fracture, and even infection. Each of these bone loss patterns must be recognized and treated appropriately for the best surgical outcome.
The articles in this month of The American Journal of Orthopedics address the most up-to-date concepts and solutions regarding both humeral and glenoid bone loss in shoulder arthroplasty of all types.
HUMERAL BONE LOSS
Humeral bone loss is typically encountered in proximal humerus fractures, in revision surgery necessitating humeral component removal, and, less commonly, in tumors and infection.
In many displaced proximal humeral fractures indicated for shoulder arthroplasty, the bone is comminuted with displacement of the lesser and greater tuberosities. In these situations, failure of tuberosity healing may result in loss of rotator cuff function with loss of elevation, rotation, and even instability. Humeral shortening can also occur as a result of bone loss and can compromise deltoid function by loss of proper muscle tension, leading to instability, dysfunction, or both. In addition to possible instability, humeral shortening with metaphyseal bone loss can adversely affect long-term fixation of the humeral component, leading to stem loosening or failure. Cuff and colleagues3 showed significantly more rotational micromotion in cases lacking metaphyseal support, leading to aseptic loosening of the humeral stem.
Humeral bone loss can also result from humeral stem component removal in revision shoulder arthroplasty for infection, component failure or loosening, and even periprosthetic fracture resulting from surgery or trauma.
For the surgeon, humeral bone loss can create a complex set of circumstances related to rotator cuff attachment failure, soft-tissue balancing effects, and component fixation issues. Any such issue must be recognized and addressed for best outcomes. Best results can be obtained with preoperative imaging, planning, use of bone graft techniques, proximal humeral allografts, and, more recently, modular and patient-specific implants. All of these issues are discussed comprehensively in the articles this month.
Continue to: GLENOID BONE LOSS
GLENOID BONE LOSS
Proper glenoid component placement with durable fixation is crucial for success in anatomical total shoulder arthroplasty and RSA. Glenoid bone deformity and loss can result from intrinsic deformity characteristics seen in primary osteoarthritis, cuff tear arthropathy, or glenoid component removal in revision situations and infection. These bone deformity complications can be extremely difficult to treat and in some cases lead to catastrophic failure of the index arthroplasty.
We are now aware that one key to success in the face of moderate to severe deformity is proper recognition. Newer imaging techniques, including 2-dimensional (2-D) computed tomography (CT) and 3-dimensional (3-D) modeling and surgical planning software tools, which are outlined in an upcoming article, have given surgeons important new instruments that can help in treating these difficult cases.
Glenoid bone deformity in primary osteoarthritis was well delineated in the 1999 seminal study of CT changes by Walch and colleagues.1 The Walch classification system, which characterized glenoid morphology based on 2-D CT findings, was recently upgraded, based on 3-D imaging technology, to include Walch B3 and D patterns (Figure 1).2 Recognition of certain primary deformities in osteoarthritis has led to increased use of RSA in some cases of Walch B2, B3, and C deformities with substantial glenoid retroversion and/or humeral head subluxation.4
In cases of rotator cuff tear arthropathy, glenoid bone deformities are well described with several classification systems based on degree and dimension of bone insufficiency. The Hamada classification system defines the degree of medial glenoid erosion and superior bone loss, as well as acetabularization of the acromion in 5 grades; 5 Rispoli and colleagues6 defined and graded the degree of medicalization of the glenohumeral joint based on degree of subchondral plate erosion; and Visotsky and colleagues7 based their classification system on wear patterns of bone loss, alignment, and concomitant soft-tissue insufficiencies leading to instability and rotation loss.
In severe glenoid bone deficiency after glenoid component removal, Antuna and colleagues8 described the classic findings related to medial bone loss, anterior and posterior wall failure, and combinations thereof.
Continue to: All these classification systems...
All these classification systems are based on the 2-D appearance of the glenoid and should be considered cautiously. The glenoid is a complex 3-D structure that can be affected by any number of disease processes, trauma, and surgical intervention. Using more modern CT techniques and 3-D imaging, we now know that many deformities previously classified as unidirectional are, instead, complex and multidirectional.
Frankle and colleagues9 developed a classification based more 3-D CT models which has further classified severe glenoid vault deformities in relation to direction and degree of bone loss (Figures 2A-2E). Using this system, they were better able to determine degree and direction of deformity than in previous 2-D evaluations, and they were able to determine the amount of glenoid vault bone available for baseplate fixation. Scalise and colleagues10 further defined the influence of such 3-D planning in total shoulder arthroplasty.
With knowledge of these classification systems and use of contemporary imaging systems, shoulder arthroplasty in cases of severe glenoid deficiency can be more successful. Potentially, we can improve outcomes even more in the more severe cases of bone loss with use of patient-specific planning tools, including the guides and patient-specific implants that are now readily available with many implant systems.11
Preoperative planning tools, bone-grafting techniques, augmented and specialized glenoid and humeral implants, and patient-specific implants are discussed this month to give our readers a comprehensive review of the latest concepts in shoulder arthroplasty in cases of significant bone loss or deformity.
This month of The American Journal of Orthopedics presents the most current and cutting-edge solutions for humeral and glenoid bone deformities and deficiencies in contemporary shoulder arthroplasties.
References
1. Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999;14(6):756-760.
2. Bercik MJ, Kruse K 2nd, Yalizis M, Gauci MO, Chaoui J, Walch G. A modification to the Walch classification of the glenoid in primary glenohumeral osteoarthritis using three-dimensional imaging. J Shoulder Elbow Surg. 2016;25(10):1601-1606.
3. Cuff D, Levy JC, Gutiérrez S, Frankle M. Torsional stability of modular and non-modular reverse shoulder humeral components in a proximal humeral bone loss model. J Shoulder Elbow Surg. 2011;20(4):646-651.
4. Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013;22(11):1589-1598.
5. Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990;(254):92-96.
6. Rispoli D, Sperling JW, Athwal GS, Schleck CD, Cofield RH. Humeral head replacement for the treatment of osteoarthritis. J Bone Joint Surg Am. 2006;88(12):2637-2644.
7. Visotsky JL, Basamania C, Seebauer L, Rockwood CA, Jensen KL. Cuff tear arthropathy: pathogenesis, classification, and algorithm for treatment. J Bone Joint Surg Am. 2004;86(suppl 2):35-40.
8. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224.
9. Frankle MA, Teramoto A, Luo ZP, Levy JC, Pupello D. Glenoid morphology in reverse shoulder arthroplasty: classification and surgical implications. J Shoulder Elbow Surg. 2009;18(6):874-885.
10. Scalise JJ, Codsi MJ, Bryan J, Brems JJ, Iannotti JP. The influence of three-dimensional computed tomography images of the shoulder in preoperative planning for total shoulder arthroplasty. J Bone Joint Surg Am. 2008;90(11):2438-2445.
11. Dines DM, Gulotta L, Craig EV, Dines JS. Novel solution for massive glenoid defects in shoulder arthroplasty: a patient-specific glenoid vault reconstruction system. Am J Orthop. 2017;46(2):104-108.
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. David M. Dines reports that he has a financial relationship involving royalties with Zimmer Biomet and Thieme Inc. Dr. Joshua S. Dines reports that he has a financial relationship with Arthrex, and receives royalties from Thieme Inc.
Dr. D.M. Dines is Co-Director, Shoulder Fellowship, and an Attending, Sports and Shoulder Fellowship, Hospital for Special Surgery, New York, New York, and Professor of Orthopedic Surgery, Weill Cornell Medical College, New York, New York. Dr. J.S. Dines is an Attending Orthopedic Surgeon, Shoulder Fellowship and Sports and Shoulder Fellowship, Hospital for Special Surgery, New York, New York, and Assistant Professor, Weill Cornell Medical College, New York, New York.
Address correspondence to: David M. Dines, MD, Hospital for Special Surgery, 535 E 70th Street, New York, NY 10021 (tel, 516-482-1037; email, dinesd@hss.edu).
David M. Dines, MD Joshua S. Dines, MD . Shoulder Arthroplasty in Cases of Significant Bone Loss: An Overview. Am J Orthop. January 29, 2018
Authors’ Disclosure Statement: Dr. David M. Dines reports that he has a financial relationship involving royalties with Zimmer Biomet and Thieme Inc. Dr. Joshua S. Dines reports that he has a financial relationship with Arthrex, and receives royalties from Thieme Inc.
Dr. D.M. Dines is Co-Director, Shoulder Fellowship, and an Attending, Sports and Shoulder Fellowship, Hospital for Special Surgery, New York, New York, and Professor of Orthopedic Surgery, Weill Cornell Medical College, New York, New York. Dr. J.S. Dines is an Attending Orthopedic Surgeon, Shoulder Fellowship and Sports and Shoulder Fellowship, Hospital for Special Surgery, New York, New York, and Assistant Professor, Weill Cornell Medical College, New York, New York.
Address correspondence to: David M. Dines, MD, Hospital for Special Surgery, 535 E 70th Street, New York, NY 10021 (tel, 516-482-1037; email, dinesd@hss.edu).
David M. Dines, MD Joshua S. Dines, MD . Shoulder Arthroplasty in Cases of Significant Bone Loss: An Overview. Am J Orthop. January 29, 2018
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. David M. Dines reports that he has a financial relationship involving royalties with Zimmer Biomet and Thieme Inc. Dr. Joshua S. Dines reports that he has a financial relationship with Arthrex, and receives royalties from Thieme Inc.
Dr. D.M. Dines is Co-Director, Shoulder Fellowship, and an Attending, Sports and Shoulder Fellowship, Hospital for Special Surgery, New York, New York, and Professor of Orthopedic Surgery, Weill Cornell Medical College, New York, New York. Dr. J.S. Dines is an Attending Orthopedic Surgeon, Shoulder Fellowship and Sports and Shoulder Fellowship, Hospital for Special Surgery, New York, New York, and Assistant Professor, Weill Cornell Medical College, New York, New York.
Address correspondence to: David M. Dines, MD, Hospital for Special Surgery, 535 E 70th Street, New York, NY 10021 (tel, 516-482-1037; email, dinesd@hss.edu).
David M. Dines, MD Joshua S. Dines, MD . Shoulder Arthroplasty in Cases of Significant Bone Loss: An Overview. Am J Orthop. January 29, 2018
Over the past few decades, there has been a dramatic increase in the number of shoulder arthroplasties performed around the world. This increase is the result of an aging and increasingly more active population, better implant technology, and the advent of reverse shoulder arthroplasty (RSA) for rotator cuff arthropathy. Additionally, as the indications for RSA have expanded to include pathologies such as rotator cuff insufficiency, chronic instabilities, trauma, and tumors, the number of arthroplasties will continue to increase. Although the results of most arthroplasties are good and predictable, any glenoid and/or humeral bone deficiencies can have detrimental effects on the clinical outcomes of these procedures. Bone loss becomes more of a problem in revision cases, and, as the number of primary arthroplasties increases, it follows that the number of revision procedures will also increase.
Many of the disease- or procedure-specific processes indicated for shoulder arthroplasty have predictable patterns of bone loss, especially on the glenoid side. Walch and colleagues1 and Bercik and colleagues2 made us aware that many patients with primary osteoarthritis have significant glenoid bone deformity. Similarly, there have been a number of first- and second-generation classification systems for delineating glenoid deformity in rotator cuff tear arthropathy and in revision settings. In revision settings, both glenoid and humeral bone deficiencies can occur as a result of implant removal, iatrogenic fracture, and even infection. Each of these bone loss patterns must be recognized and treated appropriately for the best surgical outcome.
The articles in this month of The American Journal of Orthopedics address the most up-to-date concepts and solutions regarding both humeral and glenoid bone loss in shoulder arthroplasty of all types.
HUMERAL BONE LOSS
Humeral bone loss is typically encountered in proximal humerus fractures, in revision surgery necessitating humeral component removal, and, less commonly, in tumors and infection.
In many displaced proximal humeral fractures indicated for shoulder arthroplasty, the bone is comminuted with displacement of the lesser and greater tuberosities. In these situations, failure of tuberosity healing may result in loss of rotator cuff function with loss of elevation, rotation, and even instability. Humeral shortening can also occur as a result of bone loss and can compromise deltoid function by loss of proper muscle tension, leading to instability, dysfunction, or both. In addition to possible instability, humeral shortening with metaphyseal bone loss can adversely affect long-term fixation of the humeral component, leading to stem loosening or failure. Cuff and colleagues3 showed significantly more rotational micromotion in cases lacking metaphyseal support, leading to aseptic loosening of the humeral stem.
Humeral bone loss can also result from humeral stem component removal in revision shoulder arthroplasty for infection, component failure or loosening, and even periprosthetic fracture resulting from surgery or trauma.
For the surgeon, humeral bone loss can create a complex set of circumstances related to rotator cuff attachment failure, soft-tissue balancing effects, and component fixation issues. Any such issue must be recognized and addressed for best outcomes. Best results can be obtained with preoperative imaging, planning, use of bone graft techniques, proximal humeral allografts, and, more recently, modular and patient-specific implants. All of these issues are discussed comprehensively in the articles this month.
Continue to: GLENOID BONE LOSS
GLENOID BONE LOSS
Proper glenoid component placement with durable fixation is crucial for success in anatomical total shoulder arthroplasty and RSA. Glenoid bone deformity and loss can result from intrinsic deformity characteristics seen in primary osteoarthritis, cuff tear arthropathy, or glenoid component removal in revision situations and infection. These bone deformity complications can be extremely difficult to treat and in some cases lead to catastrophic failure of the index arthroplasty.
We are now aware that one key to success in the face of moderate to severe deformity is proper recognition. Newer imaging techniques, including 2-dimensional (2-D) computed tomography (CT) and 3-dimensional (3-D) modeling and surgical planning software tools, which are outlined in an upcoming article, have given surgeons important new instruments that can help in treating these difficult cases.
Glenoid bone deformity in primary osteoarthritis was well delineated in the 1999 seminal study of CT changes by Walch and colleagues.1 The Walch classification system, which characterized glenoid morphology based on 2-D CT findings, was recently upgraded, based on 3-D imaging technology, to include Walch B3 and D patterns (Figure 1).2 Recognition of certain primary deformities in osteoarthritis has led to increased use of RSA in some cases of Walch B2, B3, and C deformities with substantial glenoid retroversion and/or humeral head subluxation.4
In cases of rotator cuff tear arthropathy, glenoid bone deformities are well described with several classification systems based on degree and dimension of bone insufficiency. The Hamada classification system defines the degree of medial glenoid erosion and superior bone loss, as well as acetabularization of the acromion in 5 grades; 5 Rispoli and colleagues6 defined and graded the degree of medicalization of the glenohumeral joint based on degree of subchondral plate erosion; and Visotsky and colleagues7 based their classification system on wear patterns of bone loss, alignment, and concomitant soft-tissue insufficiencies leading to instability and rotation loss.
In severe glenoid bone deficiency after glenoid component removal, Antuna and colleagues8 described the classic findings related to medial bone loss, anterior and posterior wall failure, and combinations thereof.
Continue to: All these classification systems...
All these classification systems are based on the 2-D appearance of the glenoid and should be considered cautiously. The glenoid is a complex 3-D structure that can be affected by any number of disease processes, trauma, and surgical intervention. Using more modern CT techniques and 3-D imaging, we now know that many deformities previously classified as unidirectional are, instead, complex and multidirectional.
Frankle and colleagues9 developed a classification based more 3-D CT models which has further classified severe glenoid vault deformities in relation to direction and degree of bone loss (Figures 2A-2E). Using this system, they were better able to determine degree and direction of deformity than in previous 2-D evaluations, and they were able to determine the amount of glenoid vault bone available for baseplate fixation. Scalise and colleagues10 further defined the influence of such 3-D planning in total shoulder arthroplasty.
With knowledge of these classification systems and use of contemporary imaging systems, shoulder arthroplasty in cases of severe glenoid deficiency can be more successful. Potentially, we can improve outcomes even more in the more severe cases of bone loss with use of patient-specific planning tools, including the guides and patient-specific implants that are now readily available with many implant systems.11
Preoperative planning tools, bone-grafting techniques, augmented and specialized glenoid and humeral implants, and patient-specific implants are discussed this month to give our readers a comprehensive review of the latest concepts in shoulder arthroplasty in cases of significant bone loss or deformity.
This month of The American Journal of Orthopedics presents the most current and cutting-edge solutions for humeral and glenoid bone deformities and deficiencies in contemporary shoulder arthroplasties.
Over the past few decades, there has been a dramatic increase in the number of shoulder arthroplasties performed around the world. This increase is the result of an aging and increasingly more active population, better implant technology, and the advent of reverse shoulder arthroplasty (RSA) for rotator cuff arthropathy. Additionally, as the indications for RSA have expanded to include pathologies such as rotator cuff insufficiency, chronic instabilities, trauma, and tumors, the number of arthroplasties will continue to increase. Although the results of most arthroplasties are good and predictable, any glenoid and/or humeral bone deficiencies can have detrimental effects on the clinical outcomes of these procedures. Bone loss becomes more of a problem in revision cases, and, as the number of primary arthroplasties increases, it follows that the number of revision procedures will also increase.
Many of the disease- or procedure-specific processes indicated for shoulder arthroplasty have predictable patterns of bone loss, especially on the glenoid side. Walch and colleagues1 and Bercik and colleagues2 made us aware that many patients with primary osteoarthritis have significant glenoid bone deformity. Similarly, there have been a number of first- and second-generation classification systems for delineating glenoid deformity in rotator cuff tear arthropathy and in revision settings. In revision settings, both glenoid and humeral bone deficiencies can occur as a result of implant removal, iatrogenic fracture, and even infection. Each of these bone loss patterns must be recognized and treated appropriately for the best surgical outcome.
The articles in this month of The American Journal of Orthopedics address the most up-to-date concepts and solutions regarding both humeral and glenoid bone loss in shoulder arthroplasty of all types.
HUMERAL BONE LOSS
Humeral bone loss is typically encountered in proximal humerus fractures, in revision surgery necessitating humeral component removal, and, less commonly, in tumors and infection.
In many displaced proximal humeral fractures indicated for shoulder arthroplasty, the bone is comminuted with displacement of the lesser and greater tuberosities. In these situations, failure of tuberosity healing may result in loss of rotator cuff function with loss of elevation, rotation, and even instability. Humeral shortening can also occur as a result of bone loss and can compromise deltoid function by loss of proper muscle tension, leading to instability, dysfunction, or both. In addition to possible instability, humeral shortening with metaphyseal bone loss can adversely affect long-term fixation of the humeral component, leading to stem loosening or failure. Cuff and colleagues3 showed significantly more rotational micromotion in cases lacking metaphyseal support, leading to aseptic loosening of the humeral stem.
Humeral bone loss can also result from humeral stem component removal in revision shoulder arthroplasty for infection, component failure or loosening, and even periprosthetic fracture resulting from surgery or trauma.
For the surgeon, humeral bone loss can create a complex set of circumstances related to rotator cuff attachment failure, soft-tissue balancing effects, and component fixation issues. Any such issue must be recognized and addressed for best outcomes. Best results can be obtained with preoperative imaging, planning, use of bone graft techniques, proximal humeral allografts, and, more recently, modular and patient-specific implants. All of these issues are discussed comprehensively in the articles this month.
Continue to: GLENOID BONE LOSS
GLENOID BONE LOSS
Proper glenoid component placement with durable fixation is crucial for success in anatomical total shoulder arthroplasty and RSA. Glenoid bone deformity and loss can result from intrinsic deformity characteristics seen in primary osteoarthritis, cuff tear arthropathy, or glenoid component removal in revision situations and infection. These bone deformity complications can be extremely difficult to treat and in some cases lead to catastrophic failure of the index arthroplasty.
We are now aware that one key to success in the face of moderate to severe deformity is proper recognition. Newer imaging techniques, including 2-dimensional (2-D) computed tomography (CT) and 3-dimensional (3-D) modeling and surgical planning software tools, which are outlined in an upcoming article, have given surgeons important new instruments that can help in treating these difficult cases.
Glenoid bone deformity in primary osteoarthritis was well delineated in the 1999 seminal study of CT changes by Walch and colleagues.1 The Walch classification system, which characterized glenoid morphology based on 2-D CT findings, was recently upgraded, based on 3-D imaging technology, to include Walch B3 and D patterns (Figure 1).2 Recognition of certain primary deformities in osteoarthritis has led to increased use of RSA in some cases of Walch B2, B3, and C deformities with substantial glenoid retroversion and/or humeral head subluxation.4
In cases of rotator cuff tear arthropathy, glenoid bone deformities are well described with several classification systems based on degree and dimension of bone insufficiency. The Hamada classification system defines the degree of medial glenoid erosion and superior bone loss, as well as acetabularization of the acromion in 5 grades; 5 Rispoli and colleagues6 defined and graded the degree of medicalization of the glenohumeral joint based on degree of subchondral plate erosion; and Visotsky and colleagues7 based their classification system on wear patterns of bone loss, alignment, and concomitant soft-tissue insufficiencies leading to instability and rotation loss.
In severe glenoid bone deficiency after glenoid component removal, Antuna and colleagues8 described the classic findings related to medial bone loss, anterior and posterior wall failure, and combinations thereof.
Continue to: All these classification systems...
All these classification systems are based on the 2-D appearance of the glenoid and should be considered cautiously. The glenoid is a complex 3-D structure that can be affected by any number of disease processes, trauma, and surgical intervention. Using more modern CT techniques and 3-D imaging, we now know that many deformities previously classified as unidirectional are, instead, complex and multidirectional.
Frankle and colleagues9 developed a classification based more 3-D CT models which has further classified severe glenoid vault deformities in relation to direction and degree of bone loss (Figures 2A-2E). Using this system, they were better able to determine degree and direction of deformity than in previous 2-D evaluations, and they were able to determine the amount of glenoid vault bone available for baseplate fixation. Scalise and colleagues10 further defined the influence of such 3-D planning in total shoulder arthroplasty.
With knowledge of these classification systems and use of contemporary imaging systems, shoulder arthroplasty in cases of severe glenoid deficiency can be more successful. Potentially, we can improve outcomes even more in the more severe cases of bone loss with use of patient-specific planning tools, including the guides and patient-specific implants that are now readily available with many implant systems.11
Preoperative planning tools, bone-grafting techniques, augmented and specialized glenoid and humeral implants, and patient-specific implants are discussed this month to give our readers a comprehensive review of the latest concepts in shoulder arthroplasty in cases of significant bone loss or deformity.
This month of The American Journal of Orthopedics presents the most current and cutting-edge solutions for humeral and glenoid bone deformities and deficiencies in contemporary shoulder arthroplasties.
References
1. Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999;14(6):756-760.
2. Bercik MJ, Kruse K 2nd, Yalizis M, Gauci MO, Chaoui J, Walch G. A modification to the Walch classification of the glenoid in primary glenohumeral osteoarthritis using three-dimensional imaging. J Shoulder Elbow Surg. 2016;25(10):1601-1606.
3. Cuff D, Levy JC, Gutiérrez S, Frankle M. Torsional stability of modular and non-modular reverse shoulder humeral components in a proximal humeral bone loss model. J Shoulder Elbow Surg. 2011;20(4):646-651.
4. Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013;22(11):1589-1598.
5. Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990;(254):92-96.
6. Rispoli D, Sperling JW, Athwal GS, Schleck CD, Cofield RH. Humeral head replacement for the treatment of osteoarthritis. J Bone Joint Surg Am. 2006;88(12):2637-2644.
7. Visotsky JL, Basamania C, Seebauer L, Rockwood CA, Jensen KL. Cuff tear arthropathy: pathogenesis, classification, and algorithm for treatment. J Bone Joint Surg Am. 2004;86(suppl 2):35-40.
8. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224.
9. Frankle MA, Teramoto A, Luo ZP, Levy JC, Pupello D. Glenoid morphology in reverse shoulder arthroplasty: classification and surgical implications. J Shoulder Elbow Surg. 2009;18(6):874-885.
10. Scalise JJ, Codsi MJ, Bryan J, Brems JJ, Iannotti JP. The influence of three-dimensional computed tomography images of the shoulder in preoperative planning for total shoulder arthroplasty. J Bone Joint Surg Am. 2008;90(11):2438-2445.
11. Dines DM, Gulotta L, Craig EV, Dines JS. Novel solution for massive glenoid defects in shoulder arthroplasty: a patient-specific glenoid vault reconstruction system. Am J Orthop. 2017;46(2):104-108.
References
1. Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999;14(6):756-760.
2. Bercik MJ, Kruse K 2nd, Yalizis M, Gauci MO, Chaoui J, Walch G. A modification to the Walch classification of the glenoid in primary glenohumeral osteoarthritis using three-dimensional imaging. J Shoulder Elbow Surg. 2016;25(10):1601-1606.
3. Cuff D, Levy JC, Gutiérrez S, Frankle M. Torsional stability of modular and non-modular reverse shoulder humeral components in a proximal humeral bone loss model. J Shoulder Elbow Surg. 2011;20(4):646-651.
4. Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013;22(11):1589-1598.
5. Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990;(254):92-96.
6. Rispoli D, Sperling JW, Athwal GS, Schleck CD, Cofield RH. Humeral head replacement for the treatment of osteoarthritis. J Bone Joint Surg Am. 2006;88(12):2637-2644.
7. Visotsky JL, Basamania C, Seebauer L, Rockwood CA, Jensen KL. Cuff tear arthropathy: pathogenesis, classification, and algorithm for treatment. J Bone Joint Surg Am. 2004;86(suppl 2):35-40.
8. Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001;10(3):217-224.
9. Frankle MA, Teramoto A, Luo ZP, Levy JC, Pupello D. Glenoid morphology in reverse shoulder arthroplasty: classification and surgical implications. J Shoulder Elbow Surg. 2009;18(6):874-885.
10. Scalise JJ, Codsi MJ, Bryan J, Brems JJ, Iannotti JP. The influence of three-dimensional computed tomography images of the shoulder in preoperative planning for total shoulder arthroplasty. J Bone Joint Surg Am. 2008;90(11):2438-2445.
11. Dines DM, Gulotta L, Craig EV, Dines JS. Novel solution for massive glenoid defects in shoulder arthroplasty: a patient-specific glenoid vault reconstruction system. Am J Orthop. 2017;46(2):104-108.
An increasing number of THAs and HAs were performed over time for FNF.
HA patients tended to be older.
Hospitalization and blood transfusion rates were higher for THA.
Hospital size affected the rate of HAs, while hospital location affected the rate of THAs.
A larger proportion of THA patients had private insurance.
Femoral neck fractures (FNFs) are a common source of morbidity and mortality worldwide. The increasing number of FNFs in the United States is attributed to increases in number of US residents >65 years old, the average life span, and the incidence of osteoporosis.1 Three hundred forty thousand hip fractures occurred in the United States in 1996, and the number is expected to double by 2050.2 By that year, an estimated 6.3 million hip fractures will occur worldwide.3 Given the 1-year mortality rate of 14% to 36%, optimizing the management of these fractures is an important public health issue that must be addressed.4
Treatment is based on preoperative ambulatory status, cognitive function, comorbidities, fracture type and displacement, and other factors. In physiologically elderly patients with displaced fractures, surgical treatment usually involves either hemiarthroplasty (HA) or total hip arthroplasty (THA). There is controversy regarding which modality is the preferred treatment.
Proponents of HA point to a higher rate of dislocation for FNFs treated with THAs,5,6 attributed to increased range of motion.7 Proponents of THA point to superior short-term clinical results and fewer complications, especially in mobile, independent patients.8
We conducted a study to assess recent US national trends in performing THA and HA for FNFs and to evaluate perioperative outcomes for each treatment group.
Materials and Methods
Data for this study were obtained from the National Center for Health Statistics (NCHS) National Hospital Discharge Survey (NHDS) and were imported into Microsoft Office Excel 2010.9 The NHDS examines patient discharges from various hospitals across the US, including federal, military, and Veterans Administration hospitals.9 Only short-stay hospitals (mean stay, <30 days) and hospitals with a general specialty are included in the survey. Each year, about 1% of all hospital admissions from across the US are abstracted and weighted to provide nationwide estimates. The information collected from each hospital record includes age, sex, race, marital status, discharge month, discharge status, days of care, hospital location, hospital size (number of beds), hospital type (proprietary or for-profit, government, nonprofit/church), and up to 15 discharge diagnoses and 8 procedures performed during admission.9
International Classification of Diseases, Ninth Revision (ICD-9) procedure codes were used to search the NHDS for patients admitted after FNF for each year from 2001 through 2010. These codes were then used to identify patients within this group who underwent THA or HA. We also collected data on patient demographics, hospitalization duration, discharge disposition, in-hospital adverse events (deep vein thrombosis [DVT], pulmonary embolism [PE], blood transfusion, mortality), form of primary medical insurance, number of hospital beds (0-99, 100-199, 200-299, 300-499, ≥500), hospital type (proprietary, government, nonprofit/church), and hospital region (Northeast, Midwest, South, West).
Trends were evaluated by linear regression with the Pearson correlation coefficient (r). Statistical comparisons were made using the Student t test for continuous data, and both the Fisher exact test and the χ2 test for categorical variables. Significance level was set at P < .05. All analyses were performed with IBM SPSS Statistics 22.
Results
Figure 1.Of the 12,757 patients identified as having FNFs (Figure 1), 582 (4.6%) underwent THA, 6697 (52.5%) underwent HA, 3453 (27.1%) received internal fixation, and 1809 (14.2%) did not have their surgery documented. There were 164 men (28.2%) in the THA group and 1744 (26.0%) in the HA group (P = .27). Mean age was significantly (P < .01) higher for HA patients (81.1 years; range, 18-99 years) than for THA patients (76.9 years; range, 19-99 years), and there were significantly (P < .01) more medical comorbidities for HA patients (6.4 diagnoses; range, 1-7+ diagnoses) than for THA patients (6.1 diagnoses; range, 1-7 diagnoses).
Figure 2.There was no clear trend in prevalence of FNFs between 2001 and 2010 (r = 0.25; Figure 2). During this period, fracture prevalence ranged from 406 to 477 per 100,000 admissions. However, there was increased frequency in use of both surgical techniques for FNFs over time: THA (r = 0.82; Figure 3) and HA (r = 0.80; Figure 4).
Figure 3.
Figure 4.The rate of THAs for FNFs increased from 4.2% for 2001 to 2005 to 5.0% for 2006 to 2010 (P = .04); similarly, the rate of HAs for FNFs increased from 51.0% for 2001 to 2005 to 54.7% for 2006 to 2010 (P < .01).
Hospital stay was longer (P < .01) for THA patients (7.7 days; range, 1-312 days) than for HA patients (6.7 days; range, 1-118 days), and blood transfusion rate was higher (P = .02) for THA patients (30.4%) than for HA patients (25.7%), but the groups did not differ in their rates of DVT (THA, 1.2%; HA, 0.80%, P = .50), PE (THA, 0.52%; HA, 0.72%, P = .52), or mortality (THA, 1.8%; HA, 2.9%; P = .16). Discharge disposition varied with surgical status (P < .01): 23.2% of THA patients and 11.6% of HA patients were discharged directly home after their inpatient stay, and 76.8% of THA patients and 88.4% of HA patients were discharged or transferred to a short- or long-term care facility.
Table.
Figure 5.Hospital size (number of beds) affected the number of HAs performed (P < .01) but not the number of THAs performed (P = .10; Table). Hospital location (Northeast, Midwest, South, West) affected THA frequency (P = .01), but not HA frequency (P = .07; Figure 5). In contrast, hospital type (proprietary, government, nonprofit/church) affected the HA rate (P < .01) but not the THA rate (P = .12; Table).
Private medical insurance provided coverage for 14.3% of THAs and 9.1% of HAs, and Medicare provided coverage for 80.9% of THAs and 86.0% of HAs (P < .01).
Discussion
The NHDS data showed a preference for HA over THA in the treatment of FNFs and suggested THA was favored for younger, healthier patients while HA was reserved for older patients with more comorbidities. Despite being younger and healthier, the THA group had higher transfusion rates and longer hospitalizations, possibly because of the increased complexity of THA procedures, which generally involve more operative time and increased blood loss. The resultant higher transfusion rate for THAs likely contributed to longer hospitalizations for FNFs. However, the THA and HA groups did not differ in their rates of DVT, PE, or mortality.
Multiple studies have noted no differences in mortality, infection, or general complications between THA and HA for FNF.8,10,11 THA patients have better functional outcomes, including Harris and Oxford hip scores and walking distance, but higher dislocation rates,8,10-12 and HA patients are at higher risk for reoperation because of progressive acetabular erosion.8,10,11
We noted an increase in use of both THA and HA for FNF over the study period (2001-2010). In a review of operative treatment for FNF by surgeons applying for the American Board of Orthopaedic Surgery certification between 1999 and 2011, Miller and colleagues13 found a similar increase in the THA rate over time, but decreases in the HA and internal fixation rates, with candidates in the “adult reconstruction” subspecialty showing a particularly strong trend toward THA use.
These findings reflect a general propensity toward femoral head replacement rather than preservation through open reduction and internal fixation (ORIF). Recent studies have found that ORIF carries a 39% to 43% rate of fixation failure and need for secondary revision, as well as risks of avascular necrosis, malunion, and nonunion.1,14-16 This need for secondary surgery makes ORIF ultimately less cost-effective than either THA or HA.16,17 Most authors would recommend arthroplasty for FNF in elderly patients with normal mental function1,16,18 and would reserve ORIF for young patients with good bone stock, joint space preservation, and reducible noncomminuted fractures.1,19
Our study results suggest that smaller hospitals (<100 beds) tend to have lower rates of HA (P < .01, significant) and THA (P = .10, not significant; Table), possibly because FNF patients who present to these hospitals may be referred elsewhere because of regional differences in the availability of orthopedic traumatologists and arthroplasty subspecialists. Surgeon volume affects postoperative outcomes and may play a role in referral patterns.20 Ames and colleagues20 found that HA performed for FNF by surgeons with high-volume THA experience (vs non-hip-arthroplasty surgeons) had lower rates of dislocation, superficial infection, and mortality.
Regional differences were significant for THA alone, with the highest THA rates in the South (5.2%) and the lowest in the West (3.3%; Figure 5). There were no clear regional trends for HA. Possible explanations include a propensity toward a more aggressive approach in these regions, increased regional prevalence of acetabular disease, regional surgeon preferences, and regional differences in patient characteristics (eg, increased prevalence of obesity in the South).21
HA rates were highest for nonprofit/church hospitals and lowest for proprietary hospitals, whereas THA rates did not differ by hospital type. Possible explanations include an older, less mobile nonprofit/church patient cohort that is more amenable to HA, and surgeon preference.
THA patients were more likely to be covered by private medical insurance than by Medicare—a finding in agreement with Hochfelder and colleagues,22 who found that, compared with federal insurance and self-pay patients, private insurance patients were 41% more likely to undergo THA than HA or internal fixation for FNF. We think that the age difference between our THA and HA groups contributed to the insurance variability in our study.
Our study had several limitations. It was conducted to examine the rates of THA and HA after FNF, not to survey treatment types, including ORIF and nonoperative management. The NHDS database does not provide information on HA implant type (unipolar, bipolar), use or nonuse of cement with HA, or surgical approach. Surgical approach could influence the rate of postoperative dislocation, an outcome measure that was not examined in this study. Last, the NHDS database tracks admissions and discharges, not patients. When a patient is discharged, collection of information on the patient’s postoperative course stops; a patient who returns even only 1 day later is recorded as a new or unique patient. Therefore, intermediate or long-term outcome information is unavailable, which likely led to an underrepresentation of DVT, PE, and mortality after these THA and HA procedures.
There was a trend toward femoral head replacement rather than ORIF in the treatment of FNF. Cognitively functional and independent elderly patients, and patients with osteoarthritis or rheumatoid arthritis, may benefit from THA, whereas HA may be better suited to cognitively dysfunctional patients.23,24 The NHDS reflects an increasing trend toward arthroplasty over ORIF, but the exact treatment choice is affected by hospital type, size, location and surgeon preference, training, and subspecialization.
References
1. Macaulay W, Pagnotto MR, Iorio R, Mont MA, Saleh KJ. Displaced femoral neck fractures in the elderly: hemiarthroplasty versus total hip arthroplasty. J Am Acad Orthop Surg. 2006;14(5):287-293.
2. Miyamoto RG, Kaplan KM, Levine BR, Egol KA, Zuckerman JD. Surgical management of hip fractures: an evidence-based review of the literature. I: femoral neck fractures. J Am Acad Orthop Surg. 2008;16(10):596-607.
3. Kannus P, Parkkari J, Sievänen H, Heinonen A, Vuori I, Järvinen M. Epidemiology of hip fractures. Bone. 1996;18(1 suppl):57S-63S.
4. Zuckerman JD. Hip fracture. N Engl J Med. 1996;334(23):1519-1525.
5. Papandrea RF, Froimson MI. Total hip arthroplasty after acute displaced femoral neck fractures. Am J Orthop. 1996;25(2):85-88.
6. Burgers PT, Van Geene AR, Van den Bekerom MP, et al. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials. Int Orthop. 2012;36(8):1549-1560.
7. Skinner P, Riley D, Ellery J, Beaumont A, Coumine R, Shafighian B. Displaced subcapital fractures of the femur: a prospective randomized comparison of internal fixation, hemiarthroplasty and total hip replacement. Injury. 1989;20(5):291-293.
8. Baker RP, Squires B, Gargan MF, Bannister GC. Total hip arthroplasty and hemiarthroplasty in mobile, independent patients with a displaced intracapsular fracture of the femoral neck. A randomized, controlled trial. J Bone Joint Surg Am. 2006;88(12):2583-2589.
9. Centers for Disease Control and Prevention, National Center for Health Statistics. National Hospital Discharge Survey. http://www.cdc.gov/nchs/nhds/about_nhds.htm. Last updated December 6, 2011. Accessed December 10, 2013.
10. Zi-Sheng A, You-Shui G, Zhi-Zhen J, Ting Y, Chang-Qing Z. Hemiarthroplasty vs primary total hip arthroplasty for displaced fractures of the femoral neck in the elderly: a meta-analysis. J Arthroplasty. 2012;27(4):583-590.
11. Yu L, Wang Y, Chen J. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures: meta-analysis of randomized trials. Clin Orthop Relat Res. 2012;470(8):2235-2243.
12. Hopley C, Stengel D, Ekkernkamp A, Wich M. Primary total hip arthroplasty versus hemiarthroplasty for displaced intracapsular hip fractures in older patients: systematic review. BMJ. 2010;340:c2332.
13. Miller BJ, Callaghan JJ, Cram P, Karam M, Marsh JL, Noiseux NO. Changing trends in the treatment of femoral neck fractures: a review of the American Board of Orthopaedic Surgery database. J Bone Joint Surg Am. 2014;96(17):e149.
14. Rogmark C, Carlsson A, Johnell O, Sernbo I. A prospective randomised trial of internal fixation versus arthroplasty for displaced fractures of the neck of the femur. Functional outcome for 450 patients at two years. J Bone Joint Surg Br. 2002;84(2):183-188.
15. Bhandari M, Devereaux PJ, Swiontkowski MF, et al. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. J Bone Joint Surg Am. 2003;85(9):1673-1681.
16. Keating JF, Grant A, Masson M, Scott NW, Forbes JF. Randomized comparison of reduction and fixation, bipolar hemiarthroplasty, and total hip arthroplasty. Treatment of displaced intracapsular hip fractures in healthy older patients. J Bone Joint Surg Am. 2006;88(2):249-260.
17. Iorio R, Healy WL, Lemos DW, Appleby D, Lucchesi CA, Saleh KJ. Displaced femoral neck fractures in the elderly: outcomes and cost effectiveness. Clin Orthop Relat Res. 2001;(383):229-242.
18. Johansson T, Jacobsson SA, Ivarsson I, Knutsson A, Wahlström O. Internal fixation versus total hip arthroplasty in the treatment of displaced femoral neck fractures: a prospective randomized study of 100 hips. Acta Orthop Scand. 2000;71(6):597-602.
19. Shah AK, Eissler J, Radomisli T. Algorithms for the treatment of femoral neck fractures. Clin Orthop Relat Res. 2002;(399):28-34.
20. Ames JB, Lurie JD, Tomek IM, Zhou W, Koval KJ. Does surgeon volume for total hip arthroplasty affect outcomes after hemiarthroplasty for femoral neck fracture? Am J Orthop. 2010;39(8):E84-E89.
21. Le A, Judd SE, Allison DB, et al. The geographic distribution of obesity in the US and the potential regional differences in misreporting of obesity. Obesity. 2014;22(1):300-306.
22. Hochfelder JP, Khatib ON, Glait SA, Slover JD. Femoral neck fractures in New York state. Is the rate of THA increasing, and do race or payer influence decision making? J Orthop Trauma. 2014;28(7):422-426.
23. Lowe JA, Crist BD, Bhandari M, Ferguson TA. Optimal treatment of femoral neck fractures according to patient’s physiologic age: an evidence-based review. Orthop Clin North Am. 2010;41(2):157-166.
24. Callaghan JJ, Liu SS, Haidukewych GJ. Subcapital fractures: a changing paradigm. J Bone Joint Surg Br. 2012;94(11 suppl A):19-21.
An increasing number of THAs and HAs were performed over time for FNF.
HA patients tended to be older.
Hospitalization and blood transfusion rates were higher for THA.
Hospital size affected the rate of HAs, while hospital location affected the rate of THAs.
A larger proportion of THA patients had private insurance.
Femoral neck fractures (FNFs) are a common source of morbidity and mortality worldwide. The increasing number of FNFs in the United States is attributed to increases in number of US residents >65 years old, the average life span, and the incidence of osteoporosis.1 Three hundred forty thousand hip fractures occurred in the United States in 1996, and the number is expected to double by 2050.2 By that year, an estimated 6.3 million hip fractures will occur worldwide.3 Given the 1-year mortality rate of 14% to 36%, optimizing the management of these fractures is an important public health issue that must be addressed.4
Treatment is based on preoperative ambulatory status, cognitive function, comorbidities, fracture type and displacement, and other factors. In physiologically elderly patients with displaced fractures, surgical treatment usually involves either hemiarthroplasty (HA) or total hip arthroplasty (THA). There is controversy regarding which modality is the preferred treatment.
