Orthopedics

Proximal humerus fractures (PHFs), AO/OTA (Ar­ beitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association) type 11,¹ are common, representing 4% to 5% of all fractures in adults.² However, there is no consensus as to optimal management of these injuries, with some reports supporting and others rejecting the various fixation methods,³ and there are no evidence-based practice guidelines informing treatment decisions.⁴ Not surprisingly, orthopedic surgeons do not agree on ideal treatment for PHFs^5,6 and differ by region in their rates of surgical management.² In addition, analyses of national databases have found variation in choice of surgical treatment for PHFs between surgeons and between hospitals of different patient volumes.⁴ Few studies have assessed surgeon agreement on treatment decisions. Findings from these limited investigations indicate there is little agreement on treatment choices, but training may have some impact.^5-7 In 3 studies,^5-7 shoulder and trauma fellowship–trained surgeons differed in their management of PHFs both in terms of rates of operative treatment^5,7 and specific operative management choices.^5,6 No study has assessed surgeon agreement on radiographic outcomes.

We conducted a study to compare expert shoulder and trauma surgeons’ treatment decision-making and agreement on final radiographic outcomes of surgically treated PHFs. We hypothesized there would be poor agreement on treatment decisions and better agreement on radiographic outcomes, with a difference between shoulder and trauma fellowship–trained surgeons.

Materials and Methods

After receiving institutional review board approval for this study, we collected data on 100 consecutive PHFs (AO/OTA type 11¹) surgically treated at 2 affiliated level I trauma centers between January 2004 and July 2008. None of the cases in the series was managed by any of the surgeons participating in this study.

We created a PowerPoint (Microsoft, Redmond, Washington) survey that included radiographs (preoperative, immediate postoperative, final postoperative) and, if available, a computed tomography image. This survey was sent to 4 orthopedic surgeons: Drs. Gardner, Gerber, Lorich, and Walch. Two of these authors are fellowship-trained in shoulder surgery, the other 2 in orthopedic traumatology with specialization in treating PHFs. All are internationally renowned in PHF management. Using the survey images and a 4-point Likert scale ranging from disagree strongly to agree strongly, the examiners rated their agreement with treatment decisions (arthroplasty vs fixation). They also rated (very poor to very good) immediate postoperative reduction or arthroplasty placement, immediate postoperative fixation methods for fractures treated with open reduction and internal fixation (ORIF), and final radiographic outcomes.

Interobserver agreement was calculated using the intraclass correlation coefficient (ICC),^8,9 with scores of <0.2 (poor), 0.21 to 0.4 (fair), 0.41 to 0.6 (moderate), 0.61 to 0.8 (good), and >0.8 (excellent) used to indicate agreement among observers. ICC scores were determined by treating the 4 examiners as independent entities. Subgroup analyses were also performed to determine ICC scores comparing the 2 shoulder surgeons, comparing the 2 trauma surgeons, and comparing the shoulder surgeons and trauma surgeons as 2 separate groups. ICC scores were used instead of κ coefficients to assess agreement because ICC scores treat ratings as continuous variables, allow for comparison of 2 or more raters, and allow for assessment of correlation among raters, whereas κ coefficients treat data as categorical variables and assume the ratings have no natural ordering. ICC scores were generated by SAS 9.1.3 software (SAS Institute, Cary, North Carolina).

Results

The 4 surgeons’ overall ICC scores for agreement with the rating of immediate reduction or arthroplasty placement and the rating of final radiographic outcome indicated moderate levels of agreement (Table 1). Regarding treatment decision-making and ratings of fixation, the surgeons demonstrated poor and fair levels of agreement, respectively.

The ICC scores comparing the shoulder and trauma surgeons revealed similar levels of agreement (Table 2): moderate levels of agreement for ratings of both immediate postoperative reduction or arthroplasty placement and final radiographic outcomes, but poor and fair levels of agreement regarding treatment decision-making and the rating of immediate postoperative fixation methods for fractures treated with ORIF, respectively.

Subgroup analysis revealed that the 2 shoulder surgeons had poor and fair levels of agreement for treatment decisions and rating of immediate postoperative fixation, respectively, though they moderately agreed on rating of immediate postoperative reduction or arthroplasty placement and rating of final radiographic outcome (Table 3). When the 2 trauma surgeons were compared with each other, ICC scores revealed higher levels of agreement overall (Table 4). In other words, the 2 trauma surgeons agreed with each other more than the 2 shoulder surgeons agreed with each other.

Discussion

This study had 3 major findings: (1) Surgeons do not agree on treatment decisions, including fixation methods, regarding PHFs; (2) regardless of their opinions on ideal treatment, they moderately agree on reductions and final radiographic outcomes; (3) expert trauma surgeons may agree more on treatment decisions than expert shoulder surgeons do. In other words, surgeons do not agree on the best treatment, but they radiographically recognize when a procedure has been performed technically well or poorly. These results support our hypothesis and the limited current literature.

An analysis of Medicare databases showed marked regional variation in rates of operative treatment of PHFs.² Similarly, a Nationwide Inpatient Sample analysis revealed nationwide variation in operative management of PHFs.⁴ Both findings are consistent with our results of poor agreement about treatment decisions and ratings of postoperative fixation of PHFs. In 2010, Petit and colleagues⁶ reported that surgeons do not agree on PHF management. In 2011, Foroohar and colleagues¹⁰ similarly reported low interobserver agreement for treatment recommendations made by 4 upper extremity orthopedic specialists, 4 general orthopedic surgeons, 4 senior residents, and 4 junior residents, for a series of 16 PHFs—also consistent with our findings.

The lack of agreement about PHF treatment may reflect a difference in training, particularly in light of the recent expansion of shoulder and elbow fellowships.² Three separate studies performed at 2 affiliated level I trauma centers demonstrated significant differences in treatment decision-making between shoulder and trauma fellowship–trained surgeons.^5-7 Our results are consistent with the hypothesis that training affects treatment decision-making, as we found poor agreement between shoulder and trauma fellowship–trained surgeons regarding treatment decision for PHFs. Subanalyses revealed that expert trauma surgeons agreed with each other on treatment decisions more than expert shoulder surgeons agreed with each other, further suggesting that training may affect how surgeons manage PHFs. Differences in fellowship training even within the same specialty may account for the observed lesser levels of agreement between the shoulder surgeons, even among experts in the field.

The evidence for optimal treatment historically has been poor,^4,6 with few high-quality prospective, randomized controlled studies on the topic up until the past few years. The most recent Cochrane Review on optimal PHF treatment concluded that there is insufficient evidence to make an evidence-based recommendation and that the long-term benefit of surgery is unclear.¹¹ However, at least 5 controlled trials on the topic have been published within the past 5 years.^12-16 The evidence is striking and generally supports nonoperative treatment for most PHFs, including some displaced fractures—contrary to general orthopedic practice in many parts of the United States,² which hitherto had been based mainly on individual surgeon experience and the limited literature. Without strong evidence to support one treatment option over another, surgeons are left with no objective, scientific way of coming to agreement.

Related to the poor status quo of evidence for PHF treatments is new technology (eg, locking plates, reverse total shoulder arthroplasty) that has expanded surgical indications.^2,17 Although such developments have the potential to improve surgical treatments, they may also exacerbate the disagreement between surgeons regarding optimal operative treatment of PHFs. This potential consequence of new technology may be reflected in our finding of disagreement among surgeons on immediate postoperative fixation methods. Precisely because they are new, such technological innovations have limited evidence supporting their use. This leaves surgeons with little to nothing to inform their decisions to use these devices, other than familiarity with and impressions of the new technology.

Our study had several limitations. First is the small sample size, of surgeons who are leaders in the field. Our sample therefore may not be generalizable to the general population of shoulder and trauma surgeons. Second, we did not calculate intraobserver variability. Third, inherent to studies of interobserver agreement is the uncertainty of their clinical relevance. In the clinical setting, a surgeon has much more information at hand (eg, patient history, physical examination findings, colleague consultations), thus raising the possibility of underestimations of interobserver agreements.¹⁸ Fourth, our comparison of surgeons’ ratings of outcomes was purely radiographic, which may or may not represent or be indicative of clinical outcomes (eg, pain relief, function, range of motion, patient satisfaction). The conclusions we may draw are accordingly limited, as we did not directly evaluate clinical outcome parameters.

Our study had several strengths as well. First, to our knowledge this is the first study to assess interobserver variability in surgeons’ ratings of radiographic outcomes. Its findings may provide further insight into the reasons for poor agreement among orthopedic surgeons on both classification and treatment of PHFs. Second, our surveying of internationally renowned expert surgeons from 4 different institutions may have helped reduce single-institution bias, and it presents the highest level of expertise in the treatment of PHFs.

Although the surgeons in our study moderately agreed on final radiographic outcomes of PHFs, such levels of agreement may still be clinically unacceptable.¹⁹ The overall disagreement on treatment decisions highlights the need for better evidence for optimal treatment of PHFs in order to improve consensus, particularly with anticipated increases in age and comorbidities in the population in coming years.⁴ Subgroup analysis suggested trauma fellowships may contribute to better treatment agreement, though this idea requires further study, perhaps by surveying shoulder and trauma fellowship directors and their curricula for variability in teaching treatment decision-making. The surgeons in our study agreed more on what they consider acceptable final radiographic outcomes, which is encouraging. However, treatment consensus is the primary goal. The recent publication of prospective, randomized studies is helping with this issue, but more studies are needed. It is encouraging that several are planned or under way.^20-22

Conclusion

The surgeons surveyed in this study did not agree on ideal treatment for PHFs but moderately agreed on quality of radiographic outcomes. These differences may reflect a difference in training. We conducted this study to compare experienced shoulder and trauma fellowship–trained surgeons’ treatment decision-making and ratings of radiographic outcomes of PHFs when presented with the same group of patients managed at 2 level I trauma centers. We hypothesized there would be little agreement on treatment decisions, better agreement on final radiographic outcome, and a difference between decision-making and ratings of radiographic outcomes between expert shoulder and trauma surgeons. Our results showed that surgeons do not agree on the best treatment for PHFs but radiographically recognize when an operative treatment has been performed well or poorly. Regarding treatment decisions, our results also showed that expert trauma surgeons may agree more with each other than shoulder surgeons agree with each other. These results support our hypothesis and the limited current literature. The overall disagreement among the surgeons in our study and an aging population that grows sicker each year highlight the need for better evidence for the optimal treatment of PHFs in order to improve consensus.

Proximal humerus fractures (PHFs), AO/OTA (Ar­ beitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association) type 11,¹ are common, representing 4% to 5% of all fractures in adults.² However, there is no consensus as to optimal management of these injuries, with some reports supporting and others rejecting the various fixation methods,³ and there are no evidence-based practice guidelines informing treatment decisions.⁴ Not surprisingly, orthopedic surgeons do not agree on ideal treatment for PHFs^5,6 and differ by region in their rates of surgical management.² In addition, analyses of national databases have found variation in choice of surgical treatment for PHFs between surgeons and between hospitals of different patient volumes.⁴ Few studies have assessed surgeon agreement on treatment decisions. Findings from these limited investigations indicate there is little agreement on treatment choices, but training may have some impact.^5-7 In 3 studies,^5-7 shoulder and trauma fellowship–trained surgeons differed in their management of PHFs both in terms of rates of operative treatment^5,7 and specific operative management choices.^5,6 No study has assessed surgeon agreement on radiographic outcomes.

We conducted a study to compare expert shoulder and trauma surgeons’ treatment decision-making and agreement on final radiographic outcomes of surgically treated PHFs. We hypothesized there would be poor agreement on treatment decisions and better agreement on radiographic outcomes, with a difference between shoulder and trauma fellowship–trained surgeons.

Materials and Methods

After receiving institutional review board approval for this study, we collected data on 100 consecutive PHFs (AO/OTA type 11¹) surgically treated at 2 affiliated level I trauma centers between January 2004 and July 2008. None of the cases in the series was managed by any of the surgeons participating in this study.

We created a PowerPoint (Microsoft, Redmond, Washington) survey that included radiographs (preoperative, immediate postoperative, final postoperative) and, if available, a computed tomography image. This survey was sent to 4 orthopedic surgeons: Drs. Gardner, Gerber, Lorich, and Walch. Two of these authors are fellowship-trained in shoulder surgery, the other 2 in orthopedic traumatology with specialization in treating PHFs. All are internationally renowned in PHF management. Using the survey images and a 4-point Likert scale ranging from disagree strongly to agree strongly, the examiners rated their agreement with treatment decisions (arthroplasty vs fixation). They also rated (very poor to very good) immediate postoperative reduction or arthroplasty placement, immediate postoperative fixation methods for fractures treated with open reduction and internal fixation (ORIF), and final radiographic outcomes.

Interobserver agreement was calculated using the intraclass correlation coefficient (ICC),^8,9 with scores of <0.2 (poor), 0.21 to 0.4 (fair), 0.41 to 0.6 (moderate), 0.61 to 0.8 (good), and >0.8 (excellent) used to indicate agreement among observers. ICC scores were determined by treating the 4 examiners as independent entities. Subgroup analyses were also performed to determine ICC scores comparing the 2 shoulder surgeons, comparing the 2 trauma surgeons, and comparing the shoulder surgeons and trauma surgeons as 2 separate groups. ICC scores were used instead of κ coefficients to assess agreement because ICC scores treat ratings as continuous variables, allow for comparison of 2 or more raters, and allow for assessment of correlation among raters, whereas κ coefficients treat data as categorical variables and assume the ratings have no natural ordering. ICC scores were generated by SAS 9.1.3 software (SAS Institute, Cary, North Carolina).

Results

The 4 surgeons’ overall ICC scores for agreement with the rating of immediate reduction or arthroplasty placement and the rating of final radiographic outcome indicated moderate levels of agreement (Table 1). Regarding treatment decision-making and ratings of fixation, the surgeons demonstrated poor and fair levels of agreement, respectively.

The ICC scores comparing the shoulder and trauma surgeons revealed similar levels of agreement (Table 2): moderate levels of agreement for ratings of both immediate postoperative reduction or arthroplasty placement and final radiographic outcomes, but poor and fair levels of agreement regarding treatment decision-making and the rating of immediate postoperative fixation methods for fractures treated with ORIF, respectively.

Subgroup analysis revealed that the 2 shoulder surgeons had poor and fair levels of agreement for treatment decisions and rating of immediate postoperative fixation, respectively, though they moderately agreed on rating of immediate postoperative reduction or arthroplasty placement and rating of final radiographic outcome (Table 3). When the 2 trauma surgeons were compared with each other, ICC scores revealed higher levels of agreement overall (Table 4). In other words, the 2 trauma surgeons agreed with each other more than the 2 shoulder surgeons agreed with each other.

Discussion

This study had 3 major findings: (1) Surgeons do not agree on treatment decisions, including fixation methods, regarding PHFs; (2) regardless of their opinions on ideal treatment, they moderately agree on reductions and final radiographic outcomes; (3) expert trauma surgeons may agree more on treatment decisions than expert shoulder surgeons do. In other words, surgeons do not agree on the best treatment, but they radiographically recognize when a procedure has been performed technically well or poorly. These results support our hypothesis and the limited current literature.

An analysis of Medicare databases showed marked regional variation in rates of operative treatment of PHFs.² Similarly, a Nationwide Inpatient Sample analysis revealed nationwide variation in operative management of PHFs.⁴ Both findings are consistent with our results of poor agreement about treatment decisions and ratings of postoperative fixation of PHFs. In 2010, Petit and colleagues⁶ reported that surgeons do not agree on PHF management. In 2011, Foroohar and colleagues¹⁰ similarly reported low interobserver agreement for treatment recommendations made by 4 upper extremity orthopedic specialists, 4 general orthopedic surgeons, 4 senior residents, and 4 junior residents, for a series of 16 PHFs—also consistent with our findings.

The lack of agreement about PHF treatment may reflect a difference in training, particularly in light of the recent expansion of shoulder and elbow fellowships.² Three separate studies performed at 2 affiliated level I trauma centers demonstrated significant differences in treatment decision-making between shoulder and trauma fellowship–trained surgeons.^5-7 Our results are consistent with the hypothesis that training affects treatment decision-making, as we found poor agreement between shoulder and trauma fellowship–trained surgeons regarding treatment decision for PHFs. Subanalyses revealed that expert trauma surgeons agreed with each other on treatment decisions more than expert shoulder surgeons agreed with each other, further suggesting that training may affect how surgeons manage PHFs. Differences in fellowship training even within the same specialty may account for the observed lesser levels of agreement between the shoulder surgeons, even among experts in the field.

The evidence for optimal treatment historically has been poor,^4,6 with few high-quality prospective, randomized controlled studies on the topic up until the past few years. The most recent Cochrane Review on optimal PHF treatment concluded that there is insufficient evidence to make an evidence-based recommendation and that the long-term benefit of surgery is unclear.¹¹ However, at least 5 controlled trials on the topic have been published within the past 5 years.^12-16 The evidence is striking and generally supports nonoperative treatment for most PHFs, including some displaced fractures—contrary to general orthopedic practice in many parts of the United States,² which hitherto had been based mainly on individual surgeon experience and the limited literature. Without strong evidence to support one treatment option over another, surgeons are left with no objective, scientific way of coming to agreement.

Related to the poor status quo of evidence for PHF treatments is new technology (eg, locking plates, reverse total shoulder arthroplasty) that has expanded surgical indications.^2,17 Although such developments have the potential to improve surgical treatments, they may also exacerbate the disagreement between surgeons regarding optimal operative treatment of PHFs. This potential consequence of new technology may be reflected in our finding of disagreement among surgeons on immediate postoperative fixation methods. Precisely because they are new, such technological innovations have limited evidence supporting their use. This leaves surgeons with little to nothing to inform their decisions to use these devices, other than familiarity with and impressions of the new technology.

Our study had several limitations. First is the small sample size, of surgeons who are leaders in the field. Our sample therefore may not be generalizable to the general population of shoulder and trauma surgeons. Second, we did not calculate intraobserver variability. Third, inherent to studies of interobserver agreement is the uncertainty of their clinical relevance. In the clinical setting, a surgeon has much more information at hand (eg, patient history, physical examination findings, colleague consultations), thus raising the possibility of underestimations of interobserver agreements.¹⁸ Fourth, our comparison of surgeons’ ratings of outcomes was purely radiographic, which may or may not represent or be indicative of clinical outcomes (eg, pain relief, function, range of motion, patient satisfaction). The conclusions we may draw are accordingly limited, as we did not directly evaluate clinical outcome parameters.

Our study had several strengths as well. First, to our knowledge this is the first study to assess interobserver variability in surgeons’ ratings of radiographic outcomes. Its findings may provide further insight into the reasons for poor agreement among orthopedic surgeons on both classification and treatment of PHFs. Second, our surveying of internationally renowned expert surgeons from 4 different institutions may have helped reduce single-institution bias, and it presents the highest level of expertise in the treatment of PHFs.

Although the surgeons in our study moderately agreed on final radiographic outcomes of PHFs, such levels of agreement may still be clinically unacceptable.¹⁹ The overall disagreement on treatment decisions highlights the need for better evidence for optimal treatment of PHFs in order to improve consensus, particularly with anticipated increases in age and comorbidities in the population in coming years.⁴ Subgroup analysis suggested trauma fellowships may contribute to better treatment agreement, though this idea requires further study, perhaps by surveying shoulder and trauma fellowship directors and their curricula for variability in teaching treatment decision-making. The surgeons in our study agreed more on what they consider acceptable final radiographic outcomes, which is encouraging. However, treatment consensus is the primary goal. The recent publication of prospective, randomized studies is helping with this issue, but more studies are needed. It is encouraging that several are planned or under way.^20-22

Conclusion

The surgeons surveyed in this study did not agree on ideal treatment for PHFs but moderately agreed on quality of radiographic outcomes. These differences may reflect a difference in training. We conducted this study to compare experienced shoulder and trauma fellowship–trained surgeons’ treatment decision-making and ratings of radiographic outcomes of PHFs when presented with the same group of patients managed at 2 level I trauma centers. We hypothesized there would be little agreement on treatment decisions, better agreement on final radiographic outcome, and a difference between decision-making and ratings of radiographic outcomes between expert shoulder and trauma surgeons. Our results showed that surgeons do not agree on the best treatment for PHFs but radiographically recognize when an operative treatment has been performed well or poorly. Regarding treatment decisions, our results also showed that expert trauma surgeons may agree more with each other than shoulder surgeons agree with each other. These results support our hypothesis and the limited current literature. The overall disagreement among the surgeons in our study and an aging population that grows sicker each year highlight the need for better evidence for the optimal treatment of PHFs in order to improve consensus.