Proponents of HA point to a higher rate of dislocation for FNFs treated with THAs,5,6 attributed to increased range of motion.7 Proponents of THA point to superior short-term clinical results and fewer complications, especially in mobile, independent patients.8
We conducted a study to assess recent US national trends in performing THA and HA for FNFs and to evaluate perioperative outcomes for each treatment group.
Materials and Methods
Data for this study were obtained from the National Center for Health Statistics (NCHS) National Hospital Discharge Survey (NHDS) and were imported into Microsoft Office Excel 2010.9 The NHDS examines patient discharges from various hospitals across the US, including federal, military, and Veterans Administration hospitals.9 Only short-stay hospitals (mean stay, <30 days) and hospitals with a general specialty are included in the survey. Each year, about 1% of all hospital admissions from across the US are abstracted and weighted to provide nationwide estimates. The information collected from each hospital record includes age, sex, race, marital status, discharge month, discharge status, days of care, hospital location, hospital size (number of beds), hospital type (proprietary or for-profit, government, nonprofit/church), and up to 15 discharge diagnoses and 8 procedures performed during admission.9
International Classification of Diseases, Ninth Revision (ICD-9) procedure codes were used to search the NHDS for patients admitted after FNF for each year from 2001 through 2010. These codes were then used to identify patients within this group who underwent THA or HA. We also collected data on patient demographics, hospitalization duration, discharge disposition, in-hospital adverse events (deep vein thrombosis [DVT], pulmonary embolism [PE], blood transfusion, mortality), form of primary medical insurance, number of hospital beds (0-99, 100-199, 200-299, 300-499, ≥500), hospital type (proprietary, government, nonprofit/church), and hospital region (Northeast, Midwest, South, West).
Trends were evaluated by linear regression with the Pearson correlation coefficient (r). Statistical comparisons were made using the Student t test for continuous data, and both the Fisher exact test and the χ2 test for categorical variables. Significance level was set at P < .05. All analyses were performed with IBM SPSS Statistics 22.
Results
Figure 1.Of the 12,757 patients identified as having FNFs (Figure 1), 582 (4.6%) underwent THA, 6697 (52.5%) underwent HA, 3453 (27.1%) received internal fixation, and 1809 (14.2%) did not have their surgery documented. There were 164 men (28.2%) in the THA group and 1744 (26.0%) in the HA group (P = .27). Mean age was significantly (P < .01) higher for HA patients (81.1 years; range, 18-99 years) than for THA patients (76.9 years; range, 19-99 years), and there were significantly (P < .01) more medical comorbidities for HA patients (6.4 diagnoses; range, 1-7+ diagnoses) than for THA patients (6.1 diagnoses; range, 1-7 diagnoses).
Figure 2.There was no clear trend in prevalence of FNFs between 2001 and 2010 (r = 0.25; Figure 2). During this period, fracture prevalence ranged from 406 to 477 per 100,000 admissions. However, there was increased frequency in use of both surgical techniques for FNFs over time: THA (r = 0.82; Figure 3) and HA (r = 0.80; Figure 4).
Figure 3.
Figure 4.The rate of THAs for FNFs increased from 4.2% for 2001 to 2005 to 5.0% for 2006 to 2010 (P = .04); similarly, the rate of HAs for FNFs increased from 51.0% for 2001 to 2005 to 54.7% for 2006 to 2010 (P < .01).
Hospital stay was longer (P < .01) for THA patients (7.7 days; range, 1-312 days) than for HA patients (6.7 days; range, 1-118 days), and blood transfusion rate was higher (P = .02) for THA patients (30.4%) than for HA patients (25.7%), but the groups did not differ in their rates of DVT (THA, 1.2%; HA, 0.80%, P = .50), PE (THA, 0.52%; HA, 0.72%, P = .52), or mortality (THA, 1.8%; HA, 2.9%; P = .16). Discharge disposition varied with surgical status (P < .01): 23.2% of THA patients and 11.6% of HA patients were discharged directly home after their inpatient stay, and 76.8% of THA patients and 88.4% of HA patients were discharged or transferred to a short- or long-term care facility.
Table.
Figure 5.Hospital size (number of beds) affected the number of HAs performed (P < .01) but not the number of THAs performed (P = .10; Table). Hospital location (Northeast, Midwest, South, West) affected THA frequency (P = .01), but not HA frequency (P = .07; Figure 5). In contrast, hospital type (proprietary, government, nonprofit/church) affected the HA rate (P < .01) but not the THA rate (P = .12; Table).
Private medical insurance provided coverage for 14.3% of THAs and 9.1% of HAs, and Medicare provided coverage for 80.9% of THAs and 86.0% of HAs (P < .01).
Discussion
The NHDS data showed a preference for HA over THA in the treatment of FNFs and suggested THA was favored for younger, healthier patients while HA was reserved for older patients with more comorbidities. Despite being younger and healthier, the THA group had higher transfusion rates and longer hospitalizations, possibly because of the increased complexity of THA procedures, which generally involve more operative time and increased blood loss. The resultant higher transfusion rate for THAs likely contributed to longer hospitalizations for FNFs. However, the THA and HA groups did not differ in their rates of DVT, PE, or mortality.
Multiple studies have noted no differences in mortality, infection, or general complications between THA and HA for FNF.8,10,11 THA patients have better functional outcomes, including Harris and Oxford hip scores and walking distance, but higher dislocation rates,8,10-12 and HA patients are at higher risk for reoperation because of progressive acetabular erosion.8,10,11
We noted an increase in use of both THA and HA for FNF over the study period (2001-2010). In a review of operative treatment for FNF by surgeons applying for the American Board of Orthopaedic Surgery certification between 1999 and 2011, Miller and colleagues13 found a similar increase in the THA rate over time, but decreases in the HA and internal fixation rates, with candidates in the “adult reconstruction” subspecialty showing a particularly strong trend toward THA use.
These findings reflect a general propensity toward femoral head replacement rather than preservation through open reduction and internal fixation (ORIF). Recent studies have found that ORIF carries a 39% to 43% rate of fixation failure and need for secondary revision, as well as risks of avascular necrosis, malunion, and nonunion.1,14-16 This need for secondary surgery makes ORIF ultimately less cost-effective than either THA or HA.16,17 Most authors would recommend arthroplasty for FNF in elderly patients with normal mental function1,16,18 and would reserve ORIF for young patients with good bone stock, joint space preservation, and reducible noncomminuted fractures.1,19
Our study results suggest that smaller hospitals (<100 beds) tend to have lower rates of HA (P < .01, significant) and THA (P = .10, not significant; Table), possibly because FNF patients who present to these hospitals may be referred elsewhere because of regional differences in the availability of orthopedic traumatologists and arthroplasty subspecialists. Surgeon volume affects postoperative outcomes and may play a role in referral patterns.20 Ames and colleagues20 found that HA performed for FNF by surgeons with high-volume THA experience (vs non-hip-arthroplasty surgeons) had lower rates of dislocation, superficial infection, and mortality.
Regional differences were significant for THA alone, with the highest THA rates in the South (5.2%) and the lowest in the West (3.3%; Figure 5). There were no clear regional trends for HA. Possible explanations include a propensity toward a more aggressive approach in these regions, increased regional prevalence of acetabular disease, regional surgeon preferences, and regional differences in patient characteristics (eg, increased prevalence of obesity in the South).21
HA rates were highest for nonprofit/church hospitals and lowest for proprietary hospitals, whereas THA rates did not differ by hospital type. Possible explanations include an older, less mobile nonprofit/church patient cohort that is more amenable to HA, and surgeon preference.
THA patients were more likely to be covered by private medical insurance than by Medicare—a finding in agreement with Hochfelder and colleagues,22 who found that, compared with federal insurance and self-pay patients, private insurance patients were 41% more likely to undergo THA than HA or internal fixation for FNF. We think that the age difference between our THA and HA groups contributed to the insurance variability in our study.
Our study had several limitations. It was conducted to examine the rates of THA and HA after FNF, not to survey treatment types, including ORIF and nonoperative management. The NHDS database does not provide information on HA implant type (unipolar, bipolar), use or nonuse of cement with HA, or surgical approach. Surgical approach could influence the rate of postoperative dislocation, an outcome measure that was not examined in this study. Last, the NHDS database tracks admissions and discharges, not patients. When a patient is discharged, collection of information on the patient’s postoperative course stops; a patient who returns even only 1 day later is recorded as a new or unique patient. Therefore, intermediate or long-term outcome information is unavailable, which likely led to an underrepresentation of DVT, PE, and mortality after these THA and HA procedures.
There was a trend toward femoral head replacement rather than ORIF in the treatment of FNF. Cognitively functional and independent elderly patients, and patients with osteoarthritis or rheumatoid arthritis, may benefit from THA, whereas HA may be better suited to cognitively dysfunctional patients.23,24 The NHDS reflects an increasing trend toward arthroplasty over ORIF, but the exact treatment choice is affected by hospital type, size, location and surgeon preference, training, and subspecialization.
Take-Home Points
An increasing number of THAs and HAs were performed over time for FNF.
HA patients tended to be older.
Hospitalization and blood transfusion rates were higher for THA.
Hospital size affected the rate of HAs, while hospital location affected the rate of THAs.
A larger proportion of THA patients had private insurance.
Femoral neck fractures (FNFs) are a common source of morbidity and mortality worldwide. The increasing number of FNFs in the United States is attributed to increases in number of US residents >65 years old, the average life span, and the incidence of osteoporosis.1 Three hundred forty thousand hip fractures occurred in the United States in 1996, and the number is expected to double by 2050.2 By that year, an estimated 6.3 million hip fractures will occur worldwide.3 Given the 1-year mortality rate of 14% to 36%, optimizing the management of these fractures is an important public health issue that must be addressed.4
Treatment is based on preoperative ambulatory status, cognitive function, comorbidities, fracture type and displacement, and other factors. In physiologically elderly patients with displaced fractures, surgical treatment usually involves either hemiarthroplasty (HA) or total hip arthroplasty (THA). There is controversy regarding which modality is the preferred treatment.
Proponents of HA point to a higher rate of dislocation for FNFs treated with THAs,5,6 attributed to increased range of motion.7 Proponents of THA point to superior short-term clinical results and fewer complications, especially in mobile, independent patients.8
We conducted a study to assess recent US national trends in performing THA and HA for FNFs and to evaluate perioperative outcomes for each treatment group.
Materials and Methods
Data for this study were obtained from the National Center for Health Statistics (NCHS) National Hospital Discharge Survey (NHDS) and were imported into Microsoft Office Excel 2010.9 The NHDS examines patient discharges from various hospitals across the US, including federal, military, and Veterans Administration hospitals.9 Only short-stay hospitals (mean stay, <30 days) and hospitals with a general specialty are included in the survey. Each year, about 1% of all hospital admissions from across the US are abstracted and weighted to provide nationwide estimates. The information collected from each hospital record includes age, sex, race, marital status, discharge month, discharge status, days of care, hospital location, hospital size (number of beds), hospital type (proprietary or for-profit, government, nonprofit/church), and up to 15 discharge diagnoses and 8 procedures performed during admission.9
International Classification of Diseases, Ninth Revision (ICD-9) procedure codes were used to search the NHDS for patients admitted after FNF for each year from 2001 through 2010. These codes were then used to identify patients within this group who underwent THA or HA. We also collected data on patient demographics, hospitalization duration, discharge disposition, in-hospital adverse events (deep vein thrombosis [DVT], pulmonary embolism [PE], blood transfusion, mortality), form of primary medical insurance, number of hospital beds (0-99, 100-199, 200-299, 300-499, ≥500), hospital type (proprietary, government, nonprofit/church), and hospital region (Northeast, Midwest, South, West).
Trends were evaluated by linear regression with the Pearson correlation coefficient (r). Statistical comparisons were made using the Student t test for continuous data, and both the Fisher exact test and the χ2 test for categorical variables. Significance level was set at P < .05. All analyses were performed with IBM SPSS Statistics 22.
Results
Figure 1.Of the 12,757 patients identified as having FNFs (Figure 1), 582 (4.6%) underwent THA, 6697 (52.5%) underwent HA, 3453 (27.1%) received internal fixation, and 1809 (14.2%) did not have their surgery documented. There were 164 men (28.2%) in the THA group and 1744 (26.0%) in the HA group (P = .27). Mean age was significantly (P < .01) higher for HA patients (81.1 years; range, 18-99 years) than for THA patients (76.9 years; range, 19-99 years), and there were significantly (P < .01) more medical comorbidities for HA patients (6.4 diagnoses; range, 1-7+ diagnoses) than for THA patients (6.1 diagnoses; range, 1-7 diagnoses).
Figure 2.There was no clear trend in prevalence of FNFs between 2001 and 2010 (r = 0.25; Figure 2). During this period, fracture prevalence ranged from 406 to 477 per 100,000 admissions. However, there was increased frequency in use of both surgical techniques for FNFs over time: THA (r = 0.82; Figure 3) and HA (r = 0.80; Figure 4).
Figure 3.
Figure 4.The rate of THAs for FNFs increased from 4.2% for 2001 to 2005 to 5.0% for 2006 to 2010 (P = .04); similarly, the rate of HAs for FNFs increased from 51.0% for 2001 to 2005 to 54.7% for 2006 to 2010 (P < .01).
Hospital stay was longer (P < .01) for THA patients (7.7 days; range, 1-312 days) than for HA patients (6.7 days; range, 1-118 days), and blood transfusion rate was higher (P = .02) for THA patients (30.4%) than for HA patients (25.7%), but the groups did not differ in their rates of DVT (THA, 1.2%; HA, 0.80%, P = .50), PE (THA, 0.52%; HA, 0.72%, P = .52), or mortality (THA, 1.8%; HA, 2.9%; P = .16). Discharge disposition varied with surgical status (P < .01): 23.2% of THA patients and 11.6% of HA patients were discharged directly home after their inpatient stay, and 76.8% of THA patients and 88.4% of HA patients were discharged or transferred to a short- or long-term care facility.
Table.
Figure 5.Hospital size (number of beds) affected the number of HAs performed (P < .01) but not the number of THAs performed (P = .10; Table). Hospital location (Northeast, Midwest, South, West) affected THA frequency (P = .01), but not HA frequency (P = .07; Figure 5). In contrast, hospital type (proprietary, government, nonprofit/church) affected the HA rate (P < .01) but not the THA rate (P = .12; Table).
Private medical insurance provided coverage for 14.3% of THAs and 9.1% of HAs, and Medicare provided coverage for 80.9% of THAs and 86.0% of HAs (P < .01).
Discussion
The NHDS data showed a preference for HA over THA in the treatment of FNFs and suggested THA was favored for younger, healthier patients while HA was reserved for older patients with more comorbidities. Despite being younger and healthier, the THA group had higher transfusion rates and longer hospitalizations, possibly because of the increased complexity of THA procedures, which generally involve more operative time and increased blood loss. The resultant higher transfusion rate for THAs likely contributed to longer hospitalizations for FNFs. However, the THA and HA groups did not differ in their rates of DVT, PE, or mortality.
Multiple studies have noted no differences in mortality, infection, or general complications between THA and HA for FNF.8,10,11 THA patients have better functional outcomes, including Harris and Oxford hip scores and walking distance, but higher dislocation rates,8,10-12 and HA patients are at higher risk for reoperation because of progressive acetabular erosion.8,10,11
We noted an increase in use of both THA and HA for FNF over the study period (2001-2010). In a review of operative treatment for FNF by surgeons applying for the American Board of Orthopaedic Surgery certification between 1999 and 2011, Miller and colleagues13 found a similar increase in the THA rate over time, but decreases in the HA and internal fixation rates, with candidates in the “adult reconstruction” subspecialty showing a particularly strong trend toward THA use.
These findings reflect a general propensity toward femoral head replacement rather than preservation through open reduction and internal fixation (ORIF). Recent studies have found that ORIF carries a 39% to 43% rate of fixation failure and need for secondary revision, as well as risks of avascular necrosis, malunion, and nonunion.1,14-16 This need for secondary surgery makes ORIF ultimately less cost-effective than either THA or HA.16,17 Most authors would recommend arthroplasty for FNF in elderly patients with normal mental function1,16,18 and would reserve ORIF for young patients with good bone stock, joint space preservation, and reducible noncomminuted fractures.1,19
Our study results suggest that smaller hospitals (<100 beds) tend to have lower rates of HA (P < .01, significant) and THA (P = .10, not significant; Table), possibly because FNF patients who present to these hospitals may be referred elsewhere because of regional differences in the availability of orthopedic traumatologists and arthroplasty subspecialists. Surgeon volume affects postoperative outcomes and may play a role in referral patterns.20 Ames and colleagues20 found that HA performed for FNF by surgeons with high-volume THA experience (vs non-hip-arthroplasty surgeons) had lower rates of dislocation, superficial infection, and mortality.
Regional differences were significant for THA alone, with the highest THA rates in the South (5.2%) and the lowest in the West (3.3%; Figure 5). There were no clear regional trends for HA. Possible explanations include a propensity toward a more aggressive approach in these regions, increased regional prevalence of acetabular disease, regional surgeon preferences, and regional differences in patient characteristics (eg, increased prevalence of obesity in the South).21
HA rates were highest for nonprofit/church hospitals and lowest for proprietary hospitals, whereas THA rates did not differ by hospital type. Possible explanations include an older, less mobile nonprofit/church patient cohort that is more amenable to HA, and surgeon preference.
THA patients were more likely to be covered by private medical insurance than by Medicare—a finding in agreement with Hochfelder and colleagues,22 who found that, compared with federal insurance and self-pay patients, private insurance patients were 41% more likely to undergo THA than HA or internal fixation for FNF. We think that the age difference between our THA and HA groups contributed to the insurance variability in our study.
Our study had several limitations. It was conducted to examine the rates of THA and HA after FNF, not to survey treatment types, including ORIF and nonoperative management. The NHDS database does not provide information on HA implant type (unipolar, bipolar), use or nonuse of cement with HA, or surgical approach. Surgical approach could influence the rate of postoperative dislocation, an outcome measure that was not examined in this study. Last, the NHDS database tracks admissions and discharges, not patients. When a patient is discharged, collection of information on the patient’s postoperative course stops; a patient who returns even only 1 day later is recorded as a new or unique patient. Therefore, intermediate or long-term outcome information is unavailable, which likely led to an underrepresentation of DVT, PE, and mortality after these THA and HA procedures.
There was a trend toward femoral head replacement rather than ORIF in the treatment of FNF. Cognitively functional and independent elderly patients, and patients with osteoarthritis or rheumatoid arthritis, may benefit from THA, whereas HA may be better suited to cognitively dysfunctional patients.23,24 The NHDS reflects an increasing trend toward arthroplasty over ORIF, but the exact treatment choice is affected by hospital type, size, location and surgeon preference, training, and subspecialization.
References
1. Macaulay W, Pagnotto MR, Iorio R, Mont MA, Saleh KJ. Displaced femoral neck fractures in the elderly: hemiarthroplasty versus total hip arthroplasty. J Am Acad Orthop Surg. 2006;14(5):287-293.
2. Miyamoto RG, Kaplan KM, Levine BR, Egol KA, Zuckerman JD. Surgical management of hip fractures: an evidence-based review of the literature. I: femoral neck fractures. J Am Acad Orthop Surg. 2008;16(10):596-607.
3. Kannus P, Parkkari J, Sievänen H, Heinonen A, Vuori I, Järvinen M. Epidemiology of hip fractures. Bone. 1996;18(1 suppl):57S-63S.
4. Zuckerman JD. Hip fracture. N Engl J Med. 1996;334(23):1519-1525.
5. Papandrea RF, Froimson MI. Total hip arthroplasty after acute displaced femoral neck fractures. Am J Orthop. 1996;25(2):85-88.
6. Burgers PT, Van Geene AR, Van den Bekerom MP, et al. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials. Int Orthop. 2012;36(8):1549-1560.
7. Skinner P, Riley D, Ellery J, Beaumont A, Coumine R, Shafighian B. Displaced subcapital fractures of the femur: a prospective randomized comparison of internal fixation, hemiarthroplasty and total hip replacement. Injury. 1989;20(5):291-293.
8. Baker RP, Squires B, Gargan MF, Bannister GC. Total hip arthroplasty and hemiarthroplasty in mobile, independent patients with a displaced intracapsular fracture of the femoral neck. A randomized, controlled trial. J Bone Joint Surg Am. 2006;88(12):2583-2589.
9. Centers for Disease Control and Prevention, National Center for Health Statistics. National Hospital Discharge Survey. http://www.cdc.gov/nchs/nhds/about_nhds.htm. Last updated December 6, 2011. Accessed December 10, 2013.
10. Zi-Sheng A, You-Shui G, Zhi-Zhen J, Ting Y, Chang-Qing Z. Hemiarthroplasty vs primary total hip arthroplasty for displaced fractures of the femoral neck in the elderly: a meta-analysis. J Arthroplasty. 2012;27(4):583-590.
11. Yu L, Wang Y, Chen J. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures: meta-analysis of randomized trials. Clin Orthop Relat Res. 2012;470(8):2235-2243.
12. Hopley C, Stengel D, Ekkernkamp A, Wich M. Primary total hip arthroplasty versus hemiarthroplasty for displaced intracapsular hip fractures in older patients: systematic review. BMJ. 2010;340:c2332.
13. Miller BJ, Callaghan JJ, Cram P, Karam M, Marsh JL, Noiseux NO. Changing trends in the treatment of femoral neck fractures: a review of the American Board of Orthopaedic Surgery database. J Bone Joint Surg Am. 2014;96(17):e149.
14. Rogmark C, Carlsson A, Johnell O, Sernbo I. A prospective randomised trial of internal fixation versus arthroplasty for displaced fractures of the neck of the femur. Functional outcome for 450 patients at two years. J Bone Joint Surg Br. 2002;84(2):183-188.
15. Bhandari M, Devereaux PJ, Swiontkowski MF, et al. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. J Bone Joint Surg Am. 2003;85(9):1673-1681.
16. Keating JF, Grant A, Masson M, Scott NW, Forbes JF. Randomized comparison of reduction and fixation, bipolar hemiarthroplasty, and total hip arthroplasty. Treatment of displaced intracapsular hip fractures in healthy older patients. J Bone Joint Surg Am. 2006;88(2):249-260.
17. Iorio R, Healy WL, Lemos DW, Appleby D, Lucchesi CA, Saleh KJ. Displaced femoral neck fractures in the elderly: outcomes and cost effectiveness. Clin Orthop Relat Res. 2001;(383):229-242.
18. Johansson T, Jacobsson SA, Ivarsson I, Knutsson A, Wahlström O. Internal fixation versus total hip arthroplasty in the treatment of displaced femoral neck fractures: a prospective randomized study of 100 hips. Acta Orthop Scand. 2000;71(6):597-602.
19. Shah AK, Eissler J, Radomisli T. Algorithms for the treatment of femoral neck fractures. Clin Orthop Relat Res. 2002;(399):28-34.
20. Ames JB, Lurie JD, Tomek IM, Zhou W, Koval KJ. Does surgeon volume for total hip arthroplasty affect outcomes after hemiarthroplasty for femoral neck fracture? Am J Orthop. 2010;39(8):E84-E89.
21. Le A, Judd SE, Allison DB, et al. The geographic distribution of obesity in the US and the potential regional differences in misreporting of obesity. Obesity. 2014;22(1):300-306.
22. Hochfelder JP, Khatib ON, Glait SA, Slover JD. Femoral neck fractures in New York state. Is the rate of THA increasing, and do race or payer influence decision making? J Orthop Trauma. 2014;28(7):422-426.
23. Lowe JA, Crist BD, Bhandari M, Ferguson TA. Optimal treatment of femoral neck fractures according to patient’s physiologic age: an evidence-based review. Orthop Clin North Am. 2010;41(2):157-166.
24. Callaghan JJ, Liu SS, Haidukewych GJ. Subcapital fractures: a changing paradigm. J Bone Joint Surg Br. 2012;94(11 suppl A):19-21.
References
1. Macaulay W, Pagnotto MR, Iorio R, Mont MA, Saleh KJ. Displaced femoral neck fractures in the elderly: hemiarthroplasty versus total hip arthroplasty. J Am Acad Orthop Surg. 2006;14(5):287-293.
2. Miyamoto RG, Kaplan KM, Levine BR, Egol KA, Zuckerman JD. Surgical management of hip fractures: an evidence-based review of the literature. I: femoral neck fractures. J Am Acad Orthop Surg. 2008;16(10):596-607.
3. Kannus P, Parkkari J, Sievänen H, Heinonen A, Vuori I, Järvinen M. Epidemiology of hip fractures. Bone. 1996;18(1 suppl):57S-63S.
4. Zuckerman JD. Hip fracture. N Engl J Med. 1996;334(23):1519-1525.
5. Papandrea RF, Froimson MI. Total hip arthroplasty after acute displaced femoral neck fractures. Am J Orthop. 1996;25(2):85-88.
6. Burgers PT, Van Geene AR, Van den Bekerom MP, et al. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials. Int Orthop. 2012;36(8):1549-1560.
7. Skinner P, Riley D, Ellery J, Beaumont A, Coumine R, Shafighian B. Displaced subcapital fractures of the femur: a prospective randomized comparison of internal fixation, hemiarthroplasty and total hip replacement. Injury. 1989;20(5):291-293.
8. Baker RP, Squires B, Gargan MF, Bannister GC. Total hip arthroplasty and hemiarthroplasty in mobile, independent patients with a displaced intracapsular fracture of the femoral neck. A randomized, controlled trial. J Bone Joint Surg Am. 2006;88(12):2583-2589.
9. Centers for Disease Control and Prevention, National Center for Health Statistics. National Hospital Discharge Survey. http://www.cdc.gov/nchs/nhds/about_nhds.htm. Last updated December 6, 2011. Accessed December 10, 2013.
10. Zi-Sheng A, You-Shui G, Zhi-Zhen J, Ting Y, Chang-Qing Z. Hemiarthroplasty vs primary total hip arthroplasty for displaced fractures of the femoral neck in the elderly: a meta-analysis. J Arthroplasty. 2012;27(4):583-590.
11. Yu L, Wang Y, Chen J. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures: meta-analysis of randomized trials. Clin Orthop Relat Res. 2012;470(8):2235-2243.
12. Hopley C, Stengel D, Ekkernkamp A, Wich M. Primary total hip arthroplasty versus hemiarthroplasty for displaced intracapsular hip fractures in older patients: systematic review. BMJ. 2010;340:c2332.
13. Miller BJ, Callaghan JJ, Cram P, Karam M, Marsh JL, Noiseux NO. Changing trends in the treatment of femoral neck fractures: a review of the American Board of Orthopaedic Surgery database. J Bone Joint Surg Am. 2014;96(17):e149.
14. Rogmark C, Carlsson A, Johnell O, Sernbo I. A prospective randomised trial of internal fixation versus arthroplasty for displaced fractures of the neck of the femur. Functional outcome for 450 patients at two years. J Bone Joint Surg Br. 2002;84(2):183-188.
15. Bhandari M, Devereaux PJ, Swiontkowski MF, et al. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. J Bone Joint Surg Am. 2003;85(9):1673-1681.
16. Keating JF, Grant A, Masson M, Scott NW, Forbes JF. Randomized comparison of reduction and fixation, bipolar hemiarthroplasty, and total hip arthroplasty. Treatment of displaced intracapsular hip fractures in healthy older patients. J Bone Joint Surg Am. 2006;88(2):249-260.
17. Iorio R, Healy WL, Lemos DW, Appleby D, Lucchesi CA, Saleh KJ. Displaced femoral neck fractures in the elderly: outcomes and cost effectiveness. Clin Orthop Relat Res. 2001;(383):229-242.
18. Johansson T, Jacobsson SA, Ivarsson I, Knutsson A, Wahlström O. Internal fixation versus total hip arthroplasty in the treatment of displaced femoral neck fractures: a prospective randomized study of 100 hips. Acta Orthop Scand. 2000;71(6):597-602.
19. Shah AK, Eissler J, Radomisli T. Algorithms for the treatment of femoral neck fractures. Clin Orthop Relat Res. 2002;(399):28-34.
20. Ames JB, Lurie JD, Tomek IM, Zhou W, Koval KJ. Does surgeon volume for total hip arthroplasty affect outcomes after hemiarthroplasty for femoral neck fracture? Am J Orthop. 2010;39(8):E84-E89.
21. Le A, Judd SE, Allison DB, et al. The geographic distribution of obesity in the US and the potential regional differences in misreporting of obesity. Obesity. 2014;22(1):300-306.
22. Hochfelder JP, Khatib ON, Glait SA, Slover JD. Femoral neck fractures in New York state. Is the rate of THA increasing, and do race or payer influence decision making? J Orthop Trauma. 2014;28(7):422-426.
23. Lowe JA, Crist BD, Bhandari M, Ferguson TA. Optimal treatment of femoral neck fractures according to patient’s physiologic age: an evidence-based review. Orthop Clin North Am. 2010;41(2):157-166.
24. Callaghan JJ, Liu SS, Haidukewych GJ. Subcapital fractures: a changing paradigm. J Bone Joint Surg Br. 2012;94(11 suppl A):19-21.
At our institution, LALB has shortened our hospital stay.
There is a trend towards decreased opioid consumption with LALB.
With the opioid epidemic we face today, LALB can be one of many options in our toolbox towards a solution.
As stated in prior publications, the effectiveness of LALB is definitely technique dependent.
Additional clinical studies are warranted to better determine the efficacy and cost-effectiveness of LALB.
Almost 1 million total knee arthroplasties (TKAs) are performed in the United States each year, and the number continues to grow.1.2 For patients about to undergo TKA, a significant concern is postoperative pain.3 Fear of postoperative pain is often cited as a reason for delaying surgery.3 Recent literature suggests that patients with poor pain management during the first 48 hours after surgery have a 50% chance of gaining satisfactory long-term pain relief.4 In addition, inadequate postoperative pain management can interfere with participation in and progression of physical rehabilitation, prolong hospital stay, and increase patient dissatisfaction.5 Poorly controlled pain results in decreased range of motion (ROM), strength, stability, and ambulation thereby prolongs hospital stays, and increases costs and overall dissatisfaction with the procedure.
Post-TKA pain management has received much attention in recent years. A multimodal pain management protocol is now a key component of clinical pathways in TKA. Appropriate postoperative pain control lowers postoperative complications and accelerates recovery.6 Pain-caused loss of function makes surgical patients more susceptible to edema, deep vein thrombosis, and pulmonary embolism.4 Various oral and intravenous medications are used to lessen the pain response during the perioperative period. In addition, regional or neuraxial anesthesia is often added to blunt the immediate surgical pain response.7,8 At our institution, TKA traditionally has been performed with femoral nerve catheters (FNCs) for postoperative pain control. Although effective, this method often results in decreased quadriceps musculature function, which delays rehabilitation and increases the fall risk. Recently, there has been a shift toward using local anesthetic infusions about the knee to provide adequate pain relief and restore motor function, which is often sacrificed with use of regional nerve blocks and continuous catheter infusions.9
Many institutions have started using a new long-acting local anesthetic in their multimodal pain management pathways: Exparel (Pacira Pharmaceuticals), a liposomal membrane-bound bupivacaine with sustained release of approximately 72 hours. Several studies have verified the safety of this medication.10 A systemic review of prospective studies revealed that, compared with bupivacaine, long-acting liposomal bupivacaine (LALB) in therapeutic doses had a higher safety margin and a favorable safety profile.10 However, no study has compared the effectiveness of LALB and FNC in a matched TKA cohort with each patient serving as his or her own control.
We recently reviewed our multimodal pain management protocol for any areas in need of improvement and decided to compare the effects of the indwelling FNC protocol that was in use with the effects of injecting the local anesthetic LALB. We conducted a study to compare the 2 methods with respect to pain control, ROM, ability to ambulate, and hospital length of stay (LOS). We hypothesized that the longer acting local anesthetic would provide comparable post-TKA pain control and post-TKA opioid use but would accelerate post-TKA rehabilitation.
Materials and Methods
This retrospective, longitudinal, repeated- measures study was approved by the Greenville Hospital System Institutional Review Board and conducted at the Steadman Hawkins Clinic of the Carolinas, Greenville Health System.
Interventions
Twenty-three patients underwent separately staged bilateral TKAs between 2010 and 2013. For each TKA, a Genesis II implant (Smith & Nephew) was used, and the surgery was performed with the patient under spinal anesthesia. In each case, FNC was used for pain control after the first TKA, and periarticular injection (PAI) of LALB for pain control after the second TKA.
In the first TKAs, FNC-administered ropivacaine 0.2% (2 mg/mL) was maintained at a standard basal rate of 8 mL/h for 48 hours. In the second TKAs, LALB was administered along with bupivacaine/epinephrine. Twenty milliliters of LALB from a single-use vial was diluted in 40 mL of normal (0.9%) saline to obtain a 60-mL solution, and a 25-gauge needle was used to inject this solution into the periarticular soft tissues; another needle was used for PAI of 30 mL of bupivacaine 0.25% with epinephrine.
Continuous passive motion devices were not used. Most patients began therapy on day of surgery. Knee immobilizers were not used in the FNC group.
The same standardized multimodal pain management protocol was used for all TKAs. Non- narcotic medications, including acetaminophen, ketorolac, and celecoxib, were given on a scheduled basis. Tramadol and opioid medications were administered as needed for pain. The attending physician based patient discharge timing on pain control, ability to safely ambulate, and absence of complications.
Outcome Measures
Outcome measures were LOS; extension and flexion at discharge and 3-week follow-up; total ROM (extension plus flexion) at discharge and 3-week follow-up; per-day and total hospital stay morphine -equivalent doses (MEDs); and per-attempt walking distance during gait training.
ROM was measured with a standard goniometer. Flexion was tested with the patient supine and the hip and knee in neutral rotation. The goniometer axis was along the lateral epicondyle of the femur with the proximal arm of the goniometer parallel to the long axis of the femur and pointing at the greater trochanter and with the distal arm parallel to the long axis of the fibula and pointing at the lateral malleolus. The patient was instructed to flex the hip and knee by moving the heel toward the buttock. Expected normal ROM is 135°. The same landmarks were used for extension. The patient was instructed to push the back of the knee toward the plinth/bed, for maximal active extension. The same ROM assessment strategy was used during the hospitalization and at the 3-week follow-up.
Several opioid medications (eg, hydrocodone, oxycodone, tramadol, hydromorphone, morphine) with different dosages were used during hospitalization. Opioid doses were converted to MEDs to permit FNC–LALB comparisons. For each patient, total MEDs were divided by LOS to determine MEDs per day.
Mean per-attempt walking distance was calculated by dividing the total distance walked during hospitalization—the sum of the number of feet walked during each and every attempt, as measured by the treating physical therapist—by the total number of walking attempts.
Data Analysis
A paired-samples t test was used to calculate differences between all outcome measures: LOS; extension and flexion at discharge and 3-month follow-up; per-day and total MEDs; and mean per-attempt walking distance. P < .05 was considered significant. We elected not to adjust our α for a potential familywise error.
Results
Of the 23 patients, 14 were female and 9 were male, and 19 were white and 4 were black. Mean (SD) age was 64.4 (6.4) years for the FNC group and 66.0 (6.0) years for the LALB group. The age difference was not statistically significant.
Table.Statistically significant differences favoring LALB over FNC were found for mean LOS (LALB, 2.3 days; FNC, 2.8 days; P < .01), mean per-attempt walking distance (LALB, 135.9 feet; FNC, 84.2 feet; P < .01), and mean total ROM at 3-week follow-up (LALB, 116.3°; FNC, 107.2°; P = .02). Furthermore, a statistically significant difference was found for mean total MEDs during hospitalization (LALB, 145.47; FNC, 214.30; P = .02) (Table). In addition, there was a nonsignificant trend toward less drug administration.
Discussion
Poor pain control during the post-TKA period may have a significant impact on recovery rate, standard of living, psychological health, and postoperative complications.10 Inadequate postoperative pain control increases postoperative morbidity, hinders physiotherapy, increases anxiety, disrupts sleep patterns, and decreases patient satisfaction.9 There has been increased interest in PAIs. Local anesthetics are additional sources of pain control at surgical sites. However, the half-life of most local anesthetics is short. Soft-tissue infiltration of LALB into a surgical site extends the duration of active analgesia. Our study found that, compared with patients who received FNC, patients who received LALB had comparable pain control, improved knee ROM, and shorter hospital stays. In addition, the LALB group had no reports of quadriceps weakness or falls, both of which are associated with femoral nerve blocks. The FNC group had no reported falls, either. PAIs have the benefit of avoiding the invasiveness of femoral nerve blocks and possible neuritis.
Many complications are associated with or indirectly related to delayed rehabilitation and immobility during the acute post-TKA period. From prolonged hospitalization to need for manipulation, the consequences of inadequate pain control and decreased function can be numerous and costly for patients and the healthcare system. In the present study, LALB use led to a statistically significant overall decrease in mean LOS (LALB group, 2.3 days; FNC, 2.8 days). With LALB, there was a higher likelihood of discharge the day after surgery; 20% of patients in the LALB group and no patients in the FNC group went home that day.
The implication is that inadequate pain control led to decreased motion and decreased progression during postoperative rehabilitation. Local infiltration resulted in increased total ROM (extension plus flexion) at 3-week follow-up (LALB, 116.3°; FNC, 107.2°). In addition, there was an increase in walking distance per day of hospital stay (LALB, 135.9 feet; FNC, 84.2 feet). Furthermore, patients indicated LALB when asked which anesthetic they preferred. To our knowledge, this is the first study to compare LALB and FNC data in a matched TKA cohort with each patient serving as his or her own control.
Our study had several limitations. First was the retrospective design. Second was the small sample size, which made definitive conclusions difficult. However, the statistically significant differences we noted validated our conclusions. A statistically significant difference favoring LALB over FNC was found for total MEDs during hospitalization, but there was no significant difference in per-day MEDs. A possible reason for this difference is that LALB patients had shorter hospital stays, and therefore received fewer doses overall. Another possible reason is the small sample size; whereas a larger study using our protocol may find a statistically significant difference between LALB and FNC, we found only a trend. In the FNC group, anesthetic infiltration occurred with use of a computerized pump, which was removed on postoperative day 2; most of these patients were discharged home that day or the morning of postoperative day 3. As it is possible that some of these patients could have gone home sooner, our LOS data may have been affected. We do not consider this limitation significant, as one of our discharge criteria was 150 feet of ambulation, and most patients who received FNCs could not ambulate that far until after FNC removal. Furthermore, this study compared LALB only with FNC. It is possible that our improved outcomes could have resulted from the PAIs themselves, irrespective of LALB. In a recent TKA study by Bagsby and colleagues,11 pain was controlled better with the less expensive traditional PAI of ropivacaine, epinephrine, and morphine than with the PAI of liposomal bupivacaine. Last, in our study, the experience of undergoing the first TKA may have increased patients’ confidence going into the second TKA and then helped them make faster progress in rehabilitation. Regardless, the promising results of our study and the firsthand use of LALB at our institution led us to modify our intraoperative pain management protocol for surgeons who perform TKA.
As we continue to use LALB, our study numbers will increase, and we may discover other factors that, though now underpowered, will prove to be statistically significant. Additional clinical studies are needed to better determine the efficacy and cost-effectiveness of LALB and other long-acting local anesthetic formulations.
References
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785.
2. Ruiz D Jr, Koenig L, Dall TM, et al. The direct and indirect costs to society of treatment for end-stage knee osteoarthritis. J Bone Joint Surg Am. 2013;95(16):1473-1480.
3. Trousdale RT, McGrory BJ, Berry DJ, Becker MW, Harmsen WS. Patients’ concerns prior to undergoing total hip and total knee arthroplasty. Mayo Clin Proc. 1999;74(10):978-982.
4. Wells N, Pasero C, McCaffery M. Improving the quality of care through pain assessment and management. In: Hughes RG, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses, Vol 1.Rockville, MD: Agency for Healthcare Research and Quality; 2008:469-497.
5. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10(4):287-333.
6. Parvizi J, Miller AG, Gandhi K. Multimodal pain management after total joint arthroplasty. J Bone Joint Surg Am. 2011;93(11):1075-1084.
7. Stein BE, Srikumaran U, Tan EW, Freehill MT, Wilckens JH. Lower-extremity peripheral nerve blocks in the perioperative pain management of orthopaedic patients: AAOS exhibit selection. J Bone Joint Surg Am. 2012;94(22):e167.
8. Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013;95(3):193-199.
9. Dalury DF, Lieberman JR, MacDonald SJ. Current and innovative pain management techniques in total knee arthroplasty. J Bone Joint Surg Am. 2011;93(20):1938-1943.
10. Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014;5:90.
11. Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014;29(8):1687-1690.
At our institution, LALB has shortened our hospital stay.
There is a trend towards decreased opioid consumption with LALB.
With the opioid epidemic we face today, LALB can be one of many options in our toolbox towards a solution.
As stated in prior publications, the effectiveness of LALB is definitely technique dependent.
Additional clinical studies are warranted to better determine the efficacy and cost-effectiveness of LALB.
Almost 1 million total knee arthroplasties (TKAs) are performed in the United States each year, and the number continues to grow.1.2 For patients about to undergo TKA, a significant concern is postoperative pain.3 Fear of postoperative pain is often cited as a reason for delaying surgery.3 Recent literature suggests that patients with poor pain management during the first 48 hours after surgery have a 50% chance of gaining satisfactory long-term pain relief.4 In addition, inadequate postoperative pain management can interfere with participation in and progression of physical rehabilitation, prolong hospital stay, and increase patient dissatisfaction.5 Poorly controlled pain results in decreased range of motion (ROM), strength, stability, and ambulation thereby prolongs hospital stays, and increases costs and overall dissatisfaction with the procedure.
Post-TKA pain management has received much attention in recent years. A multimodal pain management protocol is now a key component of clinical pathways in TKA. Appropriate postoperative pain control lowers postoperative complications and accelerates recovery.6 Pain-caused loss of function makes surgical patients more susceptible to edema, deep vein thrombosis, and pulmonary embolism.4 Various oral and intravenous medications are used to lessen the pain response during the perioperative period. In addition, regional or neuraxial anesthesia is often added to blunt the immediate surgical pain response.7,8 At our institution, TKA traditionally has been performed with femoral nerve catheters (FNCs) for postoperative pain control. Although effective, this method often results in decreased quadriceps musculature function, which delays rehabilitation and increases the fall risk. Recently, there has been a shift toward using local anesthetic infusions about the knee to provide adequate pain relief and restore motor function, which is often sacrificed with use of regional nerve blocks and continuous catheter infusions.9
Many institutions have started using a new long-acting local anesthetic in their multimodal pain management pathways: Exparel (Pacira Pharmaceuticals), a liposomal membrane-bound bupivacaine with sustained release of approximately 72 hours. Several studies have verified the safety of this medication.10 A systemic review of prospective studies revealed that, compared with bupivacaine, long-acting liposomal bupivacaine (LALB) in therapeutic doses had a higher safety margin and a favorable safety profile.10 However, no study has compared the effectiveness of LALB and FNC in a matched TKA cohort with each patient serving as his or her own control.
We recently reviewed our multimodal pain management protocol for any areas in need of improvement and decided to compare the effects of the indwelling FNC protocol that was in use with the effects of injecting the local anesthetic LALB. We conducted a study to compare the 2 methods with respect to pain control, ROM, ability to ambulate, and hospital length of stay (LOS). We hypothesized that the longer acting local anesthetic would provide comparable post-TKA pain control and post-TKA opioid use but would accelerate post-TKA rehabilitation.
Materials and Methods
This retrospective, longitudinal, repeated- measures study was approved by the Greenville Hospital System Institutional Review Board and conducted at the Steadman Hawkins Clinic of the Carolinas, Greenville Health System.
Interventions
Twenty-three patients underwent separately staged bilateral TKAs between 2010 and 2013. For each TKA, a Genesis II implant (Smith & Nephew) was used, and the surgery was performed with the patient under spinal anesthesia. In each case, FNC was used for pain control after the first TKA, and periarticular injection (PAI) of LALB for pain control after the second TKA.
In the first TKAs, FNC-administered ropivacaine 0.2% (2 mg/mL) was maintained at a standard basal rate of 8 mL/h for 48 hours. In the second TKAs, LALB was administered along with bupivacaine/epinephrine. Twenty milliliters of LALB from a single-use vial was diluted in 40 mL of normal (0.9%) saline to obtain a 60-mL solution, and a 25-gauge needle was used to inject this solution into the periarticular soft tissues; another needle was used for PAI of 30 mL of bupivacaine 0.25% with epinephrine.
Continuous passive motion devices were not used. Most patients began therapy on day of surgery. Knee immobilizers were not used in the FNC group.
The same standardized multimodal pain management protocol was used for all TKAs. Non- narcotic medications, including acetaminophen, ketorolac, and celecoxib, were given on a scheduled basis. Tramadol and opioid medications were administered as needed for pain. The attending physician based patient discharge timing on pain control, ability to safely ambulate, and absence of complications.
Outcome Measures
Outcome measures were LOS; extension and flexion at discharge and 3-week follow-up; total ROM (extension plus flexion) at discharge and 3-week follow-up; per-day and total hospital stay morphine -equivalent doses (MEDs); and per-attempt walking distance during gait training.
ROM was measured with a standard goniometer. Flexion was tested with the patient supine and the hip and knee in neutral rotation. The goniometer axis was along the lateral epicondyle of the femur with the proximal arm of the goniometer parallel to the long axis of the femur and pointing at the greater trochanter and with the distal arm parallel to the long axis of the fibula and pointing at the lateral malleolus. The patient was instructed to flex the hip and knee by moving the heel toward the buttock. Expected normal ROM is 135°. The same landmarks were used for extension. The patient was instructed to push the back of the knee toward the plinth/bed, for maximal active extension. The same ROM assessment strategy was used during the hospitalization and at the 3-week follow-up.
Several opioid medications (eg, hydrocodone, oxycodone, tramadol, hydromorphone, morphine) with different dosages were used during hospitalization. Opioid doses were converted to MEDs to permit FNC–LALB comparisons. For each patient, total MEDs were divided by LOS to determine MEDs per day.
Mean per-attempt walking distance was calculated by dividing the total distance walked during hospitalization—the sum of the number of feet walked during each and every attempt, as measured by the treating physical therapist—by the total number of walking attempts.
Data Analysis
A paired-samples t test was used to calculate differences between all outcome measures: LOS; extension and flexion at discharge and 3-month follow-up; per-day and total MEDs; and mean per-attempt walking distance. P < .05 was considered significant. We elected not to adjust our α for a potential familywise error.
Results
Of the 23 patients, 14 were female and 9 were male, and 19 were white and 4 were black. Mean (SD) age was 64.4 (6.4) years for the FNC group and 66.0 (6.0) years for the LALB group. The age difference was not statistically significant.
Table.Statistically significant differences favoring LALB over FNC were found for mean LOS (LALB, 2.3 days; FNC, 2.8 days; P < .01), mean per-attempt walking distance (LALB, 135.9 feet; FNC, 84.2 feet; P < .01), and mean total ROM at 3-week follow-up (LALB, 116.3°; FNC, 107.2°; P = .02). Furthermore, a statistically significant difference was found for mean total MEDs during hospitalization (LALB, 145.47; FNC, 214.30; P = .02) (Table). In addition, there was a nonsignificant trend toward less drug administration.
Discussion
Poor pain control during the post-TKA period may have a significant impact on recovery rate, standard of living, psychological health, and postoperative complications.10 Inadequate postoperative pain control increases postoperative morbidity, hinders physiotherapy, increases anxiety, disrupts sleep patterns, and decreases patient satisfaction.9 There has been increased interest in PAIs. Local anesthetics are additional sources of pain control at surgical sites. However, the half-life of most local anesthetics is short. Soft-tissue infiltration of LALB into a surgical site extends the duration of active analgesia. Our study found that, compared with patients who received FNC, patients who received LALB had comparable pain control, improved knee ROM, and shorter hospital stays. In addition, the LALB group had no reports of quadriceps weakness or falls, both of which are associated with femoral nerve blocks. The FNC group had no reported falls, either. PAIs have the benefit of avoiding the invasiveness of femoral nerve blocks and possible neuritis.
Many complications are associated with or indirectly related to delayed rehabilitation and immobility during the acute post-TKA period. From prolonged hospitalization to need for manipulation, the consequences of inadequate pain control and decreased function can be numerous and costly for patients and the healthcare system. In the present study, LALB use led to a statistically significant overall decrease in mean LOS (LALB group, 2.3 days; FNC, 2.8 days). With LALB, there was a higher likelihood of discharge the day after surgery; 20% of patients in the LALB group and no patients in the FNC group went home that day.
The implication is that inadequate pain control led to decreased motion and decreased progression during postoperative rehabilitation. Local infiltration resulted in increased total ROM (extension plus flexion) at 3-week follow-up (LALB, 116.3°; FNC, 107.2°). In addition, there was an increase in walking distance per day of hospital stay (LALB, 135.9 feet; FNC, 84.2 feet). Furthermore, patients indicated LALB when asked which anesthetic they preferred. To our knowledge, this is the first study to compare LALB and FNC data in a matched TKA cohort with each patient serving as his or her own control.
Our study had several limitations. First was the retrospective design. Second was the small sample size, which made definitive conclusions difficult. However, the statistically significant differences we noted validated our conclusions. A statistically significant difference favoring LALB over FNC was found for total MEDs during hospitalization, but there was no significant difference in per-day MEDs. A possible reason for this difference is that LALB patients had shorter hospital stays, and therefore received fewer doses overall. Another possible reason is the small sample size; whereas a larger study using our protocol may find a statistically significant difference between LALB and FNC, we found only a trend. In the FNC group, anesthetic infiltration occurred with use of a computerized pump, which was removed on postoperative day 2; most of these patients were discharged home that day or the morning of postoperative day 3. As it is possible that some of these patients could have gone home sooner, our LOS data may have been affected. We do not consider this limitation significant, as one of our discharge criteria was 150 feet of ambulation, and most patients who received FNCs could not ambulate that far until after FNC removal. Furthermore, this study compared LALB only with FNC. It is possible that our improved outcomes could have resulted from the PAIs themselves, irrespective of LALB. In a recent TKA study by Bagsby and colleagues,11 pain was controlled better with the less expensive traditional PAI of ropivacaine, epinephrine, and morphine than with the PAI of liposomal bupivacaine. Last, in our study, the experience of undergoing the first TKA may have increased patients’ confidence going into the second TKA and then helped them make faster progress in rehabilitation. Regardless, the promising results of our study and the firsthand use of LALB at our institution led us to modify our intraoperative pain management protocol for surgeons who perform TKA.
As we continue to use LALB, our study numbers will increase, and we may discover other factors that, though now underpowered, will prove to be statistically significant. Additional clinical studies are needed to better determine the efficacy and cost-effectiveness of LALB and other long-acting local anesthetic formulations.
Take-Home Points
At our institution, LALB has shortened our hospital stay.
There is a trend towards decreased opioid consumption with LALB.
With the opioid epidemic we face today, LALB can be one of many options in our toolbox towards a solution.
As stated in prior publications, the effectiveness of LALB is definitely technique dependent.
Additional clinical studies are warranted to better determine the efficacy and cost-effectiveness of LALB.
Almost 1 million total knee arthroplasties (TKAs) are performed in the United States each year, and the number continues to grow.1.2 For patients about to undergo TKA, a significant concern is postoperative pain.3 Fear of postoperative pain is often cited as a reason for delaying surgery.3 Recent literature suggests that patients with poor pain management during the first 48 hours after surgery have a 50% chance of gaining satisfactory long-term pain relief.4 In addition, inadequate postoperative pain management can interfere with participation in and progression of physical rehabilitation, prolong hospital stay, and increase patient dissatisfaction.5 Poorly controlled pain results in decreased range of motion (ROM), strength, stability, and ambulation thereby prolongs hospital stays, and increases costs and overall dissatisfaction with the procedure.
Post-TKA pain management has received much attention in recent years. A multimodal pain management protocol is now a key component of clinical pathways in TKA. Appropriate postoperative pain control lowers postoperative complications and accelerates recovery.6 Pain-caused loss of function makes surgical patients more susceptible to edema, deep vein thrombosis, and pulmonary embolism.4 Various oral and intravenous medications are used to lessen the pain response during the perioperative period. In addition, regional or neuraxial anesthesia is often added to blunt the immediate surgical pain response.7,8 At our institution, TKA traditionally has been performed with femoral nerve catheters (FNCs) for postoperative pain control. Although effective, this method often results in decreased quadriceps musculature function, which delays rehabilitation and increases the fall risk. Recently, there has been a shift toward using local anesthetic infusions about the knee to provide adequate pain relief and restore motor function, which is often sacrificed with use of regional nerve blocks and continuous catheter infusions.9
Many institutions have started using a new long-acting local anesthetic in their multimodal pain management pathways: Exparel (Pacira Pharmaceuticals), a liposomal membrane-bound bupivacaine with sustained release of approximately 72 hours. Several studies have verified the safety of this medication.10 A systemic review of prospective studies revealed that, compared with bupivacaine, long-acting liposomal bupivacaine (LALB) in therapeutic doses had a higher safety margin and a favorable safety profile.10 However, no study has compared the effectiveness of LALB and FNC in a matched TKA cohort with each patient serving as his or her own control.
We recently reviewed our multimodal pain management protocol for any areas in need of improvement and decided to compare the effects of the indwelling FNC protocol that was in use with the effects of injecting the local anesthetic LALB. We conducted a study to compare the 2 methods with respect to pain control, ROM, ability to ambulate, and hospital length of stay (LOS). We hypothesized that the longer acting local anesthetic would provide comparable post-TKA pain control and post-TKA opioid use but would accelerate post-TKA rehabilitation.
Materials and Methods
This retrospective, longitudinal, repeated- measures study was approved by the Greenville Hospital System Institutional Review Board and conducted at the Steadman Hawkins Clinic of the Carolinas, Greenville Health System.
Interventions
Twenty-three patients underwent separately staged bilateral TKAs between 2010 and 2013. For each TKA, a Genesis II implant (Smith & Nephew) was used, and the surgery was performed with the patient under spinal anesthesia. In each case, FNC was used for pain control after the first TKA, and periarticular injection (PAI) of LALB for pain control after the second TKA.
In the first TKAs, FNC-administered ropivacaine 0.2% (2 mg/mL) was maintained at a standard basal rate of 8 mL/h for 48 hours. In the second TKAs, LALB was administered along with bupivacaine/epinephrine. Twenty milliliters of LALB from a single-use vial was diluted in 40 mL of normal (0.9%) saline to obtain a 60-mL solution, and a 25-gauge needle was used to inject this solution into the periarticular soft tissues; another needle was used for PAI of 30 mL of bupivacaine 0.25% with epinephrine.
Continuous passive motion devices were not used. Most patients began therapy on day of surgery. Knee immobilizers were not used in the FNC group.
The same standardized multimodal pain management protocol was used for all TKAs. Non- narcotic medications, including acetaminophen, ketorolac, and celecoxib, were given on a scheduled basis. Tramadol and opioid medications were administered as needed for pain. The attending physician based patient discharge timing on pain control, ability to safely ambulate, and absence of complications.
Outcome Measures
Outcome measures were LOS; extension and flexion at discharge and 3-week follow-up; total ROM (extension plus flexion) at discharge and 3-week follow-up; per-day and total hospital stay morphine -equivalent doses (MEDs); and per-attempt walking distance during gait training.
ROM was measured with a standard goniometer. Flexion was tested with the patient supine and the hip and knee in neutral rotation. The goniometer axis was along the lateral epicondyle of the femur with the proximal arm of the goniometer parallel to the long axis of the femur and pointing at the greater trochanter and with the distal arm parallel to the long axis of the fibula and pointing at the lateral malleolus. The patient was instructed to flex the hip and knee by moving the heel toward the buttock. Expected normal ROM is 135°. The same landmarks were used for extension. The patient was instructed to push the back of the knee toward the plinth/bed, for maximal active extension. The same ROM assessment strategy was used during the hospitalization and at the 3-week follow-up.
Several opioid medications (eg, hydrocodone, oxycodone, tramadol, hydromorphone, morphine) with different dosages were used during hospitalization. Opioid doses were converted to MEDs to permit FNC–LALB comparisons. For each patient, total MEDs were divided by LOS to determine MEDs per day.
Mean per-attempt walking distance was calculated by dividing the total distance walked during hospitalization—the sum of the number of feet walked during each and every attempt, as measured by the treating physical therapist—by the total number of walking attempts.
Data Analysis
A paired-samples t test was used to calculate differences between all outcome measures: LOS; extension and flexion at discharge and 3-month follow-up; per-day and total MEDs; and mean per-attempt walking distance. P < .05 was considered significant. We elected not to adjust our α for a potential familywise error.
Results
Of the 23 patients, 14 were female and 9 were male, and 19 were white and 4 were black. Mean (SD) age was 64.4 (6.4) years for the FNC group and 66.0 (6.0) years for the LALB group. The age difference was not statistically significant.
Table.Statistically significant differences favoring LALB over FNC were found for mean LOS (LALB, 2.3 days; FNC, 2.8 days; P < .01), mean per-attempt walking distance (LALB, 135.9 feet; FNC, 84.2 feet; P < .01), and mean total ROM at 3-week follow-up (LALB, 116.3°; FNC, 107.2°; P = .02). Furthermore, a statistically significant difference was found for mean total MEDs during hospitalization (LALB, 145.47; FNC, 214.30; P = .02) (Table). In addition, there was a nonsignificant trend toward less drug administration.
Discussion
Poor pain control during the post-TKA period may have a significant impact on recovery rate, standard of living, psychological health, and postoperative complications.10 Inadequate postoperative pain control increases postoperative morbidity, hinders physiotherapy, increases anxiety, disrupts sleep patterns, and decreases patient satisfaction.9 There has been increased interest in PAIs. Local anesthetics are additional sources of pain control at surgical sites. However, the half-life of most local anesthetics is short. Soft-tissue infiltration of LALB into a surgical site extends the duration of active analgesia. Our study found that, compared with patients who received FNC, patients who received LALB had comparable pain control, improved knee ROM, and shorter hospital stays. In addition, the LALB group had no reports of quadriceps weakness or falls, both of which are associated with femoral nerve blocks. The FNC group had no reported falls, either. PAIs have the benefit of avoiding the invasiveness of femoral nerve blocks and possible neuritis.
Many complications are associated with or indirectly related to delayed rehabilitation and immobility during the acute post-TKA period. From prolonged hospitalization to need for manipulation, the consequences of inadequate pain control and decreased function can be numerous and costly for patients and the healthcare system. In the present study, LALB use led to a statistically significant overall decrease in mean LOS (LALB group, 2.3 days; FNC, 2.8 days). With LALB, there was a higher likelihood of discharge the day after surgery; 20% of patients in the LALB group and no patients in the FNC group went home that day.
The implication is that inadequate pain control led to decreased motion and decreased progression during postoperative rehabilitation. Local infiltration resulted in increased total ROM (extension plus flexion) at 3-week follow-up (LALB, 116.3°; FNC, 107.2°). In addition, there was an increase in walking distance per day of hospital stay (LALB, 135.9 feet; FNC, 84.2 feet). Furthermore, patients indicated LALB when asked which anesthetic they preferred. To our knowledge, this is the first study to compare LALB and FNC data in a matched TKA cohort with each patient serving as his or her own control.
Our study had several limitations. First was the retrospective design. Second was the small sample size, which made definitive conclusions difficult. However, the statistically significant differences we noted validated our conclusions. A statistically significant difference favoring LALB over FNC was found for total MEDs during hospitalization, but there was no significant difference in per-day MEDs. A possible reason for this difference is that LALB patients had shorter hospital stays, and therefore received fewer doses overall. Another possible reason is the small sample size; whereas a larger study using our protocol may find a statistically significant difference between LALB and FNC, we found only a trend. In the FNC group, anesthetic infiltration occurred with use of a computerized pump, which was removed on postoperative day 2; most of these patients were discharged home that day or the morning of postoperative day 3. As it is possible that some of these patients could have gone home sooner, our LOS data may have been affected. We do not consider this limitation significant, as one of our discharge criteria was 150 feet of ambulation, and most patients who received FNCs could not ambulate that far until after FNC removal. Furthermore, this study compared LALB only with FNC. It is possible that our improved outcomes could have resulted from the PAIs themselves, irrespective of LALB. In a recent TKA study by Bagsby and colleagues,11 pain was controlled better with the less expensive traditional PAI of ropivacaine, epinephrine, and morphine than with the PAI of liposomal bupivacaine. Last, in our study, the experience of undergoing the first TKA may have increased patients’ confidence going into the second TKA and then helped them make faster progress in rehabilitation. Regardless, the promising results of our study and the firsthand use of LALB at our institution led us to modify our intraoperative pain management protocol for surgeons who perform TKA.
As we continue to use LALB, our study numbers will increase, and we may discover other factors that, though now underpowered, will prove to be statistically significant. Additional clinical studies are needed to better determine the efficacy and cost-effectiveness of LALB and other long-acting local anesthetic formulations.
References
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785.
2. Ruiz D Jr, Koenig L, Dall TM, et al. The direct and indirect costs to society of treatment for end-stage knee osteoarthritis. J Bone Joint Surg Am. 2013;95(16):1473-1480.
3. Trousdale RT, McGrory BJ, Berry DJ, Becker MW, Harmsen WS. Patients’ concerns prior to undergoing total hip and total knee arthroplasty. Mayo Clin Proc. 1999;74(10):978-982.
4. Wells N, Pasero C, McCaffery M. Improving the quality of care through pain assessment and management. In: Hughes RG, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses, Vol 1.Rockville, MD: Agency for Healthcare Research and Quality; 2008:469-497.
5. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10(4):287-333.
6. Parvizi J, Miller AG, Gandhi K. Multimodal pain management after total joint arthroplasty. J Bone Joint Surg Am. 2011;93(11):1075-1084.
7. Stein BE, Srikumaran U, Tan EW, Freehill MT, Wilckens JH. Lower-extremity peripheral nerve blocks in the perioperative pain management of orthopaedic patients: AAOS exhibit selection. J Bone Joint Surg Am. 2012;94(22):e167.
8. Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013;95(3):193-199.
9. Dalury DF, Lieberman JR, MacDonald SJ. Current and innovative pain management techniques in total knee arthroplasty. J Bone Joint Surg Am. 2011;93(20):1938-1943.
10. Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014;5:90.
11. Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014;29(8):1687-1690.
References
1. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007;89(4):780-785.
2. Ruiz D Jr, Koenig L, Dall TM, et al. The direct and indirect costs to society of treatment for end-stage knee osteoarthritis. J Bone Joint Surg Am. 2013;95(16):1473-1480.
3. Trousdale RT, McGrory BJ, Berry DJ, Becker MW, Harmsen WS. Patients’ concerns prior to undergoing total hip and total knee arthroplasty. Mayo Clin Proc. 1999;74(10):978-982.
4. Wells N, Pasero C, McCaffery M. Improving the quality of care through pain assessment and management. In: Hughes RG, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses, Vol 1.Rockville, MD: Agency for Healthcare Research and Quality; 2008:469-497.
5. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10(4):287-333.
6. Parvizi J, Miller AG, Gandhi K. Multimodal pain management after total joint arthroplasty. J Bone Joint Surg Am. 2011;93(11):1075-1084.
7. Stein BE, Srikumaran U, Tan EW, Freehill MT, Wilckens JH. Lower-extremity peripheral nerve blocks in the perioperative pain management of orthopaedic patients: AAOS exhibit selection. J Bone Joint Surg Am. 2012;94(22):e167.
8. Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013;95(3):193-199.
9. Dalury DF, Lieberman JR, MacDonald SJ. Current and innovative pain management techniques in total knee arthroplasty. J Bone Joint Surg Am. 2011;93(20):1938-1943.
10. Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014;5:90.
11. Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014;29(8):1687-1690.
SSIs after TJA pose a substantial burden on patients, surgeons, and the healthcare system.
While different forms of preoperative skin preparation have shown varying outcomes after TJA, the importance of preoperative patient optimization (nutritional status, immune function, etc) cannot be overstated.
Intraoperative infection prevention measures include cutaneous preparation, gloving, body exhaust suits, surgical drapes, OR staff traffic and ventilation flow, and antibiotic-loaded cement.
Antibiotic prophylaxis for dental procedures in TJA patients continues to remain a controversial issue with conflicting recommendations.
SSIs have considerable financial costs and require increased resource utilization. Given the significant economic burden associated with TJA infections, it is imperative for orthopedists to establish practical and cost-effective strategies to prevent these devastating complications.
Surgical-site infection (SSI), a potentially devastating complication of lower extremity total joint arthroplasty (TJA), is estimated to occur in 1% to 2.5% of cases annually.1 Infection after TJA places a significant burden on patients, surgeons, and the healthcare system. Revision procedures that address infection after total hip arthroplasty (THA) are associated with more hospitalizations, more operations, longer hospital stay, and higher outpatient costs in comparison with primary THAs and revision surgeries for aseptic loosening.2 If left untreated, a SSI can go deeper into the joint and develop into a periprosthetic infection, which can be disastrous and costly. A periprosthetic joint infection study that used 2001 to 2009 Nationwide Inpatient Sample (NIS) data found that the cost of revision procedures increased to $560 million from $320 million, and was projected to reach $1.62 billion by 2020.3 Furthermore, society incurs indirect costs as a result of patient disability and loss of wages and productivity.2 Therefore, the issue of infection after TJA is even more crucial in our cost-conscious healthcare environment.
Patient optimization, advances in surgical technique, sterile protocol, and operative procedures have been effective in reducing bacterial counts at incision sites and minimizing SSIs. As a result, infection rates have leveled off after rising for a decade.4 Although infection prevention modalities have their differences, routine use is fundamental and recommended by the Hospital Infection Control Practices Advisory Committee.5 Furthermore, both the US Centers for Disease Control and Prevention (CDC) and its Healthcare Infection Control Practices Advisory Committee6,7 recently updated their SSI prevention guidelines by incorporating evidence-based methodology, an element missing from earlier recommendations.
The etiologies of postoperative SSIs have been discussed ad nauseam, but there are few reports summarizing the literature on infection prevention modalities. In this review, we identify and examine SSI prevention strategies as they relate to lower extremity TJA. Specifically, we discuss the literature on the preoperative, intraoperative, and postoperative actions that can be taken to reduce the incidence of SSIs after TJA. We also highlight the economic implications of SSIs that occur after TJA.
Methods
For this review, we performed a literature search with PubMed, EBSCOhost, and Scopus. We looked for reports published between the inception of each database and July 2016. Combinations of various search terms were used: surgical site, infection, total joint arthroplasty, knee, hip, preoperative, intraoperative, perioperative, postoperative, preparation, nutrition, ventilation, antibiotic, body exhaust suit, gloves, drain, costs, economic, and payment.
Our search identified 195 abstracts. Drs. Mistry and Chughtai reviewed these to determine which articles were relevant. For any uncertainties, consensus was reached with the help of Dr. Delanois. Of the 195 articles, 103 were potentially relevant, and 54 of the 103 were excluded for being not relevant to preventing SSIs after TJA or for being written in a language other than English. The references in the remaining articles were assessed, and those with potentially relevant titles were selected for abstract review. This step provided another 35 articles. After all exclusions, 48 articles remained. We discuss these in the context of preoperative, intraoperative, and postoperative measures and economic impact.
Results
Preoperative Measures
Skin Preparation. Preoperative skin preparation methods include standard washing and rinsing, antiseptic soaps, and iodine-based or chlorhexidine gluconate-based antiseptic showers or skin cloths. Iodine-based antiseptics are effective against a wide range of Gram-positive and Gram-negative bacteria, fungi, and viruses. These agents penetrate the cell wall, oxidize the microbial contents, and replace those contents with free iodine molecules.8 Iodophors are free iodine molecules associated with a polymer (eg, polyvinylpyrrolidone); the iodophor povidone-iodine is bactericidal.9 Chlorhexidine gluconate-based solutions are effective against many types of yeast, Gram-positive and Gram-negative bacteria, and a wide variety of viruses.9 Both solutions are useful. Patients with an allergy to iodine can use chlorhexidine. Table 1 summarizes the studies on preoperative measures for preventing SSIs.
Table 1A.
Table 1B.
There is no shortage of evidence of the efficacy of these antiseptics in minimizing the incidence of SSIs. Hayek and colleagues10 prospectively analyzed use of different preoperative skin preparation methods in 2015 patients. Six weeks after surgery, the infection rate was significantly lower with use of chlorhexidine than with use of an unmedicated bar of soap or placebo cloth (9% vs 11.7% and 12.8%, respectively; P < .05). In a study of 100 patients, Murray and colleagues11 found the overall bacterial culture rate was significantly lower for those who used a 2% chlorhexidine gluconate cloth before shoulder surgery than for those who took a standard shower with soap (66% vs 94%; P = .0008). Darouiche and colleagues12 found the overall SSI rate was significantly lower for 409 surgical patients prepared with chlorhexidine-alcohol than for 440 prepared with povidone-iodine (9.5% vs 16.1%; P = .004; relative risk [RR], 0.59; 95% confidence interval [CI], 0.41-0.85).
Chlorhexidine gluconate-impregnated cloths have also had promising results, which may be attributed to general ease of use and potentially improved patient adherence. Zywiel and colleagues13 reported no SSIs in 136 patients who used these cloths at home before total knee arthroplasty (TKA) and 21 SSIs (3.0%) in 711 patients who did not use the cloths. In a study of 2545 THA patients, Kapadia and colleagues14 noted a significantly lower incidence of SSIs with at-home preoperative use of chlorhexidine cloths than with only in-hospital perioperative skin preparation (0.5% vs 1.7%; P = .04). In 2293 TKAs, Johnson and colleagues15 similarly found a lower incidence of SSIs with at-home preoperative use of chlorhexidine cloths (0.6% vs 2.2%; P = .02). In another prospective, randomized trial, Kapadia and colleagues16 compared 275 patients who used chlorhexidine cloths the night before and the morning of lower extremity TJA surgery with 279 patients who underwent standard-of-care preparation (preadmission bathing with antibacterial soap and water). The chlorhexidine cohort had a lower overall incidence of infection (0.4% vs 2.9%; P = .049), and the standard-of-care cohort had a stronger association with infection (odds ratio [OR], 8.15; 95% CI, 1.01-65.6).
Patient Optimization. Poor nutritional status may compromise immune function, potentially resulting in delayed healing, increased risk of infection, and, ultimately, negative postoperative outcomes. Malnutrition can be diagnosed on the basis of a prealbumin level of <15 mg/dL (normal, 15-30 mg/dL), a serum albumin level of <3.4 g/dL (normal, 3.4-5.4 g/dL), or a total lymphocyte count under 1200 cells/μL (normal, 3900-10,000 cells/μL).17-19 Greene and colleagues18 found that patients with preoperative malnutrition had up to a 7-fold higher rate of infection after TJA. In a study of 135 THAs and TKAs, Alfargieny and colleagues20 found preoperative serum albumin was the only nutritional biomarker predictive of SSI (P = .011). Furthermore, patients who take immunomodulating medications (eg, for inflammatory arthropathies) should temporarily discontinue them before surgery in order to lower their risk of infection.21
Smoking is well established as a major risk factor for poor outcomes after surgery. It is postulated that the vasoconstrictive effects of nicotine and the hypoxic effects of carbon monoxide contribute to poor wound healing.22 In a meta-analysis of 4 studies, Sørensen23 found smokers were at increased risk for wound complications (OR, 2.27; 95% CI, 1.82-2.84), delayed wound healing and dehiscence (OR, 2.07; 95% CI, 1.53-2.81), and infection (OR, 1.79; 95% CI, 1.57-2.04). Moreover, smoking cessation decreased the incidence of SSIs (OR, 0.43; 95% CI, 0.21-0.85). A meta- analysis by Wong and colleagues24 revealed an inflection point for improved outcomes in patients who abstained from smoking for at least 4 weeks before surgery. Risk of infection was lower for these patients than for current smokers (OR, 0.69; 95% CI, 0.56-0.84).
Other comorbidities contribute to SSIs as well. In their analysis of American College of Surgeons National Surgical Quality Improvement Program registry data on 25,235 patients who underwent primary and revision lower extremity TJA, Pugely and colleagues25 found that, in the primary TJA cohort, body mass index (BMI) of >40 kg/m2 (OR, 1.9; 95% CI, 1.3-2.9), electrolyte disturbance (OR, 2.4; 95% CI, 1.0-6.0), and hypertension diagnosis (OR, 1.5; 95% CI, 1.1-2.0) increased the risk of SSI within 30 days. Furthermore, diabetes mellitus delays collagen synthesis, impairs lymphocyte function, and impairs wound healing, which may lead to poor recovery and higher risk of infection.26 In a study of 167 TKAs performed in 115 patients with type 2 diabetes mellitus, Han and Kang26 found that wound complications were 6 times more likely in those with hemoglobin A1c (HbA1c) levels higher than 8% than in those with lower HbA1c levels (OR, 6.07; 95% CI, 1.12-33.0). In a similar study of 462 patients with diabetes, Hwang and colleagues27 found a higher likelihood of superficial SSIs in patients with HbA1c levels >8% (OR, 6.1; 95% CI, 1.6-23.4; P = .008). This association was also found in patients with a fasting blood glucose level of >200 mg/dL (OR, 9.2; 95% CI, 2.2-38.2; P = .038).
Methicillin-resistant Staphylococcus aureus (MRSA) is thought to account for 10% to 25% of all periprosthetic infections in the United States.28 Nasal colonization by this pathogen increases the risk for SSIs; however, decolonization protocols have proved useful in decreasing the rates of colonization. Moroski and colleagues29 assessed the efficacy of a preoperative 5-day course of intranasal mupirocin in 289 primary or revision TJA patients. Before surgery, 12 patients had positive MRSA cultures, and 44 had positive methicillin-sensitive S aureus (MSSA) cultures. On day of surgery, a significant reduction in MRSA (P = .0073) and MSSA (P = .0341) colonization was noted. Rao and colleagues30 found that the infection rate decreased from 2.7% to 1.2% in 2284 TJA patients treated with a decolonization protocol (P = .009).
Intraoperative Measures
Cutaneous Preparation. The solutions used in perioperative skin preparation are similar to those used preoperatively: povidone-iodine, alcohol, and chlorhexidine. The efficacy of these preparations varies. Table 2 summarizes the studies on intraoperative measures for preventing SSIs.
Table 2A.
Table 2B.In a prospective study, Saltzman and colleagues31 randomly assigned 150 shoulder arthroplasty patients to one of 3 preparations: 0.75% iodine scrub with 1% iodine paint (Povidone-Iodine; Tyco Healthcare Group), 0.7% iodophor with 74% iodine povacrylex (DuraPrep; 3M Health Care), or chlorhexidine gluconate with 70% isopropyl alcohol (ChloraPrep; Enturia). All patients had their skin area prepared and swabbed for culture before incision. Although no one in any group developed a SSI, patients in the chlorhexidine group had the lowest overall incidence of positive skin cultures. That incidence (7%) and the incidence of patients in the iodophor group (19%) were significantly lower than that of patients in the iodine group (31%) (P < .001 for both). Conversely, another study32 found a higher likelihood of SSI with chlorhexidine than with povidone-iodine (OR, 4.75; 95% CI, 1.42-15.92; P = .012). This finding is controversial, but the body of evidence led the CDC to recommend use of an alcohol-based solution for preoperative skin preparation.6
The literature also highlights the importance of technique in incision-site preparation. In a prospective study, Morrison and colleagues33 randomly assigned 600 primary TJA patients to either (1) use of alcohol and povidone-iodine before draping, with additional preparation with iodine povacrylex (DuraPrep) and isopropyl alcohol before application of the final drape (300-patient intervention group) or (2) only use of alcohol and povidone-iodine before draping (300-patient control group). At the final follow-up, the incidence of SSI was significantly lower in the intervention group than in the control group (1.8% vs 6.5%; P = .015). In another study that assessed perioperative skin preparation methods, Brown and colleagues34 found that airborne bacteria levels in operating rooms were >4 times higher with patients whose legs were prepared by a scrubbed, gowned leg-holder than with patients whose legs were prepared by an unscrubbed, ungowned leg-holder (P = .0001).
Hair Removal. Although removing hair from surgical sites is common practice, the literature advocating it varies. A large comprehensive review35 revealed no increased risk of SSI with removing vs not removing hair (RR, 1.65; 95% CI, 0.85-3.19). On the other hand, some hair removal methods may affect the incidence of infection. For example, use of electric hair clippers is presumed to reduce the risk of SSIs, whereas traditional razors may compromise the epidermal barriers and create a pathway for bacterial colonization.5,36,37 In the aforementioned review,35 SSIs were more than twice as likely to occur with hair removed by shaving than with hair removed by electric clippers (RR, 2.02; 95% CI, 1.21-3.36). Cruse and Foord38 found a higher rate of SSIs with hair removed by shaving than with hair removed by clipping (2.3% vs 1.7%). Most surgeons agree that, if given the choice, they would remove hair with electric clippers rather than razors.
Gloves. Almost all orthopedists double their gloves for TJA cases. Over several studies, the incidence of glove perforation during orthopedic procedures has ranged from 3.6% to 26%,39-41 depending on the operating room personnel and glove layering studied. Orthopedists must know this startling finding, as surgical glove perforation is associated with an increase in the rate of SSIs, from 1.7% to 5.7%.38 Carter and colleagues42 found the highest risk of glove perforation occurs when double-gloved attending surgeons, adult reconstruction fellows, and registered nurses initially assist during primary and revision TJA. In their study, outer and inner glove layers were perforated 2.5% of the time. All outer-layer perforations were noticed, but inner-layer perforations went unnoticed 81% of the time, which poses a potential hazard for both patients and healthcare personnel. In addition, there was a significant increase in the incidence of glove perforations for attending surgeons during revision TJA vs primary TJA (8.9% vs 3.7%; P = .04). This finding may be expected given the complexity of revision procedures, the presence of sharp bony and metal edges, and the longer operative times. Giving more attention to glove perforations during arthroplasties may mitigate the risk of SSI. As soon as a perforation is noticed, the glove should be removed and replaced.
Body Exhaust Suits. Early TJAs had infection rates approaching 10%.43 Bacterial-laden particles shed from surgical staff were postulated to be the cause,44,45 and this idea prompted the development of new technology, such as body exhaust suits, which have demonstrated up to a 20-fold reduction in airborne bacterial contamination and decreased incidence of deep infection, from 1% to 0.1%, as compared with conventional surgical attire.46 However, the efficacy of these suits was recently challenged. Hooper and colleagues47 assessed >88,000 TJA cases in the New Zealand Joint Registry and found a significant increase in early revision THA for deep infection with vs without use of body exhaust suits (0.186% vs 0.064%; P < .0001). The incidence of revision TKAs for deep infections with use of these suits was similar (0.243% vs 0.098%; P < .001). Many of the surgeons surveyed indicated their peripheral vision was limited by the suits, which may contribute to sterile field contamination. By contrast, Miner and colleagues48 were unable to determine an increased risk of SSI with use of body exhaust suits (RR, 0.75; 95% CI, 0.34-1.62), though there was a trend toward more infections without suits. Moreover, these suits are effective in reducing mean air bacterial counts (P = .014), but it is not known if this method correlates with mean wound bacterial counts (r = –.011) and therefore increases the risk of SSI.49
Surgical Drapes. Surgical draping, including cloths, iodine-impregnated materials, and woven or unwoven materials, is the standard of care worldwide. The particular draping technique usually varies by surgeon. Plastic drapes are better barriers than cloth drapes, as found in a study by Blom and colleagues50: Bacterial growth rates were almost 10 times higher with use of wet woven cloth drapes than with plastic surgical drapes. These findings were supported in another, similar study by Blom and colleagues51: Wetting drapes with blood or normal saline enhanced bacterial penetration. In addition, wetting drapes with chlorhexidine or iodine reduced but did not eliminate bacterial penetration. Fairclough and colleagues52 emphasized that iodine-impregnated drapes reduced surgical-site bacterial contamination from 15% to 1.6%. However, a Cochrane review53 found these drapes had no effect on the SSI rate (RR, 1.03; 95% CI, 0.06-1.66; P = .89), though the risk of infection was slightly higher with adhesive draping than with no drape (RR, 1.23; 95% CI, 1.02-1.48; P = .03).
Ventilation Flow. Laminar-airflow systems are widely used to prevent SSIs after TJA. Horizontal-flow and vertical-flow ventilation provides and maintains ultra-clean air in the operating room. Evans54 found the bacterial counts in the air and the wound were lower with laminar airflow than without this airflow. The amount of airborne bacterial colony-forming units and dust large enough to carry bacteria was reduced to 1 or 2 particles more than 2 μm/m3 with use of a typical laminar- airflow system. In comparing 3922 TKA patients in laminar-airflow operating rooms with 4133 patients in conventional rooms, Lidwell and colleagues46 found a significantly lower incidence of SSIs in patients in laminar-airflow operating rooms (0.6% vs 2.3%; P < .001).
Conversely, Miner and colleagues48 did not find a lower risk of SSI with laminar-airflow systems (RR, 1.57; 95% CI, 0.75-3.31). In addition, in their analysis of >88,000 cases from the New Zealand Joint Registry, Hooper and colleagues47 found that the incidence of early infections was higher with laminar-airflow systems than with standard airflow systems for both TKA (0.193% vs 0.100%; P = .019) and THA (0.148% vs 0.061%; P < .001). They postulated that vertically oriented airflow may have transmitted contaminated particles into the surgical sites. Additional evidence may be needed to resolve these conflicting findings and determine whether clean-air practices provide significant clinical benefit in the operating room.
Staff Traffic Volume. When staff enters or exits the operating room or makes extra movements during a procedure, airflow near the wound is disturbed and no longer able to remove sufficient airborne pathogens from the sterile field. The laminar- airflow pattern may be disrupted each time the operating room doors open and close, potentially allowing airborne pathogens to be introduced near the patient. Lynch and colleagues55 found the operating room door opened almost 50 times per hour, and it took about 20 seconds to close each time. As a result, the door may remain open for up to 20 minutes per case, causing substantial airflow disruption and potentially ineffective removal of airborne bacterial particles. Similarly, Young and O’Regan56 found the operating room door opened about 19 times per hour and took 20 seconds to close each time. The theater door was open an estimated 10.7% of each hour of sterile procedure. Presence of more staff also increases airborne bacterial counts. Pryor and Messmer57 evaluated a cohort of 2864 patients to determine the effect of number of personnel in the operating theater on the incidence of SSIs. Infection rates were 6.27% with >17 different people entering the room and 1.52% with <9 different people entering the room. Restricting the number of people in the room may be one of the easiest and most efficient ways to prevent SSI.