Proximal humerus fractures (PHFs), AO/OTA (Ar­ beitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association) type 11,¹ are common, representing 4% to 5% of all fractures in adults.² However, there is no consensus as to optimal management of these injuries, with some reports supporting and others rejecting the various fixation methods,³ and there are no evidence-based practice guidelines informing treatment decisions.⁴ Not surprisingly, orthopedic surgeons do not agree on ideal treatment for PHFs^5,6 and differ by region in their rates of surgical management.² In addition, analyses of national databases have found variation in choice of surgical treatment for PHFs between surgeons and between hospitals of different patient volumes.⁴ Few studies have assessed surgeon agreement on treatment decisions. Findings from these limited investigations indicate there is little agreement on treatment choices, but training may have some impact.^5-7 In 3 studies,^5-7 shoulder and trauma fellowship–trained surgeons differed in their management of PHFs both in terms of rates of operative treatment^5,7 and specific operative management choices.^5,6 No study has assessed surgeon agreement on radiographic outcomes.

We conducted a study to compare expert shoulder and trauma surgeons’ treatment decision-making and agreement on final radiographic outcomes of surgically treated PHFs. We hypothesized there would be poor agreement on treatment decisions and better agreement on radiographic outcomes, with a difference between shoulder and trauma fellowship–trained surgeons.

Materials and Methods

After receiving institutional review board approval for this study, we collected data on 100 consecutive PHFs (AO/OTA type 11¹) surgically treated at 2 affiliated level I trauma centers between January 2004 and July 2008. None of the cases in the series was managed by any of the surgeons participating in this study.

We created a PowerPoint (Microsoft, Redmond, Washington) survey that included radiographs (preoperative, immediate postoperative, final postoperative) and, if available, a computed tomography image. This survey was sent to 4 orthopedic surgeons: Drs. Gardner, Gerber, Lorich, and Walch. Two of these authors are fellowship-trained in shoulder surgery, the other 2 in orthopedic traumatology with specialization in treating PHFs. All are internationally renowned in PHF management. Using the survey images and a 4-point Likert scale ranging from disagree strongly to agree strongly, the examiners rated their agreement with treatment decisions (arthroplasty vs fixation). They also rated (very poor to very good) immediate postoperative reduction or arthroplasty placement, immediate postoperative fixation methods for fractures treated with open reduction and internal fixation (ORIF), and final radiographic outcomes.

Interobserver agreement was calculated using the intraclass correlation coefficient (ICC),^8,9 with scores of <0.2 (poor), 0.21 to 0.4 (fair), 0.41 to 0.6 (moderate), 0.61 to 0.8 (good), and >0.8 (excellent) used to indicate agreement among observers. ICC scores were determined by treating the 4 examiners as independent entities. Subgroup analyses were also performed to determine ICC scores comparing the 2 shoulder surgeons, comparing the 2 trauma surgeons, and comparing the shoulder surgeons and trauma surgeons as 2 separate groups. ICC scores were used instead of κ coefficients to assess agreement because ICC scores treat ratings as continuous variables, allow for comparison of 2 or more raters, and allow for assessment of correlation among raters, whereas κ coefficients treat data as categorical variables and assume the ratings have no natural ordering. ICC scores were generated by SAS 9.1.3 software (SAS Institute, Cary, North Carolina).

Results

The 4 surgeons’ overall ICC scores for agreement with the rating of immediate reduction or arthroplasty placement and the rating of final radiographic outcome indicated moderate levels of agreement (Table 1). Regarding treatment decision-making and ratings of fixation, the surgeons demonstrated poor and fair levels of agreement, respectively.

The ICC scores comparing the shoulder and trauma surgeons revealed similar levels of agreement (Table 2): moderate levels of agreement for ratings of both immediate postoperative reduction or arthroplasty placement and final radiographic outcomes, but poor and fair levels of agreement regarding treatment decision-making and the rating of immediate postoperative fixation methods for fractures treated with ORIF, respectively.

Subgroup analysis revealed that the 2 shoulder surgeons had poor and fair levels of agreement for treatment decisions and rating of immediate postoperative fixation, respectively, though they moderately agreed on rating of immediate postoperative reduction or arthroplasty placement and rating of final radiographic outcome (Table 3). When the 2 trauma surgeons were compared with each other, ICC scores revealed higher levels of agreement overall (Table 4). In other words, the 2 trauma surgeons agreed with each other more than the 2 shoulder surgeons agreed with each other.

Discussion

This study had 3 major findings: (1) Surgeons do not agree on treatment decisions, including fixation methods, regarding PHFs; (2) regardless of their opinions on ideal treatment, they moderately agree on reductions and final radiographic outcomes; (3) expert trauma surgeons may agree more on treatment decisions than expert shoulder surgeons do. In other words, surgeons do not agree on the best treatment, but they radiographically recognize when a procedure has been performed technically well or poorly. These results support our hypothesis and the limited current literature.

An analysis of Medicare databases showed marked regional variation in rates of operative treatment of PHFs.² Similarly, a Nationwide Inpatient Sample analysis revealed nationwide variation in operative management of PHFs.⁴ Both findings are consistent with our results of poor agreement about treatment decisions and ratings of postoperative fixation of PHFs. In 2010, Petit and colleagues⁶ reported that surgeons do not agree on PHF management. In 2011, Foroohar and colleagues¹⁰ similarly reported low interobserver agreement for treatment recommendations made by 4 upper extremity orthopedic specialists, 4 general orthopedic surgeons, 4 senior residents, and 4 junior residents, for a series of 16 PHFs—also consistent with our findings.

The lack of agreement about PHF treatment may reflect a difference in training, particularly in light of the recent expansion of shoulder and elbow fellowships.² Three separate studies performed at 2 affiliated level I trauma centers demonstrated significant differences in treatment decision-making between shoulder and trauma fellowship–trained surgeons.^5-7 Our results are consistent with the hypothesis that training affects treatment decision-making, as we found poor agreement between shoulder and trauma fellowship–trained surgeons regarding treatment decision for PHFs. Subanalyses revealed that expert trauma surgeons agreed with each other on treatment decisions more than expert shoulder surgeons agreed with each other, further suggesting that training may affect how surgeons manage PHFs. Differences in fellowship training even within the same specialty may account for the observed lesser levels of agreement between the shoulder surgeons, even among experts in the field.

The evidence for optimal treatment historically has been poor,^4,6 with few high-quality prospective, randomized controlled studies on the topic up until the past few years. The most recent Cochrane Review on optimal PHF treatment concluded that there is insufficient evidence to make an evidence-based recommendation and that the long-term benefit of surgery is unclear.¹¹ However, at least 5 controlled trials on the topic have been published within the past 5 years.^12-16 The evidence is striking and generally supports nonoperative treatment for most PHFs, including some displaced fractures—contrary to general orthopedic practice in many parts of the United States,² which hitherto had been based mainly on individual surgeon experience and the limited literature. Without strong evidence to support one treatment option over another, surgeons are left with no objective, scientific way of coming to agreement.

Related to the poor status quo of evidence for PHF treatments is new technology (eg, locking plates, reverse total shoulder arthroplasty) that has expanded surgical indications.^2,17 Although such developments have the potential to improve surgical treatments, they may also exacerbate the disagreement between surgeons regarding optimal operative treatment of PHFs. This potential consequence of new technology may be reflected in our finding of disagreement among surgeons on immediate postoperative fixation methods. Precisely because they are new, such technological innovations have limited evidence supporting their use. This leaves surgeons with little to nothing to inform their decisions to use these devices, other than familiarity with and impressions of the new technology.

Our study had several limitations. First is the small sample size, of surgeons who are leaders in the field. Our sample therefore may not be generalizable to the general population of shoulder and trauma surgeons. Second, we did not calculate intraobserver variability. Third, inherent to studies of interobserver agreement is the uncertainty of their clinical relevance. In the clinical setting, a surgeon has much more information at hand (eg, patient history, physical examination findings, colleague consultations), thus raising the possibility of underestimations of interobserver agreements.¹⁸ Fourth, our comparison of surgeons’ ratings of outcomes was purely radiographic, which may or may not represent or be indicative of clinical outcomes (eg, pain relief, function, range of motion, patient satisfaction). The conclusions we may draw are accordingly limited, as we did not directly evaluate clinical outcome parameters.

Our study had several strengths as well. First, to our knowledge this is the first study to assess interobserver variability in surgeons’ ratings of radiographic outcomes. Its findings may provide further insight into the reasons for poor agreement among orthopedic surgeons on both classification and treatment of PHFs. Second, our surveying of internationally renowned expert surgeons from 4 different institutions may have helped reduce single-institution bias, and it presents the highest level of expertise in the treatment of PHFs.

Although the surgeons in our study moderately agreed on final radiographic outcomes of PHFs, such levels of agreement may still be clinically unacceptable.¹⁹ The overall disagreement on treatment decisions highlights the need for better evidence for optimal treatment of PHFs in order to improve consensus, particularly with anticipated increases in age and comorbidities in the population in coming years.⁴ Subgroup analysis suggested trauma fellowships may contribute to better treatment agreement, though this idea requires further study, perhaps by surveying shoulder and trauma fellowship directors and their curricula for variability in teaching treatment decision-making. The surgeons in our study agreed more on what they consider acceptable final radiographic outcomes, which is encouraging. However, treatment consensus is the primary goal. The recent publication of prospective, randomized studies is helping with this issue, but more studies are needed. It is encouraging that several are planned or under way.^20-22

Conclusion

The surgeons surveyed in this study did not agree on ideal treatment for PHFs but moderately agreed on quality of radiographic outcomes. These differences may reflect a difference in training. We conducted this study to compare experienced shoulder and trauma fellowship–trained surgeons’ treatment decision-making and ratings of radiographic outcomes of PHFs when presented with the same group of patients managed at 2 level I trauma centers. We hypothesized there would be little agreement on treatment decisions, better agreement on final radiographic outcome, and a difference between decision-making and ratings of radiographic outcomes between expert shoulder and trauma surgeons. Our results showed that surgeons do not agree on the best treatment for PHFs but radiographically recognize when an operative treatment has been performed well or poorly. Regarding treatment decisions, our results also showed that expert trauma surgeons may agree more with each other than shoulder surgeons agree with each other. These results support our hypothesis and the limited current literature. The overall disagreement among the surgeons in our study and an aging population that grows sicker each year highlight the need for better evidence for the optimal treatment of PHFs in order to improve consensus.

Elbow motion is crucial for activities of daily living and full function of the upper extremity.¹ Measuring the elbow flexion arc accurately and consistently is an important part of the physical examination of patients with elbow pathology. Orthopedic surgeons rely on these measurements to follow patients over time, and they often base their treatment decisions on the range and progression/regression of motion arc.

In the clinical setting, elbow range of motion (ROM) is commonly measured with a handheld goniometer.^2,3 The literature also suggests that goniometric measurements are highly reliable in the clinical setting and that intrarater reliability of elbow ROM measurements is high.^2-4 Despite the routine use and clinical importance of flexion arc assessment, there is no universal recommendation regarding optimal measurement position. Textbooks and journal articles commonly do not specify arm position at time of elbow ROM measurements,^5-8 and a literature review found no studies directly addressing this issue.

From a biomechanical standpoint, humeral rotation is often affected by forearm pronosupination position. Although forearm pronosupination is a product of the motion at the radioulnar joints, forearm position during elbow flexion arc measurement can influence the relationship of the distal humeral intercondylar axis to the plane of measurement. Full forearm supination rotates the distal humeral intercondylar axis externally to a position parallel to the floor and in line with the plane of measurement. Humeral rotation with the forearm in neutral pronosupination places the humeral condyles internally rotated relative to the floor. Therefore, for the purposes of this study, we defined full humeral external rotation and true plane of ulnohumeral motion as full forearm supination, and relative humeral and ulnohumeral joint internal rotation as neutral pronosupination.

Because of the potential for elbow ROM measurement changes caused by differences in the motion plane in which measurements are taken, some have advocated taking flexion arc measurements with the arm in full supination to allow measurements to be taken in the true plane of motion. We hypothesized that elbow flexion arc measurements taken with the forearm in neutral rotation would underestimate the extent of elbow flexion contractures compared with measurements taken in full supination.

Materials and Methods

This study received institutional review board approval. Eighty-four patients who presented with elbow dysfunction to a single shoulder and elbow orthopedic surgeon enrolled in the study. Skeletally immature patients and patients with a fracture or other disorder that prohibited elbow ROM were excluded. A standard goniometer was used to measure elbow flexion and extension with the humerus in 2 positions: full external rotation and neutral rotation.

All goniometer measurements were made by the same surgeon (to eliminate interobserver reliability error) using a standardized technique with the patient sitting upright. The goniometer was positioned laterally with its center of rotation over the lateral epicondyle, aligned proximally with the humeral head and distally with the center of the wrist. Measurements were obtained sequentially with the hand in both positions. For external rotation measurements, the patient’s arm was fully supinated to bring the humeral condyles parallel to the floor. For neutral positioning, the patient’s arm was placed in the “thumb-up” position with the hand perpendicular to the horizontal axis of the floor (Figures 1A–1C).

Data collected included demographics, diagnosis, hand dominance, affected side, and elbow ROM measurements with the hand in the 2 positions. These data were compiled and analyzed for all patients and then stratified into 3 groups by extent of elbow flexion contracture in the supinated position (group 1, hyperextension; group 2, 0°-29° elbow extension; group 3, ≥30° flexion contracture).

Statistically, paired t tests were used to identify differences between the 2 elbow ROM measurement methods. P < .05 was considered significant.

Results

Eighty-four (44 male, 40 female) consecutive patients (85 elbows) met the inclusion and exclusion criteria. Mean age was 51 years (range, 19-84 years). Seventy-six patients were right-handed, 7 were left-handed, and dominance was unknown in 1 patient. The right elbow was affected in 45 patients, the left in 38, and both in 1 patient. There were 25 different diagnoses, the most common of which was lateral epicondylitis; 7 patients had multiple disorders (Table).

The first set of data, elbow ROM measurements, was taken with all 84 patients analyzed as a single group. In neutral humeral rotation, mean elbow extension was 14° (range, 10°-72°), and mean elbow flexion was 134° (range, 72°-145°). In external rotation, mean elbow extension was 20° (range, 12°-87°), and mean elbow flexion was 134° (range, 72°-145°). For the group, mean absolute difference in elbow extension was 8° (range, 0°-30°; P < .0001); there was no difference between external rotation and neutral rotation in flexion (Figure 2).

The data were reanalyzed after being stratified into 3 groups based on extent of elbow flexion contracture measured in supination.

The 9 elbows in group 1 (hyperextension) had mean extension of –2° (range, 10°-2°) and mean flexion of 141° (range, 130°-145°) in the neutral position. In external rotation, mean extension was –9° (range, –12° to –1°), and mean flexion was 141° (range, 130°-145°). When the 2 measurement positions were compared, group 1 had mean elbow ROM differences of –6° (range, –14° to 0°; P = .0033) for elbow extension and 0° for elbow flexion (Figure 3A).

The 50 elbows in group 2 (0°-29° flexion contracture) had mean extension of 7° (range, 0°-20°) and mean flexion of 138° (range, 100°-145°) in the neutral position. In external rotation, mean extension was 13° (range, 0°-26°), and mean flexion was 138° (range, 100°-145°). Mean difference between neutral and external rotation measurements was 6° (range, 0°-20°; P < .0001) in extension and 0° in flexion (Figure 3B).

 The 26 elbows in group 3 (≥30° flexion contracture) had mean extension of 33° (range, 0°-72°) and mean flexion of 124° (range, 72°-145°) in the neutral position. In external rotation, mean extension was 45° (range, 30°-87°), and mean flexion was 124° (range, 72°-145°). Mean difference between neutral and external rotation measurements was 12° (range, 0°-30°; P < .0001) in extension and 0° in flexion (Figure 3C).

Discussion

Elbow flexion arc measurements are crucial for patient outcomes and activities of daily living. Commonly cited as functional ROM, the 30°-to-130° flexion arc often is used to guide clinical decisions in patients with elbow disorders.¹ However, our data indicate that humeral position can alter elbow ROM measurements. Specifically, because of neutral forearm pronosupination, measurements made with the humerus in neutral rotation underestimate both the extent of elbow hyperextension and the degree of flexion contracture (Figures 4A, 4B). The more severe the flexion contracture, the more values are altered by measurements taken in this position. The same does not apply for elbow flexion measurements, as varying humeral rotation did not significantly affect those values.

Our results indicate that patients evaluated with the arm in neutral humeral rotation had flexion contractures underestimated by a mean of 8°, while there was a negligible difference in flexion measurements. Stratifying our data into 3 groups, we found that neutral humeral rotation kept elbow extension measurements closer to 0° for patients with both hyperextension and contractures. With increasing severity of flexion contractures in groups 2 and 3, the measurement errors were magnified. The differences in extension measurement values between these 2 groups based on humeral rotation increased more than 4°—an indication that, as flexion contracture severity increases, so does the degree of measurement error when elbow extension is measured with the humerus in neutral rotation rather than external rotation.

Our literature review found no studies on ROM value differences based on position of humeral rotation. Most texts, in their descriptions of elbow ROM and biomechanics, make no reference to position of pronosupination at time of flexion arc measurement.^5-8 Although many elbow authorities recommend taking elbow ROM measurements in full external rotation, we found no corroborating evidence.

Other investigators have evaluated the reliability of goniometer measurements.^2,3 Rothstein and colleagues³ concluded that elbow and knee goniometric measurements are highly reliable in the clinical setting when taken by the same person. In particular, intratester reliability for elbow extension measurements was high. Armstrong and colleagues² specifically examined intratester, intertester, and interdevice reliability and found that intratester reliability was much higher than intertester reliability for universal goniometry. In our study, all patients were measured with the same technique by the same orthopedic surgeon to eliminate any intertester reliability error. Armstrong and colleagues² also found that intratester changes vis-a-vis extension measurements are meaningful when goniometric differences are more than 7°. In our study, the difference in extension measurements between the 2 humeral positions averaged 8° overall and 12° in group 3. This suggests that the data reported here reflect a true difference dependent on humeral rotation and are not a result of goniometer intratester variability.

Other studies have examined measurement devices other than the standard universal goniometer. Cleffken and colleagues⁴ found that the electronic digital inclinometer was reliable for elbow ROM measurements. Blonna and colleagues⁹ used digital photography–based goniometry to measure patient outcomes without doctor–patient contact at tertiary-care centers and found it to be more accurate and reliable than clinical goniometry in measuring elbow flexion and extension. Chapleau and colleagues¹⁰ compared the validity of goniometric elbow measurements in radiographic methods and concluded that the maximal error of goniometric measurements in extension was 10.3°. However, they also found high intraclass correlation coefficients for goniometric measurements. With the accepted clinical reliability of universal goniometry,^2-4,10 we believe it to be the best clinical tool for this study because of its availability, minimal cost, and ease of use.

In the clinical setting, elbow flexion arc measurements are a major factor in treatment decisions and often dictate whether to proceed with operative interventions such as capsular release. In addition, ROM measurements are crucial in determining the success of treatments and the progression of disease. Erroneous elbow extension measurements can have significant consequences if they falsely indicate functional ROM when taken in neutral position. This is particularly true for patients with elbow flexion contractures of more than 30°, in whom differences in humeral rotation resulted in about 12° of variance between measured values. For instance, a patient with a true 40° flexion contracture in the externally rotated position could be determined to have functional ROM based on measurements made in the neutral position.

Limitations of this study include those involving goniometer reliability and intraobserver variability (already described) and the validity of goniometer measurements compared with radiographic measurements.

Conclusion

Because elbow goniometer extension measurements taken in neutral humeral rotation underestimate both the degree of elbow hyperextension and the degree of elbow flexion contracture, we recommend taking elbow flexion arc measurements in the true plane of motion, with the humerus externally rotated by fully supinating the forearm, such that the distal humeral condyles are parallel to the floor.

Elbow motion is crucial for activities of daily living and full function of the upper extremity.¹ Measuring the elbow flexion arc accurately and consistently is an important part of the physical examination of patients with elbow pathology. Orthopedic surgeons rely on these measurements to follow patients over time, and they often base their treatment decisions on the range and progression/regression of motion arc.

In the clinical setting, elbow range of motion (ROM) is commonly measured with a handheld goniometer.^2,3 The literature also suggests that goniometric measurements are highly reliable in the clinical setting and that intrarater reliability of elbow ROM measurements is high.^2-4 Despite the routine use and clinical importance of flexion arc assessment, there is no universal recommendation regarding optimal measurement position. Textbooks and journal articles commonly do not specify arm position at time of elbow ROM measurements,^5-8 and a literature review found no studies directly addressing this issue.

From a biomechanical standpoint, humeral rotation is often affected by forearm pronosupination position. Although forearm pronosupination is a product of the motion at the radioulnar joints, forearm position during elbow flexion arc measurement can influence the relationship of the distal humeral intercondylar axis to the plane of measurement. Full forearm supination rotates the distal humeral intercondylar axis externally to a position parallel to the floor and in line with the plane of measurement. Humeral rotation with the forearm in neutral pronosupination places the humeral condyles internally rotated relative to the floor. Therefore, for the purposes of this study, we defined full humeral external rotation and true plane of ulnohumeral motion as full forearm supination, and relative humeral and ulnohumeral joint internal rotation as neutral pronosupination.