Systemic Antibiotic Prophylaxis. Perioperative antibiotic use is vital in minimizing the risk of infection after TJA. The Surgical Care Improvement Project recommended beginning the first antimicrobial dose either within 60 minutes before surgical incision (for cephalosporin) or within 2 hours before incision (for vancomycin) and discontinuing the prophylactic antimicrobial agents within 24 hours after surgery ends.58,59 However, Gorenoi and colleagues60 were unable to recommend a way to select particular antibiotics, as they found no difference in the effectiveness of various antibiotic agents used in TKA. A systematic review by AlBuhairan and colleagues61 revealed that antibiotic prophylaxis (vs no prophylaxis) reduced the absolute risk of a SSI by 8% and the relative risk by 81% (P < 0.0001). These findings are supported by evidence of the efficacy of perioperative antibiotics in reducing the incidence of SSI.62,63 Antibiotic regimens should be based on susceptibility and availability, depending on hospital prevalence of infections. Even more, patients should receive prophylaxis in a timely manner. Finally, bacteriostatic antibiotics (vancomycin) should not be used on their own for preoperative prophylaxis.
Antibiotic Cement. Antibiotic-loaded bone cement (ALBC), which locally releases antimicrobials in high concentration, is often used in revision joint arthroplasty, but use in primary joint arthroplasty remains controversial. In a study of THA patients, Parvizi and colleagues64 found infection rates of 1.2% with 2.3% with and without use of ALBC, respectively. Other studies have had opposing results. Namba and colleagues65 evaluated 22,889 primary TKAs, 2030 (8.9%) of which used ALBC. The incidence of deep infection was significantly higher with ALBC than with regular bone cement (1.4% vs 0.7%; P = .002). In addition, a meta- analysis of >6500 primary TKA patients, by Zhou and colleagues,66 revealed no significant difference in the incidence of deep SSIs with use of ALBC vs regular cement (1.32% vs 1.89%; RR, 0.75; 95% CI, 0.43-1.33; P = .33). More evidence is needed to determine the efficacy of ALBC in primary TJA. International Consensus Meeting on Periprosthetic Joint Infection participants recommended use of ALBC in high-risk patients, including patients who are obese or immunosuppressed or have diabetes or a prior history of infection.67
Postoperative Measures
Antibiotic Prophylaxis. The American Academy of Orthopaedic Surgeons (AAOS) and the American Dental Association (ADA) have suggestions for antibiotic prophylaxis for patients at increased risk for infection. As of 2015, the ADA no longer recommends antibiotic prophylaxis for patients with prosthetic joint implants,68 whereas the AAOS considers all patients with TJA to be at risk.69
Table 3.For TJA patients, the AAOS recommends administering antibiotic prophylaxis at least 1 hour before a dental procedure and discontinuing it within 24 hours after the procedure ends.69 Single preoperative doses are acceptable for outpatient procedures.70Table 3 summarizes the studies that reported on postoperative measures for preventing SSI.
Although recommendations exist, the actual risk of infection resulting from dental procedures and the role of antibiotic prophylaxis are not well defined. Berbari and colleagues71 found that antibiotic prophylaxis in high- or low-risk dental procedures did not decrease the risk of subsequent THA infection (OR, 0.9; 95% CI, 0.5-1.6) or TKA infection (OR, 1.2; 95% CI, 0.7-2.2). Moreover, the risk of infection was no higher for patients who had a prosthetic hip or knee and underwent a high- or low-risk dental procedure without antibiotic prophylaxis (OR, 0.8; 95% CI, 0.4-1.6) than for similar patients who did not undergo a dental procedure (OR, 0.6; 95% CI, 0.4-1.1). Some studies highlight the low level of evidence supporting antibiotic prophylaxis during dental procedures.72,73 However, there is no evidence of adverse effects of antibiotic prophylaxis. Given the potential high risk of infection after such procedures, a more robust body of evidence is needed to reach consensus.
Evacuation Drain Management. Prolonged use of surgical evacuation drains may be a risk factor for SSI. Therefore, early drain removal is paramount. Higher infection rates with prolonged drain use have been found in patients with persistent wound drainage, including malnourished, obese, and over-anticoagulated patients. Patients with wounds persistently draining for >1 week should undergo superficial wound irrigation and débridement. Jaberi and colleagues74 assessed 10,325 TJA patients and found that the majority of persistent drainage ceased within 1 week with use of less invasive measures, including oral antibiotics and local wound care. Furthermore, only 28% of patients with persistent drainage underwent surgical débridement. It is unclear if this practice alone is appropriate. Infection should always be suspected and treated aggressively, and cultures should be obtained from synovial fluid before antibiotics are started, unless there is an obvious superficial infection that does not require further work-up.67
Economic Impact
SSIs remain a significant healthcare issue, and the social and financial costs are staggering. Without appropriate measures in place, these complications will place a larger burden on the healthcare system primarily as a result of longer hospital stays, multiple procedures, and increased resource utilization.75 Given the risk of progression to prosthetic joint infection, early preventive interventions must be explored.
Table 4.Several studies have addressed the economic implications of SSIs after TJA as well as the impact of preventive interventions (Table 4). Using the NIS database, Kurtz and colleagues4 found that not only were hospital stays significantly longer for infected (vs noninfected) knee arthroplasties (7.6 vs 3.9 days; P < .0001), but hospital charges were 1.52 times higher (P < .0001), and results were similar for infected (vs noninfected) hips (9.7 vs 4.3 days; 1.76 times higher charges; P < .0001 for both). Kapadia and colleagues76 matched 21 TKA patients with periprosthetic infections with 21 noninfected TKA patients at a single institution and found the infected patients had more readmissions (3.6 vs 0.1; P < .0001), longer hospitalizations (5.3 vs 3.0 days; P = .0002), more days in the hospital within 1 year of arthroplasty (23.7 vs 3.4 days; P < .0001), and more clinic visits (6.5 vs 1.3; P < .0001). Furthermore, the infected patients had a significantly higher mean annual cost of treatment ($116,383 vs $28,249; P < .0001). Performing a Markov analysis, Slover and colleagues77 found that the decreased incidence of infection and the potential cost savings associated with preoperative S aureus screening and a decolonization protocol were able to offset the costs acquired by the screening and decolonization protocol. Similarly, Cummins and colleagues78 evaluated the effects of ALBC on overall healthcare costs; if revision surgery was the primary outcome of all infections, use of ALBC (vs cement without antibiotics) resulted in a cost-effectiveness ratio of $37,355 per quality-adjusted life year. Kapadia and colleagues79 evaluated the economic impact of adding 2% chlorhexidine gluconate-impregnated cloths to an existing preoperative skin preparation protocol for TKA. One percent of non-chlorhexidine patients and 0.6% of chlorhexidine patients developed an infection. The reduction in incidence of infection amounted to projected net savings of almost $2.1 million per 1000 TKA patients. Nationally, annual healthcare savings were expected to range from $0.78 billion to $3.18 billion with implementation of this protocol.
Improved patient selection may be an important factor in reducing SSIs. In an analysis of 8494 joint arthroplasties, Malinzak and colleagues80 noted that patients with a BMI of >50 kg/m2 had an increased OR of infection of 21.3 compared to those with BMI <50 kg/m2. Wagner and colleagues81 analyzed 21,361 THAs and found that, for every BMI unit over 25 kg/m2, there was an 8% increased risk of joint infection (P < .001). Although it is unknown if there is an association between reduction in preoperative BMI and reduction in postoperative complication risk, it may still be worthwhile and cost-effective to modify this and similar risk factors before elective procedures.
Market forces are becoming a larger consideration in healthcare and are being driven by provider competition.82 Treatment outcomes, quality of care, and healthcare prices have gained attention as a means of estimating potential costs.83 In 2011, the Centers for Medicare & Medicaid Services (CMS) advanced the Bundled Payments for Care Improvement (BPCI) initiative, which aimed to provide better coordinated care of higher quality and lower cost.84 This led to development of the Comprehensive Care for Joint Replacement (CJR) program, which gives beneficiaries flexibility in choosing services and ensures that providers adhere to required standards. During its 5-year test period beginning in 2016, the CJR program is projected to save CMS $153 million.84 Under this program, the institution where TJA is performed is responsible for all the costs of related care from time of surgery through 90 days after hospital discharge—which is known as an “episode of care.” If the cost incurred during an episode exceeds an established target cost (as determined by CMS), the hospital must repay Medicare the difference. Conversely, if the cost of an episode is less than the established target cost, the hospital is rewarded with the difference. Bundling payments for a single episode of care in this manner is thought to incentivize providers and hospitals to give patients more comprehensive and coordinated care. Given the substantial economic burden associated with joint arthroplasty infections, it is imperative for orthopedists to establish practical and cost-effective strategies that can prevent these disastrous complications.
Conclusion
SSIs are a devastating burden to patients, surgeons, and other healthcare providers. In recent years, new discoveries and innovations have helped mitigate the incidence of these complications of THA and TKA. However, the incidence of SSIs may rise with the increasing use of TJAs and with the development of new drug-resistant pathogens. In addition, the increasing number of TJAs performed on overweight and high-risk patients means the costs of postoperative infections will be substantial. With new reimbursement models in place, hospitals and providers are being held more accountable for the care they deliver during and after TJA. Consequently, more emphasis should be placed on techniques that are proved to minimize the incidence of SSIs.
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Authors’ Disclosure Statement: Dr. Chughtai reports that he is a paid consultant for DJ Orthopaedics, Sage Products, and Stryker. Dr. Mont reports that he receives grants/fees from DJ Orthopaedics, Johnson & Johnson, Merz, Microport, National Institutes of Health, Ongoing Care Solutions, Orthosensor, Pacira Pharmaceuticals, Sage Products, Stryker, TissueGene, and US Medical Innovations; he is on the editorial/governing boards of The American Academy of Orthopaedic Surgeons, The American Journal of Orthopedics, Journal of Arthroplasty, Journal of Knee Surgery, Orthopedics, and Surgical Technology International. Dr. Delanois reports that he is a paid consultant and speaker for Corin and a Maryland Orthopaedic Association board/committee member, and he receives research support from OrthoFix Inc. and Stryker. The other authors report no actual or potential conflict of interest in relation to this article.
Authors’ Disclosure Statement: Dr. Chughtai reports that he is a paid consultant for DJ Orthopaedics, Sage Products, and Stryker. Dr. Mont reports that he receives grants/fees from DJ Orthopaedics, Johnson & Johnson, Merz, Microport, National Institutes of Health, Ongoing Care Solutions, Orthosensor, Pacira Pharmaceuticals, Sage Products, Stryker, TissueGene, and US Medical Innovations; he is on the editorial/governing boards of The American Academy of Orthopaedic Surgeons, The American Journal of Orthopedics, Journal of Arthroplasty, Journal of Knee Surgery, Orthopedics, and Surgical Technology International. Dr. Delanois reports that he is a paid consultant and speaker for Corin and a Maryland Orthopaedic Association board/committee member, and he receives research support from OrthoFix Inc. and Stryker. The other authors report no actual or potential conflict of interest in relation to this article.
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. Chughtai reports that he is a paid consultant for DJ Orthopaedics, Sage Products, and Stryker. Dr. Mont reports that he receives grants/fees from DJ Orthopaedics, Johnson & Johnson, Merz, Microport, National Institutes of Health, Ongoing Care Solutions, Orthosensor, Pacira Pharmaceuticals, Sage Products, Stryker, TissueGene, and US Medical Innovations; he is on the editorial/governing boards of The American Academy of Orthopaedic Surgeons, The American Journal of Orthopedics, Journal of Arthroplasty, Journal of Knee Surgery, Orthopedics, and Surgical Technology International. Dr. Delanois reports that he is a paid consultant and speaker for Corin and a Maryland Orthopaedic Association board/committee member, and he receives research support from OrthoFix Inc. and Stryker. The other authors report no actual or potential conflict of interest in relation to this article.
SSIs after TJA pose a substantial burden on patients, surgeons, and the healthcare system.
While different forms of preoperative skin preparation have shown varying outcomes after TJA, the importance of preoperative patient optimization (nutritional status, immune function, etc) cannot be overstated.
Intraoperative infection prevention measures include cutaneous preparation, gloving, body exhaust suits, surgical drapes, OR staff traffic and ventilation flow, and antibiotic-loaded cement.
Antibiotic prophylaxis for dental procedures in TJA patients continues to remain a controversial issue with conflicting recommendations.
SSIs have considerable financial costs and require increased resource utilization. Given the significant economic burden associated with TJA infections, it is imperative for orthopedists to establish practical and cost-effective strategies to prevent these devastating complications.
Surgical-site infection (SSI), a potentially devastating complication of lower extremity total joint arthroplasty (TJA), is estimated to occur in 1% to 2.5% of cases annually.1 Infection after TJA places a significant burden on patients, surgeons, and the healthcare system. Revision procedures that address infection after total hip arthroplasty (THA) are associated with more hospitalizations, more operations, longer hospital stay, and higher outpatient costs in comparison with primary THAs and revision surgeries for aseptic loosening.2 If left untreated, a SSI can go deeper into the joint and develop into a periprosthetic infection, which can be disastrous and costly. A periprosthetic joint infection study that used 2001 to 2009 Nationwide Inpatient Sample (NIS) data found that the cost of revision procedures increased to $560 million from $320 million, and was projected to reach $1.62 billion by 2020.3 Furthermore, society incurs indirect costs as a result of patient disability and loss of wages and productivity.2 Therefore, the issue of infection after TJA is even more crucial in our cost-conscious healthcare environment.
Patient optimization, advances in surgical technique, sterile protocol, and operative procedures have been effective in reducing bacterial counts at incision sites and minimizing SSIs. As a result, infection rates have leveled off after rising for a decade.4 Although infection prevention modalities have their differences, routine use is fundamental and recommended by the Hospital Infection Control Practices Advisory Committee.5 Furthermore, both the US Centers for Disease Control and Prevention (CDC) and its Healthcare Infection Control Practices Advisory Committee6,7 recently updated their SSI prevention guidelines by incorporating evidence-based methodology, an element missing from earlier recommendations.
The etiologies of postoperative SSIs have been discussed ad nauseam, but there are few reports summarizing the literature on infection prevention modalities. In this review, we identify and examine SSI prevention strategies as they relate to lower extremity TJA. Specifically, we discuss the literature on the preoperative, intraoperative, and postoperative actions that can be taken to reduce the incidence of SSIs after TJA. We also highlight the economic implications of SSIs that occur after TJA.
Methods
For this review, we performed a literature search with PubMed, EBSCOhost, and Scopus. We looked for reports published between the inception of each database and July 2016. Combinations of various search terms were used: surgical site, infection, total joint arthroplasty, knee, hip, preoperative, intraoperative, perioperative, postoperative, preparation, nutrition, ventilation, antibiotic, body exhaust suit, gloves, drain, costs, economic, and payment.
Our search identified 195 abstracts. Drs. Mistry and Chughtai reviewed these to determine which articles were relevant. For any uncertainties, consensus was reached with the help of Dr. Delanois. Of the 195 articles, 103 were potentially relevant, and 54 of the 103 were excluded for being not relevant to preventing SSIs after TJA or for being written in a language other than English. The references in the remaining articles were assessed, and those with potentially relevant titles were selected for abstract review. This step provided another 35 articles. After all exclusions, 48 articles remained. We discuss these in the context of preoperative, intraoperative, and postoperative measures and economic impact.
Results
Preoperative Measures
Skin Preparation. Preoperative skin preparation methods include standard washing and rinsing, antiseptic soaps, and iodine-based or chlorhexidine gluconate-based antiseptic showers or skin cloths. Iodine-based antiseptics are effective against a wide range of Gram-positive and Gram-negative bacteria, fungi, and viruses. These agents penetrate the cell wall, oxidize the microbial contents, and replace those contents with free iodine molecules.8 Iodophors are free iodine molecules associated with a polymer (eg, polyvinylpyrrolidone); the iodophor povidone-iodine is bactericidal.9 Chlorhexidine gluconate-based solutions are effective against many types of yeast, Gram-positive and Gram-negative bacteria, and a wide variety of viruses.9 Both solutions are useful. Patients with an allergy to iodine can use chlorhexidine. Table 1 summarizes the studies on preoperative measures for preventing SSIs.
Table 1A.
Table 1B.
There is no shortage of evidence of the efficacy of these antiseptics in minimizing the incidence of SSIs. Hayek and colleagues10 prospectively analyzed use of different preoperative skin preparation methods in 2015 patients. Six weeks after surgery, the infection rate was significantly lower with use of chlorhexidine than with use of an unmedicated bar of soap or placebo cloth (9% vs 11.7% and 12.8%, respectively; P < .05). In a study of 100 patients, Murray and colleagues11 found the overall bacterial culture rate was significantly lower for those who used a 2% chlorhexidine gluconate cloth before shoulder surgery than for those who took a standard shower with soap (66% vs 94%; P = .0008). Darouiche and colleagues12 found the overall SSI rate was significantly lower for 409 surgical patients prepared with chlorhexidine-alcohol than for 440 prepared with povidone-iodine (9.5% vs 16.1%; P = .004; relative risk [RR], 0.59; 95% confidence interval [CI], 0.41-0.85).
Chlorhexidine gluconate-impregnated cloths have also had promising results, which may be attributed to general ease of use and potentially improved patient adherence. Zywiel and colleagues13 reported no SSIs in 136 patients who used these cloths at home before total knee arthroplasty (TKA) and 21 SSIs (3.0%) in 711 patients who did not use the cloths. In a study of 2545 THA patients, Kapadia and colleagues14 noted a significantly lower incidence of SSIs with at-home preoperative use of chlorhexidine cloths than with only in-hospital perioperative skin preparation (0.5% vs 1.7%; P = .04). In 2293 TKAs, Johnson and colleagues15 similarly found a lower incidence of SSIs with at-home preoperative use of chlorhexidine cloths (0.6% vs 2.2%; P = .02). In another prospective, randomized trial, Kapadia and colleagues16 compared 275 patients who used chlorhexidine cloths the night before and the morning of lower extremity TJA surgery with 279 patients who underwent standard-of-care preparation (preadmission bathing with antibacterial soap and water). The chlorhexidine cohort had a lower overall incidence of infection (0.4% vs 2.9%; P = .049), and the standard-of-care cohort had a stronger association with infection (odds ratio [OR], 8.15; 95% CI, 1.01-65.6).
Patient Optimization. Poor nutritional status may compromise immune function, potentially resulting in delayed healing, increased risk of infection, and, ultimately, negative postoperative outcomes. Malnutrition can be diagnosed on the basis of a prealbumin level of <15 mg/dL (normal, 15-30 mg/dL), a serum albumin level of <3.4 g/dL (normal, 3.4-5.4 g/dL), or a total lymphocyte count under 1200 cells/μL (normal, 3900-10,000 cells/μL).17-19 Greene and colleagues18 found that patients with preoperative malnutrition had up to a 7-fold higher rate of infection after TJA. In a study of 135 THAs and TKAs, Alfargieny and colleagues20 found preoperative serum albumin was the only nutritional biomarker predictive of SSI (P = .011). Furthermore, patients who take immunomodulating medications (eg, for inflammatory arthropathies) should temporarily discontinue them before surgery in order to lower their risk of infection.21
Smoking is well established as a major risk factor for poor outcomes after surgery. It is postulated that the vasoconstrictive effects of nicotine and the hypoxic effects of carbon monoxide contribute to poor wound healing.22 In a meta-analysis of 4 studies, Sørensen23 found smokers were at increased risk for wound complications (OR, 2.27; 95% CI, 1.82-2.84), delayed wound healing and dehiscence (OR, 2.07; 95% CI, 1.53-2.81), and infection (OR, 1.79; 95% CI, 1.57-2.04). Moreover, smoking cessation decreased the incidence of SSIs (OR, 0.43; 95% CI, 0.21-0.85). A meta- analysis by Wong and colleagues24 revealed an inflection point for improved outcomes in patients who abstained from smoking for at least 4 weeks before surgery. Risk of infection was lower for these patients than for current smokers (OR, 0.69; 95% CI, 0.56-0.84).
Other comorbidities contribute to SSIs as well. In their analysis of American College of Surgeons National Surgical Quality Improvement Program registry data on 25,235 patients who underwent primary and revision lower extremity TJA, Pugely and colleagues25 found that, in the primary TJA cohort, body mass index (BMI) of >40 kg/m2 (OR, 1.9; 95% CI, 1.3-2.9), electrolyte disturbance (OR, 2.4; 95% CI, 1.0-6.0), and hypertension diagnosis (OR, 1.5; 95% CI, 1.1-2.0) increased the risk of SSI within 30 days. Furthermore, diabetes mellitus delays collagen synthesis, impairs lymphocyte function, and impairs wound healing, which may lead to poor recovery and higher risk of infection.26 In a study of 167 TKAs performed in 115 patients with type 2 diabetes mellitus, Han and Kang26 found that wound complications were 6 times more likely in those with hemoglobin A1c (HbA1c) levels higher than 8% than in those with lower HbA1c levels (OR, 6.07; 95% CI, 1.12-33.0). In a similar study of 462 patients with diabetes, Hwang and colleagues27 found a higher likelihood of superficial SSIs in patients with HbA1c levels >8% (OR, 6.1; 95% CI, 1.6-23.4; P = .008). This association was also found in patients with a fasting blood glucose level of >200 mg/dL (OR, 9.2; 95% CI, 2.2-38.2; P = .038).
Methicillin-resistant Staphylococcus aureus (MRSA) is thought to account for 10% to 25% of all periprosthetic infections in the United States.28 Nasal colonization by this pathogen increases the risk for SSIs; however, decolonization protocols have proved useful in decreasing the rates of colonization. Moroski and colleagues29 assessed the efficacy of a preoperative 5-day course of intranasal mupirocin in 289 primary or revision TJA patients. Before surgery, 12 patients had positive MRSA cultures, and 44 had positive methicillin-sensitive S aureus (MSSA) cultures. On day of surgery, a significant reduction in MRSA (P = .0073) and MSSA (P = .0341) colonization was noted. Rao and colleagues30 found that the infection rate decreased from 2.7% to 1.2% in 2284 TJA patients treated with a decolonization protocol (P = .009).
Intraoperative Measures
Cutaneous Preparation. The solutions used in perioperative skin preparation are similar to those used preoperatively: povidone-iodine, alcohol, and chlorhexidine. The efficacy of these preparations varies. Table 2 summarizes the studies on intraoperative measures for preventing SSIs.
Table 2A.
Table 2B.In a prospective study, Saltzman and colleagues31 randomly assigned 150 shoulder arthroplasty patients to one of 3 preparations: 0.75% iodine scrub with 1% iodine paint (Povidone-Iodine; Tyco Healthcare Group), 0.7% iodophor with 74% iodine povacrylex (DuraPrep; 3M Health Care), or chlorhexidine gluconate with 70% isopropyl alcohol (ChloraPrep; Enturia). All patients had their skin area prepared and swabbed for culture before incision. Although no one in any group developed a SSI, patients in the chlorhexidine group had the lowest overall incidence of positive skin cultures. That incidence (7%) and the incidence of patients in the iodophor group (19%) were significantly lower than that of patients in the iodine group (31%) (P < .001 for both). Conversely, another study32 found a higher likelihood of SSI with chlorhexidine than with povidone-iodine (OR, 4.75; 95% CI, 1.42-15.92; P = .012). This finding is controversial, but the body of evidence led the CDC to recommend use of an alcohol-based solution for preoperative skin preparation.6
The literature also highlights the importance of technique in incision-site preparation. In a prospective study, Morrison and colleagues33 randomly assigned 600 primary TJA patients to either (1) use of alcohol and povidone-iodine before draping, with additional preparation with iodine povacrylex (DuraPrep) and isopropyl alcohol before application of the final drape (300-patient intervention group) or (2) only use of alcohol and povidone-iodine before draping (300-patient control group). At the final follow-up, the incidence of SSI was significantly lower in the intervention group than in the control group (1.8% vs 6.5%; P = .015). In another study that assessed perioperative skin preparation methods, Brown and colleagues34 found that airborne bacteria levels in operating rooms were >4 times higher with patients whose legs were prepared by a scrubbed, gowned leg-holder than with patients whose legs were prepared by an unscrubbed, ungowned leg-holder (P = .0001).
Hair Removal. Although removing hair from surgical sites is common practice, the literature advocating it varies. A large comprehensive review35 revealed no increased risk of SSI with removing vs not removing hair (RR, 1.65; 95% CI, 0.85-3.19). On the other hand, some hair removal methods may affect the incidence of infection. For example, use of electric hair clippers is presumed to reduce the risk of SSIs, whereas traditional razors may compromise the epidermal barriers and create a pathway for bacterial colonization.5,36,37 In the aforementioned review,35 SSIs were more than twice as likely to occur with hair removed by shaving than with hair removed by electric clippers (RR, 2.02; 95% CI, 1.21-3.36). Cruse and Foord38 found a higher rate of SSIs with hair removed by shaving than with hair removed by clipping (2.3% vs 1.7%). Most surgeons agree that, if given the choice, they would remove hair with electric clippers rather than razors.
Gloves. Almost all orthopedists double their gloves for TJA cases. Over several studies, the incidence of glove perforation during orthopedic procedures has ranged from 3.6% to 26%,39-41 depending on the operating room personnel and glove layering studied. Orthopedists must know this startling finding, as surgical glove perforation is associated with an increase in the rate of SSIs, from 1.7% to 5.7%.38 Carter and colleagues42 found the highest risk of glove perforation occurs when double-gloved attending surgeons, adult reconstruction fellows, and registered nurses initially assist during primary and revision TJA. In their study, outer and inner glove layers were perforated 2.5% of the time. All outer-layer perforations were noticed, but inner-layer perforations went unnoticed 81% of the time, which poses a potential hazard for both patients and healthcare personnel. In addition, there was a significant increase in the incidence of glove perforations for attending surgeons during revision TJA vs primary TJA (8.9% vs 3.7%; P = .04). This finding may be expected given the complexity of revision procedures, the presence of sharp bony and metal edges, and the longer operative times. Giving more attention to glove perforations during arthroplasties may mitigate the risk of SSI. As soon as a perforation is noticed, the glove should be removed and replaced.
Body Exhaust Suits. Early TJAs had infection rates approaching 10%.43 Bacterial-laden particles shed from surgical staff were postulated to be the cause,44,45 and this idea prompted the development of new technology, such as body exhaust suits, which have demonstrated up to a 20-fold reduction in airborne bacterial contamination and decreased incidence of deep infection, from 1% to 0.1%, as compared with conventional surgical attire.46 However, the efficacy of these suits was recently challenged. Hooper and colleagues47 assessed >88,000 TJA cases in the New Zealand Joint Registry and found a significant increase in early revision THA for deep infection with vs without use of body exhaust suits (0.186% vs 0.064%; P < .0001). The incidence of revision TKAs for deep infections with use of these suits was similar (0.243% vs 0.098%; P < .001). Many of the surgeons surveyed indicated their peripheral vision was limited by the suits, which may contribute to sterile field contamination. By contrast, Miner and colleagues48 were unable to determine an increased risk of SSI with use of body exhaust suits (RR, 0.75; 95% CI, 0.34-1.62), though there was a trend toward more infections without suits. Moreover, these suits are effective in reducing mean air bacterial counts (P = .014), but it is not known if this method correlates with mean wound bacterial counts (r = –.011) and therefore increases the risk of SSI.49
Surgical Drapes. Surgical draping, including cloths, iodine-impregnated materials, and woven or unwoven materials, is the standard of care worldwide. The particular draping technique usually varies by surgeon. Plastic drapes are better barriers than cloth drapes, as found in a study by Blom and colleagues50: Bacterial growth rates were almost 10 times higher with use of wet woven cloth drapes than with plastic surgical drapes. These findings were supported in another, similar study by Blom and colleagues51: Wetting drapes with blood or normal saline enhanced bacterial penetration. In addition, wetting drapes with chlorhexidine or iodine reduced but did not eliminate bacterial penetration. Fairclough and colleagues52 emphasized that iodine-impregnated drapes reduced surgical-site bacterial contamination from 15% to 1.6%. However, a Cochrane review53 found these drapes had no effect on the SSI rate (RR, 1.03; 95% CI, 0.06-1.66; P = .89), though the risk of infection was slightly higher with adhesive draping than with no drape (RR, 1.23; 95% CI, 1.02-1.48; P = .03).
Ventilation Flow. Laminar-airflow systems are widely used to prevent SSIs after TJA. Horizontal-flow and vertical-flow ventilation provides and maintains ultra-clean air in the operating room. Evans54 found the bacterial counts in the air and the wound were lower with laminar airflow than without this airflow. The amount of airborne bacterial colony-forming units and dust large enough to carry bacteria was reduced to 1 or 2 particles more than 2 μm/m3 with use of a typical laminar- airflow system. In comparing 3922 TKA patients in laminar-airflow operating rooms with 4133 patients in conventional rooms, Lidwell and colleagues46 found a significantly lower incidence of SSIs in patients in laminar-airflow operating rooms (0.6% vs 2.3%; P < .001).
Conversely, Miner and colleagues48 did not find a lower risk of SSI with laminar-airflow systems (RR, 1.57; 95% CI, 0.75-3.31). In addition, in their analysis of >88,000 cases from the New Zealand Joint Registry, Hooper and colleagues47 found that the incidence of early infections was higher with laminar-airflow systems than with standard airflow systems for both TKA (0.193% vs 0.100%; P = .019) and THA (0.148% vs 0.061%; P < .001). They postulated that vertically oriented airflow may have transmitted contaminated particles into the surgical sites. Additional evidence may be needed to resolve these conflicting findings and determine whether clean-air practices provide significant clinical benefit in the operating room.
Staff Traffic Volume. When staff enters or exits the operating room or makes extra movements during a procedure, airflow near the wound is disturbed and no longer able to remove sufficient airborne pathogens from the sterile field. The laminar- airflow pattern may be disrupted each time the operating room doors open and close, potentially allowing airborne pathogens to be introduced near the patient. Lynch and colleagues55 found the operating room door opened almost 50 times per hour, and it took about 20 seconds to close each time. As a result, the door may remain open for up to 20 minutes per case, causing substantial airflow disruption and potentially ineffective removal of airborne bacterial particles. Similarly, Young and O’Regan56 found the operating room door opened about 19 times per hour and took 20 seconds to close each time. The theater door was open an estimated 10.7% of each hour of sterile procedure. Presence of more staff also increases airborne bacterial counts. Pryor and Messmer57 evaluated a cohort of 2864 patients to determine the effect of number of personnel in the operating theater on the incidence of SSIs. Infection rates were 6.27% with >17 different people entering the room and 1.52% with <9 different people entering the room. Restricting the number of people in the room may be one of the easiest and most efficient ways to prevent SSI.
Systemic Antibiotic Prophylaxis. Perioperative antibiotic use is vital in minimizing the risk of infection after TJA. The Surgical Care Improvement Project recommended beginning the first antimicrobial dose either within 60 minutes before surgical incision (for cephalosporin) or within 2 hours before incision (for vancomycin) and discontinuing the prophylactic antimicrobial agents within 24 hours after surgery ends.58,59 However, Gorenoi and colleagues60 were unable to recommend a way to select particular antibiotics, as they found no difference in the effectiveness of various antibiotic agents used in TKA. A systematic review by AlBuhairan and colleagues61 revealed that antibiotic prophylaxis (vs no prophylaxis) reduced the absolute risk of a SSI by 8% and the relative risk by 81% (P < 0.0001). These findings are supported by evidence of the efficacy of perioperative antibiotics in reducing the incidence of SSI.62,63 Antibiotic regimens should be based on susceptibility and availability, depending on hospital prevalence of infections. Even more, patients should receive prophylaxis in a timely manner. Finally, bacteriostatic antibiotics (vancomycin) should not be used on their own for preoperative prophylaxis.
Antibiotic Cement. Antibiotic-loaded bone cement (ALBC), which locally releases antimicrobials in high concentration, is often used in revision joint arthroplasty, but use in primary joint arthroplasty remains controversial. In a study of THA patients, Parvizi and colleagues64 found infection rates of 1.2% with 2.3% with and without use of ALBC, respectively. Other studies have had opposing results. Namba and colleagues65 evaluated 22,889 primary TKAs, 2030 (8.9%) of which used ALBC. The incidence of deep infection was significantly higher with ALBC than with regular bone cement (1.4% vs 0.7%; P = .002). In addition, a meta- analysis of >6500 primary TKA patients, by Zhou and colleagues,66 revealed no significant difference in the incidence of deep SSIs with use of ALBC vs regular cement (1.32% vs 1.89%; RR, 0.75; 95% CI, 0.43-1.33; P = .33). More evidence is needed to determine the efficacy of ALBC in primary TJA. International Consensus Meeting on Periprosthetic Joint Infection participants recommended use of ALBC in high-risk patients, including patients who are obese or immunosuppressed or have diabetes or a prior history of infection.67
Postoperative Measures
Antibiotic Prophylaxis. The American Academy of Orthopaedic Surgeons (AAOS) and the American Dental Association (ADA) have suggestions for antibiotic prophylaxis for patients at increased risk for infection. As of 2015, the ADA no longer recommends antibiotic prophylaxis for patients with prosthetic joint implants,68 whereas the AAOS considers all patients with TJA to be at risk.69
Table 3.For TJA patients, the AAOS recommends administering antibiotic prophylaxis at least 1 hour before a dental procedure and discontinuing it within 24 hours after the procedure ends.69 Single preoperative doses are acceptable for outpatient procedures.70Table 3 summarizes the studies that reported on postoperative measures for preventing SSI.
Although recommendations exist, the actual risk of infection resulting from dental procedures and the role of antibiotic prophylaxis are not well defined. Berbari and colleagues71 found that antibiotic prophylaxis in high- or low-risk dental procedures did not decrease the risk of subsequent THA infection (OR, 0.9; 95% CI, 0.5-1.6) or TKA infection (OR, 1.2; 95% CI, 0.7-2.2). Moreover, the risk of infection was no higher for patients who had a prosthetic hip or knee and underwent a high- or low-risk dental procedure without antibiotic prophylaxis (OR, 0.8; 95% CI, 0.4-1.6) than for similar patients who did not undergo a dental procedure (OR, 0.6; 95% CI, 0.4-1.1). Some studies highlight the low level of evidence supporting antibiotic prophylaxis during dental procedures.72,73 However, there is no evidence of adverse effects of antibiotic prophylaxis. Given the potential high risk of infection after such procedures, a more robust body of evidence is needed to reach consensus.
Evacuation Drain Management. Prolonged use of surgical evacuation drains may be a risk factor for SSI. Therefore, early drain removal is paramount. Higher infection rates with prolonged drain use have been found in patients with persistent wound drainage, including malnourished, obese, and over-anticoagulated patients. Patients with wounds persistently draining for >1 week should undergo superficial wound irrigation and débridement. Jaberi and colleagues74 assessed 10,325 TJA patients and found that the majority of persistent drainage ceased within 1 week with use of less invasive measures, including oral antibiotics and local wound care. Furthermore, only 28% of patients with persistent drainage underwent surgical débridement. It is unclear if this practice alone is appropriate. Infection should always be suspected and treated aggressively, and cultures should be obtained from synovial fluid before antibiotics are started, unless there is an obvious superficial infection that does not require further work-up.67
Economic Impact
SSIs remain a significant healthcare issue, and the social and financial costs are staggering. Without appropriate measures in place, these complications will place a larger burden on the healthcare system primarily as a result of longer hospital stays, multiple procedures, and increased resource utilization.75 Given the risk of progression to prosthetic joint infection, early preventive interventions must be explored.
Table 4.Several studies have addressed the economic implications of SSIs after TJA as well as the impact of preventive interventions (Table 4). Using the NIS database, Kurtz and colleagues4 found that not only were hospital stays significantly longer for infected (vs noninfected) knee arthroplasties (7.6 vs 3.9 days; P < .0001), but hospital charges were 1.52 times higher (P < .0001), and results were similar for infected (vs noninfected) hips (9.7 vs 4.3 days; 1.76 times higher charges; P < .0001 for both). Kapadia and colleagues76 matched 21 TKA patients with periprosthetic infections with 21 noninfected TKA patients at a single institution and found the infected patients had more readmissions (3.6 vs 0.1; P < .0001), longer hospitalizations (5.3 vs 3.0 days; P = .0002), more days in the hospital within 1 year of arthroplasty (23.7 vs 3.4 days; P < .0001), and more clinic visits (6.5 vs 1.3; P < .0001). Furthermore, the infected patients had a significantly higher mean annual cost of treatment ($116,383 vs $28,249; P < .0001). Performing a Markov analysis, Slover and colleagues77 found that the decreased incidence of infection and the potential cost savings associated with preoperative S aureus screening and a decolonization protocol were able to offset the costs acquired by the screening and decolonization protocol. Similarly, Cummins and colleagues78 evaluated the effects of ALBC on overall healthcare costs; if revision surgery was the primary outcome of all infections, use of ALBC (vs cement without antibiotics) resulted in a cost-effectiveness ratio of $37,355 per quality-adjusted life year. Kapadia and colleagues79 evaluated the economic impact of adding 2% chlorhexidine gluconate-impregnated cloths to an existing preoperative skin preparation protocol for TKA. One percent of non-chlorhexidine patients and 0.6% of chlorhexidine patients developed an infection. The reduction in incidence of infection amounted to projected net savings of almost $2.1 million per 1000 TKA patients. Nationally, annual healthcare savings were expected to range from $0.78 billion to $3.18 billion with implementation of this protocol.
Improved patient selection may be an important factor in reducing SSIs. In an analysis of 8494 joint arthroplasties, Malinzak and colleagues80 noted that patients with a BMI of >50 kg/m2 had an increased OR of infection of 21.3 compared to those with BMI <50 kg/m2. Wagner and colleagues81 analyzed 21,361 THAs and found that, for every BMI unit over 25 kg/m2, there was an 8% increased risk of joint infection (P < .001). Although it is unknown if there is an association between reduction in preoperative BMI and reduction in postoperative complication risk, it may still be worthwhile and cost-effective to modify this and similar risk factors before elective procedures.
Market forces are becoming a larger consideration in healthcare and are being driven by provider competition.82 Treatment outcomes, quality of care, and healthcare prices have gained attention as a means of estimating potential costs.83 In 2011, the Centers for Medicare & Medicaid Services (CMS) advanced the Bundled Payments for Care Improvement (BPCI) initiative, which aimed to provide better coordinated care of higher quality and lower cost.84 This led to development of the Comprehensive Care for Joint Replacement (CJR) program, which gives beneficiaries flexibility in choosing services and ensures that providers adhere to required standards. During its 5-year test period beginning in 2016, the CJR program is projected to save CMS $153 million.84 Under this program, the institution where TJA is performed is responsible for all the costs of related care from time of surgery through 90 days after hospital discharge—which is known as an “episode of care.” If the cost incurred during an episode exceeds an established target cost (as determined by CMS), the hospital must repay Medicare the difference. Conversely, if the cost of an episode is less than the established target cost, the hospital is rewarded with the difference. Bundling payments for a single episode of care in this manner is thought to incentivize providers and hospitals to give patients more comprehensive and coordinated care. Given the substantial economic burden associated with joint arthroplasty infections, it is imperative for orthopedists to establish practical and cost-effective strategies that can prevent these disastrous complications.
Conclusion
SSIs are a devastating burden to patients, surgeons, and other healthcare providers. In recent years, new discoveries and innovations have helped mitigate the incidence of these complications of THA and TKA. However, the incidence of SSIs may rise with the increasing use of TJAs and with the development of new drug-resistant pathogens. In addition, the increasing number of TJAs performed on overweight and high-risk patients means the costs of postoperative infections will be substantial. With new reimbursement models in place, hospitals and providers are being held more accountable for the care they deliver during and after TJA. Consequently, more emphasis should be placed on techniques that are proved to minimize the incidence of SSIs.
Take-Home Points
SSIs after TJA pose a substantial burden on patients, surgeons, and the healthcare system.
While different forms of preoperative skin preparation have shown varying outcomes after TJA, the importance of preoperative patient optimization (nutritional status, immune function, etc) cannot be overstated.
Intraoperative infection prevention measures include cutaneous preparation, gloving, body exhaust suits, surgical drapes, OR staff traffic and ventilation flow, and antibiotic-loaded cement.
Antibiotic prophylaxis for dental procedures in TJA patients continues to remain a controversial issue with conflicting recommendations.
SSIs have considerable financial costs and require increased resource utilization. Given the significant economic burden associated with TJA infections, it is imperative for orthopedists to establish practical and cost-effective strategies to prevent these devastating complications.
Surgical-site infection (SSI), a potentially devastating complication of lower extremity total joint arthroplasty (TJA), is estimated to occur in 1% to 2.5% of cases annually.1 Infection after TJA places a significant burden on patients, surgeons, and the healthcare system. Revision procedures that address infection after total hip arthroplasty (THA) are associated with more hospitalizations, more operations, longer hospital stay, and higher outpatient costs in comparison with primary THAs and revision surgeries for aseptic loosening.2 If left untreated, a SSI can go deeper into the joint and develop into a periprosthetic infection, which can be disastrous and costly. A periprosthetic joint infection study that used 2001 to 2009 Nationwide Inpatient Sample (NIS) data found that the cost of revision procedures increased to $560 million from $320 million, and was projected to reach $1.62 billion by 2020.3 Furthermore, society incurs indirect costs as a result of patient disability and loss of wages and productivity.2 Therefore, the issue of infection after TJA is even more crucial in our cost-conscious healthcare environment.
Patient optimization, advances in surgical technique, sterile protocol, and operative procedures have been effective in reducing bacterial counts at incision sites and minimizing SSIs. As a result, infection rates have leveled off after rising for a decade.4 Although infection prevention modalities have their differences, routine use is fundamental and recommended by the Hospital Infection Control Practices Advisory Committee.5 Furthermore, both the US Centers for Disease Control and Prevention (CDC) and its Healthcare Infection Control Practices Advisory Committee6,7 recently updated their SSI prevention guidelines by incorporating evidence-based methodology, an element missing from earlier recommendations.