Because of the potential for elbow ROM measurement changes caused by differences in the motion plane in which measurements are taken, some have advocated taking flexion arc measurements with the arm in full supination to allow measurements to be taken in the true plane of motion. We hypothesized that elbow flexion arc measurements taken with the forearm in neutral rotation would underestimate the extent of elbow flexion contractures compared with measurements taken in full supination.

Materials and Methods

This study received institutional review board approval. Eighty-four patients who presented with elbow dysfunction to a single shoulder and elbow orthopedic surgeon enrolled in the study. Skeletally immature patients and patients with a fracture or other disorder that prohibited elbow ROM were excluded. A standard goniometer was used to measure elbow flexion and extension with the humerus in 2 positions: full external rotation and neutral rotation.

All goniometer measurements were made by the same surgeon (to eliminate interobserver reliability error) using a standardized technique with the patient sitting upright. The goniometer was positioned laterally with its center of rotation over the lateral epicondyle, aligned proximally with the humeral head and distally with the center of the wrist. Measurements were obtained sequentially with the hand in both positions. For external rotation measurements, the patient’s arm was fully supinated to bring the humeral condyles parallel to the floor. For neutral positioning, the patient’s arm was placed in the “thumb-up” position with the hand perpendicular to the horizontal axis of the floor (Figures 1A–1C).

Data collected included demographics, diagnosis, hand dominance, affected side, and elbow ROM measurements with the hand in the 2 positions. These data were compiled and analyzed for all patients and then stratified into 3 groups by extent of elbow flexion contracture in the supinated position (group 1, hyperextension; group 2, 0°-29° elbow extension; group 3, ≥30° flexion contracture).

Statistically, paired t tests were used to identify differences between the 2 elbow ROM measurement methods. P < .05 was considered significant.

Results

Eighty-four (44 male, 40 female) consecutive patients (85 elbows) met the inclusion and exclusion criteria. Mean age was 51 years (range, 19-84 years). Seventy-six patients were right-handed, 7 were left-handed, and dominance was unknown in 1 patient. The right elbow was affected in 45 patients, the left in 38, and both in 1 patient. There were 25 different diagnoses, the most common of which was lateral epicondylitis; 7 patients had multiple disorders (Table).

The first set of data, elbow ROM measurements, was taken with all 84 patients analyzed as a single group. In neutral humeral rotation, mean elbow extension was 14° (range, 10°-72°), and mean elbow flexion was 134° (range, 72°-145°). In external rotation, mean elbow extension was 20° (range, 12°-87°), and mean elbow flexion was 134° (range, 72°-145°). For the group, mean absolute difference in elbow extension was 8° (range, 0°-30°; P < .0001); there was no difference between external rotation and neutral rotation in flexion (Figure 2).

The data were reanalyzed after being stratified into 3 groups based on extent of elbow flexion contracture measured in supination.

The 9 elbows in group 1 (hyperextension) had mean extension of –2° (range, 10°-2°) and mean flexion of 141° (range, 130°-145°) in the neutral position. In external rotation, mean extension was –9° (range, –12° to –1°), and mean flexion was 141° (range, 130°-145°). When the 2 measurement positions were compared, group 1 had mean elbow ROM differences of –6° (range, –14° to 0°; P = .0033) for elbow extension and 0° for elbow flexion (Figure 3A).

The 50 elbows in group 2 (0°-29° flexion contracture) had mean extension of 7° (range, 0°-20°) and mean flexion of 138° (range, 100°-145°) in the neutral position. In external rotation, mean extension was 13° (range, 0°-26°), and mean flexion was 138° (range, 100°-145°). Mean difference between neutral and external rotation measurements was 6° (range, 0°-20°; P < .0001) in extension and 0° in flexion (Figure 3B).

 The 26 elbows in group 3 (≥30° flexion contracture) had mean extension of 33° (range, 0°-72°) and mean flexion of 124° (range, 72°-145°) in the neutral position. In external rotation, mean extension was 45° (range, 30°-87°), and mean flexion was 124° (range, 72°-145°). Mean difference between neutral and external rotation measurements was 12° (range, 0°-30°; P < .0001) in extension and 0° in flexion (Figure 3C).

Discussion

Elbow flexion arc measurements are crucial for patient outcomes and activities of daily living. Commonly cited as functional ROM, the 30°-to-130° flexion arc often is used to guide clinical decisions in patients with elbow disorders.¹ However, our data indicate that humeral position can alter elbow ROM measurements. Specifically, because of neutral forearm pronosupination, measurements made with the humerus in neutral rotation underestimate both the extent of elbow hyperextension and the degree of flexion contracture (Figures 4A, 4B). The more severe the flexion contracture, the more values are altered by measurements taken in this position. The same does not apply for elbow flexion measurements, as varying humeral rotation did not significantly affect those values.

Our results indicate that patients evaluated with the arm in neutral humeral rotation had flexion contractures underestimated by a mean of 8°, while there was a negligible difference in flexion measurements. Stratifying our data into 3 groups, we found that neutral humeral rotation kept elbow extension measurements closer to 0° for patients with both hyperextension and contractures. With increasing severity of flexion contractures in groups 2 and 3, the measurement errors were magnified. The differences in extension measurement values between these 2 groups based on humeral rotation increased more than 4°—an indication that, as flexion contracture severity increases, so does the degree of measurement error when elbow extension is measured with the humerus in neutral rotation rather than external rotation.

Our literature review found no studies on ROM value differences based on position of humeral rotation. Most texts, in their descriptions of elbow ROM and biomechanics, make no reference to position of pronosupination at time of flexion arc measurement.^5-8 Although many elbow authorities recommend taking elbow ROM measurements in full external rotation, we found no corroborating evidence.

Other investigators have evaluated the reliability of goniometer measurements.^2,3 Rothstein and colleagues³ concluded that elbow and knee goniometric measurements are highly reliable in the clinical setting when taken by the same person. In particular, intratester reliability for elbow extension measurements was high. Armstrong and colleagues² specifically examined intratester, intertester, and interdevice reliability and found that intratester reliability was much higher than intertester reliability for universal goniometry. In our study, all patients were measured with the same technique by the same orthopedic surgeon to eliminate any intertester reliability error. Armstrong and colleagues² also found that intratester changes vis-a-vis extension measurements are meaningful when goniometric differences are more than 7°. In our study, the difference in extension measurements between the 2 humeral positions averaged 8° overall and 12° in group 3. This suggests that the data reported here reflect a true difference dependent on humeral rotation and are not a result of goniometer intratester variability.

Other studies have examined measurement devices other than the standard universal goniometer. Cleffken and colleagues⁴ found that the electronic digital inclinometer was reliable for elbow ROM measurements. Blonna and colleagues⁹ used digital photography–based goniometry to measure patient outcomes without doctor–patient contact at tertiary-care centers and found it to be more accurate and reliable than clinical goniometry in measuring elbow flexion and extension. Chapleau and colleagues¹⁰ compared the validity of goniometric elbow measurements in radiographic methods and concluded that the maximal error of goniometric measurements in extension was 10.3°. However, they also found high intraclass correlation coefficients for goniometric measurements. With the accepted clinical reliability of universal goniometry,^2-4,10 we believe it to be the best clinical tool for this study because of its availability, minimal cost, and ease of use.

In the clinical setting, elbow flexion arc measurements are a major factor in treatment decisions and often dictate whether to proceed with operative interventions such as capsular release. In addition, ROM measurements are crucial in determining the success of treatments and the progression of disease. Erroneous elbow extension measurements can have significant consequences if they falsely indicate functional ROM when taken in neutral position. This is particularly true for patients with elbow flexion contractures of more than 30°, in whom differences in humeral rotation resulted in about 12° of variance between measured values. For instance, a patient with a true 40° flexion contracture in the externally rotated position could be determined to have functional ROM based on measurements made in the neutral position.

Limitations of this study include those involving goniometer reliability and intraobserver variability (already described) and the validity of goniometer measurements compared with radiographic measurements.

Conclusion

Because elbow goniometer extension measurements taken in neutral humeral rotation underestimate both the degree of elbow hyperextension and the degree of elbow flexion contracture, we recommend taking elbow flexion arc measurements in the true plane of motion, with the humerus externally rotated by fully supinating the forearm, such that the distal humeral condyles are parallel to the floor.

Elbow motion is crucial for activities of daily living and full function of the upper extremity.¹ Measuring the elbow flexion arc accurately and consistently is an important part of the physical examination of patients with elbow pathology. Orthopedic surgeons rely on these measurements to follow patients over time, and they often base their treatment decisions on the range and progression/regression of motion arc.

In the clinical setting, elbow range of motion (ROM) is commonly measured with a handheld goniometer.^2,3 The literature also suggests that goniometric measurements are highly reliable in the clinical setting and that intrarater reliability of elbow ROM measurements is high.^2-4 Despite the routine use and clinical importance of flexion arc assessment, there is no universal recommendation regarding optimal measurement position. Textbooks and journal articles commonly do not specify arm position at time of elbow ROM measurements,^5-8 and a literature review found no studies directly addressing this issue.

From a biomechanical standpoint, humeral rotation is often affected by forearm pronosupination position. Although forearm pronosupination is a product of the motion at the radioulnar joints, forearm position during elbow flexion arc measurement can influence the relationship of the distal humeral intercondylar axis to the plane of measurement. Full forearm supination rotates the distal humeral intercondylar axis externally to a position parallel to the floor and in line with the plane of measurement. Humeral rotation with the forearm in neutral pronosupination places the humeral condyles internally rotated relative to the floor. Therefore, for the purposes of this study, we defined full humeral external rotation and true plane of ulnohumeral motion as full forearm supination, and relative humeral and ulnohumeral joint internal rotation as neutral pronosupination.

Because of the potential for elbow ROM measurement changes caused by differences in the motion plane in which measurements are taken, some have advocated taking flexion arc measurements with the arm in full supination to allow measurements to be taken in the true plane of motion. We hypothesized that elbow flexion arc measurements taken with the forearm in neutral rotation would underestimate the extent of elbow flexion contractures compared with measurements taken in full supination.

Materials and Methods

This study received institutional review board approval. Eighty-four patients who presented with elbow dysfunction to a single shoulder and elbow orthopedic surgeon enrolled in the study. Skeletally immature patients and patients with a fracture or other disorder that prohibited elbow ROM were excluded. A standard goniometer was used to measure elbow flexion and extension with the humerus in 2 positions: full external rotation and neutral rotation.

All goniometer measurements were made by the same surgeon (to eliminate interobserver reliability error) using a standardized technique with the patient sitting upright. The goniometer was positioned laterally with its center of rotation over the lateral epicondyle, aligned proximally with the humeral head and distally with the center of the wrist. Measurements were obtained sequentially with the hand in both positions. For external rotation measurements, the patient’s arm was fully supinated to bring the humeral condyles parallel to the floor. For neutral positioning, the patient’s arm was placed in the “thumb-up” position with the hand perpendicular to the horizontal axis of the floor (Figures 1A–1C).

Data collected included demographics, diagnosis, hand dominance, affected side, and elbow ROM measurements with the hand in the 2 positions. These data were compiled and analyzed for all patients and then stratified into 3 groups by extent of elbow flexion contracture in the supinated position (group 1, hyperextension; group 2, 0°-29° elbow extension; group 3, ≥30° flexion contracture).

Statistically, paired t tests were used to identify differences between the 2 elbow ROM measurement methods. P < .05 was considered significant.

Results

Eighty-four (44 male, 40 female) consecutive patients (85 elbows) met the inclusion and exclusion criteria. Mean age was 51 years (range, 19-84 years). Seventy-six patients were right-handed, 7 were left-handed, and dominance was unknown in 1 patient. The right elbow was affected in 45 patients, the left in 38, and both in 1 patient. There were 25 different diagnoses, the most common of which was lateral epicondylitis; 7 patients had multiple disorders (Table).

The first set of data, elbow ROM measurements, was taken with all 84 patients analyzed as a single group. In neutral humeral rotation, mean elbow extension was 14° (range, 10°-72°), and mean elbow flexion was 134° (range, 72°-145°). In external rotation, mean elbow extension was 20° (range, 12°-87°), and mean elbow flexion was 134° (range, 72°-145°). For the group, mean absolute difference in elbow extension was 8° (range, 0°-30°; P < .0001); there was no difference between external rotation and neutral rotation in flexion (Figure 2).

The data were reanalyzed after being stratified into 3 groups based on extent of elbow flexion contracture measured in supination.

The 9 elbows in group 1 (hyperextension) had mean extension of –2° (range, 10°-2°) and mean flexion of 141° (range, 130°-145°) in the neutral position. In external rotation, mean extension was –9° (range, –12° to –1°), and mean flexion was 141° (range, 130°-145°). When the 2 measurement positions were compared, group 1 had mean elbow ROM differences of –6° (range, –14° to 0°; P = .0033) for elbow extension and 0° for elbow flexion (Figure 3A).

The 50 elbows in group 2 (0°-29° flexion contracture) had mean extension of 7° (range, 0°-20°) and mean flexion of 138° (range, 100°-145°) in the neutral position. In external rotation, mean extension was 13° (range, 0°-26°), and mean flexion was 138° (range, 100°-145°). Mean difference between neutral and external rotation measurements was 6° (range, 0°-20°; P < .0001) in extension and 0° in flexion (Figure 3B).

 The 26 elbows in group 3 (≥30° flexion contracture) had mean extension of 33° (range, 0°-72°) and mean flexion of 124° (range, 72°-145°) in the neutral position. In external rotation, mean extension was 45° (range, 30°-87°), and mean flexion was 124° (range, 72°-145°). Mean difference between neutral and external rotation measurements was 12° (range, 0°-30°; P < .0001) in extension and 0° in flexion (Figure 3C).

Discussion

Elbow flexion arc measurements are crucial for patient outcomes and activities of daily living. Commonly cited as functional ROM, the 30°-to-130° flexion arc often is used to guide clinical decisions in patients with elbow disorders.¹ However, our data indicate that humeral position can alter elbow ROM measurements. Specifically, because of neutral forearm pronosupination, measurements made with the humerus in neutral rotation underestimate both the extent of elbow hyperextension and the degree of flexion contracture (Figures 4A, 4B). The more severe the flexion contracture, the more values are altered by measurements taken in this position. The same does not apply for elbow flexion measurements, as varying humeral rotation did not significantly affect those values.

Our results indicate that patients evaluated with the arm in neutral humeral rotation had flexion contractures underestimated by a mean of 8°, while there was a negligible difference in flexion measurements. Stratifying our data into 3 groups, we found that neutral humeral rotation kept elbow extension measurements closer to 0° for patients with both hyperextension and contractures. With increasing severity of flexion contractures in groups 2 and 3, the measurement errors were magnified. The differences in extension measurement values between these 2 groups based on humeral rotation increased more than 4°—an indication that, as flexion contracture severity increases, so does the degree of measurement error when elbow extension is measured with the humerus in neutral rotation rather than external rotation.

Our literature review found no studies on ROM value differences based on position of humeral rotation. Most texts, in their descriptions of elbow ROM and biomechanics, make no reference to position of pronosupination at time of flexion arc measurement.^5-8 Although many elbow authorities recommend taking elbow ROM measurements in full external rotation, we found no corroborating evidence.

Other investigators have evaluated the reliability of goniometer measurements.^2,3 Rothstein and colleagues³ concluded that elbow and knee goniometric measurements are highly reliable in the clinical setting when taken by the same person. In particular, intratester reliability for elbow extension measurements was high. Armstrong and colleagues² specifically examined intratester, intertester, and interdevice reliability and found that intratester reliability was much higher than intertester reliability for universal goniometry. In our study, all patients were measured with the same technique by the same orthopedic surgeon to eliminate any intertester reliability error. Armstrong and colleagues² also found that intratester changes vis-a-vis extension measurements are meaningful when goniometric differences are more than 7°. In our study, the difference in extension measurements between the 2 humeral positions averaged 8° overall and 12° in group 3. This suggests that the data reported here reflect a true difference dependent on humeral rotation and are not a result of goniometer intratester variability.

Other studies have examined measurement devices other than the standard universal goniometer. Cleffken and colleagues⁴ found that the electronic digital inclinometer was reliable for elbow ROM measurements. Blonna and colleagues⁹ used digital photography–based goniometry to measure patient outcomes without doctor–patient contact at tertiary-care centers and found it to be more accurate and reliable than clinical goniometry in measuring elbow flexion and extension. Chapleau and colleagues¹⁰ compared the validity of goniometric elbow measurements in radiographic methods and concluded that the maximal error of goniometric measurements in extension was 10.3°. However, they also found high intraclass correlation coefficients for goniometric measurements. With the accepted clinical reliability of universal goniometry,^2-4,10 we believe it to be the best clinical tool for this study because of its availability, minimal cost, and ease of use.

In the clinical setting, elbow flexion arc measurements are a major factor in treatment decisions and often dictate whether to proceed with operative interventions such as capsular release. In addition, ROM measurements are crucial in determining the success of treatments and the progression of disease. Erroneous elbow extension measurements can have significant consequences if they falsely indicate functional ROM when taken in neutral position. This is particularly true for patients with elbow flexion contractures of more than 30°, in whom differences in humeral rotation resulted in about 12° of variance between measured values. For instance, a patient with a true 40° flexion contracture in the externally rotated position could be determined to have functional ROM based on measurements made in the neutral position.

Limitations of this study include those involving goniometer reliability and intraobserver variability (already described) and the validity of goniometer measurements compared with radiographic measurements.

Conclusion

Because elbow goniometer extension measurements taken in neutral humeral rotation underestimate both the degree of elbow hyperextension and the degree of elbow flexion contracture, we recommend taking elbow flexion arc measurements in the true plane of motion, with the humerus externally rotated by fully supinating the forearm, such that the distal humeral condyles are parallel to the floor.

The treatment of patients with severe shoulder pain and disability combined with a nonfunctional rotator cuff was a clinical challenge until the development of the reverse total shoulder arthroplasty (RTSA).^1-3 Massive rotator cuff tears can leave patients with a pseudoparalytic upper extremity and may result in advanced arthritis of the joint because of altered mechanical and nutritional factors.⁴ In this setting, simply replacing the arthritic joint with standard total shoulder arthroplasty (TSA) is not recommended because it does not address the functional deficits, and it has poor long-term outcomes.^3,5 RTSA works by changing the center of rotation of the shoulder joint so that the deltoid muscle can be used to elevate the arm.^6,7 The 4 rotator cuff muscles are not required for forward elevation or stability of this constrained implant.^6,8

Current indications for RTSA are cuff tear arthropathy, complex proximal humerus fractures, and revision from hemiarthroplasty or TSA with rotator cuff dysfunction. Patients with advanced cuff tear arthropathy have minimal forward elevation and pseudoparalysis. Previous studies have shown mean preoperative forward flexion of 55º and mean ASES (American Shoulder and Elbow Surgeons) Standardized Shoulder Assessment Form score of 34.3.⁹ Thus, minimal overhead activity is possible without RTSA. Advances in the RTSA technique have led to promising results (excellent functional improvement), but there is limited information regarding the activity levels patients can achieve after surgery.^7,9-11

We conducted a study of the types of sporting activities in which patients with RTSA could participate. We hypothesized that, relative to historic controls, patients with RTSA could return to low-intensity sporting activities with improvement in motion and ASES scores.

Materials and Methods

After this study received institutional review board approval, patients who had undergone RTSA at our institution between January 1, 2004 and December 31, 2010 were identified by the billing codes used for the procedure. Each patient who had RTSA performed during the study period was included in the study. Charts were then reviewed to extract demographic data, preoperative diagnosis, surgery date, operative side, dominant side, type of implant used, operative complications, and subsequent revisions. A questionnaire (Appendix) was designed and used to assess activity, functional status, pain, and satisfaction levels after RTSA. Patients had to be willing and able to complete this questionnaire in order to be included in the study.

The questionnaire included demographic questions; a list of 42 activities patients could choose from to describe their current activity level, activities they were able to perform before the surgery, and activities they wish they could perform; a list of reasons for any limitations; and questions about overall pain, strength, and satisfaction with the procedure. In addition, there was an open-ended question for activities that may not have been listed. The questionnaire also included a validated method for assessing shoulder range of motion (ROM) at home, where patients rated their overhead motion according to standardized physical landmarks, including the level of the shoulder, chin, eyebrows, top of head, and above head.^12-14 Also provided was the ASES Standardized Shoulder Assessment Form, which features a 100-point visual analog scale for pain plus functional ability questions, with higher scores indicating less pain and better function.^15,16 The minimal clinical significance in the ASES score is 6.4 points.^17,18 Scores were recorded and analyzed. Student t test was used to calculate statistical differences between patients who had primary RTSA performed and patients who underwent revision RTSA.

Study personnel contacted patients by telephone and direct mailing. Patients who could not be reached initially were called at least 4 more times: twice during the weekday, once during the evening, and once on the weekend. Patients who could not be contacted by telephone were then cross-referenced with the Social Security database to see if any were deceased. Response data were tabulated, and patients were stratified into high-, moderate-, and low-intensity activity.

One of the 3 senior authors (Dr. Ahmad, Dr. Bigliani, Dr. Levine) performed the 95 RTSAs: 84 Zimmer (Warsaw, Indiana), 7 DePuy (Warsaw, Indiana), 4 Tornier (Minneapolis, Minnesota). The DePuy and Tornier implants were used when a 30-mm glenoid peg was required (before Zimmer offered this length in its system). The procedure was done with a deltopectoral approach with 20° of retroversion. In revision cases, the same approach was used, the hardware or implants were removed, and the position of the humeral component was determined based on the pectoralis major insertion and the deltoid tension. In 80% of cases, the subscapularis was not repaired; in the other 20%, it was. Whether it was repaired depended on tendon viability and surgeon preference, as subscapularis repair status has been shown not to affect functional outcome.^19-21 No combined latissimus transfers were performed. Patients wore a sling the first 4 weeks after surgery (only wrist and elbow motion allowed) and then advanced to active shoulder ROM. Eight weeks after surgery, they began gentle shoulder strengthening.

Results

One hundred nine consecutive patients underwent RTSA at a single institution. Fifteen patients subsequently died, 14 could not be contacted, and 2 declined, leaving 78 patients available for clinical follow-up. Mean follow-up was 4.8 years (range 2-9 years). Mean (SD) age at surgery was 75.3 (7.5) years. Seventy-five percent of the patients were women. Sixty-one percent underwent surgery for cuff tear arthropathy, 31% for revision of previous arthroplasty or internal fixation, 7% for complex fractures, and 1% for tumor. Of the 24 revisions, 15 were for failed hemiarthroplasty, 3 were for failed TSA with rotator cuff dysfunction, 4 were for fracture with failed internal fixation, and 2 were for failed RTSA referred from other institutions. The dominant shoulder was involved 62% of the time. Preoperative active forward shoulder elevation was less than 90° in all patients. There were 10 complications: 2 dislocations that were closed-reduced and remained stable, 1 dislocation that required revision of the liner, 1 aseptic loosening in a patient who has declined revision, 2 dissociated glenosphere baseplates, 2 deep infections that required 2-stage exchanges, 1 deep infection that required a 2-stage exchange that was then complicated by dissociation of the glenosphere baseplate requiring revision, and 1 superficial infection that resolved with oral antibiotics.

After surgery, mean active forward elevation was 140°, mean active external rotation was 48°, and mean active internal rotation was to S1. Mean (SD) postoperative ASES score was 77.5 (23.4). Satisfaction level was high (mean, 8.3/10), and mean pain levels were low: 2.3 out of 10 on the visual analog scale and 44.0 (SD, 11.7) on the ASES pain component. Strength was rated a mean of good. Table 1 lists the clinical data for the primary and revision surgery patients.

Eighteen patients (23.1%) returned to 24 different high-intensity activities, such as hunting, golf, and skiing; 38 patients (48.7%) returned to moderate-intensity activities, such as swimming, bowling, and raking leaves; and 22 patients (28.2%) returned to low-intensity activities, such as riding a stationary bike, playing a musical instrument, and walking (Table 2). Four patients played golf before and after RTSA, but neither of the 2 patients who played tennis before RTSA were able to do so after. Patients reported they engaged in their favorite leisure activity a mean of 4.8 times per week and a mean of 1.5 hours each time.

A medical problem was cited by 58% of patients as the reason for limited activity. These patients reported physical decline resulting from cardiac disease, diabetes, asthma/chronic obstructive pulmonary disease, or arthritis in other joints. Reasons for activity limitation are listed in Table 3. Post-RTSA activities that patients could not do for any reason are listed in Table 4. Activity limitations that patients attributed to the RTSA are listed in Table 5.

The majority of patients (57.7%) reported no change, from before RTSA to after RTSA, in being unable to do certain desired activities (eg, softball, target shooting, horseback riding, running, traveling). Sixteen patients (20.8%) reported being unable to return to an activity (eg, tennis, swimming, baseball, kayaking) they had been able to do before surgery. Most (69%) of those patients reported being unable to return to a moderate- or high-intensity activity after RTSA, but 81.8% were able to return to different moderate- or high-intensity activities.

Revision patients, who reported lower overhead activity levels, constituted 73% of the patients who felt their shoulder mechanically limited their activity, despite the fact that revisions constituted only 25% of the cases overall. Mean active ROM was statistically lower for revision patients than for primary patients (P < .05). Mean ASES score was statistically lower for the revision group (P < .001) and represented a clinically significant difference. Mean pain level was low (3.3) and satisfaction still generally high (7.4), but pain, satisfaction, and strength were about 1 point worse on average in the revision group than in the primary group.

Discussion

In the United States and other countries, RTSA implant survivorship is good.^9,22 In this article, we have reported on post-RTSA activity levels, on the significant impact of comorbidities on this group, and on the negative effect of revisions on postoperative activity. Patients in this population reported that concomitant medical problems were the most important factor limiting their post-RTSA activity levels. Understanding and interpreting quality-of-life or functional scores in this elderly group must take into account the impact of comorbidities.²³

Patients should have realistic postoperative expectations.²⁴ In this study, some patients engaged in high-intensity overhead activities, such as golf, chopping wood, and shooting. However, the most difficulty was encountered trying to return to activities (eg, tennis, kayaking, archery, combing hair) that required external rotation in abduction.

Patients who had a previous implant (eg, hemiarthroplasty, TSA, failed internal fixation) revised to RTSA had lower activity levels and were 9 times more likely than primary patients to report having a mechanical shoulder limitation affecting their activity. Revision patients also had worse forward elevation, external rotation, pain, and satisfaction.

This study is limited in that it is retrospective. Subsequent prospective studies focused on younger patients who undergo primary RTSA may be useful if indications expand. In addition, subscapularis status and especially infraspinatus status may affect activity levels and could be analyzed in a study. Another limitation is that we did not specifically record detailed preoperative data, though all patients were known to have preoperative forward elevation of less than 90°.

In general, the primary measure of success for RTSA has been pain relief. Some studies have also reported on strength and ROM.^2,20,25,26 A recent study using similar methodology demonstrated comparable ROM and low pain after RTSA, though revisions were not included in that study.²⁶ In contrast to the present study, no patient in that study was able to play tennis or golf, but the reasons for the limited activity were not explored. In both studies, post-RTSA sports were generally of lower intensity than those played by patients after anatomical TSA.²⁷

Overall, the majority of patients were very satisfied with their low pain level after RTSA. In addition, many patients not limited by other medical conditions were able to return to their pre-RTSA moderate-intensity recreational activities.

The treatment of patients with severe shoulder pain and disability combined with a nonfunctional rotator cuff was a clinical challenge until the development of the reverse total shoulder arthroplasty (RTSA).^1-3 Massive rotator cuff tears can leave patients with a pseudoparalytic upper extremity and may result in advanced arthritis of the joint because of altered mechanical and nutritional factors.⁴ In this setting, simply replacing the arthritic joint with standard total shoulder arthroplasty (TSA) is not recommended because it does not address the functional deficits, and it has poor long-term outcomes.^3,5 RTSA works by changing the center of rotation of the shoulder joint so that the deltoid muscle can be used to elevate the arm.^6,7 The 4 rotator cuff muscles are not required for forward elevation or stability of this constrained implant.^6,8

Current indications for RTSA are cuff tear arthropathy, complex proximal humerus fractures, and revision from hemiarthroplasty or TSA with rotator cuff dysfunction. Patients with advanced cuff tear arthropathy have minimal forward elevation and pseudoparalysis. Previous studies have shown mean preoperative forward flexion of 55º and mean ASES (American Shoulder and Elbow Surgeons) Standardized Shoulder Assessment Form score of 34.3.⁹ Thus, minimal overhead activity is possible without RTSA. Advances in the RTSA technique have led to promising results (excellent functional improvement), but there is limited information regarding the activity levels patients can achieve after surgery.^7,9-11

We conducted a study of the types of sporting activities in which patients with RTSA could participate. We hypothesized that, relative to historic controls, patients with RTSA could return to low-intensity sporting activities with improvement in motion and ASES scores.

Materials and Methods

After this study received institutional review board approval, patients who had undergone RTSA at our institution between January 1, 2004 and December 31, 2010 were identified by the billing codes used for the procedure. Each patient who had RTSA performed during the study period was included in the study. Charts were then reviewed to extract demographic data, preoperative diagnosis, surgery date, operative side, dominant side, type of implant used, operative complications, and subsequent revisions. A questionnaire (Appendix) was designed and used to assess activity, functional status, pain, and satisfaction levels after RTSA. Patients had to be willing and able to complete this questionnaire in order to be included in the study.

The questionnaire included demographic questions; a list of 42 activities patients could choose from to describe their current activity level, activities they were able to perform before the surgery, and activities they wish they could perform; a list of reasons for any limitations; and questions about overall pain, strength, and satisfaction with the procedure. In addition, there was an open-ended question for activities that may not have been listed. The questionnaire also included a validated method for assessing shoulder range of motion (ROM) at home, where patients rated their overhead motion according to standardized physical landmarks, including the level of the shoulder, chin, eyebrows, top of head, and above head.^12-14 Also provided was the ASES Standardized Shoulder Assessment Form, which features a 100-point visual analog scale for pain plus functional ability questions, with higher scores indicating less pain and better function.^15,16 The minimal clinical significance in the ASES score is 6.4 points.^17,18 Scores were recorded and analyzed. Student t test was used to calculate statistical differences between patients who had primary RTSA performed and patients who underwent revision RTSA.

Study personnel contacted patients by telephone and direct mailing. Patients who could not be reached initially were called at least 4 more times: twice during the weekday, once during the evening, and once on the weekend. Patients who could not be contacted by telephone were then cross-referenced with the Social Security database to see if any were deceased. Response data were tabulated, and patients were stratified into high-, moderate-, and low-intensity activity.

One of the 3 senior authors (Dr. Ahmad, Dr. Bigliani, Dr. Levine) performed the 95 RTSAs: 84 Zimmer (Warsaw, Indiana), 7 DePuy (Warsaw, Indiana), 4 Tornier (Minneapolis, Minnesota). The DePuy and Tornier implants were used when a 30-mm glenoid peg was required (before Zimmer offered this length in its system). The procedure was done with a deltopectoral approach with 20° of retroversion. In revision cases, the same approach was used, the hardware or implants were removed, and the position of the humeral component was determined based on the pectoralis major insertion and the deltoid tension. In 80% of cases, the subscapularis was not repaired; in the other 20%, it was. Whether it was repaired depended on tendon viability and surgeon preference, as subscapularis repair status has been shown not to affect functional outcome.^19-21 No combined latissimus transfers were performed. Patients wore a sling the first 4 weeks after surgery (only wrist and elbow motion allowed) and then advanced to active shoulder ROM. Eight weeks after surgery, they began gentle shoulder strengthening.

Results

One hundred nine consecutive patients underwent RTSA at a single institution. Fifteen patients subsequently died, 14 could not be contacted, and 2 declined, leaving 78 patients available for clinical follow-up. Mean follow-up was 4.8 years (range 2-9 years). Mean (SD) age at surgery was 75.3 (7.5) years. Seventy-five percent of the patients were women. Sixty-one percent underwent surgery for cuff tear arthropathy, 31% for revision of previous arthroplasty or internal fixation, 7% for complex fractures, and 1% for tumor. Of the 24 revisions, 15 were for failed hemiarthroplasty, 3 were for failed TSA with rotator cuff dysfunction, 4 were for fracture with failed internal fixation, and 2 were for failed RTSA referred from other institutions. The dominant shoulder was involved 62% of the time. Preoperative active forward shoulder elevation was less than 90° in all patients. There were 10 complications: 2 dislocations that were closed-reduced and remained stable, 1 dislocation that required revision of the liner, 1 aseptic loosening in a patient who has declined revision, 2 dissociated glenosphere baseplates, 2 deep infections that required 2-stage exchanges, 1 deep infection that required a 2-stage exchange that was then complicated by dissociation of the glenosphere baseplate requiring revision, and 1 superficial infection that resolved with oral antibiotics.

After surgery, mean active forward elevation was 140°, mean active external rotation was 48°, and mean active internal rotation was to S1. Mean (SD) postoperative ASES score was 77.5 (23.4). Satisfaction level was high (mean, 8.3/10), and mean pain levels were low: 2.3 out of 10 on the visual analog scale and 44.0 (SD, 11.7) on the ASES pain component. Strength was rated a mean of good. Table 1 lists the clinical data for the primary and revision surgery patients.

Eighteen patients (23.1%) returned to 24 different high-intensity activities, such as hunting, golf, and skiing; 38 patients (48.7%) returned to moderate-intensity activities, such as swimming, bowling, and raking leaves; and 22 patients (28.2%) returned to low-intensity activities, such as riding a stationary bike, playing a musical instrument, and walking (Table 2). Four patients played golf before and after RTSA, but neither of the 2 patients who played tennis before RTSA were able to do so after. Patients reported they engaged in their favorite leisure activity a mean of 4.8 times per week and a mean of 1.5 hours each time.

A medical problem was cited by 58% of patients as the reason for limited activity. These patients reported physical decline resulting from cardiac disease, diabetes, asthma/chronic obstructive pulmonary disease, or arthritis in other joints. Reasons for activity limitation are listed in Table 3. Post-RTSA activities that patients could not do for any reason are listed in Table 4. Activity limitations that patients attributed to the RTSA are listed in Table 5.

The majority of patients (57.7%) reported no change, from before RTSA to after RTSA, in being unable to do certain desired activities (eg, softball, target shooting, horseback riding, running, traveling). Sixteen patients (20.8%) reported being unable to return to an activity (eg, tennis, swimming, baseball, kayaking) they had been able to do before surgery. Most (69%) of those patients reported being unable to return to a moderate- or high-intensity activity after RTSA, but 81.8% were able to return to different moderate- or high-intensity activities.

Revision patients, who reported lower overhead activity levels, constituted 73% of the patients who felt their shoulder mechanically limited their activity, despite the fact that revisions constituted only 25% of the cases overall. Mean active ROM was statistically lower for revision patients than for primary patients (P < .05). Mean ASES score was statistically lower for the revision group (P < .001) and represented a clinically significant difference. Mean pain level was low (3.3) and satisfaction still generally high (7.4), but pain, satisfaction, and strength were about 1 point worse on average in the revision group than in the primary group.

Discussion

In the United States and other countries, RTSA implant survivorship is good.^9,22 In this article, we have reported on post-RTSA activity levels, on the significant impact of comorbidities on this group, and on the negative effect of revisions on postoperative activity. Patients in this population reported that concomitant medical problems were the most important factor limiting their post-RTSA activity levels. Understanding and interpreting quality-of-life or functional scores in this elderly group must take into account the impact of comorbidities.²³

Patients should have realistic postoperative expectations.²⁴ In this study, some patients engaged in high-intensity overhead activities, such as golf, chopping wood, and shooting. However, the most difficulty was encountered trying to return to activities (eg, tennis, kayaking, archery, combing hair) that required external rotation in abduction.

Patients who had a previous implant (eg, hemiarthroplasty, TSA, failed internal fixation) revised to RTSA had lower activity levels and were 9 times more likely than primary patients to report having a mechanical shoulder limitation affecting their activity. Revision patients also had worse forward elevation, external rotation, pain, and satisfaction.

This study is limited in that it is retrospective. Subsequent prospective studies focused on younger patients who undergo primary RTSA may be useful if indications expand. In addition, subscapularis status and especially infraspinatus status may affect activity levels and could be analyzed in a study. Another limitation is that we did not specifically record detailed preoperative data, though all patients were known to have preoperative forward elevation of less than 90°.

In general, the primary measure of success for RTSA has been pain relief. Some studies have also reported on strength and ROM.^2,20,25,26 A recent study using similar methodology demonstrated comparable ROM and low pain after RTSA, though revisions were not included in that study.²⁶ In contrast to the present study, no patient in that study was able to play tennis or golf, but the reasons for the limited activity were not explored. In both studies, post-RTSA sports were generally of lower intensity than those played by patients after anatomical TSA.²⁷

Overall, the majority of patients were very satisfied with their low pain level after RTSA. In addition, many patients not limited by other medical conditions were able to return to their pre-RTSA moderate-intensity recreational activities.

The treatment of patients with severe shoulder pain and disability combined with a nonfunctional rotator cuff was a clinical challenge until the development of the reverse total shoulder arthroplasty (RTSA).^1-3 Massive rotator cuff tears can leave patients with a pseudoparalytic upper extremity and may result in advanced arthritis of the joint because of altered mechanical and nutritional factors.⁴ In this setting, simply replacing the arthritic joint with standard total shoulder arthroplasty (TSA) is not recommended because it does not address the functional deficits, and it has poor long-term outcomes.^3,5 RTSA works by changing the center of rotation of the shoulder joint so that the deltoid muscle can be used to elevate the arm.^6,7 The 4 rotator cuff muscles are not required for forward elevation or stability of this constrained implant.^6,8

Current indications for RTSA are cuff tear arthropathy, complex proximal humerus fractures, and revision from hemiarthroplasty or TSA with rotator cuff dysfunction. Patients with advanced cuff tear arthropathy have minimal forward elevation and pseudoparalysis. Previous studies have shown mean preoperative forward flexion of 55º and mean ASES (American Shoulder and Elbow Surgeons) Standardized Shoulder Assessment Form score of 34.3.⁹ Thus, minimal overhead activity is possible without RTSA. Advances in the RTSA technique have led to promising results (excellent functional improvement), but there is limited information regarding the activity levels patients can achieve after surgery.^7,9-11

We conducted a study of the types of sporting activities in which patients with RTSA could participate. We hypothesized that, relative to historic controls, patients with RTSA could return to low-intensity sporting activities with improvement in motion and ASES scores.

Materials and Methods

After this study received institutional review board approval, patients who had undergone RTSA at our institution between January 1, 2004 and December 31, 2010 were identified by the billing codes used for the procedure. Each patient who had RTSA performed during the study period was included in the study. Charts were then reviewed to extract demographic data, preoperative diagnosis, surgery date, operative side, dominant side, type of implant used, operative complications, and subsequent revisions. A questionnaire (Appendix) was designed and used to assess activity, functional status, pain, and satisfaction levels after RTSA. Patients had to be willing and able to complete this questionnaire in order to be included in the study.

The questionnaire included demographic questions; a list of 42 activities patients could choose from to describe their current activity level, activities they were able to perform before the surgery, and activities they wish they could perform; a list of reasons for any limitations; and questions about overall pain, strength, and satisfaction with the procedure. In addition, there was an open-ended question for activities that may not have been listed. The questionnaire also included a validated method for assessing shoulder range of motion (ROM) at home, where patients rated their overhead motion according to standardized physical landmarks, including the level of the shoulder, chin, eyebrows, top of head, and above head.^12-14 Also provided was the ASES Standardized Shoulder Assessment Form, which features a 100-point visual analog scale for pain plus functional ability questions, with higher scores indicating less pain and better function.^15,16 The minimal clinical significance in the ASES score is 6.4 points.^17,18 Scores were recorded and analyzed. Student t test was used to calculate statistical differences between patients who had primary RTSA performed and patients who underwent revision RTSA.

Study personnel contacted patients by telephone and direct mailing. Patients who could not be reached initially were called at least 4 more times: twice during the weekday, once during the evening, and once on the weekend. Patients who could not be contacted by telephone were then cross-referenced with the Social Security database to see if any were deceased. Response data were tabulated, and patients were stratified into high-, moderate-, and low-intensity activity.

One of the 3 senior authors (Dr. Ahmad, Dr. Bigliani, Dr. Levine) performed the 95 RTSAs: 84 Zimmer (Warsaw, Indiana), 7 DePuy (Warsaw, Indiana), 4 Tornier (Minneapolis, Minnesota). The DePuy and Tornier implants were used when a 30-mm glenoid peg was required (before Zimmer offered this length in its system). The procedure was done with a deltopectoral approach with 20° of retroversion. In revision cases, the same approach was used, the hardware or implants were removed, and the position of the humeral component was determined based on the pectoralis major insertion and the deltoid tension. In 80% of cases, the subscapularis was not repaired; in the other 20%, it was. Whether it was repaired depended on tendon viability and surgeon preference, as subscapularis repair status has been shown not to affect functional outcome.^19-21 No combined latissimus transfers were performed. Patients wore a sling the first 4 weeks after surgery (only wrist and elbow motion allowed) and then advanced to active shoulder ROM. Eight weeks after surgery, they began gentle shoulder strengthening.