The etiologies of postoperative SSIs have been discussed ad nauseam, but there are few reports summarizing the literature on infection prevention modalities. In this review, we identify and examine SSI prevention strategies as they relate to lower extremity TJA. Specifically, we discuss the literature on the preoperative, intraoperative, and postoperative actions that can be taken to reduce the incidence of SSIs after TJA. We also highlight the economic implications of SSIs that occur after TJA.
Methods
For this review, we performed a literature search with PubMed, EBSCOhost, and Scopus. We looked for reports published between the inception of each database and July 2016. Combinations of various search terms were used: surgical site, infection, total joint arthroplasty, knee, hip, preoperative, intraoperative, perioperative, postoperative, preparation, nutrition, ventilation, antibiotic, body exhaust suit, gloves, drain, costs, economic, and payment.
Our search identified 195 abstracts. Drs. Mistry and Chughtai reviewed these to determine which articles were relevant. For any uncertainties, consensus was reached with the help of Dr. Delanois. Of the 195 articles, 103 were potentially relevant, and 54 of the 103 were excluded for being not relevant to preventing SSIs after TJA or for being written in a language other than English. The references in the remaining articles were assessed, and those with potentially relevant titles were selected for abstract review. This step provided another 35 articles. After all exclusions, 48 articles remained. We discuss these in the context of preoperative, intraoperative, and postoperative measures and economic impact.
Results
Preoperative Measures
Skin Preparation. Preoperative skin preparation methods include standard washing and rinsing, antiseptic soaps, and iodine-based or chlorhexidine gluconate-based antiseptic showers or skin cloths. Iodine-based antiseptics are effective against a wide range of Gram-positive and Gram-negative bacteria, fungi, and viruses. These agents penetrate the cell wall, oxidize the microbial contents, and replace those contents with free iodine molecules.8 Iodophors are free iodine molecules associated with a polymer (eg, polyvinylpyrrolidone); the iodophor povidone-iodine is bactericidal.9 Chlorhexidine gluconate-based solutions are effective against many types of yeast, Gram-positive and Gram-negative bacteria, and a wide variety of viruses.9 Both solutions are useful. Patients with an allergy to iodine can use chlorhexidine. Table 1 summarizes the studies on preoperative measures for preventing SSIs.
Table 1A.
Table 1B.
There is no shortage of evidence of the efficacy of these antiseptics in minimizing the incidence of SSIs. Hayek and colleagues10 prospectively analyzed use of different preoperative skin preparation methods in 2015 patients. Six weeks after surgery, the infection rate was significantly lower with use of chlorhexidine than with use of an unmedicated bar of soap or placebo cloth (9% vs 11.7% and 12.8%, respectively; P < .05). In a study of 100 patients, Murray and colleagues11 found the overall bacterial culture rate was significantly lower for those who used a 2% chlorhexidine gluconate cloth before shoulder surgery than for those who took a standard shower with soap (66% vs 94%; P = .0008). Darouiche and colleagues12 found the overall SSI rate was significantly lower for 409 surgical patients prepared with chlorhexidine-alcohol than for 440 prepared with povidone-iodine (9.5% vs 16.1%; P = .004; relative risk [RR], 0.59; 95% confidence interval [CI], 0.41-0.85).
Chlorhexidine gluconate-impregnated cloths have also had promising results, which may be attributed to general ease of use and potentially improved patient adherence. Zywiel and colleagues13 reported no SSIs in 136 patients who used these cloths at home before total knee arthroplasty (TKA) and 21 SSIs (3.0%) in 711 patients who did not use the cloths. In a study of 2545 THA patients, Kapadia and colleagues14 noted a significantly lower incidence of SSIs with at-home preoperative use of chlorhexidine cloths than with only in-hospital perioperative skin preparation (0.5% vs 1.7%; P = .04). In 2293 TKAs, Johnson and colleagues15 similarly found a lower incidence of SSIs with at-home preoperative use of chlorhexidine cloths (0.6% vs 2.2%; P = .02). In another prospective, randomized trial, Kapadia and colleagues16 compared 275 patients who used chlorhexidine cloths the night before and the morning of lower extremity TJA surgery with 279 patients who underwent standard-of-care preparation (preadmission bathing with antibacterial soap and water). The chlorhexidine cohort had a lower overall incidence of infection (0.4% vs 2.9%; P = .049), and the standard-of-care cohort had a stronger association with infection (odds ratio [OR], 8.15; 95% CI, 1.01-65.6).
Patient Optimization. Poor nutritional status may compromise immune function, potentially resulting in delayed healing, increased risk of infection, and, ultimately, negative postoperative outcomes. Malnutrition can be diagnosed on the basis of a prealbumin level of <15 mg/dL (normal, 15-30 mg/dL), a serum albumin level of <3.4 g/dL (normal, 3.4-5.4 g/dL), or a total lymphocyte count under 1200 cells/μL (normal, 3900-10,000 cells/μL).17-19 Greene and colleagues18 found that patients with preoperative malnutrition had up to a 7-fold higher rate of infection after TJA. In a study of 135 THAs and TKAs, Alfargieny and colleagues20 found preoperative serum albumin was the only nutritional biomarker predictive of SSI (P = .011). Furthermore, patients who take immunomodulating medications (eg, for inflammatory arthropathies) should temporarily discontinue them before surgery in order to lower their risk of infection.21
Smoking is well established as a major risk factor for poor outcomes after surgery. It is postulated that the vasoconstrictive effects of nicotine and the hypoxic effects of carbon monoxide contribute to poor wound healing.22 In a meta-analysis of 4 studies, Sørensen23 found smokers were at increased risk for wound complications (OR, 2.27; 95% CI, 1.82-2.84), delayed wound healing and dehiscence (OR, 2.07; 95% CI, 1.53-2.81), and infection (OR, 1.79; 95% CI, 1.57-2.04). Moreover, smoking cessation decreased the incidence of SSIs (OR, 0.43; 95% CI, 0.21-0.85). A meta- analysis by Wong and colleagues24 revealed an inflection point for improved outcomes in patients who abstained from smoking for at least 4 weeks before surgery. Risk of infection was lower for these patients than for current smokers (OR, 0.69; 95% CI, 0.56-0.84).
Other comorbidities contribute to SSIs as well. In their analysis of American College of Surgeons National Surgical Quality Improvement Program registry data on 25,235 patients who underwent primary and revision lower extremity TJA, Pugely and colleagues25 found that, in the primary TJA cohort, body mass index (BMI) of >40 kg/m2 (OR, 1.9; 95% CI, 1.3-2.9), electrolyte disturbance (OR, 2.4; 95% CI, 1.0-6.0), and hypertension diagnosis (OR, 1.5; 95% CI, 1.1-2.0) increased the risk of SSI within 30 days. Furthermore, diabetes mellitus delays collagen synthesis, impairs lymphocyte function, and impairs wound healing, which may lead to poor recovery and higher risk of infection.26 In a study of 167 TKAs performed in 115 patients with type 2 diabetes mellitus, Han and Kang26 found that wound complications were 6 times more likely in those with hemoglobin A1c (HbA1c) levels higher than 8% than in those with lower HbA1c levels (OR, 6.07; 95% CI, 1.12-33.0). In a similar study of 462 patients with diabetes, Hwang and colleagues27 found a higher likelihood of superficial SSIs in patients with HbA1c levels >8% (OR, 6.1; 95% CI, 1.6-23.4; P = .008). This association was also found in patients with a fasting blood glucose level of >200 mg/dL (OR, 9.2; 95% CI, 2.2-38.2; P = .038).
Methicillin-resistant Staphylococcus aureus (MRSA) is thought to account for 10% to 25% of all periprosthetic infections in the United States.28 Nasal colonization by this pathogen increases the risk for SSIs; however, decolonization protocols have proved useful in decreasing the rates of colonization. Moroski and colleagues29 assessed the efficacy of a preoperative 5-day course of intranasal mupirocin in 289 primary or revision TJA patients. Before surgery, 12 patients had positive MRSA cultures, and 44 had positive methicillin-sensitive S aureus (MSSA) cultures. On day of surgery, a significant reduction in MRSA (P = .0073) and MSSA (P = .0341) colonization was noted. Rao and colleagues30 found that the infection rate decreased from 2.7% to 1.2% in 2284 TJA patients treated with a decolonization protocol (P = .009).
Intraoperative Measures
Cutaneous Preparation. The solutions used in perioperative skin preparation are similar to those used preoperatively: povidone-iodine, alcohol, and chlorhexidine. The efficacy of these preparations varies. Table 2 summarizes the studies on intraoperative measures for preventing SSIs.
Table 2A.
Table 2B.In a prospective study, Saltzman and colleagues31 randomly assigned 150 shoulder arthroplasty patients to one of 3 preparations: 0.75% iodine scrub with 1% iodine paint (Povidone-Iodine; Tyco Healthcare Group), 0.7% iodophor with 74% iodine povacrylex (DuraPrep; 3M Health Care), or chlorhexidine gluconate with 70% isopropyl alcohol (ChloraPrep; Enturia). All patients had their skin area prepared and swabbed for culture before incision. Although no one in any group developed a SSI, patients in the chlorhexidine group had the lowest overall incidence of positive skin cultures. That incidence (7%) and the incidence of patients in the iodophor group (19%) were significantly lower than that of patients in the iodine group (31%) (P < .001 for both). Conversely, another study32 found a higher likelihood of SSI with chlorhexidine than with povidone-iodine (OR, 4.75; 95% CI, 1.42-15.92; P = .012). This finding is controversial, but the body of evidence led the CDC to recommend use of an alcohol-based solution for preoperative skin preparation.6
The literature also highlights the importance of technique in incision-site preparation. In a prospective study, Morrison and colleagues33 randomly assigned 600 primary TJA patients to either (1) use of alcohol and povidone-iodine before draping, with additional preparation with iodine povacrylex (DuraPrep) and isopropyl alcohol before application of the final drape (300-patient intervention group) or (2) only use of alcohol and povidone-iodine before draping (300-patient control group). At the final follow-up, the incidence of SSI was significantly lower in the intervention group than in the control group (1.8% vs 6.5%; P = .015). In another study that assessed perioperative skin preparation methods, Brown and colleagues34 found that airborne bacteria levels in operating rooms were >4 times higher with patients whose legs were prepared by a scrubbed, gowned leg-holder than with patients whose legs were prepared by an unscrubbed, ungowned leg-holder (P = .0001).
Hair Removal. Although removing hair from surgical sites is common practice, the literature advocating it varies. A large comprehensive review35 revealed no increased risk of SSI with removing vs not removing hair (RR, 1.65; 95% CI, 0.85-3.19). On the other hand, some hair removal methods may affect the incidence of infection. For example, use of electric hair clippers is presumed to reduce the risk of SSIs, whereas traditional razors may compromise the epidermal barriers and create a pathway for bacterial colonization.5,36,37 In the aforementioned review,35 SSIs were more than twice as likely to occur with hair removed by shaving than with hair removed by electric clippers (RR, 2.02; 95% CI, 1.21-3.36). Cruse and Foord38 found a higher rate of SSIs with hair removed by shaving than with hair removed by clipping (2.3% vs 1.7%). Most surgeons agree that, if given the choice, they would remove hair with electric clippers rather than razors.
Gloves. Almost all orthopedists double their gloves for TJA cases. Over several studies, the incidence of glove perforation during orthopedic procedures has ranged from 3.6% to 26%,39-41 depending on the operating room personnel and glove layering studied. Orthopedists must know this startling finding, as surgical glove perforation is associated with an increase in the rate of SSIs, from 1.7% to 5.7%.38 Carter and colleagues42 found the highest risk of glove perforation occurs when double-gloved attending surgeons, adult reconstruction fellows, and registered nurses initially assist during primary and revision TJA. In their study, outer and inner glove layers were perforated 2.5% of the time. All outer-layer perforations were noticed, but inner-layer perforations went unnoticed 81% of the time, which poses a potential hazard for both patients and healthcare personnel. In addition, there was a significant increase in the incidence of glove perforations for attending surgeons during revision TJA vs primary TJA (8.9% vs 3.7%; P = .04). This finding may be expected given the complexity of revision procedures, the presence of sharp bony and metal edges, and the longer operative times. Giving more attention to glove perforations during arthroplasties may mitigate the risk of SSI. As soon as a perforation is noticed, the glove should be removed and replaced.
Body Exhaust Suits. Early TJAs had infection rates approaching 10%.43 Bacterial-laden particles shed from surgical staff were postulated to be the cause,44,45 and this idea prompted the development of new technology, such as body exhaust suits, which have demonstrated up to a 20-fold reduction in airborne bacterial contamination and decreased incidence of deep infection, from 1% to 0.1%, as compared with conventional surgical attire.46 However, the efficacy of these suits was recently challenged. Hooper and colleagues47 assessed >88,000 TJA cases in the New Zealand Joint Registry and found a significant increase in early revision THA for deep infection with vs without use of body exhaust suits (0.186% vs 0.064%; P < .0001). The incidence of revision TKAs for deep infections with use of these suits was similar (0.243% vs 0.098%; P < .001). Many of the surgeons surveyed indicated their peripheral vision was limited by the suits, which may contribute to sterile field contamination. By contrast, Miner and colleagues48 were unable to determine an increased risk of SSI with use of body exhaust suits (RR, 0.75; 95% CI, 0.34-1.62), though there was a trend toward more infections without suits. Moreover, these suits are effective in reducing mean air bacterial counts (P = .014), but it is not known if this method correlates with mean wound bacterial counts (r = –.011) and therefore increases the risk of SSI.49
Surgical Drapes. Surgical draping, including cloths, iodine-impregnated materials, and woven or unwoven materials, is the standard of care worldwide. The particular draping technique usually varies by surgeon. Plastic drapes are better barriers than cloth drapes, as found in a study by Blom and colleagues50: Bacterial growth rates were almost 10 times higher with use of wet woven cloth drapes than with plastic surgical drapes. These findings were supported in another, similar study by Blom and colleagues51: Wetting drapes with blood or normal saline enhanced bacterial penetration. In addition, wetting drapes with chlorhexidine or iodine reduced but did not eliminate bacterial penetration. Fairclough and colleagues52 emphasized that iodine-impregnated drapes reduced surgical-site bacterial contamination from 15% to 1.6%. However, a Cochrane review53 found these drapes had no effect on the SSI rate (RR, 1.03; 95% CI, 0.06-1.66; P = .89), though the risk of infection was slightly higher with adhesive draping than with no drape (RR, 1.23; 95% CI, 1.02-1.48; P = .03).
Ventilation Flow. Laminar-airflow systems are widely used to prevent SSIs after TJA. Horizontal-flow and vertical-flow ventilation provides and maintains ultra-clean air in the operating room. Evans54 found the bacterial counts in the air and the wound were lower with laminar airflow than without this airflow. The amount of airborne bacterial colony-forming units and dust large enough to carry bacteria was reduced to 1 or 2 particles more than 2 μm/m3 with use of a typical laminar- airflow system. In comparing 3922 TKA patients in laminar-airflow operating rooms with 4133 patients in conventional rooms, Lidwell and colleagues46 found a significantly lower incidence of SSIs in patients in laminar-airflow operating rooms (0.6% vs 2.3%; P < .001).
Conversely, Miner and colleagues48 did not find a lower risk of SSI with laminar-airflow systems (RR, 1.57; 95% CI, 0.75-3.31). In addition, in their analysis of >88,000 cases from the New Zealand Joint Registry, Hooper and colleagues47 found that the incidence of early infections was higher with laminar-airflow systems than with standard airflow systems for both TKA (0.193% vs 0.100%; P = .019) and THA (0.148% vs 0.061%; P < .001). They postulated that vertically oriented airflow may have transmitted contaminated particles into the surgical sites. Additional evidence may be needed to resolve these conflicting findings and determine whether clean-air practices provide significant clinical benefit in the operating room.
Staff Traffic Volume. When staff enters or exits the operating room or makes extra movements during a procedure, airflow near the wound is disturbed and no longer able to remove sufficient airborne pathogens from the sterile field. The laminar- airflow pattern may be disrupted each time the operating room doors open and close, potentially allowing airborne pathogens to be introduced near the patient. Lynch and colleagues55 found the operating room door opened almost 50 times per hour, and it took about 20 seconds to close each time. As a result, the door may remain open for up to 20 minutes per case, causing substantial airflow disruption and potentially ineffective removal of airborne bacterial particles. Similarly, Young and O’Regan56 found the operating room door opened about 19 times per hour and took 20 seconds to close each time. The theater door was open an estimated 10.7% of each hour of sterile procedure. Presence of more staff also increases airborne bacterial counts. Pryor and Messmer57 evaluated a cohort of 2864 patients to determine the effect of number of personnel in the operating theater on the incidence of SSIs. Infection rates were 6.27% with >17 different people entering the room and 1.52% with <9 different people entering the room. Restricting the number of people in the room may be one of the easiest and most efficient ways to prevent SSI.
Systemic Antibiotic Prophylaxis. Perioperative antibiotic use is vital in minimizing the risk of infection after TJA. The Surgical Care Improvement Project recommended beginning the first antimicrobial dose either within 60 minutes before surgical incision (for cephalosporin) or within 2 hours before incision (for vancomycin) and discontinuing the prophylactic antimicrobial agents within 24 hours after surgery ends.58,59 However, Gorenoi and colleagues60 were unable to recommend a way to select particular antibiotics, as they found no difference in the effectiveness of various antibiotic agents used in TKA. A systematic review by AlBuhairan and colleagues61 revealed that antibiotic prophylaxis (vs no prophylaxis) reduced the absolute risk of a SSI by 8% and the relative risk by 81% (P < 0.0001). These findings are supported by evidence of the efficacy of perioperative antibiotics in reducing the incidence of SSI.62,63 Antibiotic regimens should be based on susceptibility and availability, depending on hospital prevalence of infections. Even more, patients should receive prophylaxis in a timely manner. Finally, bacteriostatic antibiotics (vancomycin) should not be used on their own for preoperative prophylaxis.
Antibiotic Cement. Antibiotic-loaded bone cement (ALBC), which locally releases antimicrobials in high concentration, is often used in revision joint arthroplasty, but use in primary joint arthroplasty remains controversial. In a study of THA patients, Parvizi and colleagues64 found infection rates of 1.2% with 2.3% with and without use of ALBC, respectively. Other studies have had opposing results. Namba and colleagues65 evaluated 22,889 primary TKAs, 2030 (8.9%) of which used ALBC. The incidence of deep infection was significantly higher with ALBC than with regular bone cement (1.4% vs 0.7%; P = .002). In addition, a meta- analysis of >6500 primary TKA patients, by Zhou and colleagues,66 revealed no significant difference in the incidence of deep SSIs with use of ALBC vs regular cement (1.32% vs 1.89%; RR, 0.75; 95% CI, 0.43-1.33; P = .33). More evidence is needed to determine the efficacy of ALBC in primary TJA. International Consensus Meeting on Periprosthetic Joint Infection participants recommended use of ALBC in high-risk patients, including patients who are obese or immunosuppressed or have diabetes or a prior history of infection.67
Postoperative Measures
Antibiotic Prophylaxis. The American Academy of Orthopaedic Surgeons (AAOS) and the American Dental Association (ADA) have suggestions for antibiotic prophylaxis for patients at increased risk for infection. As of 2015, the ADA no longer recommends antibiotic prophylaxis for patients with prosthetic joint implants,68 whereas the AAOS considers all patients with TJA to be at risk.69
Table 3.For TJA patients, the AAOS recommends administering antibiotic prophylaxis at least 1 hour before a dental procedure and discontinuing it within 24 hours after the procedure ends.69 Single preoperative doses are acceptable for outpatient procedures.70Table 3 summarizes the studies that reported on postoperative measures for preventing SSI.
Although recommendations exist, the actual risk of infection resulting from dental procedures and the role of antibiotic prophylaxis are not well defined. Berbari and colleagues71 found that antibiotic prophylaxis in high- or low-risk dental procedures did not decrease the risk of subsequent THA infection (OR, 0.9; 95% CI, 0.5-1.6) or TKA infection (OR, 1.2; 95% CI, 0.7-2.2). Moreover, the risk of infection was no higher for patients who had a prosthetic hip or knee and underwent a high- or low-risk dental procedure without antibiotic prophylaxis (OR, 0.8; 95% CI, 0.4-1.6) than for similar patients who did not undergo a dental procedure (OR, 0.6; 95% CI, 0.4-1.1). Some studies highlight the low level of evidence supporting antibiotic prophylaxis during dental procedures.72,73 However, there is no evidence of adverse effects of antibiotic prophylaxis. Given the potential high risk of infection after such procedures, a more robust body of evidence is needed to reach consensus.
Evacuation Drain Management. Prolonged use of surgical evacuation drains may be a risk factor for SSI. Therefore, early drain removal is paramount. Higher infection rates with prolonged drain use have been found in patients with persistent wound drainage, including malnourished, obese, and over-anticoagulated patients. Patients with wounds persistently draining for >1 week should undergo superficial wound irrigation and débridement. Jaberi and colleagues74 assessed 10,325 TJA patients and found that the majority of persistent drainage ceased within 1 week with use of less invasive measures, including oral antibiotics and local wound care. Furthermore, only 28% of patients with persistent drainage underwent surgical débridement. It is unclear if this practice alone is appropriate. Infection should always be suspected and treated aggressively, and cultures should be obtained from synovial fluid before antibiotics are started, unless there is an obvious superficial infection that does not require further work-up.67
Economic Impact
SSIs remain a significant healthcare issue, and the social and financial costs are staggering. Without appropriate measures in place, these complications will place a larger burden on the healthcare system primarily as a result of longer hospital stays, multiple procedures, and increased resource utilization.75 Given the risk of progression to prosthetic joint infection, early preventive interventions must be explored.
Table 4.Several studies have addressed the economic implications of SSIs after TJA as well as the impact of preventive interventions (Table 4). Using the NIS database, Kurtz and colleagues4 found that not only were hospital stays significantly longer for infected (vs noninfected) knee arthroplasties (7.6 vs 3.9 days; P < .0001), but hospital charges were 1.52 times higher (P < .0001), and results were similar for infected (vs noninfected) hips (9.7 vs 4.3 days; 1.76 times higher charges; P < .0001 for both). Kapadia and colleagues76 matched 21 TKA patients with periprosthetic infections with 21 noninfected TKA patients at a single institution and found the infected patients had more readmissions (3.6 vs 0.1; P < .0001), longer hospitalizations (5.3 vs 3.0 days; P = .0002), more days in the hospital within 1 year of arthroplasty (23.7 vs 3.4 days; P < .0001), and more clinic visits (6.5 vs 1.3; P < .0001). Furthermore, the infected patients had a significantly higher mean annual cost of treatment ($116,383 vs $28,249; P < .0001). Performing a Markov analysis, Slover and colleagues77 found that the decreased incidence of infection and the potential cost savings associated with preoperative S aureus screening and a decolonization protocol were able to offset the costs acquired by the screening and decolonization protocol. Similarly, Cummins and colleagues78 evaluated the effects of ALBC on overall healthcare costs; if revision surgery was the primary outcome of all infections, use of ALBC (vs cement without antibiotics) resulted in a cost-effectiveness ratio of $37,355 per quality-adjusted life year. Kapadia and colleagues79 evaluated the economic impact of adding 2% chlorhexidine gluconate-impregnated cloths to an existing preoperative skin preparation protocol for TKA. One percent of non-chlorhexidine patients and 0.6% of chlorhexidine patients developed an infection. The reduction in incidence of infection amounted to projected net savings of almost $2.1 million per 1000 TKA patients. Nationally, annual healthcare savings were expected to range from $0.78 billion to $3.18 billion with implementation of this protocol.
Improved patient selection may be an important factor in reducing SSIs. In an analysis of 8494 joint arthroplasties, Malinzak and colleagues80 noted that patients with a BMI of >50 kg/m2 had an increased OR of infection of 21.3 compared to those with BMI <50 kg/m2. Wagner and colleagues81 analyzed 21,361 THAs and found that, for every BMI unit over 25 kg/m2, there was an 8% increased risk of joint infection (P < .001). Although it is unknown if there is an association between reduction in preoperative BMI and reduction in postoperative complication risk, it may still be worthwhile and cost-effective to modify this and similar risk factors before elective procedures.
Market forces are becoming a larger consideration in healthcare and are being driven by provider competition.82 Treatment outcomes, quality of care, and healthcare prices have gained attention as a means of estimating potential costs.83 In 2011, the Centers for Medicare & Medicaid Services (CMS) advanced the Bundled Payments for Care Improvement (BPCI) initiative, which aimed to provide better coordinated care of higher quality and lower cost.84 This led to development of the Comprehensive Care for Joint Replacement (CJR) program, which gives beneficiaries flexibility in choosing services and ensures that providers adhere to required standards. During its 5-year test period beginning in 2016, the CJR program is projected to save CMS $153 million.84 Under this program, the institution where TJA is performed is responsible for all the costs of related care from time of surgery through 90 days after hospital discharge—which is known as an “episode of care.” If the cost incurred during an episode exceeds an established target cost (as determined by CMS), the hospital must repay Medicare the difference. Conversely, if the cost of an episode is less than the established target cost, the hospital is rewarded with the difference. Bundling payments for a single episode of care in this manner is thought to incentivize providers and hospitals to give patients more comprehensive and coordinated care. Given the substantial economic burden associated with joint arthroplasty infections, it is imperative for orthopedists to establish practical and cost-effective strategies that can prevent these disastrous complications.
Conclusion
SSIs are a devastating burden to patients, surgeons, and other healthcare providers. In recent years, new discoveries and innovations have helped mitigate the incidence of these complications of THA and TKA. However, the incidence of SSIs may rise with the increasing use of TJAs and with the development of new drug-resistant pathogens. In addition, the increasing number of TJAs performed on overweight and high-risk patients means the costs of postoperative infections will be substantial. With new reimbursement models in place, hospitals and providers are being held more accountable for the care they deliver during and after TJA. Consequently, more emphasis should be placed on techniques that are proved to minimize the incidence of SSIs.
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47. Hooper GJ, Rothwell AG, Frampton C, Wyatt MC. Does the use of laminar flow and space suits reduce early deep infection after total hip and knee replacement? The ten-year results of the New Zealand Joint Registry. J Bone Joint Surg Br. 2011;93(1):85-90.
48. Miner AL, Losina E, Katz JN, Fossel AH, Platt R. Deep infection after total knee replacement: impact of laminar airflow systems and body exhaust suits in the modern operating room. Infect Control Hosp Epidemiol. 2007;28(2):222-226.
49. Der Tavitian J, Ong SM, Taub NA, Taylor GJ. Body-exhaust suit versus occlusive clothing. A randomised, prospective trial using air and wound bacterial counts. J Bone Joint Surg Br. 2003;85(4):490-494.
50. Blom A, Estela C, Bowker K, MacGowan A, Hardy JR. The passage of bacteria through surgical drapes. Ann R Coll Surg Engl. 2000;82(6):405-407.
51. Blom AW, Gozzard C, Heal J, Bowker K, Estela CM. Bacterial strike-through of re-usable surgical drapes: the effect of different wetting agents. J Hosp Infect. 2002;52(1):52-55.
52. Fairclough JA, Johnson D, Mackie I. The prevention of wound contamination by skin organisms by the pre-operative application of an iodophor impregnated plastic adhesive drape. J Int Med Res. 1986;14(2):105-109.
53. Webster J, Alghamdi AA. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev. 2007;(4):CD006353.
54. Evans RP. Current concepts for clean air and total joint arthroplasty: laminar airflow and ultraviolet radiation: a systematic review. Clin Orthop Relat Res. 2011;469(4):945-953.
55. Lynch RJ, Englesbe MJ, Sturm L, et al. Measurement of foot traffic in the operating room: implications for infection control. Am J Med Qual. 2009;24(1):45-52.
56. Young RS, O’Regan DJ. Cardiac surgical theatre traffic: time for traffic calming measures? Interact Cardiovasc Thorac Surg. 2010;10(4):526-529.
57. Pryor F, Messmer PR. The effect of traffic patterns in the OR on surgical site infections. AORN J. 1998;68(4):649-660.
58. Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup, American Academy of Orthopaedic Surgeons, American Association of Critical Care Nurses, et al. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004;38(12):1706-1715.
59. Rosenberger LH, Politano AD, Sawyer RG. The Surgical Care Improvement Project and prevention of post-operative infection, including surgical site infection. Surg Infect (Larchmt). 2011;12(3):163-168.
60. Gorenoi V, Schonermark MP, Hagen A. Prevention of infection after knee arthroplasty. GMS Health Technol Assess. 2010;6:Doc10.
61. AlBuhairan B, Hind D, Hutchinson A. Antibiotic prophylaxis for wound infections in total joint arthroplasty: a systematic review. J Bone Joint Surg Br. 2008;90(7):915-919.
62. Bratzler DW, Houck PM; Surgical Infection Prevention Guideline Writers Workgroup. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Am J Surg. 2005;189(4):395-404.
63. Quenon JL, Eveillard M, Vivien A, et al. Evaluation of current practices in surgical antimicrobial prophylaxis in primary total hip prosthesis—a multicentre survey in private and public French hospitals. J Hosp Infect. 2004;56(3):202-207.
64. Parvizi J, Saleh KJ, Ragland PS, Pour AE, Mont MA. Efficacy of antibiotic-impregnated cement in total hip replacement. Acta Orthop. 2008;79(3):335-341.
65. Namba RS, Chen Y, Paxton EW, Slipchenko T, Fithian DC. Outcomes of routine use of antibiotic-loaded cement in primary total knee arthroplasty. J Arthroplasty. 2009;24(6 suppl):44-47.
66. Zhou Y, Li L, Zhou Q, et al. Lack of efficacy of prophylactic application of antibiotic-loaded bone cement for prevention of infection in primary total knee arthroplasty: results of a meta-analysis. Surg Infect (Larchmt). 2015;16(2):183-187.
67. Leopold SS. Consensus statement from the International Consensus Meeting on Periprosthetic Joint Infection. Clin Orthop Relat Res. 2013;471(12):3731-3732.
68. Sollecito TP, Abt E, Lockhart PB, et al. The use of prophylactic antibiotics prior to dental procedures in patients with prosthetic joints: evidence-based clinical practice guideline for dental practitioners—a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2015;146(1):11-16.e18.
69. Watters W 3rd, Rethman MP, Hanson NB, et al. Prevention of orthopaedic implant infection in patients undergoing dental procedures. J Am Acad Orthop Surg. 2013;21(3):180-189.
70. Merchant VA; American Academy of Orthopaedic Surgeons, American Dental Association. The new AAOS/ADA clinical practice guidelines for management of patients with prosthetic joint replacements. J Mich Dent Assoc. 2013;95(2):16, 74.
71. Berbari EF, Osmon DR, Carr A, et al. Dental procedures as risk factors for prosthetic hip or knee infection: a hospital-based prospective case–control study. Clin Infect Dis. 2010;50(1):8-16.
72. Little JW, Jacobson JJ, Lockhart PB; American Academy of Oral Medicine. The dental treatment of patients with joint replacements: a position paper from the American Academy of Oral Medicine. J Am Dent Assoc. 2010;141(6):667-671.
73. Curry S, Phillips H. Joint arthroplasty, dental treatment, and antibiotics: a review. J Arthroplasty. 2002;17(1):111-113.
74. Jaberi FM, Parvizi J, Haytmanek CT, Joshi A, Purtill J. Procrastination of wound drainage and malnutrition affect the outcome of joint arthroplasty. Clin Orthop Relat Res. 2008;466(6):1368-1371.
75. Stone PW. Economic burden of healthcare-associated infections: an American perspective. Expert Rev Pharmacoecon Outcomes Res. 2009;9(5):417-422.
76. Kapadia BH, McElroy MJ, Issa K, Johnson AJ, Bozic KJ, Mont MA. The economic impact of periprosthetic infections following total knee arthroplasty at a specialized tertiary-care center. J Arthroplasty. 2014;29(5):929-932.
77. Slover J, Haas JP, Quirno M, Phillips MS, Bosco JA 3rd. Cost-effectiveness of a Staphylococcus aureus screening and decolonization program for high-risk orthopedic patients. J Arthroplasty. 2011;26(3):360-365.
78. Cummins JS, Tomek IM, Kantor SR, Furnes O, Engesaeter LB, Finlayson SR. Cost-effectiveness of antibiotic-impregnated bone cement used in primary total hip arthroplasty. J Bone Joint Surg Am. 2009;91(3):634-641.
79. Kapadia BH, Johnson AJ, Issa K, Mont MA. Economic evaluation of chlorhexidine cloths on healthcare costs due to surgical site infections following total knee arthroplasty. J Arthroplasty. 2013;28(7):1061-1065.
80. Malinzak RA, Ritter MA, Berend ME, Meding JB, Olberding EM, Davis KE. Morbidly obese, diabetic, younger, and unilateral joint arthroplasty patients have elevated total joint arthroplasty infection rates. J Arthroplasty. 2009;24(6 suppl):84-88.
81. Wagner ER, Kamath AF, Fruth KM, Harmsen WS, Berry DJ. Effect of body mass index on complications and reoperations after total hip arthroplasty. J Bone Joint Surg Am. 2016;98(3):169-179.
82 Broex EC, van Asselt AD, Bruggeman CA, van Tiel FH. Surgical site infections: how high are the costs? J Hosp Infect. 2009;72(3):193-201.
83. Anderson DJ, Kirkland KB, Kaye KS, et al. Underresourced hospital infection control and prevention programs: penny wise, pound foolish? Infect Control Hosp Epidemiol. 2007;28(7):767-773.
84. Centers for Medicare & Medicaid Services (CMS), HHS. Medicare program; comprehensive care for joint replacement payment model for acute care hospitals furnishing lower extremity joint replacement services. Final rule. Fed Regist. 2015;80(226):73273-73554.
References
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26. Han HS, Kang SB. Relations between long-term glycemic control and postoperative wound and infectious complications after total knee arthroplasty in type 2 diabetics. Clin Orthop Surg. 2013;5(2):118-123.
27. Hwang JS, Kim SJ, Bamne AB, Na YG, Kim TK. Do glycemic markers predict occurrence of complications after total knee arthroplasty in patients with diabetes? Clin Orthop Relat Res. 2015;473(5):1726-1731.
28. Whiteside LA, Peppers M, Nayfeh TA, Roy ME. Methicillin-resistant Staphylococcus aureus in TKA treated with revision and direct intra-articular antibiotic infusion. Clin Orthop Relat Res. 2011;469(1):26-33.
29. Moroski NM, Woolwine S, Schwarzkopf R. Is preoperative staphylococcal decolonization efficient in total joint arthroplasty. J Arthroplasty. 2015;30(3):444-446.
30. Rao N, Cannella BA, Crossett LS, Yates AJ Jr, McGough RL 3rd, Hamilton CW. Preoperative screening/decolonization for Staphylococcus aureus to prevent orthopedic surgical site infection: prospective cohort study with 2-year follow-up. J Arthroplasty. 2011;26(8):1501-1507.
31. Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009;91(8):1949-1953.
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33. Morrison TN, Chen AF, Taneja M, Kucukdurmaz F, Rothman RH, Parvizi J. Single vs repeat surgical skin preparations for reducing surgical site infection after total joint arthroplasty: a prospective, randomized, double-blinded study. J Arthroplasty. 2016;31(6):1289-1294.
34. Brown AR, Taylor GJ, Gregg PJ. Air contamination during skin preparation and draping in joint replacement surgery. J Bone Joint Surg Br. 1996;78(1):92-94.
35. Tanner J, Woodings D, Moncaster K. Preoperative hair removal to reduce surgical site infection. Cochrane Database Syst Rev. 2006;(3):CD004122.
36. Mishriki SF, Law DJ, Jeffery PJ. Factors affecting the incidence of postoperative wound infection. J Hosp Infect. 1990;16(3):223-230.
37. Harrop JS, Styliaras JC, Ooi YC, Radcliff KE, Vaccaro AR, Wu C. Contributing factors to surgical site infections. J Am Acad Orthop Surg. 2012;20(2):94-101.
38. Cruse PJ, Foord R. A five-year prospective study of 23,649 surgical wounds. Arch Surg. 1973;107(2):206-210.
39. Laine T, Aarnio P. Glove perforation in orthopaedic and trauma surgery. A comparison between single, double indicator gloving and double gloving with two regular gloves. J Bone Joint Surg Br. 2004;86(6):898-900.
40. Ersozlu S, Sahin O, Ozgur AF, Akkaya T, Tuncay C. Glove punctures in major and minor orthopaedic surgery with double gloving. Acta Orthop Belg. 2007;73(6):760-764.
41. Chan KY, Singh VA, Oun BH, To BH. The rate of glove perforations in orthopaedic procedures: single versus double gloving. A prospective study. Med J Malaysia. 2006;61(suppl B):3-7.
42. Carter AH, Casper DS, Parvizi J, Austin MS. A prospective analysis of glove perforation in primary and revision total hip and total knee arthroplasty. J Arthroplasty. 2012;27(7):1271-1275.
43. Charnley J. A clean-air operating enclosure. Br J Surg. 1964;51:202-205.
44. Whyte W, Hodgson R, Tinkler J. The importance of airborne bacterial contamination of wounds. J Hosp Infect. 1982;3(2):123-135.
45. Owers KL, James E, Bannister GC. Source of bacterial shedding in laminar flow theatres. J Hosp Infect. 2004;58(3):230-232.
46. Lidwell OM, Lowbury EJ, Whyte W, Blowers R, Stanley SJ, Lowe D. Effect of ultraclean air in operating rooms on deep sepsis in the joint after total hip or knee replacement: a randomised study. Br Med J (Clin Res Ed). 1982;285(6334):10-14.
47. Hooper GJ, Rothwell AG, Frampton C, Wyatt MC. Does the use of laminar flow and space suits reduce early deep infection after total hip and knee replacement? The ten-year results of the New Zealand Joint Registry. J Bone Joint Surg Br. 2011;93(1):85-90.
48. Miner AL, Losina E, Katz JN, Fossel AH, Platt R. Deep infection after total knee replacement: impact of laminar airflow systems and body exhaust suits in the modern operating room. Infect Control Hosp Epidemiol. 2007;28(2):222-226.
49. Der Tavitian J, Ong SM, Taub NA, Taylor GJ. Body-exhaust suit versus occlusive clothing. A randomised, prospective trial using air and wound bacterial counts. J Bone Joint Surg Br. 2003;85(4):490-494.
50. Blom A, Estela C, Bowker K, MacGowan A, Hardy JR. The passage of bacteria through surgical drapes. Ann R Coll Surg Engl. 2000;82(6):405-407.
51. Blom AW, Gozzard C, Heal J, Bowker K, Estela CM. Bacterial strike-through of re-usable surgical drapes: the effect of different wetting agents. J Hosp Infect. 2002;52(1):52-55.
52. Fairclough JA, Johnson D, Mackie I. The prevention of wound contamination by skin organisms by the pre-operative application of an iodophor impregnated plastic adhesive drape. J Int Med Res. 1986;14(2):105-109.
53. Webster J, Alghamdi AA. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev. 2007;(4):CD006353.
54. Evans RP. Current concepts for clean air and total joint arthroplasty: laminar airflow and ultraviolet radiation: a systematic review. Clin Orthop Relat Res. 2011;469(4):945-953.
55. Lynch RJ, Englesbe MJ, Sturm L, et al. Measurement of foot traffic in the operating room: implications for infection control. Am J Med Qual. 2009;24(1):45-52.
56. Young RS, O’Regan DJ. Cardiac surgical theatre traffic: time for traffic calming measures? Interact Cardiovasc Thorac Surg. 2010;10(4):526-529.
57. Pryor F, Messmer PR. The effect of traffic patterns in the OR on surgical site infections. AORN J. 1998;68(4):649-660.
58. Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup, American Academy of Orthopaedic Surgeons, American Association of Critical Care Nurses, et al. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004;38(12):1706-1715.
59. Rosenberger LH, Politano AD, Sawyer RG. The Surgical Care Improvement Project and prevention of post-operative infection, including surgical site infection. Surg Infect (Larchmt). 2011;12(3):163-168.
60. Gorenoi V, Schonermark MP, Hagen A. Prevention of infection after knee arthroplasty. GMS Health Technol Assess. 2010;6:Doc10.
61. AlBuhairan B, Hind D, Hutchinson A. Antibiotic prophylaxis for wound infections in total joint arthroplasty: a systematic review. J Bone Joint Surg Br. 2008;90(7):915-919.
62. Bratzler DW, Houck PM; Surgical Infection Prevention Guideline Writers Workgroup. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Am J Surg. 2005;189(4):395-404.
63. Quenon JL, Eveillard M, Vivien A, et al. Evaluation of current practices in surgical antimicrobial prophylaxis in primary total hip prosthesis—a multicentre survey in private and public French hospitals. J Hosp Infect. 2004;56(3):202-207.
64. Parvizi J, Saleh KJ, Ragland PS, Pour AE, Mont MA. Efficacy of antibiotic-impregnated cement in total hip replacement. Acta Orthop. 2008;79(3):335-341.
65. Namba RS, Chen Y, Paxton EW, Slipchenko T, Fithian DC. Outcomes of routine use of antibiotic-loaded cement in primary total knee arthroplasty. J Arthroplasty. 2009;24(6 suppl):44-47.
66. Zhou Y, Li L, Zhou Q, et al. Lack of efficacy of prophylactic application of antibiotic-loaded bone cement for prevention of infection in primary total knee arthroplasty: results of a meta-analysis. Surg Infect (Larchmt). 2015;16(2):183-187.
67. Leopold SS. Consensus statement from the International Consensus Meeting on Periprosthetic Joint Infection. Clin Orthop Relat Res. 2013;471(12):3731-3732.