Results

One hundred nine consecutive patients underwent RTSA at a single institution. Fifteen patients subsequently died, 14 could not be contacted, and 2 declined, leaving 78 patients available for clinical follow-up. Mean follow-up was 4.8 years (range 2-9 years). Mean (SD) age at surgery was 75.3 (7.5) years. Seventy-five percent of the patients were women. Sixty-one percent underwent surgery for cuff tear arthropathy, 31% for revision of previous arthroplasty or internal fixation, 7% for complex fractures, and 1% for tumor. Of the 24 revisions, 15 were for failed hemiarthroplasty, 3 were for failed TSA with rotator cuff dysfunction, 4 were for fracture with failed internal fixation, and 2 were for failed RTSA referred from other institutions. The dominant shoulder was involved 62% of the time. Preoperative active forward shoulder elevation was less than 90° in all patients. There were 10 complications: 2 dislocations that were closed-reduced and remained stable, 1 dislocation that required revision of the liner, 1 aseptic loosening in a patient who has declined revision, 2 dissociated glenosphere baseplates, 2 deep infections that required 2-stage exchanges, 1 deep infection that required a 2-stage exchange that was then complicated by dissociation of the glenosphere baseplate requiring revision, and 1 superficial infection that resolved with oral antibiotics.

After surgery, mean active forward elevation was 140°, mean active external rotation was 48°, and mean active internal rotation was to S1. Mean (SD) postoperative ASES score was 77.5 (23.4). Satisfaction level was high (mean, 8.3/10), and mean pain levels were low: 2.3 out of 10 on the visual analog scale and 44.0 (SD, 11.7) on the ASES pain component. Strength was rated a mean of good. Table 1 lists the clinical data for the primary and revision surgery patients.

Eighteen patients (23.1%) returned to 24 different high-intensity activities, such as hunting, golf, and skiing; 38 patients (48.7%) returned to moderate-intensity activities, such as swimming, bowling, and raking leaves; and 22 patients (28.2%) returned to low-intensity activities, such as riding a stationary bike, playing a musical instrument, and walking (Table 2). Four patients played golf before and after RTSA, but neither of the 2 patients who played tennis before RTSA were able to do so after. Patients reported they engaged in their favorite leisure activity a mean of 4.8 times per week and a mean of 1.5 hours each time.

A medical problem was cited by 58% of patients as the reason for limited activity. These patients reported physical decline resulting from cardiac disease, diabetes, asthma/chronic obstructive pulmonary disease, or arthritis in other joints. Reasons for activity limitation are listed in Table 3. Post-RTSA activities that patients could not do for any reason are listed in Table 4. Activity limitations that patients attributed to the RTSA are listed in Table 5.

The majority of patients (57.7%) reported no change, from before RTSA to after RTSA, in being unable to do certain desired activities (eg, softball, target shooting, horseback riding, running, traveling). Sixteen patients (20.8%) reported being unable to return to an activity (eg, tennis, swimming, baseball, kayaking) they had been able to do before surgery. Most (69%) of those patients reported being unable to return to a moderate- or high-intensity activity after RTSA, but 81.8% were able to return to different moderate- or high-intensity activities.

Revision patients, who reported lower overhead activity levels, constituted 73% of the patients who felt their shoulder mechanically limited their activity, despite the fact that revisions constituted only 25% of the cases overall. Mean active ROM was statistically lower for revision patients than for primary patients (P < .05). Mean ASES score was statistically lower for the revision group (P < .001) and represented a clinically significant difference. Mean pain level was low (3.3) and satisfaction still generally high (7.4), but pain, satisfaction, and strength were about 1 point worse on average in the revision group than in the primary group.

Discussion

In the United States and other countries, RTSA implant survivorship is good.^9,22 In this article, we have reported on post-RTSA activity levels, on the significant impact of comorbidities on this group, and on the negative effect of revisions on postoperative activity. Patients in this population reported that concomitant medical problems were the most important factor limiting their post-RTSA activity levels. Understanding and interpreting quality-of-life or functional scores in this elderly group must take into account the impact of comorbidities.²³

Patients should have realistic postoperative expectations.²⁴ In this study, some patients engaged in high-intensity overhead activities, such as golf, chopping wood, and shooting. However, the most difficulty was encountered trying to return to activities (eg, tennis, kayaking, archery, combing hair) that required external rotation in abduction.

Patients who had a previous implant (eg, hemiarthroplasty, TSA, failed internal fixation) revised to RTSA had lower activity levels and were 9 times more likely than primary patients to report having a mechanical shoulder limitation affecting their activity. Revision patients also had worse forward elevation, external rotation, pain, and satisfaction.

This study is limited in that it is retrospective. Subsequent prospective studies focused on younger patients who undergo primary RTSA may be useful if indications expand. In addition, subscapularis status and especially infraspinatus status may affect activity levels and could be analyzed in a study. Another limitation is that we did not specifically record detailed preoperative data, though all patients were known to have preoperative forward elevation of less than 90°.

In general, the primary measure of success for RTSA has been pain relief. Some studies have also reported on strength and ROM.^2,20,25,26 A recent study using similar methodology demonstrated comparable ROM and low pain after RTSA, though revisions were not included in that study.²⁶ In contrast to the present study, no patient in that study was able to play tennis or golf, but the reasons for the limited activity were not explored. In both studies, post-RTSA sports were generally of lower intensity than those played by patients after anatomical TSA.²⁷

Overall, the majority of patients were very satisfied with their low pain level after RTSA. In addition, many patients not limited by other medical conditions were able to return to their pre-RTSA moderate-intensity recreational activities.

The diagnosis of cancer is a life-changing event for the patient as well as the patient’s family, friends, and relatives. Once diagnosed, most cancer patients want more information about their prognosis, future procedures, and/or treatment options.¹ Receiving such information has been shown to reduce patient anxiety, increase patient satisfaction with care, and improve self-care.^2-6 With the evolution of the Internet, patients in general^7-9 and, specifically, cancer patients^10-17 have turned to websites and online patient education materials (PEMs) to gather more health information.

For online PEMs to convey health information, their reading level must match the health literacy of the individuals who access them. Health literacy is the ability of an individual to gather and comprehend information about their condition to make the best decisions for their health.¹⁸ According to a report by the Institute of Medicine, 90 million American adults cannot properly use the US health care system because they do not possess adequate health literacy.¹⁸ Additionally, 36% of adults in the United States have basic or less-than-basic health literacy.¹⁹ This is starkly contrasted with the 12% of US adults who have proficient health literacy. A 2012 survey showed that about 31% of individuals who look for health information on the Internet have a high school education or less.⁸ In order to address the low health literacy of adults, the National Institutes of Health (NIH) has recommended that online PEMs be written at a sixth- to seventh-grade reading level.²⁰ 

Unfortunately, many online PEMs related to certain cancer^21-25 and orthopedic conditions^26-31 do not meet NIH recommendations. Only 1 study has specifically looked at PEMs related to an orthopedic cancer condition.³² Lam and colleagues³² evaluated the readability of osteosarcoma PEMs from 56 websites using only 2 readability instruments and identified 86% of the websites as having a greater than eighth-grade reading level. No study has thoroughly assessed the readability of PEMs about bone and soft-tissue sarcomas and related conditions nor has any used 10 different readability instruments. Since each readability instrument has different variables (eg, sentence length, number of paragraphs, or number of complex words), averaging the scores of 10 of these instruments may result in less bias.

The purpose of this study was to evaluate the readability of online PEMs concerning bone and soft-tissue sarcomas and related conditions. The online PEMs came from websites that sarcoma patients may visit to obtain information about their condition. Our hypothesis was that the majority of these online PEMs will have a higher reading level than the NIH recommendations.

Materials and Methods

In May 2013, we identified online PEMs that included background, diagnosis, tests, or treatments for bone and soft-tissue sarcomas and conditions that mimic bone sarcoma. We included articles from the Tumors section of the American Academy of Orthopaedic Surgeons (AAOS) website.³³ A second source of online PEMs came from a list of academic training centers created through the American Medical Association’s Fellowship and Residency Electronic Internet Database (FREIDA) with search criteria narrowed to orthopedic surgery. If we did not find PEMs of bone and soft-tissue cancers in the orthopedic department of a given academic training center’s website, we searched its cancer center website. We chose 4 programs with PEMs relevant to bone and soft-tissue sarcomas from each region in FREIDA for a balanced representation, except for the Territory region because it had only 1 academic training center and no relevant PEMs. Specialized websites, including Bonetumor.org, Sarcoma Alliance (Sarcomaalliance.org), and Sarcoma Foundation of America (Curesarcoma.org), were also evaluated. Within the Sarcoma Specialists section of the Sarcoma Alliance website,³⁴ sarcoma specialists who were not identified from the FREIDA search for academic training centers were selected for review.

Because 8 of 10 individuals looking for health information on the Internet start their investigation at search engines, we also looked for PEMs through a Google search (Google.com) of bone cancer, and evaluated the first 10 hits for PEMs.⁸ Of these 10 hits, 8 had relevant PEMs, which we searched for additional PEMs about bone and soft-tissue cancers and related conditions. We also conducted a Google search of the most common bone sarcoma and soft-tissue sarcoma, osteosarcoma and malignant fibrous histiocytoma, respectively, and found 2 additional websites with relevant PEMs. LaCoursiere and colleagues³⁵ surveyed cancer patients who used the Internet and found that they preferred WebMD (Webmd.com) and Medscape (Medscape.com) as sources for content about their medical condition.³⁵ WebMD had been identified in the Google search, and we gathered the PEMs from Medscape also. It is worth noting that some of these websites are written for patients as well as clinicians.

Text from these PEMs were copied and pasted into separate Microsoft Word documents (Microsoft, Redmond, Washington). Advertisements, pictures, picture text, hyperlinks, copyright notices, page navigation links, paragraphs with no text, and any text that was not related to the given condition were deleted from the document to format the text for the readability software. Then, each Microsoft Word document was uploaded into the software package Readability Studio Professional (RSP) Edition Version 2012.1 for Windows (Oleander Software, Vandalia, Ohio). The 10 distinct readability instruments that were used to gauge the readability of each document were the Flesch Reading Ease score (FRE), the New Fog Count, the New Automated Readability Index, the Coleman-Liau Index (CLI), the Fry readability graph, the New Dale-Chall formula (NDC), the Gunning Frequency of Gobbledygook (Gunning FOG), the Powers-Sumner-Kearl formula, the Simple Measure of Gobbledygook (SMOG), and the Raygor Estimate Graph.

The FRE’s formula takes the average number of words per sentence and average number of syllables per word to compute a score ranging from 0 to 100 with 0 being the hardest to read.³⁶ The New Fog Count tallies the number of sentences, easy words, and hard words (polysyllables) to calculate the grade level of the document.³⁷ The New Automated Readability Index takes the average characters per word and average words per sentence to calculate a grade level for the document.³⁷ The CLI randomly samples a few hundred words from the document, averages the number of letters and sentences per sample, and calculates an estimated grade level.³⁸ The Fry readability graph selects samples of 100 words from the document, averages the number of syllables and sentences per 100 words, plots these data points on a graph, with the intersection determining the reading level.³⁹ The NDC uses a list of 3000 familiar words that most fourth-grade students know.⁴⁰ The percentage of difficult words, which are not on the list of familiar words, and the average sentence length in words are used to calculate the reading grade level of the document. The Gunning FOG uses the average sentence length in words and the percentage of hard words from a sample of at least 100 words to determine the reading grade level of the document.⁴¹ The Powers-Sumner-Kearl formula uses the average sentence length and percentage of monosyllables from a 100-word sample passage to calculate the reading grade level.⁴² The SMOG formula counts the number of polysyllabic words from 30 sentences and calculates the reading grade level of the document.⁴³ In contrast to other formulas that test for 50% to 75% comprehension, the SMOG formula tests for 100% comprehension. As a result, the SMOG formula generally assigns a reading level 2 grades higher than the Dale-Chall level. The Raygor Estimate Graph selects a 100-word passage, counts the number of sentences and number of words with 6 or more letters, and plots the 2 variables on a graph to determine the reading grade level.⁴⁴ The software package calculated the results from each reading instrument and reported the mean grade level score
for each document.

Results

We identified a total of 72 websites with relevant PEMs and included them in this study. Of these 72 websites, 36 websites were academic training centers, 10 were Google search hits, and 21 were from the Sarcoma Alliance list of sarcoma specialists. The remaining 5 websites were AAOS, Bonetumor.org, Sarcoma Alliance, Sarcoma Foundation of America, and Medscape. A list of conditions and treatments that were considered relevant PEMs is found in Appendix 1. A total of 774 articles were obtained from the 72 websites.

None of the websites had a mean readability score of 7 (seventh grade) or lower (Figures 1A, 1B). Mid-America Sarcoma Institute’s PEMs had the lowest mean readability score, 8.9. The lowest readability score was 5.3, which the New Fog Count readability instrument calculated for Vanderbilt University Medical Center’s (VUMC’s) PEMs (Appendix 2). The mean readability score of all websites was 11.4 (range, 8.9-15.5) (Appendix 2).

Seventy of 72 websites (97%) had PEMs that were fairly difficult or difficult, according to the FRE analysis (Figure 2). The American Cancer Society and Mid-America Sarcoma Institute had PEMs that were written in plain English. Sixty-nine of 72 websites (96%) had PEMs with a readability score of 10 or higher, according to the Raygor readability estimate (Figure 3). Using this instrument, the scores of the American Cancer Society and the University of Pennsylvania–Joan Karnell Cancer Center were 9; Mid-America Sarcoma Institute’s score was 8. 

Discussion

Many cancer patients have turned to websites and online PEMs to gather health information about their condition.^10-17 Basch and colleagues¹⁰ reported almost a decade ago that 44% of cancer patients, as well as 60% of their companions, used the Internet to find cancer-related information.¹⁰ When LaCoursiere and colleagues³⁵ surveyed cancer patients, they found that patients handled their condition better and had less anxiety and uncertainty after using the Internet to find health information and support.³⁵ In addition, many orthopedic patients, specifically 46% of orthopedic community outpatients,⁴⁵ consult the Internet for information about their condition and future surgical procedures.^46,47

This study comprehensively evaluated the readability of online PEMs of bone and soft-tissue sarcomas and related conditions by using 10 different readability instruments. After identifying 72 websites and 774 articles, we found that all 72 websites’ PEMs had a mean readability score that did not meet the NIH recommendation of writing PEMs at a sixth- to seventh-grade reading level. These results are consistent with studies evaluating the readability of online PEMs related to other cancer conditions^21-25 and other orthopedic conditions.^26-31

The combination of low health literacy of many US adults and high reading grade levels of the majority of online PEMs is not conducive to patients’ better understanding their condition(s). Even individuals with high reading skills prefer information that is simpler to read.⁴⁸ In many areas of medicine, there is evidence that patients’ understanding of their condition has a positive impact on health outcomes, well-being, and the patient–physician relationship.^49-61 Regarding cancer patients, Davis and colleagues⁵⁴ and Peterson and colleagues⁵⁷ showed that lower health literacy contributes to less knowledge and lower rates of breast⁵⁴ and colorectal cancer⁵⁷ screening tests. Even low health literacy of family caregivers of cancer patients can result in increased stress and lack of communication of important medical information between caregiver and physician.⁵² Among cancer patients, poor health literacy has been associated with mental distress⁶⁰ as well as decreased compliance with treatment and lower involvement in clinical trials.⁵⁵

The disparity between patients’ health literacy and the readability of online PEMs needs to be addressed by finding methods to improve patients’ understanding of their condition and to lower the readability scores of online PEMs. Better communication between patient and physician may improve patients’ comprehension of their condition and different aspects of their care.^59,62-66 Doak and colleagues⁶³ recommend giving cancer patients the most important information first; presenting information to patients in smaller doses; intermittently asking patients questions; and incorporating graphs, tables, and drawings into communication with patients.⁶³ Additionally, allowing patients to repeat information they have just received/heard to the physician is another useful tool to improve patient education.^62,64-66

Another way to address the disparity between patients’ health literacy and the readability of online PEMs is to reduce the reading grade level of existing PEMs. According to results from this study and others, the majority of online PEMs are above the reading grade level of a significant number of US adults. Many available and inexpensive readability instruments allow authors to assess their articles’ readability. Many writing guidelines also exist to help authors improve the readability of their PEMs.^20,64,67-71 Living Word Vocabulary⁷⁰ and Plain Language⁷¹ help authors replace complex words or medical terms with simpler words.²⁹ Visual aids, audio, and video help patients with low health literacy remember the information.⁶⁴

Efforts to improve PEM readability are effective. Of all the websites reviewed, VUMC was identified as having PEMs with the lowest readability score (5.3). This score was reported by the New Fog Count readability instrument, which accounts for the number of sentences, easy words, and hard words. In 2011, VUMC formed the Department of Patient Education to review and update its online and printed PEMs to make sure patients could read them.⁷² Additionally, the mean readability scores of the websites of the National Cancer Institute and MedlinePlus are in the top 50% of the websites included in this study. The NIH sponsors both sites, which follow the NIH guidelines for writing online PEMs at a reading level suitable for individuals with lower health literacy.²⁰ These materials serve as potential models to improve the readability of PEMs, and, thus, help patients to better understand their condition, medical procedures, and/or treatment options.

To illustrate ways to improve the reading grade level of PEMs, we used the article “Ewing’s Sarcoma” from the AAOS website⁷³ and followed the NIH guidelines to improve the reading grade level of the article.²⁰ We identified complex words and defined them at an eighth-grade reading level. If that word was mentioned later in the article, simpler terminology was used instead of the initial complex word. For example, Ewing’s sarcoma was defined early and then referred to as bone tumor later in the article. We also identified every word that was 3 syllables or longer and used Microsoft Word’s thesaurus to replace those words with ones that were less than 3 syllables. Lastly, all sentences longer than 15 words were rewritten to be less than 15 words. After making these 3 changes to the article, the mean reading grade level dropped from 11.2 to 7.3. 

This study has limitations. First, some readability instruments evaluate the number of syllables per word or polysyllabic words as part of their formula and, thus, can underestimate or overestimate the reading grade level of a document. Some readability formulas consider medical terms such as ulna, femur, or carpal as “easy” words because they have 2 syllables, but many laypersons may not comprehend these words. On the other hand, some readability formulas consider medical terms such as medications, diagnosis, or radiation as “hard” words because they contain 3 or more syllables, but the majority of laypersons likely comprehend these words. Second, the reading level of the patient population accessing those online sites was not assessed. Third, the readability instruments in this study did not evaluate the accuracy of the content, pictures, or tables of the PEMs. However, using 10 readability instruments allowed evaluation of many different readability aspects of the text. Fourth, because some websites identified in this study, such as Bonetumor.org, were written for patients as well as clinicians, the reading grade level of these sites may be higher than that of those sites written just for patients.

Conclusion

Because many orthopedic cancer patients rely on the Internet as a source of information, the need for online PEMs to match the reading skills of the patient population who accesses them is vital. However, this study shows that many organizations, academic training centers, and other entities need to update their online PEMs because all PEMs in this study had a mean readability grade level higher than the NIH recommendation. Further research needs to evaluate the effectiveness of other media, such as video, illustrations, and audio, to provide health information to patients. With many guidelines available that provide plans and advice to improve the readability of PEMs, research also must assess the most effective plans and advice in order to allow authors to focus their attention on 1 set of guidelines to improve the readability of their PEMs.

The diagnosis of cancer is a life-changing event for the patient as well as the patient’s family, friends, and relatives. Once diagnosed, most cancer patients want more information about their prognosis, future procedures, and/or treatment options.¹ Receiving such information has been shown to reduce patient anxiety, increase patient satisfaction with care, and improve self-care.^2-6 With the evolution of the Internet, patients in general^7-9 and, specifically, cancer patients^10-17 have turned to websites and online patient education materials (PEMs) to gather more health information.

For online PEMs to convey health information, their reading level must match the health literacy of the individuals who access them. Health literacy is the ability of an individual to gather and comprehend information about their condition to make the best decisions for their health.¹⁸ According to a report by the Institute of Medicine, 90 million American adults cannot properly use the US health care system because they do not possess adequate health literacy.¹⁸ Additionally, 36% of adults in the United States have basic or less-than-basic health literacy.¹⁹ This is starkly contrasted with the 12% of US adults who have proficient health literacy. A 2012 survey showed that about 31% of individuals who look for health information on the Internet have a high school education or less.⁸ In order to address the low health literacy of adults, the National Institutes of Health (NIH) has recommended that online PEMs be written at a sixth- to seventh-grade reading level.²⁰ 

Unfortunately, many online PEMs related to certain cancer^21-25 and orthopedic conditions^26-31 do not meet NIH recommendations. Only 1 study has specifically looked at PEMs related to an orthopedic cancer condition.³² Lam and colleagues³² evaluated the readability of osteosarcoma PEMs from 56 websites using only 2 readability instruments and identified 86% of the websites as having a greater than eighth-grade reading level. No study has thoroughly assessed the readability of PEMs about bone and soft-tissue sarcomas and related conditions nor has any used 10 different readability instruments. Since each readability instrument has different variables (eg, sentence length, number of paragraphs, or number of complex words), averaging the scores of 10 of these instruments may result in less bias.

The purpose of this study was to evaluate the readability of online PEMs concerning bone and soft-tissue sarcomas and related conditions. The online PEMs came from websites that sarcoma patients may visit to obtain information about their condition. Our hypothesis was that the majority of these online PEMs will have a higher reading level than the NIH recommendations.

Materials and Methods

In May 2013, we identified online PEMs that included background, diagnosis, tests, or treatments for bone and soft-tissue sarcomas and conditions that mimic bone sarcoma. We included articles from the Tumors section of the American Academy of Orthopaedic Surgeons (AAOS) website.³³ A second source of online PEMs came from a list of academic training centers created through the American Medical Association’s Fellowship and Residency Electronic Internet Database (FREIDA) with search criteria narrowed to orthopedic surgery. If we did not find PEMs of bone and soft-tissue cancers in the orthopedic department of a given academic training center’s website, we searched its cancer center website. We chose 4 programs with PEMs relevant to bone and soft-tissue sarcomas from each region in FREIDA for a balanced representation, except for the Territory region because it had only 1 academic training center and no relevant PEMs. Specialized websites, including Bonetumor.org, Sarcoma Alliance (Sarcomaalliance.org), and Sarcoma Foundation of America (Curesarcoma.org), were also evaluated. Within the Sarcoma Specialists section of the Sarcoma Alliance website,³⁴ sarcoma specialists who were not identified from the FREIDA search for academic training centers were selected for review.

Because 8 of 10 individuals looking for health information on the Internet start their investigation at search engines, we also looked for PEMs through a Google search (Google.com) of bone cancer, and evaluated the first 10 hits for PEMs.⁸ Of these 10 hits, 8 had relevant PEMs, which we searched for additional PEMs about bone and soft-tissue cancers and related conditions. We also conducted a Google search of the most common bone sarcoma and soft-tissue sarcoma, osteosarcoma and malignant fibrous histiocytoma, respectively, and found 2 additional websites with relevant PEMs. LaCoursiere and colleagues³⁵ surveyed cancer patients who used the Internet and found that they preferred WebMD (Webmd.com) and Medscape (Medscape.com) as sources for content about their medical condition.³⁵ WebMD had been identified in the Google search, and we gathered the PEMs from Medscape also. It is worth noting that some of these websites are written for patients as well as clinicians.

Text from these PEMs were copied and pasted into separate Microsoft Word documents (Microsoft, Redmond, Washington). Advertisements, pictures, picture text, hyperlinks, copyright notices, page navigation links, paragraphs with no text, and any text that was not related to the given condition were deleted from the document to format the text for the readability software. Then, each Microsoft Word document was uploaded into the software package Readability Studio Professional (RSP) Edition Version 2012.1 for Windows (Oleander Software, Vandalia, Ohio). The 10 distinct readability instruments that were used to gauge the readability of each document were the Flesch Reading Ease score (FRE), the New Fog Count, the New Automated Readability Index, the Coleman-Liau Index (CLI), the Fry readability graph, the New Dale-Chall formula (NDC), the Gunning Frequency of Gobbledygook (Gunning FOG), the Powers-Sumner-Kearl formula, the Simple Measure of Gobbledygook (SMOG), and the Raygor Estimate Graph.

The FRE’s formula takes the average number of words per sentence and average number of syllables per word to compute a score ranging from 0 to 100 with 0 being the hardest to read.³⁶ The New Fog Count tallies the number of sentences, easy words, and hard words (polysyllables) to calculate the grade level of the document.³⁷ The New Automated Readability Index takes the average characters per word and average words per sentence to calculate a grade level for the document.³⁷ The CLI randomly samples a few hundred words from the document, averages the number of letters and sentences per sample, and calculates an estimated grade level.³⁸ The Fry readability graph selects samples of 100 words from the document, averages the number of syllables and sentences per 100 words, plots these data points on a graph, with the intersection determining the reading level.³⁹ The NDC uses a list of 3000 familiar words that most fourth-grade students know.⁴⁰ The percentage of difficult words, which are not on the list of familiar words, and the average sentence length in words are used to calculate the reading grade level of the document. The Gunning FOG uses the average sentence length in words and the percentage of hard words from a sample of at least 100 words to determine the reading grade level of the document.⁴¹ The Powers-Sumner-Kearl formula uses the average sentence length and percentage of monosyllables from a 100-word sample passage to calculate the reading grade level.⁴² The SMOG formula counts the number of polysyllabic words from 30 sentences and calculates the reading grade level of the document.⁴³ In contrast to other formulas that test for 50% to 75% comprehension, the SMOG formula tests for 100% comprehension. As a result, the SMOG formula generally assigns a reading level 2 grades higher than the Dale-Chall level. The Raygor Estimate Graph selects a 100-word passage, counts the number of sentences and number of words with 6 or more letters, and plots the 2 variables on a graph to determine the reading grade level.⁴⁴ The software package calculated the results from each reading instrument and reported the mean grade level score
for each document.

Results

We identified a total of 72 websites with relevant PEMs and included them in this study. Of these 72 websites, 36 websites were academic training centers, 10 were Google search hits, and 21 were from the Sarcoma Alliance list of sarcoma specialists. The remaining 5 websites were AAOS, Bonetumor.org, Sarcoma Alliance, Sarcoma Foundation of America, and Medscape. A list of conditions and treatments that were considered relevant PEMs is found in Appendix 1. A total of 774 articles were obtained from the 72 websites.

None of the websites had a mean readability score of 7 (seventh grade) or lower (Figures 1A, 1B). Mid-America Sarcoma Institute’s PEMs had the lowest mean readability score, 8.9. The lowest readability score was 5.3, which the New Fog Count readability instrument calculated for Vanderbilt University Medical Center’s (VUMC’s) PEMs (Appendix 2). The mean readability score of all websites was 11.4 (range, 8.9-15.5) (Appendix 2).

Seventy of 72 websites (97%) had PEMs that were fairly difficult or difficult, according to the FRE analysis (Figure 2). The American Cancer Society and Mid-America Sarcoma Institute had PEMs that were written in plain English. Sixty-nine of 72 websites (96%) had PEMs with a readability score of 10 or higher, according to the Raygor readability estimate (Figure 3). Using this instrument, the scores of the American Cancer Society and the University of Pennsylvania–Joan Karnell Cancer Center were 9; Mid-America Sarcoma Institute’s score was 8. 

Discussion

Many cancer patients have turned to websites and online PEMs to gather health information about their condition.^10-17 Basch and colleagues¹⁰ reported almost a decade ago that 44% of cancer patients, as well as 60% of their companions, used the Internet to find cancer-related information.¹⁰ When LaCoursiere and colleagues³⁵ surveyed cancer patients, they found that patients handled their condition better and had less anxiety and uncertainty after using the Internet to find health information and support.³⁵ In addition, many orthopedic patients, specifically 46% of orthopedic community outpatients,⁴⁵ consult the Internet for information about their condition and future surgical procedures.^46,47

This study comprehensively evaluated the readability of online PEMs of bone and soft-tissue sarcomas and related conditions by using 10 different readability instruments. After identifying 72 websites and 774 articles, we found that all 72 websites’ PEMs had a mean readability score that did not meet the NIH recommendation of writing PEMs at a sixth- to seventh-grade reading level. These results are consistent with studies evaluating the readability of online PEMs related to other cancer conditions^21-25 and other orthopedic conditions.^26-31

The combination of low health literacy of many US adults and high reading grade levels of the majority of online PEMs is not conducive to patients’ better understanding their condition(s). Even individuals with high reading skills prefer information that is simpler to read.⁴⁸ In many areas of medicine, there is evidence that patients’ understanding of their condition has a positive impact on health outcomes, well-being, and the patient–physician relationship.^49-61 Regarding cancer patients, Davis and colleagues⁵⁴ and Peterson and colleagues⁵⁷ showed that lower health literacy contributes to less knowledge and lower rates of breast⁵⁴ and colorectal cancer⁵⁷ screening tests. Even low health literacy of family caregivers of cancer patients can result in increased stress and lack of communication of important medical information between caregiver and physician.⁵² Among cancer patients, poor health literacy has been associated with mental distress⁶⁰ as well as decreased compliance with treatment and lower involvement in clinical trials.⁵⁵

The disparity between patients’ health literacy and the readability of online PEMs needs to be addressed by finding methods to improve patients’ understanding of their condition and to lower the readability scores of online PEMs. Better communication between patient and physician may improve patients’ comprehension of their condition and different aspects of their care.^59,62-66 Doak and colleagues⁶³ recommend giving cancer patients the most important information first; presenting information to patients in smaller doses; intermittently asking patients questions; and incorporating graphs, tables, and drawings into communication with patients.⁶³ Additionally, allowing patients to repeat information they have just received/heard to the physician is another useful tool to improve patient education.^62,64-66

Another way to address the disparity between patients’ health literacy and the readability of online PEMs is to reduce the reading grade level of existing PEMs. According to results from this study and others, the majority of online PEMs are above the reading grade level of a significant number of US adults. Many available and inexpensive readability instruments allow authors to assess their articles’ readability. Many writing guidelines also exist to help authors improve the readability of their PEMs.^20,64,67-71 Living Word Vocabulary⁷⁰ and Plain Language⁷¹ help authors replace complex words or medical terms with simpler words.²⁹ Visual aids, audio, and video help patients with low health literacy remember the information.⁶⁴

Efforts to improve PEM readability are effective. Of all the websites reviewed, VUMC was identified as having PEMs with the lowest readability score (5.3). This score was reported by the New Fog Count readability instrument, which accounts for the number of sentences, easy words, and hard words. In 2011, VUMC formed the Department of Patient Education to review and update its online and printed PEMs to make sure patients could read them.⁷² Additionally, the mean readability scores of the websites of the National Cancer Institute and MedlinePlus are in the top 50% of the websites included in this study. The NIH sponsors both sites, which follow the NIH guidelines for writing online PEMs at a reading level suitable for individuals with lower health literacy.²⁰ These materials serve as potential models to improve the readability of PEMs, and, thus, help patients to better understand their condition, medical procedures, and/or treatment options.

To illustrate ways to improve the reading grade level of PEMs, we used the article “Ewing’s Sarcoma” from the AAOS website⁷³ and followed the NIH guidelines to improve the reading grade level of the article.²⁰ We identified complex words and defined them at an eighth-grade reading level. If that word was mentioned later in the article, simpler terminology was used instead of the initial complex word. For example, Ewing’s sarcoma was defined early and then referred to as bone tumor later in the article. We also identified every word that was 3 syllables or longer and used Microsoft Word’s thesaurus to replace those words with ones that were less than 3 syllables. Lastly, all sentences longer than 15 words were rewritten to be less than 15 words. After making these 3 changes to the article, the mean reading grade level dropped from 11.2 to 7.3. 

This study has limitations. First, some readability instruments evaluate the number of syllables per word or polysyllabic words as part of their formula and, thus, can underestimate or overestimate the reading grade level of a document. Some readability formulas consider medical terms such as ulna, femur, or carpal as “easy” words because they have 2 syllables, but many laypersons may not comprehend these words. On the other hand, some readability formulas consider medical terms such as medications, diagnosis, or radiation as “hard” words because they contain 3 or more syllables, but the majority of laypersons likely comprehend these words. Second, the reading level of the patient population accessing those online sites was not assessed. Third, the readability instruments in this study did not evaluate the accuracy of the content, pictures, or tables of the PEMs. However, using 10 readability instruments allowed evaluation of many different readability aspects of the text. Fourth, because some websites identified in this study, such as Bonetumor.org, were written for patients as well as clinicians, the reading grade level of these sites may be higher than that of those sites written just for patients.

Conclusion

Because many orthopedic cancer patients rely on the Internet as a source of information, the need for online PEMs to match the reading skills of the patient population who accesses them is vital. However, this study shows that many organizations, academic training centers, and other entities need to update their online PEMs because all PEMs in this study had a mean readability grade level higher than the NIH recommendation. Further research needs to evaluate the effectiveness of other media, such as video, illustrations, and audio, to provide health information to patients. With many guidelines available that provide plans and advice to improve the readability of PEMs, research also must assess the most effective plans and advice in order to allow authors to focus their attention on 1 set of guidelines to improve the readability of their PEMs.

The diagnosis of cancer is a life-changing event for the patient as well as the patient’s family, friends, and relatives. Once diagnosed, most cancer patients want more information about their prognosis, future procedures, and/or treatment options.¹ Receiving such information has been shown to reduce patient anxiety, increase patient satisfaction with care, and improve self-care.^2-6 With the evolution of the Internet, patients in general^7-9 and, specifically, cancer patients^10-17 have turned to websites and online patient education materials (PEMs) to gather more health information.

For online PEMs to convey health information, their reading level must match the health literacy of the individuals who access them. Health literacy is the ability of an individual to gather and comprehend information about their condition to make the best decisions for their health.¹⁸ According to a report by the Institute of Medicine, 90 million American adults cannot properly use the US health care system because they do not possess adequate health literacy.¹⁸ Additionally, 36% of adults in the United States have basic or less-than-basic health literacy.¹⁹ This is starkly contrasted with the 12% of US adults who have proficient health literacy. A 2012 survey showed that about 31% of individuals who look for health information on the Internet have a high school education or less.⁸ In order to address the low health literacy of adults, the National Institutes of Health (NIH) has recommended that online PEMs be written at a sixth- to seventh-grade reading level.²⁰ 

Unfortunately, many online PEMs related to certain cancer^21-25 and orthopedic conditions^26-31 do not meet NIH recommendations. Only 1 study has specifically looked at PEMs related to an orthopedic cancer condition.³² Lam and colleagues³² evaluated the readability of osteosarcoma PEMs from 56 websites using only 2 readability instruments and identified 86% of the websites as having a greater than eighth-grade reading level. No study has thoroughly assessed the readability of PEMs about bone and soft-tissue sarcomas and related conditions nor has any used 10 different readability instruments. Since each readability instrument has different variables (eg, sentence length, number of paragraphs, or number of complex words), averaging the scores of 10 of these instruments may result in less bias.

The purpose of this study was to evaluate the readability of online PEMs concerning bone and soft-tissue sarcomas and related conditions. The online PEMs came from websites that sarcoma patients may visit to obtain information about their condition. Our hypothesis was that the majority of these online PEMs will have a higher reading level than the NIH recommendations.

Materials and Methods

In May 2013, we identified online PEMs that included background, diagnosis, tests, or treatments for bone and soft-tissue sarcomas and conditions that mimic bone sarcoma. We included articles from the Tumors section of the American Academy of Orthopaedic Surgeons (AAOS) website.³³ A second source of online PEMs came from a list of academic training centers created through the American Medical Association’s Fellowship and Residency Electronic Internet Database (FREIDA) with search criteria narrowed to orthopedic surgery. If we did not find PEMs of bone and soft-tissue cancers in the orthopedic department of a given academic training center’s website, we searched its cancer center website. We chose 4 programs with PEMs relevant to bone and soft-tissue sarcomas from each region in FREIDA for a balanced representation, except for the Territory region because it had only 1 academic training center and no relevant PEMs. Specialized websites, including Bonetumor.org, Sarcoma Alliance (Sarcomaalliance.org), and Sarcoma Foundation of America (Curesarcoma.org), were also evaluated. Within the Sarcoma Specialists section of the Sarcoma Alliance website,³⁴ sarcoma specialists who were not identified from the FREIDA search for academic training centers were selected for review.

Because 8 of 10 individuals looking for health information on the Internet start their investigation at search engines, we also looked for PEMs through a Google search (Google.com) of bone cancer, and evaluated the first 10 hits for PEMs.⁸ Of these 10 hits, 8 had relevant PEMs, which we searched for additional PEMs about bone and soft-tissue cancers and related conditions. We also conducted a Google search of the most common bone sarcoma and soft-tissue sarcoma, osteosarcoma and malignant fibrous histiocytoma, respectively, and found 2 additional websites with relevant PEMs. LaCoursiere and colleagues³⁵ surveyed cancer patients who used the Internet and found that they preferred WebMD (Webmd.com) and Medscape (Medscape.com) as sources for content about their medical condition.³⁵ WebMD had been identified in the Google search, and we gathered the PEMs from Medscape also. It is worth noting that some of these websites are written for patients as well as clinicians.

Text from these PEMs were copied and pasted into separate Microsoft Word documents (Microsoft, Redmond, Washington). Advertisements, pictures, picture text, hyperlinks, copyright notices, page navigation links, paragraphs with no text, and any text that was not related to the given condition were deleted from the document to format the text for the readability software. Then, each Microsoft Word document was uploaded into the software package Readability Studio Professional (RSP) Edition Version 2012.1 for Windows (Oleander Software, Vandalia, Ohio). The 10 distinct readability instruments that were used to gauge the readability of each document were the Flesch Reading Ease score (FRE), the New Fog Count, the New Automated Readability Index, the Coleman-Liau Index (CLI), the Fry readability graph, the New Dale-Chall formula (NDC), the Gunning Frequency of Gobbledygook (Gunning FOG), the Powers-Sumner-Kearl formula, the Simple Measure of Gobbledygook (SMOG), and the Raygor Estimate Graph.

The FRE’s formula takes the average number of words per sentence and average number of syllables per word to compute a score ranging from 0 to 100 with 0 being the hardest to read.³⁶ The New Fog Count tallies the number of sentences, easy words, and hard words (polysyllables) to calculate the grade level of the document.³⁷ The New Automated Readability Index takes the average characters per word and average words per sentence to calculate a grade level for the document.³⁷ The CLI randomly samples a few hundred words from the document, averages the number of letters and sentences per sample, and calculates an estimated grade level.³⁸ The Fry readability graph selects samples of 100 words from the document, averages the number of syllables and sentences per 100 words, plots these data points on a graph, with the intersection determining the reading level.³⁹ The NDC uses a list of 3000 familiar words that most fourth-grade students know.⁴⁰ The percentage of difficult words, which are not on the list of familiar words, and the average sentence length in words are used to calculate the reading grade level of the document. The Gunning FOG uses the average sentence length in words and the percentage of hard words from a sample of at least 100 words to determine the reading grade level of the document.⁴¹ The Powers-Sumner-Kearl formula uses the average sentence length and percentage of monosyllables from a 100-word sample passage to calculate the reading grade level.⁴² The SMOG formula counts the number of polysyllabic words from 30 sentences and calculates the reading grade level of the document.⁴³ In contrast to other formulas that test for 50% to 75% comprehension, the SMOG formula tests for 100% comprehension. As a result, the SMOG formula generally assigns a reading level 2 grades higher than the Dale-Chall level. The Raygor Estimate Graph selects a 100-word passage, counts the number of sentences and number of words with 6 or more letters, and plots the 2 variables on a graph to determine the reading grade level.⁴⁴ The software package calculated the results from each reading instrument and reported the mean grade level score
for each document.

Results

We identified a total of 72 websites with relevant PEMs and included them in this study. Of these 72 websites, 36 websites were academic training centers, 10 were Google search hits, and 21 were from the Sarcoma Alliance list of sarcoma specialists. The remaining 5 websites were AAOS, Bonetumor.org, Sarcoma Alliance, Sarcoma Foundation of America, and Medscape. A list of conditions and treatments that were considered relevant PEMs is found in Appendix 1. A total of 774 articles were obtained from the 72 websites.

None of the websites had a mean readability score of 7 (seventh grade) or lower (Figures 1A, 1B). Mid-America Sarcoma Institute’s PEMs had the lowest mean readability score, 8.9. The lowest readability score was 5.3, which the New Fog Count readability instrument calculated for Vanderbilt University Medical Center’s (VUMC’s) PEMs (Appendix 2). The mean readability score of all websites was 11.4 (range, 8.9-15.5) (Appendix 2).

Seventy of 72 websites (97%) had PEMs that were fairly difficult or difficult, according to the FRE analysis (Figure 2). The American Cancer Society and Mid-America Sarcoma Institute had PEMs that were written in plain English. Sixty-nine of 72 websites (96%) had PEMs with a readability score of 10 or higher, according to the Raygor readability estimate (Figure 3). Using this instrument, the scores of the American Cancer Society and the University of Pennsylvania–Joan Karnell Cancer Center were 9; Mid-America Sarcoma Institute’s score was 8. 