68. Sollecito TP, Abt E, Lockhart PB, et al. The use of prophylactic antibiotics prior to dental procedures in patients with prosthetic joints: evidence-based clinical practice guideline for dental practitioners—a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2015;146(1):11-16.e18.
69. Watters W 3rd, Rethman MP, Hanson NB, et al. Prevention of orthopaedic implant infection in patients undergoing dental procedures. J Am Acad Orthop Surg. 2013;21(3):180-189.
70. Merchant VA; American Academy of Orthopaedic Surgeons, American Dental Association. The new AAOS/ADA clinical practice guidelines for management of patients with prosthetic joint replacements. J Mich Dent Assoc. 2013;95(2):16, 74.
71. Berbari EF, Osmon DR, Carr A, et al. Dental procedures as risk factors for prosthetic hip or knee infection: a hospital-based prospective case–control study. Clin Infect Dis. 2010;50(1):8-16.
72. Little JW, Jacobson JJ, Lockhart PB; American Academy of Oral Medicine. The dental treatment of patients with joint replacements: a position paper from the American Academy of Oral Medicine. J Am Dent Assoc. 2010;141(6):667-671.
73. Curry S, Phillips H. Joint arthroplasty, dental treatment, and antibiotics: a review. J Arthroplasty. 2002;17(1):111-113.
74. Jaberi FM, Parvizi J, Haytmanek CT, Joshi A, Purtill J. Procrastination of wound drainage and malnutrition affect the outcome of joint arthroplasty. Clin Orthop Relat Res. 2008;466(6):1368-1371.
75. Stone PW. Economic burden of healthcare-associated infections: an American perspective. Expert Rev Pharmacoecon Outcomes Res. 2009;9(5):417-422.
76. Kapadia BH, McElroy MJ, Issa K, Johnson AJ, Bozic KJ, Mont MA. The economic impact of periprosthetic infections following total knee arthroplasty at a specialized tertiary-care center. J Arthroplasty. 2014;29(5):929-932.
77. Slover J, Haas JP, Quirno M, Phillips MS, Bosco JA 3rd. Cost-effectiveness of a Staphylococcus aureus screening and decolonization program for high-risk orthopedic patients. J Arthroplasty. 2011;26(3):360-365.
78. Cummins JS, Tomek IM, Kantor SR, Furnes O, Engesaeter LB, Finlayson SR. Cost-effectiveness of antibiotic-impregnated bone cement used in primary total hip arthroplasty. J Bone Joint Surg Am. 2009;91(3):634-641.
79. Kapadia BH, Johnson AJ, Issa K, Mont MA. Economic evaluation of chlorhexidine cloths on healthcare costs due to surgical site infections following total knee arthroplasty. J Arthroplasty. 2013;28(7):1061-1065.
80. Malinzak RA, Ritter MA, Berend ME, Meding JB, Olberding EM, Davis KE. Morbidly obese, diabetic, younger, and unilateral joint arthroplasty patients have elevated total joint arthroplasty infection rates. J Arthroplasty. 2009;24(6 suppl):84-88.
81. Wagner ER, Kamath AF, Fruth KM, Harmsen WS, Berry DJ. Effect of body mass index on complications and reoperations after total hip arthroplasty. J Bone Joint Surg Am. 2016;98(3):169-179.
82 Broex EC, van Asselt AD, Bruggeman CA, van Tiel FH. Surgical site infections: how high are the costs? J Hosp Infect. 2009;72(3):193-201.
83. Anderson DJ, Kirkland KB, Kaye KS, et al. Underresourced hospital infection control and prevention programs: penny wise, pound foolish? Infect Control Hosp Epidemiol. 2007;28(7):767-773.
84. Centers for Medicare & Medicaid Services (CMS), HHS. Medicare program; comprehensive care for joint replacement payment model for acute care hospitals furnishing lower extremity joint replacement services. Final rule. Fed Regist. 2015;80(226):73273-73554.
Shared decision-making tools, such as predictive models, can help empower the patient to make decisions for or against surgery equipped with more information about the expected outcome.
There is a role for preoperative collection of PROMs in the clinical decision-making process.
Mental health state, as reported by the VR-12 MCS, is a significant predictor of postoperative pain and function as reported by the VAS pain and ASES function scores.
A significant portion of the predictive ability of this model comes from the fact that at 1-year postoperatively, patients receiving a rTSA will on average have a 3.8 point lower on ASES function score than those receiving a TSA (P < .001, ω2=.083).
Future studies to discern the role of different modalities to improve a patient’s emotional health preoperatively will be beneficial as the healthcare industry trends toward value based medicine collecting PROMs as part of reimbursement schemes.
Over the past few decades, decisions regarding patients’ care have gradually transitioned from a paternalistic model to a more cooperative exchange between patient and physician. Shared decision-making provides patients a measure of autonomy in making choices for their health and their future. Patient participation may mitigate uncertainty and discomfort during selection of a course of treatment, which may lead to increased satisfaction levels after surgery.1 Moreover, shared decision-making may help patients better manage postoperative expectations through evidenced-based discussions of preoperative health levels and their corresponding outcomes. Patient-reported outcome measures (PROMs) use clinically sensitive and specific metrics to evaluate a patient’s self-reported pain, functional ability, and mental state.2 These metrics are useful in setting patient expectations for potential outcomes of treatment options. Use of evidence-based clinical decision-making tools, such as PROM-based predictive models, can facilitate a collaborative decision-making environment for patient and physician. Given the present cost-containment era, and the need for preoperative metrics that can assist in predictive analysis of postoperative improvement, models are clearly valuable.
In attempts to help patients set well-informed and reasonable expectations, physicians have turned to PROMs to facilitate preoperative evidence-based discussions. Although PROMs have been in use for almost 30 years, only recently have they been used to create tools that can aid quantitatively in the surgical decision-making process.2-6 Combining physical examination findings, imaging studies, comorbidities, and quantitative tools, such as this model, may enhance patients’ understanding of their preoperative condition and expected prognosis and thereby guide their surgical decisions.
We conducted a study to determine whether certain preoperative PROMs can predict 1-year postoperative visual analog scale (VAS) pain scores and American Shoulder and Elbow Surgeons (ASES) Function scores in total shoulder arthroplasty (TSA) and reverse TSA (rTSA). We hypothesized that preoperative mental health status as captured by Veterans RAND 12-Item Health Survey (VR-12) mental health component summary (MCS) score and preoperative VAS pain score would predict both VAS pain score and ASES Function score 1 year after surgery. Specifically, we hypothesized that a higher preoperative VR-12 MCS score would predict less pain and better function 1 year after surgery and that a higher preoperative VAS pain score would predict more pain and worse function 1 year after surgery.
Methods
This study was approved by the Institutional Review Board of Partners Healthcare. The study used the Surgical Outcome System (Arthrex), a comprehensive prospective database that stores preoperative and 1-year postoperative patient demographics and TSA-PROM data. Surveys are emailed to all enrolled patients before surgery and 1 year after surgery. As indicated by the Institutional Review Boards of all participating institutions, patients in the Surgical Outcome System have to sign a consent form to permit use of their responses in research.
The database includes patient data from 42 orthopedic surgeons across the United States. All primary TSAs and primary rTSAs in the database were included in this study, regardless of arthroplasty indication. Revisions were excluded. Also excluded were cases in which the 1-year postoperative questionnaire was not completed. Of the 1681 patients eligible for 1-year follow-up, 1225 (73%) completed the 1-year postoperative questionnaire. PROMs used in the study were VAS pain score, ASES Function score, VR-12 MCS score, and Single Assessment Numerical Evaluation (SANE). Unfortunately, not all surgeons use every measure in the 1-year postoperative questionnaire set. Thus, in our complete models, total number of observations was 1004 for modeling 1-year postoperative VAS pain scores and 986 for modeling 1-year postoperative ASES Function scores.
Metrics
On VAS, pain is rated from 0 (no pain) to 10 (pain as bad as it can be). Tashjian and colleagues7 estimated that the minimal clinically important difference (MCID) for postoperative VAS pain scores was 1.4 in a cohort of 326 patients who had TSA, rTSA, or shoulder hemiarthroplasty. ASES Function score is scaled from 0 to 30, with 30 representing best function.8 Wong and colleagues9 identified an MCID of 6.5 for ASES Function scores in a cohort of 107 patients who had TSA or rTSA. SANE ratings range from 0% to 100%, with 100% indicating the patient’s shoulder was totally “normal.”10 VR-12 MCS scores appear on a logarithmic scale, with higher numbers representing better mental health. The population mean estimate for VR-12 MCS scores is 50.1 (SD, 11.49; overall possible range, –2.47 to 76.1).11 Our patient population’s scores ranged from 12.5 to 73.8.
Statistical Analysis
Simple bivariate and multivariate linear regressions were performed to evaluate the predictive value of each of the outlined PROMs. Our complete model controls for patient sex, age, and type of arthroplasty. Categorical variables were dummy-coded. Both 1-year postoperative VAS pain score and 1-year postoperative ASES Function score were investigated as dependent variables. Regression coefficients and P and ω2 values are reported. Omega square represents how much of the variance in an outcome variable a model explains, like R2, and ω2 values can also be calculated for individual factors to see how much variance a given factor accounts for. For a simple relative risk calculation, we divided our cohort into 3 equal-sized groups based on preoperative VR-12 MCS scores and compared the risk that patients with scores in the top third (better mental health) would end up below certain ASES Total scores with the risk of patients with scores in the bottom third (worse mental health). All statistical analyses were performed with Stata (StataCorp).
Results
Table 1 lists summary statistics for the population used in these models.
Table 1.Our complete model for predicting VAS pain score 1 year after surgery accounted for 8% of the variability in this pain score (ω2 = .076), whereas our complete model for predicting ASES Function score 1 year after surgery accounted for 22% of the variability (ω2 = .219). These models include preoperative scores for VAS pain, ASES Function, VR-12 MCS, SANE, age at time of surgery, sex, and type of arthroplasty as possible explanatory variables.
Table 2.Predicting VAS Pain Score (Table 2)
Preoperative VAS pain score and VR-12 MCS score both predicted 1-year postoperative VAS pain score (P < .001). Preoperative ASES Function score did not predict pain 1 year after surgery. By contrast, higher preoperative VAS pain scores were associated with higher VAS pain scores 1 year after surgery. Higher preoperative VR-12 MCS scores were significantly associated with lower VAS pain scores 1 year after surgery, indicating that better preoperative mental health is significantly associated with better self-reported outcomes in terms of pain 1 year after surgery. These associations remained statistically significant when controlling for age at time of surgery, sex, and type of arthroplasty.
Preoperative VR-12 MCS score was more predictive of 1-year postoperative VAS pain score than preoperative VAS pain score was. In other words, preoperative VR-12 MCS score accounted for more variability in outcome for 1-year postoperative VAS pain score (2.4%; ω2 = .023) than preoperative VAS pain score did (1.6%; ω2 = .015).
Table 3.Predicting ASES Function Score (Table 3)
By contrast, preoperative VAS pain score did not predict 1-year postoperative ASES Function score. Preoperative ASES Function and VR-12 MCS scores both predicted 1-year postoperative ASES Function score (P < .001). Higher preoperative ASES Function scores were associated with higher 1-year postoperative ASES Function scores. In other words, reporting better shoulder function before surgery was associated with reporting better shoulder function after surgery.
An example gives a sense of the effect size associated with the coefficient for preoperative ASES Function score. Our model predicts that, compared with a patient who reports 5 points lower on preoperative ASES Function (which ranges from 0-30), a patient who reports 5 points higher will report on average about 1 point higher on 1-year postoperative ASES Function. As in the model for postoperative pain, these associations with preoperative function and mental health scores held when controlling for age, sex, and type of arthroplasty.
As in the postoperative pain model, preoperative VR-12 MCS score was more predictive of 1-year postoperative ASES Function score than preoperative ASES Function score was. Preoperative VR-12 MCS score accounted for more of the variation that our model predicts (ω2 = .029) than preoperative ASES Function score did (ω2 = .020). We compared the risk that patients with high preoperative VR-12 MCS scores (top third of cohort) would end up with ASES Total scores below 70, below 80, or below 90 with the risk of patients with low preoperative VR-12 MCS scores (bottom third). Results appear in Table 4.
Table 4.
A significant part of the predictive ability of our model for postoperative ASES Function scores stems from the fact that a patient who undergoes rTSA (vs TSA) is predicted to have an ASES Function score 3.8 points lower 1 year after surgery (P < .001, ω2 = .083). With type of arthroplasty controlled for, female sex is associated with an ASES Function score 1.6 points lower 1 year after surgery (P < .001, ω2 = .016).
Preoperative SANE score did not predict 1-year postoperative VAS pain score or ASES Function score. In addition, when our complete model was run with 1-year postoperative SANE score as the dependent variable, preoperative SANE score did not predict 1-year postoperative SANE score. Our data provide no supporting evidence for the use of SANE scores for predictive modeling for shoulder arthroplasty.
Discussion
We prospectively gathered data to determine which factors would predict patient subjective outcomes of primary TSA and primary rTSA. We hypothesized that preoperative VR-12 MCS scores and preoperative VAS pain scores would predict postoperative pain and function as measured with those PROMs. Second, we hypothesized that better preoperative mental health (as measured with VR-12 MCS scores) would predict lower postoperative pain (VAS pain scores) and better postoperative function (ASES Function scores). Third, we hypothesized that higher preoperative pain (VAS pain scores) would correlate with higher postoperative pain (VAS pain scores) and worse postoperative function (ASES Function scores).
Our main goal is to provide patients and surgeons with a predictive model that generates insights into what patients can expect after surgery. This model is not intended to be a screening tool for operative indications, but a clinical tool for helping set expectations.
Our results showed that patients with more pain before surgery were more likely to have more pain 1 year after surgery—confirming the hypothesized relationship between pain before and after surgery. Contrary to the hypothesis, however, degree of pain before surgery was not associated with function 1 year after surgery. Our mental health hypothesis was confirmed: Patients with better preoperative mental health scores had on average less pain and better function 1 year after surgery. Not surprisingly, our model demonstrated that patients with better self-reported function before surgery had better self-reported function after surgery. Patient-reported function before surgery did not significantly affect how much pain the patient had 1 year after surgery. Although we did not hypothesize about the role of function in predicting 1-year outcomes, function is a significant factor to be considered when setting patient expectations regarding shoulder arthroplasty outcomes (Table 5).
Table 5.
Although the effect sizes of each analyzed factor are small, together our models for 1-year postoperative pain and function provide significant insight into patients’ likely outcomes 1 year after TSA and rTSA.
Table 6.
Table 7.Table 6 and Table 7 listpreoperative PROMs and baseline characteristics for 2 sample patients and the corresponding 1-year postoperative results they should expect according to our model. Patient 1 (Table 6) achieves a theoretical ASES Total score of 67, and patient 2 (Table 7) achieves a theoretical ASES Total score of 90. During discussion of surgical options, these patients should be counseled differently. If patient 1 expects a “normal” shoulder after surgery, he or she likely will be disappointed with the outcome. Tools such as those provided here can contribute to evidence-based discussions and well-informed decision making.
Many studies have found that mental health correlated with pain and function during recovery from orthopedic trauma.12-18 For example, Wylie and colleagues19 found that preoperative mental health, as measured with the 36-Item Short Form Health Survey (SF-36) MCS score, predicted patient-reported pain and function in the setting of rotator cuff injury, regardless of treatment type (operative, nonoperative). Others have found that mental health may play a role in how patients report their pain and function on various PROMs.20,21 Modalities for improving patients’ emotional health baseline may even become a preoperative requirement as the healthcare industry moves toward value-based medicine and collection of patient-related outcomes as part of reimbursement schemes.
By contrast, some studies have found that preoperative mental health did not predict postoperative outcomes. For example, Kennedy and colleagues22 found that preoperative mental health (as measured with SF-36 MCS scores) did not predict functional outcome in patients with ankle arthritis treated with ankle arthroplasty or arthrodesis. Likewise, Styron and colleagues23 found no correlation between preoperative mental health (SF-12 MCS scores) and postoperative mental health and function in TSA. Their findings contradict those of the present study and many other studies.12-18 The contradiction in findings demonstrates the need for well-designed, sufficiently powered studies of the link between preoperative mental health and postoperative outcome. Our study, with its large sample and heterogeneous population, is a start.
Two other groups (Simmen and colleagues,18 Matsen and colleagues24) have attempted to develop a model predicting outcomes of shoulder arthroplasty. Simmen and colleagues18 estimated the probability of “treatment success” 1 year after TSA. Their model had 4 factors predictive of patient outcomes. Previous shoulder surgery and age over 75 years were significantly associated with lower probability of success, whereas higher preoperative SF-36 MCS scores and higher preoperative DASH (Disabilities of the Arm, Shoulder, and Hand) Function scores were associated with higher probability of success. The authors deemed TSA successful if the patient achieved a Constant score of ≥80 out of 100. Their model predicts probability of TSA “success,” whereas our models predict particular outcome scores. Both their results and ours support the hypothesis that preoperative mental health and function scores can predict how well a patient fares after surgery. Simmen and colleagues18 based their model on a cohort of only 140 patients and reported a 33.6% success rate (47/140 surgeries).
Matsen and colleagues24 used a 1-practice cohort of 337 patients who underwent different types of arthroplasties, including TSA, rTSA, hemiarthroplasty, and ream-and-run arthroplasty. Although their focus was not preoperative PROMs predicting postoperative PROMs, they used the Simple Shoulder Test (SST) baseline score as a predictive variable. They found that 6 baseline characteristics—American Society of Anesthesiologists class I, shoulder problem unrelated to work, no prior shoulder surgery, glenoid type other than A1, humeral head not superiorly displaced on anteroposterior radiograph, and lower baseline SST score—were statistically associated with better outcomes, and they developed a model driven by these characteristics. They urged other investigators to perform the same kind of analysis with larger patient populations from multiple practices. One of the strengths of our study is its large patient population. We collected data on 1004 patients for modeling 1-year postoperative VAS pain scores and 986 patients for modeling 1-year postoperative ASES Function scores.
Our study had several limitations. First, its data came from a 42-surgeon database, and there may be variations in how these surgeons enroll patients in the registry. If some surgeons did not enroll all their surgical patients, our sample could have been subject to selection bias. Second, in developing our model, we used only patient characteristics that were available in the database. On the other hand, the heterogeneity of the surgeon sample lended external validity to the model. A third limitation was that the model always predicts better pain and function outcomes after TSA than after rTSA. In other words, it does not consider whether TSA is appropriate for a particular patient. Instead, it predicts 1-year shoulder arthroplasty outcomes.
Our goal here is not to provide outcomes information or a surgical screening tool, but to report on our use of a simple data-driven tool for setting expectations. When appropriate data become available, tools like this should be expanded to predict longer-term shoulder arthroplasty outcomes. We need more studies that combine preoperative PROMs, more baseline clinical and patient characteristics (following the Matsen and colleagues24 model), and large sample sizes.
Conclusion
The educational models presented here can help patients and surgeons learn what to expect after surgery. These models reveal the value in collecting preoperative subjective PROMs and show how a quantitative tool can help facilitate shared decision-making and set patient expectations. Separately, the effect size of each factor is small, but together a patient’s preoperative VAS pain score, ASES Function score, VR-12 MCS score, age, sex, and type of arthroplasty can provide information predictive of the patient’s self-reported pain and function 1 year after surgery.
References
1. Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014;(1):CD001431.
2. Berliner JL, Brodke DJ, Chan V, SooHoo NF, Bozic KJ. Can preoperative patient-reported outcome measures be used to predict meaningful improvement in function after TKA? Clin Orthop Relat Res. 2017;475(1):149-157.
3. Berliner JL, Brodke DJ, Chan V, SooHoo NF, Bozic KJ. John Charnley award: preoperative patient-reported outcome measures predict clinically meaningful improvement in function after THA. Clin Orthop Relat Res. 2016;474(2):321-329.
4. Wong SE, Zhang AL, Berliner JL, Ma CB, Feeley BT. Preoperative patient-reported scores can predict postoperative outcomes after shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(6):913-919.
5. Werner BC, Chang B, Nguyen JT, Dines DM, Gulotta LV. What change in American Shoulder and Elbow Surgeons score represents a clinically important change after shoulder arthroplasty? Clin Orthop Relat Res. 2016;474(12):2672-2681.
7. Tashjian RZ, Hung M, Keener JD, et al. Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty. J Shoulder Elbow Surg. 2017;26(1):144-148.
8. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.
9. Wong SE, Zhang AL, Berliner JL, Ma CB, Feeley BT. Preoperative patient-reported scores can predict postoperative outcomes after shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(6):913-919.
10. Williams GN, Gangel TJ, Arciero RA, Uhorchak JM, Taylor DC. Comparison of the Single Assessment Numeric Evaluation method and two shoulder rating scales. Outcomes measures after shoulder surgery. Am J Sports Med. 1999;27(2):214-221.
11. Selim AJ, Rogers W, Fleishman JA, et al. Updated U.S. population standard for the Veterans RAND 12-Item Health Survey (VR-12). Qual Life Res. 2009;18(1):43-52.
12. Ayers DC, Franklin PD, Ploutz-Snyder R, Boisvert CB. Total knee replacement outcome and coexisting physical and emotional illness. Clin Orthop Relat Res. 2005;(440):157-161.
13. Ayers DC, Franklin PD, Trief PM, Ploutz-Snyder R, Freund D. Psychological attributes of preoperative total joint replacement patients: implications for optimal physical outcome. J Arthroplasty. 2004;19(7 suppl 2):125-130.
14. Barlow JD, Bishop JY, Dunn WR, Kuhn JE; MOON Shoulder Group. What factors are predictors of emotional health in patients with full-thickness rotator cuff tears? J Shoulder Elbow Surg. 2016;25(11):1769-1773.
15. Gandhi R, Davey JR, Mahomed NN. Predicting patient dissatisfaction following joint replacement surgery. J Rheumatol. 2008;35(12):2415-2418.
16. Parr J, Borsa P, Fillingim R, et al. Psychological influences predict recovery following exercise induced shoulder pain. Int J Sports Med. 2014;35(3):232-237.
18. Simmen BR, Bachmann LM, Drerup S, Schwyzer HK, Burkhart A, Goldhahn J. Development of a predictive model for estimating the probability of treatment success one year after total shoulder replacement—cohort study. Osteoarthritis Cartilage. 2008;16(5):631-634.
19. Wylie JD, Suter T, Potter MQ, Granger EK, Tashjian RZ. Mental health has a stronger association with patient-reported shoulder pain and function than tear size in patients with full-thickness rotator cuff tears. J Bone Joint Surg Am. 2016;98(4):251-256.
20. Potter MQ, Wylie JD, Greis PE, Burks RT, Tashjian RZ. Psychological distress negatively affects self-assessment of shoulder function in patients with rotator cuff tears. Clin Orthop Relat Res. 2014;472(12):3926-3932.
21. Roh YH, Noh JH, Oh JH, Baek GH, Gong HS. To what degree do shoulder outcome instruments reflect patients’ psychologic distress? Clin Orthop Relat Res. 2012;470(12):3470-3477.
22. Kennedy S, Barske H, Wing K, et al. SF-36 mental component summary (MCS) score does not predict functional outcome after surgery for end-stage ankle arthritis. J Bone Joint Surg Am. 2015;97(20):1702-1707.
23. Styron JF, Higuera CA, Strnad G, Iannotti JP. Greater patient confidence yields greater functional outcomes after primary total shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(8):1263-1267.
24. Matsen FA, Russ SM, Vu PT, Hsu JE, Lucas RM, Comstock BA. What factors are predictive of patient-reported outcomes? A prospective study of 337 shoulder arthroplasties. Clin Orthop Relat Res. 2016;474(11):2496-2510.
Shared decision-making tools, such as predictive models, can help empower the patient to make decisions for or against surgery equipped with more information about the expected outcome.
There is a role for preoperative collection of PROMs in the clinical decision-making process.
Mental health state, as reported by the VR-12 MCS, is a significant predictor of postoperative pain and function as reported by the VAS pain and ASES function scores.
A significant portion of the predictive ability of this model comes from the fact that at 1-year postoperatively, patients receiving a rTSA will on average have a 3.8 point lower on ASES function score than those receiving a TSA (P < .001, ω2=.083).
Future studies to discern the role of different modalities to improve a patient’s emotional health preoperatively will be beneficial as the healthcare industry trends toward value based medicine collecting PROMs as part of reimbursement schemes.
Over the past few decades, decisions regarding patients’ care have gradually transitioned from a paternalistic model to a more cooperative exchange between patient and physician. Shared decision-making provides patients a measure of autonomy in making choices for their health and their future. Patient participation may mitigate uncertainty and discomfort during selection of a course of treatment, which may lead to increased satisfaction levels after surgery.1 Moreover, shared decision-making may help patients better manage postoperative expectations through evidenced-based discussions of preoperative health levels and their corresponding outcomes. Patient-reported outcome measures (PROMs) use clinically sensitive and specific metrics to evaluate a patient’s self-reported pain, functional ability, and mental state.2 These metrics are useful in setting patient expectations for potential outcomes of treatment options. Use of evidence-based clinical decision-making tools, such as PROM-based predictive models, can facilitate a collaborative decision-making environment for patient and physician. Given the present cost-containment era, and the need for preoperative metrics that can assist in predictive analysis of postoperative improvement, models are clearly valuable.
In attempts to help patients set well-informed and reasonable expectations, physicians have turned to PROMs to facilitate preoperative evidence-based discussions. Although PROMs have been in use for almost 30 years, only recently have they been used to create tools that can aid quantitatively in the surgical decision-making process.2-6 Combining physical examination findings, imaging studies, comorbidities, and quantitative tools, such as this model, may enhance patients’ understanding of their preoperative condition and expected prognosis and thereby guide their surgical decisions.
We conducted a study to determine whether certain preoperative PROMs can predict 1-year postoperative visual analog scale (VAS) pain scores and American Shoulder and Elbow Surgeons (ASES) Function scores in total shoulder arthroplasty (TSA) and reverse TSA (rTSA). We hypothesized that preoperative mental health status as captured by Veterans RAND 12-Item Health Survey (VR-12) mental health component summary (MCS) score and preoperative VAS pain score would predict both VAS pain score and ASES Function score 1 year after surgery. Specifically, we hypothesized that a higher preoperative VR-12 MCS score would predict less pain and better function 1 year after surgery and that a higher preoperative VAS pain score would predict more pain and worse function 1 year after surgery.
Methods
This study was approved by the Institutional Review Board of Partners Healthcare. The study used the Surgical Outcome System (Arthrex), a comprehensive prospective database that stores preoperative and 1-year postoperative patient demographics and TSA-PROM data. Surveys are emailed to all enrolled patients before surgery and 1 year after surgery. As indicated by the Institutional Review Boards of all participating institutions, patients in the Surgical Outcome System have to sign a consent form to permit use of their responses in research.
The database includes patient data from 42 orthopedic surgeons across the United States. All primary TSAs and primary rTSAs in the database were included in this study, regardless of arthroplasty indication. Revisions were excluded. Also excluded were cases in which the 1-year postoperative questionnaire was not completed. Of the 1681 patients eligible for 1-year follow-up, 1225 (73%) completed the 1-year postoperative questionnaire. PROMs used in the study were VAS pain score, ASES Function score, VR-12 MCS score, and Single Assessment Numerical Evaluation (SANE). Unfortunately, not all surgeons use every measure in the 1-year postoperative questionnaire set. Thus, in our complete models, total number of observations was 1004 for modeling 1-year postoperative VAS pain scores and 986 for modeling 1-year postoperative ASES Function scores.
Metrics
On VAS, pain is rated from 0 (no pain) to 10 (pain as bad as it can be). Tashjian and colleagues7 estimated that the minimal clinically important difference (MCID) for postoperative VAS pain scores was 1.4 in a cohort of 326 patients who had TSA, rTSA, or shoulder hemiarthroplasty. ASES Function score is scaled from 0 to 30, with 30 representing best function.8 Wong and colleagues9 identified an MCID of 6.5 for ASES Function scores in a cohort of 107 patients who had TSA or rTSA. SANE ratings range from 0% to 100%, with 100% indicating the patient’s shoulder was totally “normal.”10 VR-12 MCS scores appear on a logarithmic scale, with higher numbers representing better mental health. The population mean estimate for VR-12 MCS scores is 50.1 (SD, 11.49; overall possible range, –2.47 to 76.1).11 Our patient population’s scores ranged from 12.5 to 73.8.
Statistical Analysis
Simple bivariate and multivariate linear regressions were performed to evaluate the predictive value of each of the outlined PROMs. Our complete model controls for patient sex, age, and type of arthroplasty. Categorical variables were dummy-coded. Both 1-year postoperative VAS pain score and 1-year postoperative ASES Function score were investigated as dependent variables. Regression coefficients and P and ω2 values are reported. Omega square represents how much of the variance in an outcome variable a model explains, like R2, and ω2 values can also be calculated for individual factors to see how much variance a given factor accounts for. For a simple relative risk calculation, we divided our cohort into 3 equal-sized groups based on preoperative VR-12 MCS scores and compared the risk that patients with scores in the top third (better mental health) would end up below certain ASES Total scores with the risk of patients with scores in the bottom third (worse mental health). All statistical analyses were performed with Stata (StataCorp).
Results
Table 1 lists summary statistics for the population used in these models.
Table 1.Our complete model for predicting VAS pain score 1 year after surgery accounted for 8% of the variability in this pain score (ω2 = .076), whereas our complete model for predicting ASES Function score 1 year after surgery accounted for 22% of the variability (ω2 = .219). These models include preoperative scores for VAS pain, ASES Function, VR-12 MCS, SANE, age at time of surgery, sex, and type of arthroplasty as possible explanatory variables.
Table 2.Predicting VAS Pain Score (Table 2)
Preoperative VAS pain score and VR-12 MCS score both predicted 1-year postoperative VAS pain score (P < .001). Preoperative ASES Function score did not predict pain 1 year after surgery. By contrast, higher preoperative VAS pain scores were associated with higher VAS pain scores 1 year after surgery. Higher preoperative VR-12 MCS scores were significantly associated with lower VAS pain scores 1 year after surgery, indicating that better preoperative mental health is significantly associated with better self-reported outcomes in terms of pain 1 year after surgery. These associations remained statistically significant when controlling for age at time of surgery, sex, and type of arthroplasty.
Preoperative VR-12 MCS score was more predictive of 1-year postoperative VAS pain score than preoperative VAS pain score was. In other words, preoperative VR-12 MCS score accounted for more variability in outcome for 1-year postoperative VAS pain score (2.4%; ω2 = .023) than preoperative VAS pain score did (1.6%; ω2 = .015).
Table 3.Predicting ASES Function Score (Table 3)
By contrast, preoperative VAS pain score did not predict 1-year postoperative ASES Function score. Preoperative ASES Function and VR-12 MCS scores both predicted 1-year postoperative ASES Function score (P < .001). Higher preoperative ASES Function scores were associated with higher 1-year postoperative ASES Function scores. In other words, reporting better shoulder function before surgery was associated with reporting better shoulder function after surgery.
An example gives a sense of the effect size associated with the coefficient for preoperative ASES Function score. Our model predicts that, compared with a patient who reports 5 points lower on preoperative ASES Function (which ranges from 0-30), a patient who reports 5 points higher will report on average about 1 point higher on 1-year postoperative ASES Function. As in the model for postoperative pain, these associations with preoperative function and mental health scores held when controlling for age, sex, and type of arthroplasty.
As in the postoperative pain model, preoperative VR-12 MCS score was more predictive of 1-year postoperative ASES Function score than preoperative ASES Function score was. Preoperative VR-12 MCS score accounted for more of the variation that our model predicts (ω2 = .029) than preoperative ASES Function score did (ω2 = .020). We compared the risk that patients with high preoperative VR-12 MCS scores (top third of cohort) would end up with ASES Total scores below 70, below 80, or below 90 with the risk of patients with low preoperative VR-12 MCS scores (bottom third). Results appear in Table 4.
Table 4.
A significant part of the predictive ability of our model for postoperative ASES Function scores stems from the fact that a patient who undergoes rTSA (vs TSA) is predicted to have an ASES Function score 3.8 points lower 1 year after surgery (P < .001, ω2 = .083). With type of arthroplasty controlled for, female sex is associated with an ASES Function score 1.6 points lower 1 year after surgery (P < .001, ω2 = .016).
Preoperative SANE score did not predict 1-year postoperative VAS pain score or ASES Function score. In addition, when our complete model was run with 1-year postoperative SANE score as the dependent variable, preoperative SANE score did not predict 1-year postoperative SANE score. Our data provide no supporting evidence for the use of SANE scores for predictive modeling for shoulder arthroplasty.
Discussion
We prospectively gathered data to determine which factors would predict patient subjective outcomes of primary TSA and primary rTSA. We hypothesized that preoperative VR-12 MCS scores and preoperative VAS pain scores would predict postoperative pain and function as measured with those PROMs. Second, we hypothesized that better preoperative mental health (as measured with VR-12 MCS scores) would predict lower postoperative pain (VAS pain scores) and better postoperative function (ASES Function scores). Third, we hypothesized that higher preoperative pain (VAS pain scores) would correlate with higher postoperative pain (VAS pain scores) and worse postoperative function (ASES Function scores).
Our main goal is to provide patients and surgeons with a predictive model that generates insights into what patients can expect after surgery. This model is not intended to be a screening tool for operative indications, but a clinical tool for helping set expectations.
Our results showed that patients with more pain before surgery were more likely to have more pain 1 year after surgery—confirming the hypothesized relationship between pain before and after surgery. Contrary to the hypothesis, however, degree of pain before surgery was not associated with function 1 year after surgery. Our mental health hypothesis was confirmed: Patients with better preoperative mental health scores had on average less pain and better function 1 year after surgery. Not surprisingly, our model demonstrated that patients with better self-reported function before surgery had better self-reported function after surgery. Patient-reported function before surgery did not significantly affect how much pain the patient had 1 year after surgery. Although we did not hypothesize about the role of function in predicting 1-year outcomes, function is a significant factor to be considered when setting patient expectations regarding shoulder arthroplasty outcomes (Table 5).
Table 5.
Although the effect sizes of each analyzed factor are small, together our models for 1-year postoperative pain and function provide significant insight into patients’ likely outcomes 1 year after TSA and rTSA.
Table 6.
Table 7.Table 6 and Table 7 listpreoperative PROMs and baseline characteristics for 2 sample patients and the corresponding 1-year postoperative results they should expect according to our model. Patient 1 (Table 6) achieves a theoretical ASES Total score of 67, and patient 2 (Table 7) achieves a theoretical ASES Total score of 90. During discussion of surgical options, these patients should be counseled differently. If patient 1 expects a “normal” shoulder after surgery, he or she likely will be disappointed with the outcome. Tools such as those provided here can contribute to evidence-based discussions and well-informed decision making.
Many studies have found that mental health correlated with pain and function during recovery from orthopedic trauma.12-18 For example, Wylie and colleagues19 found that preoperative mental health, as measured with the 36-Item Short Form Health Survey (SF-36) MCS score, predicted patient-reported pain and function in the setting of rotator cuff injury, regardless of treatment type (operative, nonoperative). Others have found that mental health may play a role in how patients report their pain and function on various PROMs.20,21 Modalities for improving patients’ emotional health baseline may even become a preoperative requirement as the healthcare industry moves toward value-based medicine and collection of patient-related outcomes as part of reimbursement schemes.
By contrast, some studies have found that preoperative mental health did not predict postoperative outcomes. For example, Kennedy and colleagues22 found that preoperative mental health (as measured with SF-36 MCS scores) did not predict functional outcome in patients with ankle arthritis treated with ankle arthroplasty or arthrodesis. Likewise, Styron and colleagues23 found no correlation between preoperative mental health (SF-12 MCS scores) and postoperative mental health and function in TSA. Their findings contradict those of the present study and many other studies.12-18 The contradiction in findings demonstrates the need for well-designed, sufficiently powered studies of the link between preoperative mental health and postoperative outcome. Our study, with its large sample and heterogeneous population, is a start.
Two other groups (Simmen and colleagues,18 Matsen and colleagues24) have attempted to develop a model predicting outcomes of shoulder arthroplasty. Simmen and colleagues18 estimated the probability of “treatment success” 1 year after TSA. Their model had 4 factors predictive of patient outcomes. Previous shoulder surgery and age over 75 years were significantly associated with lower probability of success, whereas higher preoperative SF-36 MCS scores and higher preoperative DASH (Disabilities of the Arm, Shoulder, and Hand) Function scores were associated with higher probability of success. The authors deemed TSA successful if the patient achieved a Constant score of ≥80 out of 100. Their model predicts probability of TSA “success,” whereas our models predict particular outcome scores. Both their results and ours support the hypothesis that preoperative mental health and function scores can predict how well a patient fares after surgery. Simmen and colleagues18 based their model on a cohort of only 140 patients and reported a 33.6% success rate (47/140 surgeries).
Matsen and colleagues24 used a 1-practice cohort of 337 patients who underwent different types of arthroplasties, including TSA, rTSA, hemiarthroplasty, and ream-and-run arthroplasty. Although their focus was not preoperative PROMs predicting postoperative PROMs, they used the Simple Shoulder Test (SST) baseline score as a predictive variable. They found that 6 baseline characteristics—American Society of Anesthesiologists class I, shoulder problem unrelated to work, no prior shoulder surgery, glenoid type other than A1, humeral head not superiorly displaced on anteroposterior radiograph, and lower baseline SST score—were statistically associated with better outcomes, and they developed a model driven by these characteristics. They urged other investigators to perform the same kind of analysis with larger patient populations from multiple practices. One of the strengths of our study is its large patient population. We collected data on 1004 patients for modeling 1-year postoperative VAS pain scores and 986 patients for modeling 1-year postoperative ASES Function scores.
Our study had several limitations. First, its data came from a 42-surgeon database, and there may be variations in how these surgeons enroll patients in the registry. If some surgeons did not enroll all their surgical patients, our sample could have been subject to selection bias. Second, in developing our model, we used only patient characteristics that were available in the database. On the other hand, the heterogeneity of the surgeon sample lended external validity to the model. A third limitation was that the model always predicts better pain and function outcomes after TSA than after rTSA. In other words, it does not consider whether TSA is appropriate for a particular patient. Instead, it predicts 1-year shoulder arthroplasty outcomes.
Our goal here is not to provide outcomes information or a surgical screening tool, but to report on our use of a simple data-driven tool for setting expectations. When appropriate data become available, tools like this should be expanded to predict longer-term shoulder arthroplasty outcomes. We need more studies that combine preoperative PROMs, more baseline clinical and patient characteristics (following the Matsen and colleagues24 model), and large sample sizes.
Conclusion
The educational models presented here can help patients and surgeons learn what to expect after surgery. These models reveal the value in collecting preoperative subjective PROMs and show how a quantitative tool can help facilitate shared decision-making and set patient expectations. Separately, the effect size of each factor is small, but together a patient’s preoperative VAS pain score, ASES Function score, VR-12 MCS score, age, sex, and type of arthroplasty can provide information predictive of the patient’s self-reported pain and function 1 year after surgery.
Take-Home Points
Shared decision-making tools, such as predictive models, can help empower the patient to make decisions for or against surgery equipped with more information about the expected outcome.
There is a role for preoperative collection of PROMs in the clinical decision-making process.
Mental health state, as reported by the VR-12 MCS, is a significant predictor of postoperative pain and function as reported by the VAS pain and ASES function scores.
A significant portion of the predictive ability of this model comes from the fact that at 1-year postoperatively, patients receiving a rTSA will on average have a 3.8 point lower on ASES function score than those receiving a TSA (P < .001, ω2=.083).
Future studies to discern the role of different modalities to improve a patient’s emotional health preoperatively will be beneficial as the healthcare industry trends toward value based medicine collecting PROMs as part of reimbursement schemes.
Over the past few decades, decisions regarding patients’ care have gradually transitioned from a paternalistic model to a more cooperative exchange between patient and physician. Shared decision-making provides patients a measure of autonomy in making choices for their health and their future. Patient participation may mitigate uncertainty and discomfort during selection of a course of treatment, which may lead to increased satisfaction levels after surgery.1 Moreover, shared decision-making may help patients better manage postoperative expectations through evidenced-based discussions of preoperative health levels and their corresponding outcomes. Patient-reported outcome measures (PROMs) use clinically sensitive and specific metrics to evaluate a patient’s self-reported pain, functional ability, and mental state.2 These metrics are useful in setting patient expectations for potential outcomes of treatment options. Use of evidence-based clinical decision-making tools, such as PROM-based predictive models, can facilitate a collaborative decision-making environment for patient and physician. Given the present cost-containment era, and the need for preoperative metrics that can assist in predictive analysis of postoperative improvement, models are clearly valuable.
In attempts to help patients set well-informed and reasonable expectations, physicians have turned to PROMs to facilitate preoperative evidence-based discussions. Although PROMs have been in use for almost 30 years, only recently have they been used to create tools that can aid quantitatively in the surgical decision-making process.2-6 Combining physical examination findings, imaging studies, comorbidities, and quantitative tools, such as this model, may enhance patients’ understanding of their preoperative condition and expected prognosis and thereby guide their surgical decisions.
We conducted a study to determine whether certain preoperative PROMs can predict 1-year postoperative visual analog scale (VAS) pain scores and American Shoulder and Elbow Surgeons (ASES) Function scores in total shoulder arthroplasty (TSA) and reverse TSA (rTSA). We hypothesized that preoperative mental health status as captured by Veterans RAND 12-Item Health Survey (VR-12) mental health component summary (MCS) score and preoperative VAS pain score would predict both VAS pain score and ASES Function score 1 year after surgery. Specifically, we hypothesized that a higher preoperative VR-12 MCS score would predict less pain and better function 1 year after surgery and that a higher preoperative VAS pain score would predict more pain and worse function 1 year after surgery.