Discussion

Many cancer patients have turned to websites and online PEMs to gather health information about their condition.^10-17 Basch and colleagues¹⁰ reported almost a decade ago that 44% of cancer patients, as well as 60% of their companions, used the Internet to find cancer-related information.¹⁰ When LaCoursiere and colleagues³⁵ surveyed cancer patients, they found that patients handled their condition better and had less anxiety and uncertainty after using the Internet to find health information and support.³⁵ In addition, many orthopedic patients, specifically 46% of orthopedic community outpatients,⁴⁵ consult the Internet for information about their condition and future surgical procedures.^46,47

This study comprehensively evaluated the readability of online PEMs of bone and soft-tissue sarcomas and related conditions by using 10 different readability instruments. After identifying 72 websites and 774 articles, we found that all 72 websites’ PEMs had a mean readability score that did not meet the NIH recommendation of writing PEMs at a sixth- to seventh-grade reading level. These results are consistent with studies evaluating the readability of online PEMs related to other cancer conditions^21-25 and other orthopedic conditions.^26-31

The combination of low health literacy of many US adults and high reading grade levels of the majority of online PEMs is not conducive to patients’ better understanding their condition(s). Even individuals with high reading skills prefer information that is simpler to read.⁴⁸ In many areas of medicine, there is evidence that patients’ understanding of their condition has a positive impact on health outcomes, well-being, and the patient–physician relationship.^49-61 Regarding cancer patients, Davis and colleagues⁵⁴ and Peterson and colleagues⁵⁷ showed that lower health literacy contributes to less knowledge and lower rates of breast⁵⁴ and colorectal cancer⁵⁷ screening tests. Even low health literacy of family caregivers of cancer patients can result in increased stress and lack of communication of important medical information between caregiver and physician.⁵² Among cancer patients, poor health literacy has been associated with mental distress⁶⁰ as well as decreased compliance with treatment and lower involvement in clinical trials.⁵⁵

The disparity between patients’ health literacy and the readability of online PEMs needs to be addressed by finding methods to improve patients’ understanding of their condition and to lower the readability scores of online PEMs. Better communication between patient and physician may improve patients’ comprehension of their condition and different aspects of their care.^59,62-66 Doak and colleagues⁶³ recommend giving cancer patients the most important information first; presenting information to patients in smaller doses; intermittently asking patients questions; and incorporating graphs, tables, and drawings into communication with patients.⁶³ Additionally, allowing patients to repeat information they have just received/heard to the physician is another useful tool to improve patient education.^62,64-66

Another way to address the disparity between patients’ health literacy and the readability of online PEMs is to reduce the reading grade level of existing PEMs. According to results from this study and others, the majority of online PEMs are above the reading grade level of a significant number of US adults. Many available and inexpensive readability instruments allow authors to assess their articles’ readability. Many writing guidelines also exist to help authors improve the readability of their PEMs.^20,64,67-71 Living Word Vocabulary⁷⁰ and Plain Language⁷¹ help authors replace complex words or medical terms with simpler words.²⁹ Visual aids, audio, and video help patients with low health literacy remember the information.⁶⁴

Efforts to improve PEM readability are effective. Of all the websites reviewed, VUMC was identified as having PEMs with the lowest readability score (5.3). This score was reported by the New Fog Count readability instrument, which accounts for the number of sentences, easy words, and hard words. In 2011, VUMC formed the Department of Patient Education to review and update its online and printed PEMs to make sure patients could read them.⁷² Additionally, the mean readability scores of the websites of the National Cancer Institute and MedlinePlus are in the top 50% of the websites included in this study. The NIH sponsors both sites, which follow the NIH guidelines for writing online PEMs at a reading level suitable for individuals with lower health literacy.²⁰ These materials serve as potential models to improve the readability of PEMs, and, thus, help patients to better understand their condition, medical procedures, and/or treatment options.

To illustrate ways to improve the reading grade level of PEMs, we used the article “Ewing’s Sarcoma” from the AAOS website⁷³ and followed the NIH guidelines to improve the reading grade level of the article.²⁰ We identified complex words and defined them at an eighth-grade reading level. If that word was mentioned later in the article, simpler terminology was used instead of the initial complex word. For example, Ewing’s sarcoma was defined early and then referred to as bone tumor later in the article. We also identified every word that was 3 syllables or longer and used Microsoft Word’s thesaurus to replace those words with ones that were less than 3 syllables. Lastly, all sentences longer than 15 words were rewritten to be less than 15 words. After making these 3 changes to the article, the mean reading grade level dropped from 11.2 to 7.3. 

This study has limitations. First, some readability instruments evaluate the number of syllables per word or polysyllabic words as part of their formula and, thus, can underestimate or overestimate the reading grade level of a document. Some readability formulas consider medical terms such as ulna, femur, or carpal as “easy” words because they have 2 syllables, but many laypersons may not comprehend these words. On the other hand, some readability formulas consider medical terms such as medications, diagnosis, or radiation as “hard” words because they contain 3 or more syllables, but the majority of laypersons likely comprehend these words. Second, the reading level of the patient population accessing those online sites was not assessed. Third, the readability instruments in this study did not evaluate the accuracy of the content, pictures, or tables of the PEMs. However, using 10 readability instruments allowed evaluation of many different readability aspects of the text. Fourth, because some websites identified in this study, such as Bonetumor.org, were written for patients as well as clinicians, the reading grade level of these sites may be higher than that of those sites written just for patients.

Conclusion

Because many orthopedic cancer patients rely on the Internet as a source of information, the need for online PEMs to match the reading skills of the patient population who accesses them is vital. However, this study shows that many organizations, academic training centers, and other entities need to update their online PEMs because all PEMs in this study had a mean readability grade level higher than the NIH recommendation. Further research needs to evaluate the effectiveness of other media, such as video, illustrations, and audio, to provide health information to patients. With many guidelines available that provide plans and advice to improve the readability of PEMs, research also must assess the most effective plans and advice in order to allow authors to focus their attention on 1 set of guidelines to improve the readability of their PEMs.

Ulnar collateral ligament (UCL) reconstruction, commonly referred to as Tommy John surgery, is a well-described surgical treatment for elite athletes with a symptomatic, deficient UCL.^{1, 2} The procedure was first performed by the late Dr. Frank Jobe in 1974, described in 1986, and has undergone several modifications over the past 30 years.³ Different graft choices, tunnel positions, graft configurations, and tunnel fixation methods are just some of the alterations that have been made to the original Jobe technique.^4-6 With time, the index procedure has become more refined, with predictable outcomes in Major League Baseball (MLB) pitchers as well as other elite overhead throwing athletes.^2,7,8 However, though this surgery was originally described for elite athletes suffering from UCL deficiency, recent times have seen an increase of over 50% in the number of UCL reconstructions performed on high school–aged and younger athletes.⁹ Furthermore, in 2000, a total of 13 MLB pitchers underwent UCL reconstruction, while in 2012 this number increased nearly threefold to 32.² This paradigm shift of performing UCL reconstructions more frequently and on younger athletes raises a very important question: what is the role of the orthopedic surgeon in this epidemic?

UCL reconstruction has become a reliable procedure for MLB pitchers and other overhead throwing athletes.^7,10,11 Recent studies have reported that MLB pitchers who undergo UCL reconstruction return to pitch in the MLB 83% of the time, whereas only 3% fail to return to pitch in either MLB or the minor league.² Furthermore, pitchers who undergo UCL reconstruction perform similarly after surgery as prior to their UCL reconstruction, with fewer innings pitched after surgery, but, more importantly, a lower earned run average (ERA) and walks plus hits per inning pitched (WHIP) after surgery. These last 2 statistics, known as sabermetrics, evaluate the pitcher’s effectiveness; the fact that these are improved after surgery is reassuring for pitchers who undergo this procedure. However, it must be recognized that these pitchers pitched fewer innings after surgery.

There has been a sharp increase in the number of MLB pitchers who have undergone UCL reconstruction in recent years, especially the past 3 seasons, in which over 60 pitchers have had Tommy John surgery.² This increase, however, is not confined to MLB pitchers. High school–aged pitchers have also been part of this drastic rise in the number of UCL reconstructions performed throughout the country. Dr. James Andrews and colleagues noted a 50% increase from 1988-1994 to 1995-2003 in the proportion of high school–aged pitchers who underwent UCL reconstruction (while the absolute number increased from 7 to 77 in high school–aged players compared with 85 to 609 in adult athletes).⁹ Given the increase in MLB pitchers over the past few years, it is likely this number has also increased among adolescent pitchers.

This data again raises the question: what is the role of the orthopedic surgeon in this epidemic? There are many plausible responses, but in my opinion, there is one answer that surpasses the others. As a trained professional, surgeons are tasked with the responsibility of looking out for the best interest of their patients, even when this conflicts with the patient’s, or the patient’s parent’s or coach’s desires. This includes injury prevention, such as instituting pitch counts and developing products that allow coaches to determine when a pitcher may be at risk for injury from fatigue, as well as injury treatment.¹² It is difficult for a patient to understand the gravity of surgery and the rehabilitation process, specifically a procedure as involved as UCL reconstruction, and especially if the patient is an adolescent who has their outlook clouded by the fact that they believe they will be the next MLB star pitcher. The reality is that the National Collegiate Athletic Association (NCAA)¹³ has released data that has demonstrated that only 6.8% of high school baseball players will play baseball in college. Furthermore, only 9.4% of college baseball players will reach the professional level. That equates to 0.5%, or 1 in 200 high school players who will eventually play professional baseball.¹³ However, the reverse of this is also true, that out of every 200 players, 1 will make it to the major leagues, and that 1 player could be the patient in question. Hence, the purpose of this data is to show parents and athletes that, while they do have a chance of playing professional, and certainly collegiate, baseball, that percentage must be weighed against the risks of surgery.

MLB pitchers who have an endless supply of rehabilitation facilities, trainers, etc, do not return to pitching competitively and consistently in the majors for more than 15 months after UCL reconstruction.² The time commitment and rehabilitation required for these patients is staggering.^14,15 Furthermore, parents of these children who are consenting for them also have a difficult time comprehending the workload they are signing their child up for. Some parents believe this surgery will help their child throw faster, longer, and more accurately—beliefs that numerous studies have shown to be flat-out inaccurate. In fact, pitchers tend to lose a slight amount of velocity and accuracy after UCL reconstruction.^11,16 Ahmad and colleagues¹⁷ administered a questionnaire to 189 players, 15 coaches, and 31 parents about the indications, risks, benefits, etc, regarding UCL reconstruction to determine the public’s perception regarding this surgery. The results demonstrated that the public, including coaches, have a significantly skewed perception of exactly how serious this surgery is. The study showed that 28% of players and 20% of coaches believed the pitcher’s performance would be improved after surgery, and, more strikingly, 26% of collegiate athletes, 30% percent of coaches, 37% of parents, and 51% of high school athletes believed UCL reconstruction should be performed as a prophylactic procedure to enhance performance in an uninjured athlete.¹⁷

Henceforth, it becomes the surgeon’s responsibility to ensure that both the patient and the parents understand what the surgery and rehabilitation process entails, to keep the expectations of the patient and his or her family realistic, and to counsel these patients on alternative options with lower risks. As Ahmad and colleagues¹⁷ demonstrated, this is not an easy task given the public’s preconceived notions. Many patients, especially patients of the younger generation, seem to be willing to jump to surgery as the first option for treatment without having truly tried any nonoperative measures, because they believe surgery to be a quick, easy, and definitive answer. This is not always the case, and a trial of nonoperative treatment, including rest, ice, physical therapy, and possibly platelet-rich plasma (PRP), should be instituted for high school–aged players who present with UCL insufficiency prior to discussing surgery.^18,19

Medial UCL reconstruction is a successful procedure for elite MLB athletes. However, UCL reconstruction is becoming a victim of its own success as younger and younger athletes who will likely never play at the major league level are undergoing this procedure at an alarming rate. This is an epidemic which must be addressed by surgeons, coaches, and parents alike to curb the beliefs that UCL reconstruction will make high school–aged pitchers more successful. This procedure should not be performed prophylactically on an athlete of any age, especially those in high school. Further studies on the effectiveness of both nonoperative rest and rehabilitation and of PRP on partial-thickness UCL tears are warranted. New technology in the form of a compression sleeve with imbedded sensors to track the biomechanics of a pitcher’s elbow has been released and will hopefully provide information to coaches about when pitchers’ elbows begin to fatigue based on several biomechanical parameters.¹² The future of UCL reconstruction is still fluid, and with proper prevention strategies, nonoperative treatment, indications, and preoperative discussions, the Tommy John epidemic can be cured. ◾

Ulnar collateral ligament (UCL) reconstruction, commonly referred to as Tommy John surgery, is a well-described surgical treatment for elite athletes with a symptomatic, deficient UCL.^{1, 2} The procedure was first performed by the late Dr. Frank Jobe in 1974, described in 1986, and has undergone several modifications over the past 30 years.³ Different graft choices, tunnel positions, graft configurations, and tunnel fixation methods are just some of the alterations that have been made to the original Jobe technique.^4-6 With time, the index procedure has become more refined, with predictable outcomes in Major League Baseball (MLB) pitchers as well as other elite overhead throwing athletes.^2,7,8 However, though this surgery was originally described for elite athletes suffering from UCL deficiency, recent times have seen an increase of over 50% in the number of UCL reconstructions performed on high school–aged and younger athletes.⁹ Furthermore, in 2000, a total of 13 MLB pitchers underwent UCL reconstruction, while in 2012 this number increased nearly threefold to 32.² This paradigm shift of performing UCL reconstructions more frequently and on younger athletes raises a very important question: what is the role of the orthopedic surgeon in this epidemic?

UCL reconstruction has become a reliable procedure for MLB pitchers and other overhead throwing athletes.^7,10,11 Recent studies have reported that MLB pitchers who undergo UCL reconstruction return to pitch in the MLB 83% of the time, whereas only 3% fail to return to pitch in either MLB or the minor league.² Furthermore, pitchers who undergo UCL reconstruction perform similarly after surgery as prior to their UCL reconstruction, with fewer innings pitched after surgery, but, more importantly, a lower earned run average (ERA) and walks plus hits per inning pitched (WHIP) after surgery. These last 2 statistics, known as sabermetrics, evaluate the pitcher’s effectiveness; the fact that these are improved after surgery is reassuring for pitchers who undergo this procedure. However, it must be recognized that these pitchers pitched fewer innings after surgery.

There has been a sharp increase in the number of MLB pitchers who have undergone UCL reconstruction in recent years, especially the past 3 seasons, in which over 60 pitchers have had Tommy John surgery.² This increase, however, is not confined to MLB pitchers. High school–aged pitchers have also been part of this drastic rise in the number of UCL reconstructions performed throughout the country. Dr. James Andrews and colleagues noted a 50% increase from 1988-1994 to 1995-2003 in the proportion of high school–aged pitchers who underwent UCL reconstruction (while the absolute number increased from 7 to 77 in high school–aged players compared with 85 to 609 in adult athletes).⁹ Given the increase in MLB pitchers over the past few years, it is likely this number has also increased among adolescent pitchers.

This data again raises the question: what is the role of the orthopedic surgeon in this epidemic? There are many plausible responses, but in my opinion, there is one answer that surpasses the others. As a trained professional, surgeons are tasked with the responsibility of looking out for the best interest of their patients, even when this conflicts with the patient’s, or the patient’s parent’s or coach’s desires. This includes injury prevention, such as instituting pitch counts and developing products that allow coaches to determine when a pitcher may be at risk for injury from fatigue, as well as injury treatment.¹² It is difficult for a patient to understand the gravity of surgery and the rehabilitation process, specifically a procedure as involved as UCL reconstruction, and especially if the patient is an adolescent who has their outlook clouded by the fact that they believe they will be the next MLB star pitcher. The reality is that the National Collegiate Athletic Association (NCAA)¹³ has released data that has demonstrated that only 6.8% of high school baseball players will play baseball in college. Furthermore, only 9.4% of college baseball players will reach the professional level. That equates to 0.5%, or 1 in 200 high school players who will eventually play professional baseball.¹³ However, the reverse of this is also true, that out of every 200 players, 1 will make it to the major leagues, and that 1 player could be the patient in question. Hence, the purpose of this data is to show parents and athletes that, while they do have a chance of playing professional, and certainly collegiate, baseball, that percentage must be weighed against the risks of surgery.

MLB pitchers who have an endless supply of rehabilitation facilities, trainers, etc, do not return to pitching competitively and consistently in the majors for more than 15 months after UCL reconstruction.² The time commitment and rehabilitation required for these patients is staggering.^14,15 Furthermore, parents of these children who are consenting for them also have a difficult time comprehending the workload they are signing their child up for. Some parents believe this surgery will help their child throw faster, longer, and more accurately—beliefs that numerous studies have shown to be flat-out inaccurate. In fact, pitchers tend to lose a slight amount of velocity and accuracy after UCL reconstruction.^11,16 Ahmad and colleagues¹⁷ administered a questionnaire to 189 players, 15 coaches, and 31 parents about the indications, risks, benefits, etc, regarding UCL reconstruction to determine the public’s perception regarding this surgery. The results demonstrated that the public, including coaches, have a significantly skewed perception of exactly how serious this surgery is. The study showed that 28% of players and 20% of coaches believed the pitcher’s performance would be improved after surgery, and, more strikingly, 26% of collegiate athletes, 30% percent of coaches, 37% of parents, and 51% of high school athletes believed UCL reconstruction should be performed as a prophylactic procedure to enhance performance in an uninjured athlete.¹⁷

Henceforth, it becomes the surgeon’s responsibility to ensure that both the patient and the parents understand what the surgery and rehabilitation process entails, to keep the expectations of the patient and his or her family realistic, and to counsel these patients on alternative options with lower risks. As Ahmad and colleagues¹⁷ demonstrated, this is not an easy task given the public’s preconceived notions. Many patients, especially patients of the younger generation, seem to be willing to jump to surgery as the first option for treatment without having truly tried any nonoperative measures, because they believe surgery to be a quick, easy, and definitive answer. This is not always the case, and a trial of nonoperative treatment, including rest, ice, physical therapy, and possibly platelet-rich plasma (PRP), should be instituted for high school–aged players who present with UCL insufficiency prior to discussing surgery.^18,19

Medial UCL reconstruction is a successful procedure for elite MLB athletes. However, UCL reconstruction is becoming a victim of its own success as younger and younger athletes who will likely never play at the major league level are undergoing this procedure at an alarming rate. This is an epidemic which must be addressed by surgeons, coaches, and parents alike to curb the beliefs that UCL reconstruction will make high school–aged pitchers more successful. This procedure should not be performed prophylactically on an athlete of any age, especially those in high school. Further studies on the effectiveness of both nonoperative rest and rehabilitation and of PRP on partial-thickness UCL tears are warranted. New technology in the form of a compression sleeve with imbedded sensors to track the biomechanics of a pitcher’s elbow has been released and will hopefully provide information to coaches about when pitchers’ elbows begin to fatigue based on several biomechanical parameters.¹² The future of UCL reconstruction is still fluid, and with proper prevention strategies, nonoperative treatment, indications, and preoperative discussions, the Tommy John epidemic can be cured. ◾

Ulnar collateral ligament (UCL) reconstruction, commonly referred to as Tommy John surgery, is a well-described surgical treatment for elite athletes with a symptomatic, deficient UCL.^{1, 2} The procedure was first performed by the late Dr. Frank Jobe in 1974, described in 1986, and has undergone several modifications over the past 30 years.³ Different graft choices, tunnel positions, graft configurations, and tunnel fixation methods are just some of the alterations that have been made to the original Jobe technique.^4-6 With time, the index procedure has become more refined, with predictable outcomes in Major League Baseball (MLB) pitchers as well as other elite overhead throwing athletes.^2,7,8 However, though this surgery was originally described for elite athletes suffering from UCL deficiency, recent times have seen an increase of over 50% in the number of UCL reconstructions performed on high school–aged and younger athletes.⁹ Furthermore, in 2000, a total of 13 MLB pitchers underwent UCL reconstruction, while in 2012 this number increased nearly threefold to 32.² This paradigm shift of performing UCL reconstructions more frequently and on younger athletes raises a very important question: what is the role of the orthopedic surgeon in this epidemic?

UCL reconstruction has become a reliable procedure for MLB pitchers and other overhead throwing athletes.^7,10,11 Recent studies have reported that MLB pitchers who undergo UCL reconstruction return to pitch in the MLB 83% of the time, whereas only 3% fail to return to pitch in either MLB or the minor league.² Furthermore, pitchers who undergo UCL reconstruction perform similarly after surgery as prior to their UCL reconstruction, with fewer innings pitched after surgery, but, more importantly, a lower earned run average (ERA) and walks plus hits per inning pitched (WHIP) after surgery. These last 2 statistics, known as sabermetrics, evaluate the pitcher’s effectiveness; the fact that these are improved after surgery is reassuring for pitchers who undergo this procedure. However, it must be recognized that these pitchers pitched fewer innings after surgery.

There has been a sharp increase in the number of MLB pitchers who have undergone UCL reconstruction in recent years, especially the past 3 seasons, in which over 60 pitchers have had Tommy John surgery.² This increase, however, is not confined to MLB pitchers. High school–aged pitchers have also been part of this drastic rise in the number of UCL reconstructions performed throughout the country. Dr. James Andrews and colleagues noted a 50% increase from 1988-1994 to 1995-2003 in the proportion of high school–aged pitchers who underwent UCL reconstruction (while the absolute number increased from 7 to 77 in high school–aged players compared with 85 to 609 in adult athletes).⁹ Given the increase in MLB pitchers over the past few years, it is likely this number has also increased among adolescent pitchers.