Methods
This study was approved by the Institutional Review Board of Partners Healthcare. The study used the Surgical Outcome System (Arthrex), a comprehensive prospective database that stores preoperative and 1-year postoperative patient demographics and TSA-PROM data. Surveys are emailed to all enrolled patients before surgery and 1 year after surgery. As indicated by the Institutional Review Boards of all participating institutions, patients in the Surgical Outcome System have to sign a consent form to permit use of their responses in research.
The database includes patient data from 42 orthopedic surgeons across the United States. All primary TSAs and primary rTSAs in the database were included in this study, regardless of arthroplasty indication. Revisions were excluded. Also excluded were cases in which the 1-year postoperative questionnaire was not completed. Of the 1681 patients eligible for 1-year follow-up, 1225 (73%) completed the 1-year postoperative questionnaire. PROMs used in the study were VAS pain score, ASES Function score, VR-12 MCS score, and Single Assessment Numerical Evaluation (SANE). Unfortunately, not all surgeons use every measure in the 1-year postoperative questionnaire set. Thus, in our complete models, total number of observations was 1004 for modeling 1-year postoperative VAS pain scores and 986 for modeling 1-year postoperative ASES Function scores.
Metrics
On VAS, pain is rated from 0 (no pain) to 10 (pain as bad as it can be). Tashjian and colleagues7 estimated that the minimal clinically important difference (MCID) for postoperative VAS pain scores was 1.4 in a cohort of 326 patients who had TSA, rTSA, or shoulder hemiarthroplasty. ASES Function score is scaled from 0 to 30, with 30 representing best function.8 Wong and colleagues9 identified an MCID of 6.5 for ASES Function scores in a cohort of 107 patients who had TSA or rTSA. SANE ratings range from 0% to 100%, with 100% indicating the patient’s shoulder was totally “normal.”10 VR-12 MCS scores appear on a logarithmic scale, with higher numbers representing better mental health. The population mean estimate for VR-12 MCS scores is 50.1 (SD, 11.49; overall possible range, –2.47 to 76.1).11 Our patient population’s scores ranged from 12.5 to 73.8.
Statistical Analysis
Simple bivariate and multivariate linear regressions were performed to evaluate the predictive value of each of the outlined PROMs. Our complete model controls for patient sex, age, and type of arthroplasty. Categorical variables were dummy-coded. Both 1-year postoperative VAS pain score and 1-year postoperative ASES Function score were investigated as dependent variables. Regression coefficients and P and ω2 values are reported. Omega square represents how much of the variance in an outcome variable a model explains, like R2, and ω2 values can also be calculated for individual factors to see how much variance a given factor accounts for. For a simple relative risk calculation, we divided our cohort into 3 equal-sized groups based on preoperative VR-12 MCS scores and compared the risk that patients with scores in the top third (better mental health) would end up below certain ASES Total scores with the risk of patients with scores in the bottom third (worse mental health). All statistical analyses were performed with Stata (StataCorp).
Results
Table 1 lists summary statistics for the population used in these models.
Table 1.Our complete model for predicting VAS pain score 1 year after surgery accounted for 8% of the variability in this pain score (ω2 = .076), whereas our complete model for predicting ASES Function score 1 year after surgery accounted for 22% of the variability (ω2 = .219). These models include preoperative scores for VAS pain, ASES Function, VR-12 MCS, SANE, age at time of surgery, sex, and type of arthroplasty as possible explanatory variables.
Table 2.Predicting VAS Pain Score (Table 2)
Preoperative VAS pain score and VR-12 MCS score both predicted 1-year postoperative VAS pain score (P < .001). Preoperative ASES Function score did not predict pain 1 year after surgery. By contrast, higher preoperative VAS pain scores were associated with higher VAS pain scores 1 year after surgery. Higher preoperative VR-12 MCS scores were significantly associated with lower VAS pain scores 1 year after surgery, indicating that better preoperative mental health is significantly associated with better self-reported outcomes in terms of pain 1 year after surgery. These associations remained statistically significant when controlling for age at time of surgery, sex, and type of arthroplasty.
Preoperative VR-12 MCS score was more predictive of 1-year postoperative VAS pain score than preoperative VAS pain score was. In other words, preoperative VR-12 MCS score accounted for more variability in outcome for 1-year postoperative VAS pain score (2.4%; ω2 = .023) than preoperative VAS pain score did (1.6%; ω2 = .015).
Table 3.Predicting ASES Function Score (Table 3)
By contrast, preoperative VAS pain score did not predict 1-year postoperative ASES Function score. Preoperative ASES Function and VR-12 MCS scores both predicted 1-year postoperative ASES Function score (P < .001). Higher preoperative ASES Function scores were associated with higher 1-year postoperative ASES Function scores. In other words, reporting better shoulder function before surgery was associated with reporting better shoulder function after surgery.
An example gives a sense of the effect size associated with the coefficient for preoperative ASES Function score. Our model predicts that, compared with a patient who reports 5 points lower on preoperative ASES Function (which ranges from 0-30), a patient who reports 5 points higher will report on average about 1 point higher on 1-year postoperative ASES Function. As in the model for postoperative pain, these associations with preoperative function and mental health scores held when controlling for age, sex, and type of arthroplasty.
As in the postoperative pain model, preoperative VR-12 MCS score was more predictive of 1-year postoperative ASES Function score than preoperative ASES Function score was. Preoperative VR-12 MCS score accounted for more of the variation that our model predicts (ω2 = .029) than preoperative ASES Function score did (ω2 = .020). We compared the risk that patients with high preoperative VR-12 MCS scores (top third of cohort) would end up with ASES Total scores below 70, below 80, or below 90 with the risk of patients with low preoperative VR-12 MCS scores (bottom third). Results appear in Table 4.
Table 4.
A significant part of the predictive ability of our model for postoperative ASES Function scores stems from the fact that a patient who undergoes rTSA (vs TSA) is predicted to have an ASES Function score 3.8 points lower 1 year after surgery (P < .001, ω2 = .083). With type of arthroplasty controlled for, female sex is associated with an ASES Function score 1.6 points lower 1 year after surgery (P < .001, ω2 = .016).
Preoperative SANE score did not predict 1-year postoperative VAS pain score or ASES Function score. In addition, when our complete model was run with 1-year postoperative SANE score as the dependent variable, preoperative SANE score did not predict 1-year postoperative SANE score. Our data provide no supporting evidence for the use of SANE scores for predictive modeling for shoulder arthroplasty.
Discussion
We prospectively gathered data to determine which factors would predict patient subjective outcomes of primary TSA and primary rTSA. We hypothesized that preoperative VR-12 MCS scores and preoperative VAS pain scores would predict postoperative pain and function as measured with those PROMs. Second, we hypothesized that better preoperative mental health (as measured with VR-12 MCS scores) would predict lower postoperative pain (VAS pain scores) and better postoperative function (ASES Function scores). Third, we hypothesized that higher preoperative pain (VAS pain scores) would correlate with higher postoperative pain (VAS pain scores) and worse postoperative function (ASES Function scores).
Our main goal is to provide patients and surgeons with a predictive model that generates insights into what patients can expect after surgery. This model is not intended to be a screening tool for operative indications, but a clinical tool for helping set expectations.
Our results showed that patients with more pain before surgery were more likely to have more pain 1 year after surgery—confirming the hypothesized relationship between pain before and after surgery. Contrary to the hypothesis, however, degree of pain before surgery was not associated with function 1 year after surgery. Our mental health hypothesis was confirmed: Patients with better preoperative mental health scores had on average less pain and better function 1 year after surgery. Not surprisingly, our model demonstrated that patients with better self-reported function before surgery had better self-reported function after surgery. Patient-reported function before surgery did not significantly affect how much pain the patient had 1 year after surgery. Although we did not hypothesize about the role of function in predicting 1-year outcomes, function is a significant factor to be considered when setting patient expectations regarding shoulder arthroplasty outcomes (Table 5).
Table 5.
Although the effect sizes of each analyzed factor are small, together our models for 1-year postoperative pain and function provide significant insight into patients’ likely outcomes 1 year after TSA and rTSA.
Table 6.
Table 7.Table 6 and Table 7 listpreoperative PROMs and baseline characteristics for 2 sample patients and the corresponding 1-year postoperative results they should expect according to our model. Patient 1 (Table 6) achieves a theoretical ASES Total score of 67, and patient 2 (Table 7) achieves a theoretical ASES Total score of 90. During discussion of surgical options, these patients should be counseled differently. If patient 1 expects a “normal” shoulder after surgery, he or she likely will be disappointed with the outcome. Tools such as those provided here can contribute to evidence-based discussions and well-informed decision making.
Many studies have found that mental health correlated with pain and function during recovery from orthopedic trauma.12-18 For example, Wylie and colleagues19 found that preoperative mental health, as measured with the 36-Item Short Form Health Survey (SF-36) MCS score, predicted patient-reported pain and function in the setting of rotator cuff injury, regardless of treatment type (operative, nonoperative). Others have found that mental health may play a role in how patients report their pain and function on various PROMs.20,21 Modalities for improving patients’ emotional health baseline may even become a preoperative requirement as the healthcare industry moves toward value-based medicine and collection of patient-related outcomes as part of reimbursement schemes.
By contrast, some studies have found that preoperative mental health did not predict postoperative outcomes. For example, Kennedy and colleagues22 found that preoperative mental health (as measured with SF-36 MCS scores) did not predict functional outcome in patients with ankle arthritis treated with ankle arthroplasty or arthrodesis. Likewise, Styron and colleagues23 found no correlation between preoperative mental health (SF-12 MCS scores) and postoperative mental health and function in TSA. Their findings contradict those of the present study and many other studies.12-18 The contradiction in findings demonstrates the need for well-designed, sufficiently powered studies of the link between preoperative mental health and postoperative outcome. Our study, with its large sample and heterogeneous population, is a start.
Two other groups (Simmen and colleagues,18 Matsen and colleagues24) have attempted to develop a model predicting outcomes of shoulder arthroplasty. Simmen and colleagues18 estimated the probability of “treatment success” 1 year after TSA. Their model had 4 factors predictive of patient outcomes. Previous shoulder surgery and age over 75 years were significantly associated with lower probability of success, whereas higher preoperative SF-36 MCS scores and higher preoperative DASH (Disabilities of the Arm, Shoulder, and Hand) Function scores were associated with higher probability of success. The authors deemed TSA successful if the patient achieved a Constant score of ≥80 out of 100. Their model predicts probability of TSA “success,” whereas our models predict particular outcome scores. Both their results and ours support the hypothesis that preoperative mental health and function scores can predict how well a patient fares after surgery. Simmen and colleagues18 based their model on a cohort of only 140 patients and reported a 33.6% success rate (47/140 surgeries).
Matsen and colleagues24 used a 1-practice cohort of 337 patients who underwent different types of arthroplasties, including TSA, rTSA, hemiarthroplasty, and ream-and-run arthroplasty. Although their focus was not preoperative PROMs predicting postoperative PROMs, they used the Simple Shoulder Test (SST) baseline score as a predictive variable. They found that 6 baseline characteristics—American Society of Anesthesiologists class I, shoulder problem unrelated to work, no prior shoulder surgery, glenoid type other than A1, humeral head not superiorly displaced on anteroposterior radiograph, and lower baseline SST score—were statistically associated with better outcomes, and they developed a model driven by these characteristics. They urged other investigators to perform the same kind of analysis with larger patient populations from multiple practices. One of the strengths of our study is its large patient population. We collected data on 1004 patients for modeling 1-year postoperative VAS pain scores and 986 patients for modeling 1-year postoperative ASES Function scores.
Our study had several limitations. First, its data came from a 42-surgeon database, and there may be variations in how these surgeons enroll patients in the registry. If some surgeons did not enroll all their surgical patients, our sample could have been subject to selection bias. Second, in developing our model, we used only patient characteristics that were available in the database. On the other hand, the heterogeneity of the surgeon sample lended external validity to the model. A third limitation was that the model always predicts better pain and function outcomes after TSA than after rTSA. In other words, it does not consider whether TSA is appropriate for a particular patient. Instead, it predicts 1-year shoulder arthroplasty outcomes.
Our goal here is not to provide outcomes information or a surgical screening tool, but to report on our use of a simple data-driven tool for setting expectations. When appropriate data become available, tools like this should be expanded to predict longer-term shoulder arthroplasty outcomes. We need more studies that combine preoperative PROMs, more baseline clinical and patient characteristics (following the Matsen and colleagues24 model), and large sample sizes.
Conclusion
The educational models presented here can help patients and surgeons learn what to expect after surgery. These models reveal the value in collecting preoperative subjective PROMs and show how a quantitative tool can help facilitate shared decision-making and set patient expectations. Separately, the effect size of each factor is small, but together a patient’s preoperative VAS pain score, ASES Function score, VR-12 MCS score, age, sex, and type of arthroplasty can provide information predictive of the patient’s self-reported pain and function 1 year after surgery.
References
1. Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014;(1):CD001431.
2. Berliner JL, Brodke DJ, Chan V, SooHoo NF, Bozic KJ. Can preoperative patient-reported outcome measures be used to predict meaningful improvement in function after TKA? Clin Orthop Relat Res. 2017;475(1):149-157.
3. Berliner JL, Brodke DJ, Chan V, SooHoo NF, Bozic KJ. John Charnley award: preoperative patient-reported outcome measures predict clinically meaningful improvement in function after THA. Clin Orthop Relat Res. 2016;474(2):321-329.
4. Wong SE, Zhang AL, Berliner JL, Ma CB, Feeley BT. Preoperative patient-reported scores can predict postoperative outcomes after shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(6):913-919.
5. Werner BC, Chang B, Nguyen JT, Dines DM, Gulotta LV. What change in American Shoulder and Elbow Surgeons score represents a clinically important change after shoulder arthroplasty? Clin Orthop Relat Res. 2016;474(12):2672-2681.
7. Tashjian RZ, Hung M, Keener JD, et al. Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty. J Shoulder Elbow Surg. 2017;26(1):144-148.
8. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.
9. Wong SE, Zhang AL, Berliner JL, Ma CB, Feeley BT. Preoperative patient-reported scores can predict postoperative outcomes after shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(6):913-919.
10. Williams GN, Gangel TJ, Arciero RA, Uhorchak JM, Taylor DC. Comparison of the Single Assessment Numeric Evaluation method and two shoulder rating scales. Outcomes measures after shoulder surgery. Am J Sports Med. 1999;27(2):214-221.
11. Selim AJ, Rogers W, Fleishman JA, et al. Updated U.S. population standard for the Veterans RAND 12-Item Health Survey (VR-12). Qual Life Res. 2009;18(1):43-52.
12. Ayers DC, Franklin PD, Ploutz-Snyder R, Boisvert CB. Total knee replacement outcome and coexisting physical and emotional illness. Clin Orthop Relat Res. 2005;(440):157-161.
13. Ayers DC, Franklin PD, Trief PM, Ploutz-Snyder R, Freund D. Psychological attributes of preoperative total joint replacement patients: implications for optimal physical outcome. J Arthroplasty. 2004;19(7 suppl 2):125-130.
14. Barlow JD, Bishop JY, Dunn WR, Kuhn JE; MOON Shoulder Group. What factors are predictors of emotional health in patients with full-thickness rotator cuff tears? J Shoulder Elbow Surg. 2016;25(11):1769-1773.
15. Gandhi R, Davey JR, Mahomed NN. Predicting patient dissatisfaction following joint replacement surgery. J Rheumatol. 2008;35(12):2415-2418.
16. Parr J, Borsa P, Fillingim R, et al. Psychological influences predict recovery following exercise induced shoulder pain. Int J Sports Med. 2014;35(3):232-237.
18. Simmen BR, Bachmann LM, Drerup S, Schwyzer HK, Burkhart A, Goldhahn J. Development of a predictive model for estimating the probability of treatment success one year after total shoulder replacement—cohort study. Osteoarthritis Cartilage. 2008;16(5):631-634.
19. Wylie JD, Suter T, Potter MQ, Granger EK, Tashjian RZ. Mental health has a stronger association with patient-reported shoulder pain and function than tear size in patients with full-thickness rotator cuff tears. J Bone Joint Surg Am. 2016;98(4):251-256.
20. Potter MQ, Wylie JD, Greis PE, Burks RT, Tashjian RZ. Psychological distress negatively affects self-assessment of shoulder function in patients with rotator cuff tears. Clin Orthop Relat Res. 2014;472(12):3926-3932.
21. Roh YH, Noh JH, Oh JH, Baek GH, Gong HS. To what degree do shoulder outcome instruments reflect patients’ psychologic distress? Clin Orthop Relat Res. 2012;470(12):3470-3477.
22. Kennedy S, Barske H, Wing K, et al. SF-36 mental component summary (MCS) score does not predict functional outcome after surgery for end-stage ankle arthritis. J Bone Joint Surg Am. 2015;97(20):1702-1707.
23. Styron JF, Higuera CA, Strnad G, Iannotti JP. Greater patient confidence yields greater functional outcomes after primary total shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(8):1263-1267.
24. Matsen FA, Russ SM, Vu PT, Hsu JE, Lucas RM, Comstock BA. What factors are predictive of patient-reported outcomes? A prospective study of 337 shoulder arthroplasties. Clin Orthop Relat Res. 2016;474(11):2496-2510.
References
1. Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014;(1):CD001431.
2. Berliner JL, Brodke DJ, Chan V, SooHoo NF, Bozic KJ. Can preoperative patient-reported outcome measures be used to predict meaningful improvement in function after TKA? Clin Orthop Relat Res. 2017;475(1):149-157.
3. Berliner JL, Brodke DJ, Chan V, SooHoo NF, Bozic KJ. John Charnley award: preoperative patient-reported outcome measures predict clinically meaningful improvement in function after THA. Clin Orthop Relat Res. 2016;474(2):321-329.
4. Wong SE, Zhang AL, Berliner JL, Ma CB, Feeley BT. Preoperative patient-reported scores can predict postoperative outcomes after shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(6):913-919.
5. Werner BC, Chang B, Nguyen JT, Dines DM, Gulotta LV. What change in American Shoulder and Elbow Surgeons score represents a clinically important change after shoulder arthroplasty? Clin Orthop Relat Res. 2016;474(12):2672-2681.
7. Tashjian RZ, Hung M, Keener JD, et al. Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty. J Shoulder Elbow Surg. 2017;26(1):144-148.
8. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.
9. Wong SE, Zhang AL, Berliner JL, Ma CB, Feeley BT. Preoperative patient-reported scores can predict postoperative outcomes after shoulder arthroplasty. J Shoulder Elbow Surg. 2016;25(6):913-919.
10. Williams GN, Gangel TJ, Arciero RA, Uhorchak JM, Taylor DC. Comparison of the Single Assessment Numeric Evaluation method and two shoulder rating scales. Outcomes measures after shoulder surgery. Am J Sports Med. 1999;27(2):214-221.
11. Selim AJ, Rogers W, Fleishman JA, et al. Updated U.S. population standard for the Veterans RAND 12-Item Health Survey (VR-12). Qual Life Res. 2009;18(1):43-52.
12. Ayers DC, Franklin PD, Ploutz-Snyder R, Boisvert CB. Total knee replacement outcome and coexisting physical and emotional illness. Clin Orthop Relat Res. 2005;(440):157-161.
13. Ayers DC, Franklin PD, Trief PM, Ploutz-Snyder R, Freund D. Psychological attributes of preoperative total joint replacement patients: implications for optimal physical outcome. J Arthroplasty. 2004;19(7 suppl 2):125-130.
14. Barlow JD, Bishop JY, Dunn WR, Kuhn JE; MOON Shoulder Group. What factors are predictors of emotional health in patients with full-thickness rotator cuff tears? J Shoulder Elbow Surg. 2016;25(11):1769-1773.
15. Gandhi R, Davey JR, Mahomed NN. Predicting patient dissatisfaction following joint replacement surgery. J Rheumatol. 2008;35(12):2415-2418.
16. Parr J, Borsa P, Fillingim R, et al. Psychological influences predict recovery following exercise induced shoulder pain. Int J Sports Med. 2014;35(3):232-237.
18. Simmen BR, Bachmann LM, Drerup S, Schwyzer HK, Burkhart A, Goldhahn J. Development of a predictive model for estimating the probability of treatment success one year after total shoulder replacement—cohort study. Osteoarthritis Cartilage. 2008;16(5):631-634.
19. Wylie JD, Suter T, Potter MQ, Granger EK, Tashjian RZ. Mental health has a stronger association with patient-reported shoulder pain and function than tear size in patients with full-thickness rotator cuff tears. J Bone Joint Surg Am. 2016;98(4):251-256.
20. Potter MQ, Wylie JD, Greis PE, Burks RT, Tashjian RZ. Psychological distress negatively affects self-assessment of shoulder function in patients with rotator cuff tears. Clin Orthop Relat Res. 2014;472(12):3926-3932.
21. Roh YH, Noh JH, Oh JH, Baek GH, Gong HS. To what degree do shoulder outcome instruments reflect patients’ psychologic distress? Clin Orthop Relat Res. 2012;470(12):3470-3477.
22. Kennedy S, Barske H, Wing K, et al. SF-36 mental component summary (MCS) score does not predict functional outcome after surgery for end-stage ankle arthritis. J Bone Joint Surg Am. 2015;97(20):1702-1707.
23. Styron JF, Higuera CA, Strnad G, Iannotti JP. Greater patient confidence yields greater functional outcomes after primary total shoulder arthroplasty. J Shoulder Elbow Surg. 2015;24(8):1263-1267.
24. Matsen FA, Russ SM, Vu PT, Hsu JE, Lucas RM, Comstock BA. What factors are predictive of patient-reported outcomes? A prospective study of 337 shoulder arthroplasties. Clin Orthop Relat Res. 2016;474(11):2496-2510.
The authors have developed a total shoulder glenoid prosthesis that conforms with the humeral head in its center and is nonconforming on its peripheral edge.
All clinical survey and range of motion parameters demonstrated statistically significant improvements at final follow-up.
Only 3 shoulders (1.7%) required revision surgery.
Eighty-six (63%) of 136 shoulders demonstrated no radiographic evidence of glenoid loosening.
This is the first and largest study that evaluates the clinical and radiographic outcomes of this hybrid shoulder prosthesis.
Fixation of the glenoid component is the limiting factor in modern total shoulder arthroplasty (TSA). Glenoid loosening, the most common long-term complication, necessitates revision in up to 12% of patients.1-4 By contrast, humeral component loosening is relatively uncommon, affecting as few as 0.34% of patients.5 Multiple long-term studies have found consistently high rates (45%-93%) of radiolucencies around the glenoid component.3,6,7 Although their clinical significance has been debated, radiolucencies around the glenoid component raise concern about progressive loss of fixation.
Since TSA was introduced in the 1970s, complications with the glenoid component have been addressed with 2 different designs: conforming (congruent) and nonconforming. In a congruent articulation, the radii of curvature of the glenoid and humeral head components are identical, whereas they differ in a nonconforming model. Joint conformity is inversely related to glenohumeral translation.8 Neer’s original TSA was made congruent in order to limit translation and maximize the contact area. However, this design results in edge loading and a so-called rocking-horse phenomenon, which may lead to glenoid loosening.9-13 Surgeons therefore have increasingly turned to nonconforming implants. In the nonconforming design, the radius of curvature of the humeral head is smaller than that of the glenoid. Although this design may reduce edge loading,14 it allows more translation and reduces the relative contact area of the glenohumeral joint. As a result, more contact stress is transmitted to the glenoid component, leading to polyethylene deformation and wear.15,16
Figure 1.A desire to integrate the advantages of the 2 designs led to a novel glenoid implant design with variable conformity. This innovative component has a central conforming region and a peripheral nonconforming region or “translation zone” (Figure 1).
Dual radii of curvature are designed to augment joint stability without increasing component wear. Biomechanical data have indicated that edge loading is not increased by having a central conforming region added to a nonconforming model.17 The clinical value of this prosthesis, however, has not been determined. Therefore, we conducted a study to describe the intermediate-term clinical and radiographic outcomes of TSAs that use a novel hybrid glenoid component.
Materials and Methods
This study was approved (protocol AAAD3473) by the Institutional Review Board of Columbia University and was conducted in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.
Patient Selection
At Columbia University Medical Center, Dr. Bigliani performed 196 TSAs with a hybrid glenoid component (Bigliani-Flatow; Zimmer Biomet) in 169 patients between September 1998 and November 2007. All patients had received a diagnosis of primary glenohumeral arthritis as defined by Neer.18 Patients with previous surgery such as rotator cuff repair or subacromial decompression were included in our review, and patients with a nonprimary form of arthritis, such as rheumatoid, posttraumatic, or post-capsulorrhaphy arthritis, were excluded.
Operative Technique
For all surgeries, Dr. Bigliani performed a subscapularis tenotomy with regional anesthesia and a standard deltopectoral approach. A partial anterior capsulectomy was performed to increase the glenoid’s visibility. The inferior labrum was removed with a needle-tip bovie while the axillary nerve was being protected with a metal finger or narrow Darrach retractor. After reaming and trialing, the final glenoid component was cemented into place. Cement was placed only in the peg or keel holes and pressurized twice before final implantation. Of the 196 glenoid components, 168 (86%) were pegged and 28 (14%) keeled; in addition,190 of these components were all-polyethylene, whereas 6 had trabecular-metal backing. All glenoid components incorporated the hybrid design of dual radii of curvature. After the glenoid was cemented, the final humeral component was placed in 30° of retroversion. Whenever posterior wear was found, retroversion was reduced by 5° to 10°. The humeral prosthesis was cemented in cases (104/196, 53%) of poor bone quality or a large canal.
After surgery, the patient’s sling was fitted with an abduction pillow and a swathe, to be worn the first 24 hours, and the arm was passively ranged. Patients typically were discharged on postoperative day 2. Then, for 2 weeks, they followed an assisted passive range of motion (ROM) protocol, with limited external rotation, for promotion of subscapularis healing.
Clinical Outcomes
Dr. Bigliani assessed preoperative ROM in all planes. During initial evaluation, patients completed a questionnaire that consisted of the 36-Item Short Form Health Survey19,20 (SF-36) and the American Shoulder and Elbow Surgeons21 (ASES) and Simple Shoulder Test22 (SST) surveys. Postoperative clinical data were collected from office follow-up visits, survey questionnaires, or both. Postoperative office data included ROM, subscapularis integrity testing (belly-press or lift-off), and any complications. Patients with <1 year of office follow-up were excluded. In addition, the same survey questionnaire that was used before surgery was mailed to all patients after surgery; then, for anyone who did not respond by mail, we attempted contact by telephone. Neer criteria were based on patients’ subjective assessment of each arm on a 3-point Likert scale (1 = very satisfied, 2 = satisfied, 3 = dissatisfied). Patients were also asked about any specific complications or revision operations since their index procedure.
Physical examination and office follow-up data were obtained for 129 patients (148/196 shoulders, 76% follow-up) at a mean of 3.7 years (range 1.0-10.2 years) after surgery. Surveys were completed by 117 patients (139/196 shoulders, 71% follow-up) at a mean of 5.1 years (range, 1.6-11.2 years) after surgery. Only 15 patients had neither 1 year of office follow-up nor a completed questionnaire. The remaining 154 patients (178/196 shoulders, 91% follow-up) had clinical follow-up with office, mail, or telephone questionnaire at a mean of 4.8 years (range, 1.0-11.2 years) after surgery. This cohort of patients was used to determine rates of surgical revisions, subscapularis tears, dislocations, and other complications.
Figure 2.Acromioplasty, performed in TSA patients who had subacromial impingement stemming from improved ROM, represented a second operation, and therefore the need for this surgery was deemed a complication as well. Figure 2 breaks down the 4 major study cohorts.
Radiographic Outcomes
Patients were included in the radiographic analysis if they had a shoulder radiograph at least 1 year after surgery. One hundred nineteen patients (136/196 shoulders, 69% follow-up) had radiographic follow-up at a mean of 3.7 years (range, 1.0-9.4 years) after surgery.
Table 1.All radiographs were independently assessed by 2 blinded physicians who were not involved in the index procedure. Any disputed radiographs were reassessed by these physicians together, until consensus was reached. Radiographs were reviewed for the presence of glenoid lucencies around the pegs or keel and were scored using the system of Lazarus and colleagues23 (Table 1). The humerus was assessed for total number of lucent lines in any of 8 periprosthetic zones, as described by Sperling and colleagues.24
Statistical Analysis
Statistical analysis was performed with Stata Version 10.0. Paired t tests were used to compare preoperative and postoperative numerical data, including ROM and survey scores. We calculated 95% confidence intervals (CIs) and set statistical significance at P < .05. For qualitative measures, the Fisher exact test was used. Survivorship analysis was performed according to the Kaplan-Meier method, with right-censored data for no event or missing data.25
Results
Clinical Analysis of Demographics
In demographics, the clinical and radiographic patient subgroups were similar to each other and to the overall study population (Table 2). Of 196 patients overall, 16 (8%) had a concomitant rotator cuff repair, and 27 (14%) underwent staged bilateral shoulder arthroplasties.
Table 2.
Clinical Analysis of ROM and Survey Scores
Operative shoulder ROM in forward elevation, external rotation at side, external rotation in abduction, and internal rotation all showed statistically significant (P < .001) improvement from before surgery to after surgery. Over 3.7 years, mean (SD) forward elevation improved from 107.3° (34.8°) to 159.0° (29.4°), external rotation at side improved from 20.4° (16.7°) to 49.4° (11.3°), and external rotation in abduction improved from 53.7° (24.3°) to 84.7° (9.1°). Internal rotation improved from a mean (SD) vertebral level of S1 (6.0 levels) to T9 (3.7 levels).
All validated survey scores also showed statistically significant (P < .001) improvement from before surgery to after surgery. Over 5.1 years, mean (SD) SF-36 scores improved from 64.9 (13.4) to 73.6 (17.1), ASES scores improved from 41.1 (22.5) to 82.7 (17.7), SST scores improved from 3.9 (2.8) to 9.7 (2.2), and visual analog scale pain scores improved from 5.6 (3.2) to 1.4 (2.1). Of 139 patients with follow-up, 130 (93.5%) were either satisfied or very satisfied with their TSA, and only 119 (86%) were either satisfied or very satisfied with the nonoperative shoulder.
Clinical Analysis of Postoperative Complications
Of the 178 shoulders evaluated for complications, 3 (1.7%) underwent revision surgery. Mean time to revision was 2.3 years (range, 1.5-3.9 years). Two revisions involved the glenoid component, and the third involved the humerus. In one of the glenoid cases, a 77-year-old woman fell and sustained a fracture at the base of the trabecular metal glenoid pegs; her component was revised to an all-polyethylene component, and she had no further complications. In the other glenoid case, a 73-year-old man’s all-polyethylene component loosened after 2 years and was revised to a trabecular metal implant, which loosened as well and was later converted to a hemiarthroplasty. In the humeral case, a 33-year-old man had his 4-year-old index TSA revised to a cemented stem and had no further complications.
Table 3.Of the 148 patients with office follow-up, only 8 had a positive belly-press or lift-off test. Of all 178 clinical study shoulders, 10 (5.6%) had a subscapularis tear confirmed by magnetic resonance imaging or a physician. Of these 10 tears, 3 resulted from traumatic falls. Four of the 10 tears were managed nonoperatively, and the other 6 underwent surgical repair at a mean of 2.9 years (range, 0.3-7.8 years) after index TSA. In 2 of the 6 repair cases, a 46-mm humeral head had been used, and, in the other 4 cases, a 52-mm humeral head. Of the 6 repaired tears, 2 were massive, and 4 were isolated to the subscapularis. None of these 6 tears required a second repair. Seven (4%) of the 178 shoulders experienced a clinically significant posterosuperior subluxation or dislocation; 5 of the 7 were managed nonoperatively, and the other 2 underwent open capsular shift, at 0.5 year and 3.0 years, respectively. Table 3 lists the other postoperative complications that required surgery.
Table 4.
Table 4 compares the clinical and radiographic outcomes of patients who required subscapularis repair, capsular shift, or implant revision with the outcomes of all other study patients, and Figure 3 shows Kaplan-Meier survivorship.
Figure 3.
Postoperative Radiographic Analysis
Glenoid Component. At a mean of 3.7 years (minimum, 1 year) after surgery, 86 (63%) of 136 radiographically evaluated shoulders showed no glenoid lucencies; the other 50 (37%) showed ≥1 lucency. Of the 136 shoulders, 33 (24%) had a Lazarus score of 1, 15 (11%) had a score of 2, and only 2 (2%) had a score of 3. None of the shoulders had a score of 4 or 5.
Humeral Component. Of the 136 shoulders, 91 (67%) showed no lucencies in any of the 8 humeral stem zones; the other 45 (33%) showed 1 to 3 lucencies. Thirty (22%) of the 136 shoulders had 1 stem lucency zone, 8 (6%) had 2, and 3 (2%) had 3. None of the shoulders had >3 periprosthetic zones with lucent lines.
Discussion
In this article, we describe a hybrid glenoid TSA component with dual radii of curvature. Its central portion is congruent with the humeral head, and its peripheral portion is noncongruent and larger. The most significant finding of our study is the low rate (1.1%) of glenoid component revision 4.8 years after surgery. This rate is the lowest that has been reported in a study of ≥100 patients. Overall implant survival appeared as an almost flat Kaplan-Meir curve. We attribute this low revision rate to improved biomechanics with the hybrid glenoid design.
Symptomatic glenoid component loosening is the most common TSA complication.1,26-28 In a review of 73 Neer TSAs, Cofield7 found glenoid radiolucencies in 71% of patients 3.8 years after surgery. Radiographic evidence of loosening, defined as component migration, or tilt, or a circumferential lucency 1.5 mm thick, was present in another 11% of patients, and 4.1% developed symptomatic loosening that required glenoid revision. In a study with 12.2-year follow-up, Torchia and colleagues3 found rates of 84% for glenoid radiolucencies, 44% for radiographic loosening, and 5.6% for symptomatic loosening that required revision. In a systematic review of studies with follow-up of ≥10 years, Bohsali and colleagues27 found similar lucency and radiographic loosening rates and a 7% glenoid revision rate. These data suggest glenoid radiolucencies may progress to component loosening.
Degree of joint congruence is a key factor in glenoid loosening. Neer’s congruent design increases the contact area with concentric loading and reduces glenohumeral translation, which leads to reduced polyethylene wear and improved joint stability. In extreme arm positions, however, humeral head subluxation results in edge loading and a glenoid rocking-horse effect.9-13,17,29-31 Conversely, nonconforming implants allow increased glenohumeral translation without edge loading,14 though they also reduce the relative glenohumeral contact area and thus transmit more contact stress to the glenoid.16,17 A hybrid glenoid component with central conforming and peripheral nonconforming zones may reduce the rocking-horse effect while maximizing ROM and joint stability. Wang and colleagues32 studied the biomechanical properties of this glenoid design and found that the addition of a central conforming region did not increase edge loading.
Additional results from our study support the efficacy of a hybrid glenoid component. Patients’ clinical outcomes improved significantly. At 5.1 years after surgery, 93.5% of patients were satisfied or very satisfied with their procedure and reported less satisfaction (86%) with the nonoperative shoulder. Also significant was the reduced number of radiolucencies. At 3.7 years after surgery, the overall percentage of shoulders with ≥1 glenoid radiolucency was 37%, considerably lower than the 82% reported by Cofield7 and the rates in more recent studies.3,16,33-36 Of the 178 shoulders in our study, 10 (5.6%) had subscapularis tears, and 6 (3.4%) of 178 had these tears surgically repaired. This 3.4% compares favorably with the 5.9% (of 119 patients) found by Miller and colleagues37 28 months after surgery. Of our 178 shoulders, 27 (15.2%) had clinically significant postoperative complications; 18 (10.1%) of the 178 had these complications surgically treated, and 9 (5.1%) had them managed nonoperatively. Bohsali and colleagues27 systematically reviewed 33 TSA studies and found a slightly higher complication rate (16.3%) 5.3 years after surgery. Furthermore, in our study, the 11 patients who underwent revision, capsular shift, or subscapularis repair had final outcomes comparable to those of the rest of our study population.
Our study had several potential weaknesses. First, its minimum clinical and radiographic follow-up was 1 year, whereas most long-term TSA series set a minimum of 2 years. We used 1 year because this was the first clinical study of the hybrid glenoid component design, and we wanted to maximize its sample size by reporting on intermediate-length outcomes. Even so, 93% (166/178) of our clinical patients and 83% (113/136) of our radiographic patients have had ≥2 years of follow-up, and we continue to follow all study patients for long-term outcomes. Another weakness of the study was its lack of a uniform group of patients with all the office, survey, complications, and radiographic data. Our retrospective study design made it difficult to obtain such a group without significantly reducing the sample size, so we divided patients into 4 data groups. A third potential weakness was the study’s variable method for collecting complications data. Rates of complications in the 178 shoulders were calculated from either office evaluation or patient self-report by mail or telephone. This data collection method is subject to recall bias, but mail and telephone contact was needed so the study would capture the large number of patients who had traveled to our institution for their surgery or had since moved away. Fourth, belly-press and lift-off tests were used in part to assess subscapularis function, but recent literature suggests post-TSA subscapularis assessment can be unreliable.38 These tests may be positive in up to two-thirds of patients after 2 years.39 Fifth, the generalizability of our findings to diagnoses such as rheumatoid and posttraumatic arthritis is limited. We had to restrict the study to patients with primary glenohumeral arthritis in order to minimize confounders.
This study’s main strength is its description of the clinical and radiographic outcomes of using a single prosthetic system in operations performed by a single surgeon in a large number of patients. This was the first and largest study evaluating the clinical and radiographic outcomes of this hybrid glenoid implant. Excluding patients with nonprimary arthritis allowed us to minimize potential confounding factors that affect patient outcomes. In conclusion, our study results showed the favorable clinical and radiographic outcomes of TSAs that have a hybrid glenoid component with dual radii of curvature. At a mean of 3.7 years after surgery, 63% of patients had no glenoid lucencies, and, at a mean of 4.8 years, only 1.7% of patients required revision. We continue to follow these patients to obtain long-term results of this innovative prosthesis.
References
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2. Boyd AD Jr, Thomas WH, Scott RD, Sledge CB, Thornhill TS. Total shoulder arthroplasty versus hemiarthroplasty. Indications for glenoid resurfacing. J Arthroplasty. 1990;5(4):329-336.
3. Torchia ME, Cofield RH, Settergren CR. Total shoulder arthroplasty with the Neer prosthesis: long-term results. J Shoulder Elbow Surg. 1997;6(6):495-505.
4. Iannotti JP, Norris TR. Influence of preoperative factors on outcome of shoulder arthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 2003;85(2):251-258.
5. Cofield RH. Degenerative and arthritic problems of the glenohumeral joint. In: Rockwood CA, Matsen FA, eds. The Shoulder. Philadelphia, PA: Saunders; 1990:740-745.
6. Neer CS 2nd, Watson KC, Stanton FJ. Recent experience in total shoulder replacement. J Bone Joint Surg Am. 1982;64(3):319-337.
7. Cofield RH. Total shoulder arthroplasty with the Neer prosthesis. J Bone Joint Surg Am. 1984;66(6):899-906.
8. Karduna AR, Williams GR, Williams JL, Iannotti JP. Kinematics of the glenohumeral joint: influences of muscle forces, ligamentous constraints, and articular geometry. J Orthop Res. 1996;14(6):986-993.
9. Karduna AR, Williams GR, Iannotti JP, Williams JL. Total shoulder arthroplasty biomechanics: a study of the forces and strains at the glenoid component. J Biomech Eng. 1998;120(1):92-99.
10. Karduna AR, Williams GR, Williams JL, Iannotti JP. Glenohumeral joint translations before and after total shoulder arthroplasty. A study in cadavera. J Bone Joint Surg Am. 1997;79(8):1166-1174.
11. Matsen FA 3rd, Clinton J, Lynch J, Bertelsen A, Richardson ML. Glenoid component failure in total shoulder arthroplasty. J Bone Joint Surg Am. 2008;90(4):885-896.
12. Franklin JL, Barrett WP, Jackins SE, Matsen FA 3rd. Glenoid loosening in total shoulder arthroplasty. Association with rotator cuff deficiency. J Arthroplasty. 1988;3(1):39-46.
13. Barrett WP, Franklin JL, Jackins SE, Wyss CR, Matsen FA 3rd. Total shoulder arthroplasty. J Bone Joint Surg Am. 1987;69(6):865-872.
14. Harryman DT, Sidles JA, Harris SL, Lippitt SB, Matsen FA 3rd. The effect of articular conformity and the size of the humeral head component on laxity and motion after glenohumeral arthroplasty. A study in cadavera. J Bone Joint Surg Am. 1995;77(4):555-563.
15. Flatow EL. Prosthetic design considerations in total shoulder arthroplasty. Semin Arthroplasty. 1995;6(4):233-244.
16. Klimkiewicz JJ, Iannotti JP, Rubash HE, Shanbhag AS. Aseptic loosening of the humeral component in total shoulder arthroplasty. J Shoulder Elbow Surg. 1998;7(4):422-426.
17. Wang VM, Krishnan R, Ugwonali OF, Flatow EL, Bigliani LU, Ateshian GA. Biomechanical evaluation of a novel glenoid design in total shoulder arthroplasty. J Shoulder Elbow Surg. 2005;14(1 suppl S):129S-140S.
18. Neer CS 2nd. Replacement arthroplasty for glenohumeral osteoarthritis. J Bone Joint Surg Am. 1974;56(1):1-13.
19. Boorman RS, Kopjar B, Fehringer E, Churchill RS, Smith K, Matsen FA 3rd. The effect of total shoulder arthroplasty on self-assessed health status is comparable to that of total hip arthroplasty and coronary artery bypass grafting. J Shoulder Elbow Surg. 2003;12(2):158-163.
20. Patel AA, Donegan D, Albert T. The 36-Item Short Form. J Am Acad Orthop Surg. 2007;15(2):126-134.
21. Richards RR, An KN, Bigliani LU, et al. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994;3(6):347-352.
22. Wright RW, Baumgarten KM. Shoulder outcomes measures. J Am Acad Orthop Surg. 2010;18(7):436-444.
23. Lazarus MD, Jensen KL, Southworth C, Matsen FA 3rd. The radiographic evaluation of keeled and pegged glenoid component insertion. J Bone Joint Surg Am. 2002;84(7):1174-1182.
24. Sperling JW, Cofield RH, O’Driscoll SW, Torchia ME, Rowland CM. Radiographic assessment of ingrowth total shoulder arthroplasty. J Shoulder Elbow Surg. 2000;9(6):507-513.
25. Dinse GE, Lagakos SW. Nonparametric estimation of lifetime and disease onset distributions from incomplete observations. Biometrics. 1982;38(4):921-932.
26. Baumgarten KM, Lashgari CJ, Yamaguchi K. Glenoid resurfacing in shoulder arthroplasty: indications and contraindications. Instr Course Lect. 2004;53:3-11.
27. Bohsali KI, Wirth MA, Rockwood CA Jr. Complications of total shoulder arthroplasty. J Bone Joint Surg Am. 2006;88(10):2279-2292.
28. Wirth MA, Rockwood CA Jr. Complications of total shoulder-replacement arthroplasty. J Bone Joint Surg Am. 1996;78(4):603-616.
29. Poppen NK, Walker PS. Normal and abnormal motion of the shoulder. J Bone Joint Surg Am. 1976;58(2):195-201.
30. Cotton RE, Rideout DF. Tears of the humeral rotator cuff; a radiological and pathological necropsy survey. J Bone Joint Surg Br. 1964;46:314-328.
31. Bigliani LU, Kelkar R, Flatow EL, Pollock RG, Mow VC. Glenohumeral stability. Biomechanical properties of passive and active stabilizers. Clin Orthop Relat Res. 1996;(330):13-30.
32. Wang VM, Sugalski MT, Levine WN, Pawluk RJ, Mow VC, Bigliani LU. Comparison of glenohumeral mechanics following a capsular shift and anterior tightening. J Bone Joint Surg Am. 2005;87(6):1312-1322.
33. Young A, Walch G, Boileau P, et al. A multicentre study of the long-term results of using a flat-back polyethylene glenoid component in shoulder replacement for primary osteoarthritis. J Bone Joint Surg Br. 2011;93(2):210-216.
34. Khan A, Bunker TD, Kitson JB. Clinical and radiological follow-up of the Aequalis third-generation cemented total shoulder replacement: a minimum ten-year study. J Bone Joint Surg Br. 2009;91(12):1594-1600.
35. Walch G, Edwards TB, Boulahia A, Boileau P, Mole D, Adeleine P. The influence of glenohumeral prosthetic mismatch on glenoid radiolucent lines: results of a multicenter study. J Bone Joint Surg Am. 2002;84(12):2186-2191.
36. Bartelt R, Sperling JW, Schleck CD, Cofield RH. Shoulder arthroplasty in patients aged fifty-five years or younger with osteoarthritis. J Shoulder Elbow Surg. 2011;20(1):123-130.
37. Miller BS, Joseph TA, Noonan TJ, Horan MP, Hawkins RJ. Rupture of the subscapularis tendon after shoulder arthroplasty: diagnosis, treatment, and outcome. J Shoulder Elbow Surg. 2005;14(5):492-496.
38. Armstrong A, Lashgari C, Teefey S, Menendez J, Yamaguchi K, Galatz LM. Ultrasound evaluation and clinical correlation of subscapularis repair after total shoulder arthroplasty. J Shoulder Elbow Surg. 2006;15(5):541-548.
39. Miller SL, Hazrati Y, Klepps S, Chiang A, Flatow EL. Loss of subscapularis function after total shoulder replacement: a seldom recognized problem. J Shoulder Elbow Surg. 2003;12(1):29-34.
Authors’ Disclosure Statement: Dr. Bigliani reports that he helped design the Zimmer Biomet prosthesis discussed in this article and has received royalties from Zimmer Biomet and Innomed. Columbia University, where Dr. Levine and Dr. Ahmad are employed, receives royalties from Zimmer Biomet, and Dr. Levine reports that he is an unpaid consultant to Zimmer Biomet. The other authors report no actual or potential conflict of interest in relation to this article.
Authors’ Disclosure Statement: Dr. Bigliani reports that he helped design the Zimmer Biomet prosthesis discussed in this article and has received royalties from Zimmer Biomet and Innomed. Columbia University, where Dr. Levine and Dr. Ahmad are employed, receives royalties from Zimmer Biomet, and Dr. Levine reports that he is an unpaid consultant to Zimmer Biomet. The other authors report no actual or potential conflict of interest in relation to this article.
Author and Disclosure Information
Authors’ Disclosure Statement: Dr. Bigliani reports that he helped design the Zimmer Biomet prosthesis discussed in this article and has received royalties from Zimmer Biomet and Innomed. Columbia University, where Dr. Levine and Dr. Ahmad are employed, receives royalties from Zimmer Biomet, and Dr. Levine reports that he is an unpaid consultant to Zimmer Biomet. The other authors report no actual or potential conflict of interest in relation to this article.
The authors have developed a total shoulder glenoid prosthesis that conforms with the humeral head in its center and is nonconforming on its peripheral edge.
All clinical survey and range of motion parameters demonstrated statistically significant improvements at final follow-up.
Only 3 shoulders (1.7%) required revision surgery.
Eighty-six (63%) of 136 shoulders demonstrated no radiographic evidence of glenoid loosening.
This is the first and largest study that evaluates the clinical and radiographic outcomes of this hybrid shoulder prosthesis.
Fixation of the glenoid component is the limiting factor in modern total shoulder arthroplasty (TSA). Glenoid loosening, the most common long-term complication, necessitates revision in up to 12% of patients.1-4 By contrast, humeral component loosening is relatively uncommon, affecting as few as 0.34% of patients.5 Multiple long-term studies have found consistently high rates (45%-93%) of radiolucencies around the glenoid component.3,6,7 Although their clinical significance has been debated, radiolucencies around the glenoid component raise concern about progressive loss of fixation.
Since TSA was introduced in the 1970s, complications with the glenoid component have been addressed with 2 different designs: conforming (congruent) and nonconforming. In a congruent articulation, the radii of curvature of the glenoid and humeral head components are identical, whereas they differ in a nonconforming model. Joint conformity is inversely related to glenohumeral translation.8 Neer’s original TSA was made congruent in order to limit translation and maximize the contact area. However, this design results in edge loading and a so-called rocking-horse phenomenon, which may lead to glenoid loosening.9-13 Surgeons therefore have increasingly turned to nonconforming implants. In the nonconforming design, the radius of curvature of the humeral head is smaller than that of the glenoid. Although this design may reduce edge loading,14 it allows more translation and reduces the relative contact area of the glenohumeral joint. As a result, more contact stress is transmitted to the glenoid component, leading to polyethylene deformation and wear.15,16
Figure 1.A desire to integrate the advantages of the 2 designs led to a novel glenoid implant design with variable conformity. This innovative component has a central conforming region and a peripheral nonconforming region or “translation zone” (Figure 1).
Dual radii of curvature are designed to augment joint stability without increasing component wear. Biomechanical data have indicated that edge loading is not increased by having a central conforming region added to a nonconforming model.17 The clinical value of this prosthesis, however, has not been determined. Therefore, we conducted a study to describe the intermediate-term clinical and radiographic outcomes of TSAs that use a novel hybrid glenoid component.
Materials and Methods
This study was approved (protocol AAAD3473) by the Institutional Review Board of Columbia University and was conducted in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.
Patient Selection
At Columbia University Medical Center, Dr. Bigliani performed 196 TSAs with a hybrid glenoid component (Bigliani-Flatow; Zimmer Biomet) in 169 patients between September 1998 and November 2007. All patients had received a diagnosis of primary glenohumeral arthritis as defined by Neer.18 Patients with previous surgery such as rotator cuff repair or subacromial decompression were included in our review, and patients with a nonprimary form of arthritis, such as rheumatoid, posttraumatic, or post-capsulorrhaphy arthritis, were excluded.
Operative Technique
For all surgeries, Dr. Bigliani performed a subscapularis tenotomy with regional anesthesia and a standard deltopectoral approach. A partial anterior capsulectomy was performed to increase the glenoid’s visibility. The inferior labrum was removed with a needle-tip bovie while the axillary nerve was being protected with a metal finger or narrow Darrach retractor. After reaming and trialing, the final glenoid component was cemented into place. Cement was placed only in the peg or keel holes and pressurized twice before final implantation. Of the 196 glenoid components, 168 (86%) were pegged and 28 (14%) keeled; in addition,190 of these components were all-polyethylene, whereas 6 had trabecular-metal backing. All glenoid components incorporated the hybrid design of dual radii of curvature. After the glenoid was cemented, the final humeral component was placed in 30° of retroversion. Whenever posterior wear was found, retroversion was reduced by 5° to 10°. The humeral prosthesis was cemented in cases (104/196, 53%) of poor bone quality or a large canal.
After surgery, the patient’s sling was fitted with an abduction pillow and a swathe, to be worn the first 24 hours, and the arm was passively ranged. Patients typically were discharged on postoperative day 2. Then, for 2 weeks, they followed an assisted passive range of motion (ROM) protocol, with limited external rotation, for promotion of subscapularis healing.
Clinical Outcomes
Dr. Bigliani assessed preoperative ROM in all planes. During initial evaluation, patients completed a questionnaire that consisted of the 36-Item Short Form Health Survey19,20 (SF-36) and the American Shoulder and Elbow Surgeons21 (ASES) and Simple Shoulder Test22 (SST) surveys. Postoperative clinical data were collected from office follow-up visits, survey questionnaires, or both. Postoperative office data included ROM, subscapularis integrity testing (belly-press or lift-off), and any complications. Patients with <1 year of office follow-up were excluded. In addition, the same survey questionnaire that was used before surgery was mailed to all patients after surgery; then, for anyone who did not respond by mail, we attempted contact by telephone. Neer criteria were based on patients’ subjective assessment of each arm on a 3-point Likert scale (1 = very satisfied, 2 = satisfied, 3 = dissatisfied). Patients were also asked about any specific complications or revision operations since their index procedure.
Physical examination and office follow-up data were obtained for 129 patients (148/196 shoulders, 76% follow-up) at a mean of 3.7 years (range 1.0-10.2 years) after surgery. Surveys were completed by 117 patients (139/196 shoulders, 71% follow-up) at a mean of 5.1 years (range, 1.6-11.2 years) after surgery. Only 15 patients had neither 1 year of office follow-up nor a completed questionnaire. The remaining 154 patients (178/196 shoulders, 91% follow-up) had clinical follow-up with office, mail, or telephone questionnaire at a mean of 4.8 years (range, 1.0-11.2 years) after surgery. This cohort of patients was used to determine rates of surgical revisions, subscapularis tears, dislocations, and other complications.
Figure 2.Acromioplasty, performed in TSA patients who had subacromial impingement stemming from improved ROM, represented a second operation, and therefore the need for this surgery was deemed a complication as well. Figure 2 breaks down the 4 major study cohorts.
Radiographic Outcomes
Patients were included in the radiographic analysis if they had a shoulder radiograph at least 1 year after surgery. One hundred nineteen patients (136/196 shoulders, 69% follow-up) had radiographic follow-up at a mean of 3.7 years (range, 1.0-9.4 years) after surgery.
Table 1.All radiographs were independently assessed by 2 blinded physicians who were not involved in the index procedure. Any disputed radiographs were reassessed by these physicians together, until consensus was reached. Radiographs were reviewed for the presence of glenoid lucencies around the pegs or keel and were scored using the system of Lazarus and colleagues23 (Table 1). The humerus was assessed for total number of lucent lines in any of 8 periprosthetic zones, as described by Sperling and colleagues.24
Statistical Analysis
Statistical analysis was performed with Stata Version 10.0. Paired t tests were used to compare preoperative and postoperative numerical data, including ROM and survey scores. We calculated 95% confidence intervals (CIs) and set statistical significance at P < .05. For qualitative measures, the Fisher exact test was used. Survivorship analysis was performed according to the Kaplan-Meier method, with right-censored data for no event or missing data.25
Results
Clinical Analysis of Demographics
In demographics, the clinical and radiographic patient subgroups were similar to each other and to the overall study population (Table 2). Of 196 patients overall, 16 (8%) had a concomitant rotator cuff repair, and 27 (14%) underwent staged bilateral shoulder arthroplasties.
Table 2.
Clinical Analysis of ROM and Survey Scores
Operative shoulder ROM in forward elevation, external rotation at side, external rotation in abduction, and internal rotation all showed statistically significant (P < .001) improvement from before surgery to after surgery. Over 3.7 years, mean (SD) forward elevation improved from 107.3° (34.8°) to 159.0° (29.4°), external rotation at side improved from 20.4° (16.7°) to 49.4° (11.3°), and external rotation in abduction improved from 53.7° (24.3°) to 84.7° (9.1°). Internal rotation improved from a mean (SD) vertebral level of S1 (6.0 levels) to T9 (3.7 levels).
All validated survey scores also showed statistically significant (P < .001) improvement from before surgery to after surgery. Over 5.1 years, mean (SD) SF-36 scores improved from 64.9 (13.4) to 73.6 (17.1), ASES scores improved from 41.1 (22.5) to 82.7 (17.7), SST scores improved from 3.9 (2.8) to 9.7 (2.2), and visual analog scale pain scores improved from 5.6 (3.2) to 1.4 (2.1). Of 139 patients with follow-up, 130 (93.5%) were either satisfied or very satisfied with their TSA, and only 119 (86%) were either satisfied or very satisfied with the nonoperative shoulder.
Clinical Analysis of Postoperative Complications
Of the 178 shoulders evaluated for complications, 3 (1.7%) underwent revision surgery. Mean time to revision was 2.3 years (range, 1.5-3.9 years). Two revisions involved the glenoid component, and the third involved the humerus. In one of the glenoid cases, a 77-year-old woman fell and sustained a fracture at the base of the trabecular metal glenoid pegs; her component was revised to an all-polyethylene component, and she had no further complications. In the other glenoid case, a 73-year-old man’s all-polyethylene component loosened after 2 years and was revised to a trabecular metal implant, which loosened as well and was later converted to a hemiarthroplasty. In the humeral case, a 33-year-old man had his 4-year-old index TSA revised to a cemented stem and had no further complications.
Table 3.Of the 148 patients with office follow-up, only 8 had a positive belly-press or lift-off test. Of all 178 clinical study shoulders, 10 (5.6%) had a subscapularis tear confirmed by magnetic resonance imaging or a physician. Of these 10 tears, 3 resulted from traumatic falls. Four of the 10 tears were managed nonoperatively, and the other 6 underwent surgical repair at a mean of 2.9 years (range, 0.3-7.8 years) after index TSA. In 2 of the 6 repair cases, a 46-mm humeral head had been used, and, in the other 4 cases, a 52-mm humeral head. Of the 6 repaired tears, 2 were massive, and 4 were isolated to the subscapularis. None of these 6 tears required a second repair. Seven (4%) of the 178 shoulders experienced a clinically significant posterosuperior subluxation or dislocation; 5 of the 7 were managed nonoperatively, and the other 2 underwent open capsular shift, at 0.5 year and 3.0 years, respectively. Table 3 lists the other postoperative complications that required surgery.
Table 4.
Table 4 compares the clinical and radiographic outcomes of patients who required subscapularis repair, capsular shift, or implant revision with the outcomes of all other study patients, and Figure 3 shows Kaplan-Meier survivorship.
Figure 3.
Postoperative Radiographic Analysis
Glenoid Component. At a mean of 3.7 years (minimum, 1 year) after surgery, 86 (63%) of 136 radiographically evaluated shoulders showed no glenoid lucencies; the other 50 (37%) showed ≥1 lucency. Of the 136 shoulders, 33 (24%) had a Lazarus score of 1, 15 (11%) had a score of 2, and only 2 (2%) had a score of 3. None of the shoulders had a score of 4 or 5.
Humeral Component. Of the 136 shoulders, 91 (67%) showed no lucencies in any of the 8 humeral stem zones; the other 45 (33%) showed 1 to 3 lucencies. Thirty (22%) of the 136 shoulders had 1 stem lucency zone, 8 (6%) had 2, and 3 (2%) had 3. None of the shoulders had >3 periprosthetic zones with lucent lines.
Discussion
In this article, we describe a hybrid glenoid TSA component with dual radii of curvature. Its central portion is congruent with the humeral head, and its peripheral portion is noncongruent and larger. The most significant finding of our study is the low rate (1.1%) of glenoid component revision 4.8 years after surgery. This rate is the lowest that has been reported in a study of ≥100 patients. Overall implant survival appeared as an almost flat Kaplan-Meir curve. We attribute this low revision rate to improved biomechanics with the hybrid glenoid design.
Symptomatic glenoid component loosening is the most common TSA complication.1,26-28 In a review of 73 Neer TSAs, Cofield7 found glenoid radiolucencies in 71% of patients 3.8 years after surgery. Radiographic evidence of loosening, defined as component migration, or tilt, or a circumferential lucency 1.5 mm thick, was present in another 11% of patients, and 4.1% developed symptomatic loosening that required glenoid revision. In a study with 12.2-year follow-up, Torchia and colleagues3 found rates of 84% for glenoid radiolucencies, 44% for radiographic loosening, and 5.6% for symptomatic loosening that required revision. In a systematic review of studies with follow-up of ≥10 years, Bohsali and colleagues27 found similar lucency and radiographic loosening rates and a 7% glenoid revision rate. These data suggest glenoid radiolucencies may progress to component loosening.
Degree of joint congruence is a key factor in glenoid loosening. Neer’s congruent design increases the contact area with concentric loading and reduces glenohumeral translation, which leads to reduced polyethylene wear and improved joint stability. In extreme arm positions, however, humeral head subluxation results in edge loading and a glenoid rocking-horse effect.9-13,17,29-31 Conversely, nonconforming implants allow increased glenohumeral translation without edge loading,14 though they also reduce the relative glenohumeral contact area and thus transmit more contact stress to the glenoid.16,17 A hybrid glenoid component with central conforming and peripheral nonconforming zones may reduce the rocking-horse effect while maximizing ROM and joint stability. Wang and colleagues32 studied the biomechanical properties of this glenoid design and found that the addition of a central conforming region did not increase edge loading.
Additional results from our study support the efficacy of a hybrid glenoid component. Patients’ clinical outcomes improved significantly. At 5.1 years after surgery, 93.5% of patients were satisfied or very satisfied with their procedure and reported less satisfaction (86%) with the nonoperative shoulder. Also significant was the reduced number of radiolucencies. At 3.7 years after surgery, the overall percentage of shoulders with ≥1 glenoid radiolucency was 37%, considerably lower than the 82% reported by Cofield7 and the rates in more recent studies.3,16,33-36 Of the 178 shoulders in our study, 10 (5.6%) had subscapularis tears, and 6 (3.4%) of 178 had these tears surgically repaired. This 3.4% compares favorably with the 5.9% (of 119 patients) found by Miller and colleagues37 28 months after surgery. Of our 178 shoulders, 27 (15.2%) had clinically significant postoperative complications; 18 (10.1%) of the 178 had these complications surgically treated, and 9 (5.1%) had them managed nonoperatively. Bohsali and colleagues27 systematically reviewed 33 TSA studies and found a slightly higher complication rate (16.3%) 5.3 years after surgery. Furthermore, in our study, the 11 patients who underwent revision, capsular shift, or subscapularis repair had final outcomes comparable to those of the rest of our study population.
Our study had several potential weaknesses. First, its minimum clinical and radiographic follow-up was 1 year, whereas most long-term TSA series set a minimum of 2 years. We used 1 year because this was the first clinical study of the hybrid glenoid component design, and we wanted to maximize its sample size by reporting on intermediate-length outcomes. Even so, 93% (166/178) of our clinical patients and 83% (113/136) of our radiographic patients have had ≥2 years of follow-up, and we continue to follow all study patients for long-term outcomes. Another weakness of the study was its lack of a uniform group of patients with all the office, survey, complications, and radiographic data. Our retrospective study design made it difficult to obtain such a group without significantly reducing the sample size, so we divided patients into 4 data groups. A third potential weakness was the study’s variable method for collecting complications data. Rates of complications in the 178 shoulders were calculated from either office evaluation or patient self-report by mail or telephone. This data collection method is subject to recall bias, but mail and telephone contact was needed so the study would capture the large number of patients who had traveled to our institution for their surgery or had since moved away. Fourth, belly-press and lift-off tests were used in part to assess subscapularis function, but recent literature suggests post-TSA subscapularis assessment can be unreliable.38 These tests may be positive in up to two-thirds of patients after 2 years.39 Fifth, the generalizability of our findings to diagnoses such as rheumatoid and posttraumatic arthritis is limited. We had to restrict the study to patients with primary glenohumeral arthritis in order to minimize confounders.
This study’s main strength is its description of the clinical and radiographic outcomes of using a single prosthetic system in operations performed by a single surgeon in a large number of patients. This was the first and largest study evaluating the clinical and radiographic outcomes of this hybrid glenoid implant. Excluding patients with nonprimary arthritis allowed us to minimize potential confounding factors that affect patient outcomes. In conclusion, our study results showed the favorable clinical and radiographic outcomes of TSAs that have a hybrid glenoid component with dual radii of curvature. At a mean of 3.7 years after surgery, 63% of patients had no glenoid lucencies, and, at a mean of 4.8 years, only 1.7% of patients required revision. We continue to follow these patients to obtain long-term results of this innovative prosthesis.
Take-Home Points
The authors have developed a total shoulder glenoid prosthesis that conforms with the humeral head in its center and is nonconforming on its peripheral edge.
All clinical survey and range of motion parameters demonstrated statistically significant improvements at final follow-up.
Only 3 shoulders (1.7%) required revision surgery.
Eighty-six (63%) of 136 shoulders demonstrated no radiographic evidence of glenoid loosening.
This is the first and largest study that evaluates the clinical and radiographic outcomes of this hybrid shoulder prosthesis.
Fixation of the glenoid component is the limiting factor in modern total shoulder arthroplasty (TSA). Glenoid loosening, the most common long-term complication, necessitates revision in up to 12% of patients.1-4 By contrast, humeral component loosening is relatively uncommon, affecting as few as 0.34% of patients.5 Multiple long-term studies have found consistently high rates (45%-93%) of radiolucencies around the glenoid component.3,6,7 Although their clinical significance has been debated, radiolucencies around the glenoid component raise concern about progressive loss of fixation.
Since TSA was introduced in the 1970s, complications with the glenoid component have been addressed with 2 different designs: conforming (congruent) and nonconforming. In a congruent articulation, the radii of curvature of the glenoid and humeral head components are identical, whereas they differ in a nonconforming model. Joint conformity is inversely related to glenohumeral translation.8 Neer’s original TSA was made congruent in order to limit translation and maximize the contact area. However, this design results in edge loading and a so-called rocking-horse phenomenon, which may lead to glenoid loosening.9-13 Surgeons therefore have increasingly turned to nonconforming implants. In the nonconforming design, the radius of curvature of the humeral head is smaller than that of the glenoid. Although this design may reduce edge loading,14 it allows more translation and reduces the relative contact area of the glenohumeral joint. As a result, more contact stress is transmitted to the glenoid component, leading to polyethylene deformation and wear.15,16
Figure 1.A desire to integrate the advantages of the 2 designs led to a novel glenoid implant design with variable conformity. This innovative component has a central conforming region and a peripheral nonconforming region or “translation zone” (Figure 1).
Dual radii of curvature are designed to augment joint stability without increasing component wear. Biomechanical data have indicated that edge loading is not increased by having a central conforming region added to a nonconforming model.17 The clinical value of this prosthesis, however, has not been determined. Therefore, we conducted a study to describe the intermediate-term clinical and radiographic outcomes of TSAs that use a novel hybrid glenoid component.
Materials and Methods
This study was approved (protocol AAAD3473) by the Institutional Review Board of Columbia University and was conducted in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.
Patient Selection
At Columbia University Medical Center, Dr. Bigliani performed 196 TSAs with a hybrid glenoid component (Bigliani-Flatow; Zimmer Biomet) in 169 patients between September 1998 and November 2007. All patients had received a diagnosis of primary glenohumeral arthritis as defined by Neer.18 Patients with previous surgery such as rotator cuff repair or subacromial decompression were included in our review, and patients with a nonprimary form of arthritis, such as rheumatoid, posttraumatic, or post-capsulorrhaphy arthritis, were excluded.
Operative Technique
For all surgeries, Dr. Bigliani performed a subscapularis tenotomy with regional anesthesia and a standard deltopectoral approach. A partial anterior capsulectomy was performed to increase the glenoid’s visibility. The inferior labrum was removed with a needle-tip bovie while the axillary nerve was being protected with a metal finger or narrow Darrach retractor. After reaming and trialing, the final glenoid component was cemented into place. Cement was placed only in the peg or keel holes and pressurized twice before final implantation. Of the 196 glenoid components, 168 (86%) were pegged and 28 (14%) keeled; in addition,190 of these components were all-polyethylene, whereas 6 had trabecular-metal backing. All glenoid components incorporated the hybrid design of dual radii of curvature. After the glenoid was cemented, the final humeral component was placed in 30° of retroversion. Whenever posterior wear was found, retroversion was reduced by 5° to 10°. The humeral prosthesis was cemented in cases (104/196, 53%) of poor bone quality or a large canal.
After surgery, the patient’s sling was fitted with an abduction pillow and a swathe, to be worn the first 24 hours, and the arm was passively ranged. Patients typically were discharged on postoperative day 2. Then, for 2 weeks, they followed an assisted passive range of motion (ROM) protocol, with limited external rotation, for promotion of subscapularis healing.
Clinical Outcomes
Dr. Bigliani assessed preoperative ROM in all planes. During initial evaluation, patients completed a questionnaire that consisted of the 36-Item Short Form Health Survey19,20 (SF-36) and the American Shoulder and Elbow Surgeons21 (ASES) and Simple Shoulder Test22 (SST) surveys. Postoperative clinical data were collected from office follow-up visits, survey questionnaires, or both. Postoperative office data included ROM, subscapularis integrity testing (belly-press or lift-off), and any complications. Patients with <1 year of office follow-up were excluded. In addition, the same survey questionnaire that was used before surgery was mailed to all patients after surgery; then, for anyone who did not respond by mail, we attempted contact by telephone. Neer criteria were based on patients’ subjective assessment of each arm on a 3-point Likert scale (1 = very satisfied, 2 = satisfied, 3 = dissatisfied). Patients were also asked about any specific complications or revision operations since their index procedure.
Physical examination and office follow-up data were obtained for 129 patients (148/196 shoulders, 76% follow-up) at a mean of 3.7 years (range 1.0-10.2 years) after surgery. Surveys were completed by 117 patients (139/196 shoulders, 71% follow-up) at a mean of 5.1 years (range, 1.6-11.2 years) after surgery. Only 15 patients had neither 1 year of office follow-up nor a completed questionnaire. The remaining 154 patients (178/196 shoulders, 91% follow-up) had clinical follow-up with office, mail, or telephone questionnaire at a mean of 4.8 years (range, 1.0-11.2 years) after surgery. This cohort of patients was used to determine rates of surgical revisions, subscapularis tears, dislocations, and other complications.
Figure 2.Acromioplasty, performed in TSA patients who had subacromial impingement stemming from improved ROM, represented a second operation, and therefore the need for this surgery was deemed a complication as well. Figure 2 breaks down the 4 major study cohorts.
Radiographic Outcomes
Patients were included in the radiographic analysis if they had a shoulder radiograph at least 1 year after surgery. One hundred nineteen patients (136/196 shoulders, 69% follow-up) had radiographic follow-up at a mean of 3.7 years (range, 1.0-9.4 years) after surgery.
Table 1.All radiographs were independently assessed by 2 blinded physicians who were not involved in the index procedure. Any disputed radiographs were reassessed by these physicians together, until consensus was reached. Radiographs were reviewed for the presence of glenoid lucencies around the pegs or keel and were scored using the system of Lazarus and colleagues23 (Table 1). The humerus was assessed for total number of lucent lines in any of 8 periprosthetic zones, as described by Sperling and colleagues.24
Statistical Analysis
Statistical analysis was performed with Stata Version 10.0. Paired t tests were used to compare preoperative and postoperative numerical data, including ROM and survey scores. We calculated 95% confidence intervals (CIs) and set statistical significance at P < .05. For qualitative measures, the Fisher exact test was used. Survivorship analysis was performed according to the Kaplan-Meier method, with right-censored data for no event or missing data.25
Results
Clinical Analysis of Demographics
In demographics, the clinical and radiographic patient subgroups were similar to each other and to the overall study population (Table 2). Of 196 patients overall, 16 (8%) had a concomitant rotator cuff repair, and 27 (14%) underwent staged bilateral shoulder arthroplasties.
Table 2.
Clinical Analysis of ROM and Survey Scores
Operative shoulder ROM in forward elevation, external rotation at side, external rotation in abduction, and internal rotation all showed statistically significant (P < .001) improvement from before surgery to after surgery. Over 3.7 years, mean (SD) forward elevation improved from 107.3° (34.8°) to 159.0° (29.4°), external rotation at side improved from 20.4° (16.7°) to 49.4° (11.3°), and external rotation in abduction improved from 53.7° (24.3°) to 84.7° (9.1°). Internal rotation improved from a mean (SD) vertebral level of S1 (6.0 levels) to T9 (3.7 levels).
All validated survey scores also showed statistically significant (P < .001) improvement from before surgery to after surgery. Over 5.1 years, mean (SD) SF-36 scores improved from 64.9 (13.4) to 73.6 (17.1), ASES scores improved from 41.1 (22.5) to 82.7 (17.7), SST scores improved from 3.9 (2.8) to 9.7 (2.2), and visual analog scale pain scores improved from 5.6 (3.2) to 1.4 (2.1). Of 139 patients with follow-up, 130 (93.5%) were either satisfied or very satisfied with their TSA, and only 119 (86%) were either satisfied or very satisfied with the nonoperative shoulder.
Clinical Analysis of Postoperative Complications
Of the 178 shoulders evaluated for complications, 3 (1.7%) underwent revision surgery. Mean time to revision was 2.3 years (range, 1.5-3.9 years). Two revisions involved the glenoid component, and the third involved the humerus. In one of the glenoid cases, a 77-year-old woman fell and sustained a fracture at the base of the trabecular metal glenoid pegs; her component was revised to an all-polyethylene component, and she had no further complications. In the other glenoid case, a 73-year-old man’s all-polyethylene component loosened after 2 years and was revised to a trabecular metal implant, which loosened as well and was later converted to a hemiarthroplasty. In the humeral case, a 33-year-old man had his 4-year-old index TSA revised to a cemented stem and had no further complications.
Table 3.Of the 148 patients with office follow-up, only 8 had a positive belly-press or lift-off test. Of all 178 clinical study shoulders, 10 (5.6%) had a subscapularis tear confirmed by magnetic resonance imaging or a physician. Of these 10 tears, 3 resulted from traumatic falls. Four of the 10 tears were managed nonoperatively, and the other 6 underwent surgical repair at a mean of 2.9 years (range, 0.3-7.8 years) after index TSA. In 2 of the 6 repair cases, a 46-mm humeral head had been used, and, in the other 4 cases, a 52-mm humeral head. Of the 6 repaired tears, 2 were massive, and 4 were isolated to the subscapularis. None of these 6 tears required a second repair. Seven (4%) of the 178 shoulders experienced a clinically significant posterosuperior subluxation or dislocation; 5 of the 7 were managed nonoperatively, and the other 2 underwent open capsular shift, at 0.5 year and 3.0 years, respectively. Table 3 lists the other postoperative complications that required surgery.
Table 4.
Table 4 compares the clinical and radiographic outcomes of patients who required subscapularis repair, capsular shift, or implant revision with the outcomes of all other study patients, and Figure 3 shows Kaplan-Meier survivorship.
Figure 3.
Postoperative Radiographic Analysis
Glenoid Component. At a mean of 3.7 years (minimum, 1 year) after surgery, 86 (63%) of 136 radiographically evaluated shoulders showed no glenoid lucencies; the other 50 (37%) showed ≥1 lucency. Of the 136 shoulders, 33 (24%) had a Lazarus score of 1, 15 (11%) had a score of 2, and only 2 (2%) had a score of 3. None of the shoulders had a score of 4 or 5.
Humeral Component. Of the 136 shoulders, 91 (67%) showed no lucencies in any of the 8 humeral stem zones; the other 45 (33%) showed 1 to 3 lucencies. Thirty (22%) of the 136 shoulders had 1 stem lucency zone, 8 (6%) had 2, and 3 (2%) had 3. None of the shoulders had >3 periprosthetic zones with lucent lines.
Discussion
In this article, we describe a hybrid glenoid TSA component with dual radii of curvature. Its central portion is congruent with the humeral head, and its peripheral portion is noncongruent and larger. The most significant finding of our study is the low rate (1.1%) of glenoid component revision 4.8 years after surgery. This rate is the lowest that has been reported in a study of ≥100 patients. Overall implant survival appeared as an almost flat Kaplan-Meir curve. We attribute this low revision rate to improved biomechanics with the hybrid glenoid design.
Symptomatic glenoid component loosening is the most common TSA complication.1,26-28 In a review of 73 Neer TSAs, Cofield7 found glenoid radiolucencies in 71% of patients 3.8 years after surgery. Radiographic evidence of loosening, defined as component migration, or tilt, or a circumferential lucency 1.5 mm thick, was present in another 11% of patients, and 4.1% developed symptomatic loosening that required glenoid revision. In a study with 12.2-year follow-up, Torchia and colleagues3 found rates of 84% for glenoid radiolucencies, 44% for radiographic loosening, and 5.6% for symptomatic loosening that required revision. In a systematic review of studies with follow-up of ≥10 years, Bohsali and colleagues27 found similar lucency and radiographic loosening rates and a 7% glenoid revision rate. These data suggest glenoid radiolucencies may progress to component loosening.
Degree of joint congruence is a key factor in glenoid loosening. Neer’s congruent design increases the contact area with concentric loading and reduces glenohumeral translation, which leads to reduced polyethylene wear and improved joint stability. In extreme arm positions, however, humeral head subluxation results in edge loading and a glenoid rocking-horse effect.9-13,17,29-31 Conversely, nonconforming implants allow increased glenohumeral translation without edge loading,14 though they also reduce the relative glenohumeral contact area and thus transmit more contact stress to the glenoid.16,17 A hybrid glenoid component with central conforming and peripheral nonconforming zones may reduce the rocking-horse effect while maximizing ROM and joint stability. Wang and colleagues32 studied the biomechanical properties of this glenoid design and found that the addition of a central conforming region did not increase edge loading.
Additional results from our study support the efficacy of a hybrid glenoid component. Patients’ clinical outcomes improved significantly. At 5.1 years after surgery, 93.5% of patients were satisfied or very satisfied with their procedure and reported less satisfaction (86%) with the nonoperative shoulder. Also significant was the reduced number of radiolucencies. At 3.7 years after surgery, the overall percentage of shoulders with ≥1 glenoid radiolucency was 37%, considerably lower than the 82% reported by Cofield7 and the rates in more recent studies.3,16,33-36 Of the 178 shoulders in our study, 10 (5.6%) had subscapularis tears, and 6 (3.4%) of 178 had these tears surgically repaired. This 3.4% compares favorably with the 5.9% (of 119 patients) found by Miller and colleagues37 28 months after surgery. Of our 178 shoulders, 27 (15.2%) had clinically significant postoperative complications; 18 (10.1%) of the 178 had these complications surgically treated, and 9 (5.1%) had them managed nonoperatively. Bohsali and colleagues27 systematically reviewed 33 TSA studies and found a slightly higher complication rate (16.3%) 5.3 years after surgery. Furthermore, in our study, the 11 patients who underwent revision, capsular shift, or subscapularis repair had final outcomes comparable to those of the rest of our study population.
Our study had several potential weaknesses. First, its minimum clinical and radiographic follow-up was 1 year, whereas most long-term TSA series set a minimum of 2 years. We used 1 year because this was the first clinical study of the hybrid glenoid component design, and we wanted to maximize its sample size by reporting on intermediate-length outcomes. Even so, 93% (166/178) of our clinical patients and 83% (113/136) of our radiographic patients have had ≥2 years of follow-up, and we continue to follow all study patients for long-term outcomes. Another weakness of the study was its lack of a uniform group of patients with all the office, survey, complications, and radiographic data. Our retrospective study design made it difficult to obtain such a group without significantly reducing the sample size, so we divided patients into 4 data groups. A third potential weakness was the study’s variable method for collecting complications data. Rates of complications in the 178 shoulders were calculated from either office evaluation or patient self-report by mail or telephone. This data collection method is subject to recall bias, but mail and telephone contact was needed so the study would capture the large number of patients who had traveled to our institution for their surgery or had since moved away. Fourth, belly-press and lift-off tests were used in part to assess subscapularis function, but recent literature suggests post-TSA subscapularis assessment can be unreliable.38 These tests may be positive in up to two-thirds of patients after 2 years.39 Fifth, the generalizability of our findings to diagnoses such as rheumatoid and posttraumatic arthritis is limited. We had to restrict the study to patients with primary glenohumeral arthritis in order to minimize confounders.
This study’s main strength is its description of the clinical and radiographic outcomes of using a single prosthetic system in operations performed by a single surgeon in a large number of patients. This was the first and largest study evaluating the clinical and radiographic outcomes of this hybrid glenoid implant. Excluding patients with nonprimary arthritis allowed us to minimize potential confounding factors that affect patient outcomes. In conclusion, our study results showed the favorable clinical and radiographic outcomes of TSAs that have a hybrid glenoid component with dual radii of curvature. At a mean of 3.7 years after surgery, 63% of patients had no glenoid lucencies, and, at a mean of 4.8 years, only 1.7% of patients required revision. We continue to follow these patients to obtain long-term results of this innovative prosthesis.
References
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32. Wang VM, Sugalski MT, Levine WN, Pawluk RJ, Mow VC, Bigliani LU. Comparison of glenohumeral mechanics following a capsular shift and anterior tightening. J Bone Joint Surg Am. 2005;87(6):1312-1322.
33. Young A, Walch G, Boileau P, et al. A multicentre study of the long-term results of using a flat-back polyethylene glenoid component in shoulder replacement for primary osteoarthritis. J Bone Joint Surg Br. 2011;93(2):210-216.
34. Khan A, Bunker TD, Kitson JB. Clinical and radiological follow-up of the Aequalis third-generation cemented total shoulder replacement: a minimum ten-year study. J Bone Joint Surg Br. 2009;91(12):1594-1600.
35. Walch G, Edwards TB, Boulahia A, Boileau P, Mole D, Adeleine P. The influence of glenohumeral prosthetic mismatch on glenoid radiolucent lines: results of a multicenter study. J Bone Joint Surg Am. 2002;84(12):2186-2191.
36. Bartelt R, Sperling JW, Schleck CD, Cofield RH. Shoulder arthroplasty in patients aged fifty-five years or younger with osteoarthritis. J Shoulder Elbow Surg. 2011;20(1):123-130.
37. Miller BS, Joseph TA, Noonan TJ, Horan MP, Hawkins RJ. Rupture of the subscapularis tendon after shoulder arthroplasty: diagnosis, treatment, and outcome. J Shoulder Elbow Surg. 2005;14(5):492-496.
38. Armstrong A, Lashgari C, Teefey S, Menendez J, Yamaguchi K, Galatz LM. Ultrasound evaluation and clinical correlation of subscapularis repair after total shoulder arthroplasty. J Shoulder Elbow Surg. 2006;15(5):541-548.
39. Miller SL, Hazrati Y, Klepps S, Chiang A, Flatow EL. Loss of subscapularis function after total shoulder replacement: a seldom recognized problem. J Shoulder Elbow Surg. 2003;12(1):29-34.
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33. Young A, Walch G, Boileau P, et al. A multicentre study of the long-term results of using a flat-back polyethylene glenoid component in shoulder replacement for primary osteoarthritis. J Bone Joint Surg Br. 2011;93(2):210-216.
34. Khan A, Bunker TD, Kitson JB. Clinical and radiological follow-up of the Aequalis third-generation cemented total shoulder replacement: a minimum ten-year study. J Bone Joint Surg Br. 2009;91(12):1594-1600.
35. Walch G, Edwards TB, Boulahia A, Boileau P, Mole D, Adeleine P. The influence of glenohumeral prosthetic mismatch on glenoid radiolucent lines: results of a multicenter study. J Bone Joint Surg Am. 2002;84(12):2186-2191.
36. Bartelt R, Sperling JW, Schleck CD, Cofield RH. Shoulder arthroplasty in patients aged fifty-five years or younger with osteoarthritis. J Shoulder Elbow Surg. 2011;20(1):123-130.
37. Miller BS, Joseph TA, Noonan TJ, Horan MP, Hawkins RJ. Rupture of the subscapularis tendon after shoulder arthroplasty: diagnosis, treatment, and outcome. J Shoulder Elbow Surg. 2005;14(5):492-496.
38. Armstrong A, Lashgari C, Teefey S, Menendez J, Yamaguchi K, Galatz LM. Ultrasound evaluation and clinical correlation of subscapularis repair after total shoulder arthroplasty. J Shoulder Elbow Surg. 2006;15(5):541-548.
39. Miller SL, Hazrati Y, Klepps S, Chiang A, Flatow EL. Loss of subscapularis function after total shoulder replacement: a seldom recognized problem. J Shoulder Elbow Surg. 2003;12(1):29-34.