This data again raises the question: what is the role of the orthopedic surgeon in this epidemic? There are many plausible responses, but in my opinion, there is one answer that surpasses the others. As a trained professional, surgeons are tasked with the responsibility of looking out for the best interest of their patients, even when this conflicts with the patient’s, or the patient’s parent’s or coach’s desires. This includes injury prevention, such as instituting pitch counts and developing products that allow coaches to determine when a pitcher may be at risk for injury from fatigue, as well as injury treatment.¹² It is difficult for a patient to understand the gravity of surgery and the rehabilitation process, specifically a procedure as involved as UCL reconstruction, and especially if the patient is an adolescent who has their outlook clouded by the fact that they believe they will be the next MLB star pitcher. The reality is that the National Collegiate Athletic Association (NCAA)¹³ has released data that has demonstrated that only 6.8% of high school baseball players will play baseball in college. Furthermore, only 9.4% of college baseball players will reach the professional level. That equates to 0.5%, or 1 in 200 high school players who will eventually play professional baseball.¹³ However, the reverse of this is also true, that out of every 200 players, 1 will make it to the major leagues, and that 1 player could be the patient in question. Hence, the purpose of this data is to show parents and athletes that, while they do have a chance of playing professional, and certainly collegiate, baseball, that percentage must be weighed against the risks of surgery.

MLB pitchers who have an endless supply of rehabilitation facilities, trainers, etc, do not return to pitching competitively and consistently in the majors for more than 15 months after UCL reconstruction.² The time commitment and rehabilitation required for these patients is staggering.^14,15 Furthermore, parents of these children who are consenting for them also have a difficult time comprehending the workload they are signing their child up for. Some parents believe this surgery will help their child throw faster, longer, and more accurately—beliefs that numerous studies have shown to be flat-out inaccurate. In fact, pitchers tend to lose a slight amount of velocity and accuracy after UCL reconstruction.^11,16 Ahmad and colleagues¹⁷ administered a questionnaire to 189 players, 15 coaches, and 31 parents about the indications, risks, benefits, etc, regarding UCL reconstruction to determine the public’s perception regarding this surgery. The results demonstrated that the public, including coaches, have a significantly skewed perception of exactly how serious this surgery is. The study showed that 28% of players and 20% of coaches believed the pitcher’s performance would be improved after surgery, and, more strikingly, 26% of collegiate athletes, 30% percent of coaches, 37% of parents, and 51% of high school athletes believed UCL reconstruction should be performed as a prophylactic procedure to enhance performance in an uninjured athlete.¹⁷

Henceforth, it becomes the surgeon’s responsibility to ensure that both the patient and the parents understand what the surgery and rehabilitation process entails, to keep the expectations of the patient and his or her family realistic, and to counsel these patients on alternative options with lower risks. As Ahmad and colleagues¹⁷ demonstrated, this is not an easy task given the public’s preconceived notions. Many patients, especially patients of the younger generation, seem to be willing to jump to surgery as the first option for treatment without having truly tried any nonoperative measures, because they believe surgery to be a quick, easy, and definitive answer. This is not always the case, and a trial of nonoperative treatment, including rest, ice, physical therapy, and possibly platelet-rich plasma (PRP), should be instituted for high school–aged players who present with UCL insufficiency prior to discussing surgery.^18,19

Medial UCL reconstruction is a successful procedure for elite MLB athletes. However, UCL reconstruction is becoming a victim of its own success as younger and younger athletes who will likely never play at the major league level are undergoing this procedure at an alarming rate. This is an epidemic which must be addressed by surgeons, coaches, and parents alike to curb the beliefs that UCL reconstruction will make high school–aged pitchers more successful. This procedure should not be performed prophylactically on an athlete of any age, especially those in high school. Further studies on the effectiveness of both nonoperative rest and rehabilitation and of PRP on partial-thickness UCL tears are warranted. New technology in the form of a compression sleeve with imbedded sensors to track the biomechanics of a pitcher’s elbow has been released and will hopefully provide information to coaches about when pitchers’ elbows begin to fatigue based on several biomechanical parameters.¹² The future of UCL reconstruction is still fluid, and with proper prevention strategies, nonoperative treatment, indications, and preoperative discussions, the Tommy John epidemic can be cured. ◾

Soft-tissue sarcomas are quite rare, with an annual incidence of 20 to 30 per 1,000,000 persons in the United States.¹ Because of their heterogeneous presentation, they remain a diagnostic challenge and are often initially confused for more common, benign disorders.² Chronic expanding hematoma, first described by Friedlander and colleagues³ in 1968, is a rare entity that is particularly difficult to distinguish from soft-tissue malignancy.^3-5 Chronic expanding hematoma is defined as a hematoma that gradually expands over 1 month or longer, is absent of neoplastic change on histologic sections, and does not occur in the setting of coagulopathy.⁶

Typically associated with remote trauma, these lesions often present as a slowly growing mass on the anterior or lateral thigh, calf, or buttock.^3-4,7-9 They have been reported to persist as long as 46 years, with sizes ranging from 3 to 55 cm in maximum diameter.⁷ On imaging, they have a cystic appearance with a dense fibrous capsule.^7-8 Most cases resolve uneventfully after drainage or marginal excision, although some cases require repeated intervention.⁷ This case report describes a morbidly obese patient with a chronic expanding hematoma in the distal posterior thigh whose definitive treatment was delayed 6 months because of her pregnancy status and inability to lie prone for open biopsy. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 27-year-old morbidly obese woman, who was pregnant at 12 weeks gestation, was seen in an orthopedic oncology clinic with a 1-month history of a slowly growing, painful posterior thigh mass. She had no history of cancer or bleeding disorder, and denied a history of trauma or constitutional symptoms consistent with malignancy. Coagulation studies were normal. Magnetic resonance imaging (MRI) obtained 2 weeks prior in the emergency room showed a cystic lesion with mass-like components in the posterior compartment of the distal right thigh, measuring 17 cm longitudinally. The lesion was located adjacent to, but not involving, the sciatic nerve and femoral vasculature. On initial examination, the large soft-tissue mass was evident and moderately painful to palpation; no skin changes were noted, and the patient had a normal sensorimotor examination. Fine-needle aspiration was performed, which resulted in amorphous debris consistent with hematoma.

Repeat MRI 2 months later showed increased size of the lesion (9.5×10.5 cm axial, 22.0 cm craniocaudal). Although most findings of a more extensive imaging protocol, including precontrast and postcontrast sequences, were consistent with hematoma, the lesion also had several characteristics that indicated soft-tissue sarcoma. Specifically, findings suggestive of chronic hematoma included the hyperintense short tau inversion recovery (STIR) T1/T2 signal of the cystic component consistent with proteinaceous fluid and the low STIR TI/T2 signal of the periphery consistent with a rim of hemosiderin (Figure 1). Additionally, the cystic component of the lesion had multiple fine septations that are atypical for a hematoma (Figure 1), and several lymph nodes greater than 1.7 cm in short axis were noted in the anterior thigh and hemipelvis that were suspicious of metastatic lymphadenopathy. The encapsulated appearance of the lesion with a sharply defined margin and short transition zone were also reassuring findings for a benign lesion (Figures 1, 2A, 2B). However, several findings were identified that suggested soft-tissue sarcoma, including a nodular soft-tissue component on the medial wall of the lesion that had heterogeneous enhancement with contrast (Figure 2B). We, therefore, proceeded with ultrasound-guided core needle biopsy of the mass and cytologic sampling of the fluid components, which were again consistent with hematoma; no evidence of internal vascular flow was noted on Doppler ultrasound. Ultrasound-guided right inguinal lymph node biopsy was also performed and was negative for malignancy. Because of her large body habitus and pregnancy status, it was agreed that open biopsy should be delayed until after delivery to avoid placing the patient in a prone position.

The patient visited the emergency room several times during the following months because of intermittent exacerbations of her lower extremity pain, swelling, and occasional paresthesias. About 6 months after initial presentation, repeat MRI again showed increased size of the mass (13.5×13.5 cm axial, 28 cm craniocaudal). There was also increased displacement of the adjacent neurovascular structures but no evidence of deep vein thrombosis. Because of concerns about the increased symptomatology of her thigh mass and possible sampling error of the previous biopsies, an elective cesarean section was performed at 35 weeks gestation. One week later, after clearance by her obstetrician, we proceeded with open biopsy of the mass in prone position. Initial sampling was negative for malignancy on frozen section; then, we expressed 1.75 L of brown fluid and solidified blood products, irrigated copiously, and placed a surgical drain. The permanent histologic specimens were again consistent with hematoma, and microbial cultures were negative. A week later, the patient accidentally removed her drain, and she presented with a fever (101°F) on postoperative day (POD) 15. Computed tomography showed reaccumulation of fluid; duplex ultrasound was negative. She was placed on cephalexin and underwent ultrasound-guided replacement of the drain with removal of an additional 750 mL fluid on POD 20. She drained an additional 150 to 200 mL/d for 1 month, with marked improvement in her leg swelling and knee range of motion. The drainage decreased during the next 3 weeks, and the drain was removed on POD 75.

Discussion

The presence of a hematoma in the extremities is usually a straightforward diagnosis. However, the unusual circumstances of this case highlight all the indications for investigation for possible soft-tissue sarcoma when a patient presents with what appears to be a benign condition.

Hematomas are rare in the absence of trauma or coagulopathy, with chronic expansion of hematomas rarer still.^4,7,10-11 The patient had no evidence of coagulopathy because of her ability to have an uncomplicated pregnancy and elective cesarean section. She denied a history of trauma, and the location of her hematoma at the posterior distal thigh is an uncommon site of injury. In this setting, fine-needle aspiration and serial imaging to assess for progressive increase in lesion size were indicated to rule out malignancy.²

MRI is the gold-standard imaging modality for distinguishing soft-tissue masses from hematomas.^5,12-14 Unlike the typical appearance of a hematoma, sarcomas of the soft-tissue extremities are often complex cystic lesions with multiple septations, internal soft-tissue components, and relatively ill-defined margins.^15-17 However, as a hematoma becomes chronic, it can develop a fibrinous capsule, and the contents can manifest an atypical, heterogeneous appearance from scattered, progressive accumulation of blood products that is essentially indistinguishable from sarcomas on imaging.⁵

Because of the expansion of the hematoma and the atypical appearance of the mass on imaging, repeated core biopsy and, eventually, open biopsy were indicated, despite a preliminary negative diagnosis based on fine-needle aspiration. This resulted from the possibility of sampling error that is particularly relevant to cystic sarcomas, because only portions of the mass may be composed of malignant cells.² An unusual aspect of this case is the regional lymphadenopathy noted on MRI, because regional lymphatic spread is a known mechanism of metastasis in soft-tissue sarcomas.¹⁸ However, the inguinal biopsies showed a chronic inflammatory infiltrate and were negative for malignancy, and enlarged nodes were not seen on imaging several months later. It is possible that the lymphadenopathy resulted from an unrelated process; alternatively, it may have been secondary to impaired lymphatic drainage because of mass effect from the hematoma, which also caused temporary lower extremity swelling.

The distal posterior thigh is an unreported location for a chronic expanding hematoma. Our patient developed slowly progressive lower-limb swelling and, eventually, paresthesias because of displacement of the neurovasculature, an unusual sequela that was recently reported in a similar case of an acute spontaneous hematoma in a patient on warfarin.¹⁹ Rupture of a Baker cyst is a possible inciting factor in our patient, although the proximal location of the lesion and the clearly defined tissue plane on MRI between the hematoma and the popliteal region make this unlikely. Finally, the patient’s lesion showed no evidence of vascular flow on Doppler ultrasonography, although giant hematomas secondary to popliteal aneurysm rupture have been reported.^20-22

Conclusion

This case highlights the features of a chronic expanding hematoma that can suggest soft-tissue sarcoma and shows the recommended diagnostic steps to differentiate the 2 conditions. This case also describes an unreported location for a chronic expanding hematoma with resulting progressive neurovascular displacement caused by mass effect. We recommend careful monitoring of patients with similarly expansile lesions in this region for signs of neurovascular compromise.

Soft-tissue sarcomas are quite rare, with an annual incidence of 20 to 30 per 1,000,000 persons in the United States.¹ Because of their heterogeneous presentation, they remain a diagnostic challenge and are often initially confused for more common, benign disorders.² Chronic expanding hematoma, first described by Friedlander and colleagues³ in 1968, is a rare entity that is particularly difficult to distinguish from soft-tissue malignancy.^3-5 Chronic expanding hematoma is defined as a hematoma that gradually expands over 1 month or longer, is absent of neoplastic change on histologic sections, and does not occur in the setting of coagulopathy.⁶

Typically associated with remote trauma, these lesions often present as a slowly growing mass on the anterior or lateral thigh, calf, or buttock.^3-4,7-9 They have been reported to persist as long as 46 years, with sizes ranging from 3 to 55 cm in maximum diameter.⁷ On imaging, they have a cystic appearance with a dense fibrous capsule.^7-8 Most cases resolve uneventfully after drainage or marginal excision, although some cases require repeated intervention.⁷ This case report describes a morbidly obese patient with a chronic expanding hematoma in the distal posterior thigh whose definitive treatment was delayed 6 months because of her pregnancy status and inability to lie prone for open biopsy. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 27-year-old morbidly obese woman, who was pregnant at 12 weeks gestation, was seen in an orthopedic oncology clinic with a 1-month history of a slowly growing, painful posterior thigh mass. She had no history of cancer or bleeding disorder, and denied a history of trauma or constitutional symptoms consistent with malignancy. Coagulation studies were normal. Magnetic resonance imaging (MRI) obtained 2 weeks prior in the emergency room showed a cystic lesion with mass-like components in the posterior compartment of the distal right thigh, measuring 17 cm longitudinally. The lesion was located adjacent to, but not involving, the sciatic nerve and femoral vasculature. On initial examination, the large soft-tissue mass was evident and moderately painful to palpation; no skin changes were noted, and the patient had a normal sensorimotor examination. Fine-needle aspiration was performed, which resulted in amorphous debris consistent with hematoma.

Repeat MRI 2 months later showed increased size of the lesion (9.5×10.5 cm axial, 22.0 cm craniocaudal). Although most findings of a more extensive imaging protocol, including precontrast and postcontrast sequences, were consistent with hematoma, the lesion also had several characteristics that indicated soft-tissue sarcoma. Specifically, findings suggestive of chronic hematoma included the hyperintense short tau inversion recovery (STIR) T1/T2 signal of the cystic component consistent with proteinaceous fluid and the low STIR TI/T2 signal of the periphery consistent with a rim of hemosiderin (Figure 1). Additionally, the cystic component of the lesion had multiple fine septations that are atypical for a hematoma (Figure 1), and several lymph nodes greater than 1.7 cm in short axis were noted in the anterior thigh and hemipelvis that were suspicious of metastatic lymphadenopathy. The encapsulated appearance of the lesion with a sharply defined margin and short transition zone were also reassuring findings for a benign lesion (Figures 1, 2A, 2B). However, several findings were identified that suggested soft-tissue sarcoma, including a nodular soft-tissue component on the medial wall of the lesion that had heterogeneous enhancement with contrast (Figure 2B). We, therefore, proceeded with ultrasound-guided core needle biopsy of the mass and cytologic sampling of the fluid components, which were again consistent with hematoma; no evidence of internal vascular flow was noted on Doppler ultrasound. Ultrasound-guided right inguinal lymph node biopsy was also performed and was negative for malignancy. Because of her large body habitus and pregnancy status, it was agreed that open biopsy should be delayed until after delivery to avoid placing the patient in a prone position.

The patient visited the emergency room several times during the following months because of intermittent exacerbations of her lower extremity pain, swelling, and occasional paresthesias. About 6 months after initial presentation, repeat MRI again showed increased size of the mass (13.5×13.5 cm axial, 28 cm craniocaudal). There was also increased displacement of the adjacent neurovascular structures but no evidence of deep vein thrombosis. Because of concerns about the increased symptomatology of her thigh mass and possible sampling error of the previous biopsies, an elective cesarean section was performed at 35 weeks gestation. One week later, after clearance by her obstetrician, we proceeded with open biopsy of the mass in prone position. Initial sampling was negative for malignancy on frozen section; then, we expressed 1.75 L of brown fluid and solidified blood products, irrigated copiously, and placed a surgical drain. The permanent histologic specimens were again consistent with hematoma, and microbial cultures were negative. A week later, the patient accidentally removed her drain, and she presented with a fever (101°F) on postoperative day (POD) 15. Computed tomography showed reaccumulation of fluid; duplex ultrasound was negative. She was placed on cephalexin and underwent ultrasound-guided replacement of the drain with removal of an additional 750 mL fluid on POD 20. She drained an additional 150 to 200 mL/d for 1 month, with marked improvement in her leg swelling and knee range of motion. The drainage decreased during the next 3 weeks, and the drain was removed on POD 75.

Discussion

The presence of a hematoma in the extremities is usually a straightforward diagnosis. However, the unusual circumstances of this case highlight all the indications for investigation for possible soft-tissue sarcoma when a patient presents with what appears to be a benign condition.

Hematomas are rare in the absence of trauma or coagulopathy, with chronic expansion of hematomas rarer still.^4,7,10-11 The patient had no evidence of coagulopathy because of her ability to have an uncomplicated pregnancy and elective cesarean section. She denied a history of trauma, and the location of her hematoma at the posterior distal thigh is an uncommon site of injury. In this setting, fine-needle aspiration and serial imaging to assess for progressive increase in lesion size were indicated to rule out malignancy.²

MRI is the gold-standard imaging modality for distinguishing soft-tissue masses from hematomas.^5,12-14 Unlike the typical appearance of a hematoma, sarcomas of the soft-tissue extremities are often complex cystic lesions with multiple septations, internal soft-tissue components, and relatively ill-defined margins.^15-17 However, as a hematoma becomes chronic, it can develop a fibrinous capsule, and the contents can manifest an atypical, heterogeneous appearance from scattered, progressive accumulation of blood products that is essentially indistinguishable from sarcomas on imaging.⁵

Because of the expansion of the hematoma and the atypical appearance of the mass on imaging, repeated core biopsy and, eventually, open biopsy were indicated, despite a preliminary negative diagnosis based on fine-needle aspiration. This resulted from the possibility of sampling error that is particularly relevant to cystic sarcomas, because only portions of the mass may be composed of malignant cells.² An unusual aspect of this case is the regional lymphadenopathy noted on MRI, because regional lymphatic spread is a known mechanism of metastasis in soft-tissue sarcomas.¹⁸ However, the inguinal biopsies showed a chronic inflammatory infiltrate and were negative for malignancy, and enlarged nodes were not seen on imaging several months later. It is possible that the lymphadenopathy resulted from an unrelated process; alternatively, it may have been secondary to impaired lymphatic drainage because of mass effect from the hematoma, which also caused temporary lower extremity swelling.

The distal posterior thigh is an unreported location for a chronic expanding hematoma. Our patient developed slowly progressive lower-limb swelling and, eventually, paresthesias because of displacement of the neurovasculature, an unusual sequela that was recently reported in a similar case of an acute spontaneous hematoma in a patient on warfarin.¹⁹ Rupture of a Baker cyst is a possible inciting factor in our patient, although the proximal location of the lesion and the clearly defined tissue plane on MRI between the hematoma and the popliteal region make this unlikely. Finally, the patient’s lesion showed no evidence of vascular flow on Doppler ultrasonography, although giant hematomas secondary to popliteal aneurysm rupture have been reported.^20-22

Conclusion

This case highlights the features of a chronic expanding hematoma that can suggest soft-tissue sarcoma and shows the recommended diagnostic steps to differentiate the 2 conditions. This case also describes an unreported location for a chronic expanding hematoma with resulting progressive neurovascular displacement caused by mass effect. We recommend careful monitoring of patients with similarly expansile lesions in this region for signs of neurovascular compromise.

Soft-tissue sarcomas are quite rare, with an annual incidence of 20 to 30 per 1,000,000 persons in the United States.¹ Because of their heterogeneous presentation, they remain a diagnostic challenge and are often initially confused for more common, benign disorders.² Chronic expanding hematoma, first described by Friedlander and colleagues³ in 1968, is a rare entity that is particularly difficult to distinguish from soft-tissue malignancy.^3-5 Chronic expanding hematoma is defined as a hematoma that gradually expands over 1 month or longer, is absent of neoplastic change on histologic sections, and does not occur in the setting of coagulopathy.⁶

Typically associated with remote trauma, these lesions often present as a slowly growing mass on the anterior or lateral thigh, calf, or buttock.^3-4,7-9 They have been reported to persist as long as 46 years, with sizes ranging from 3 to 55 cm in maximum diameter.⁷ On imaging, they have a cystic appearance with a dense fibrous capsule.^7-8 Most cases resolve uneventfully after drainage or marginal excision, although some cases require repeated intervention.⁷ This case report describes a morbidly obese patient with a chronic expanding hematoma in the distal posterior thigh whose definitive treatment was delayed 6 months because of her pregnancy status and inability to lie prone for open biopsy. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 27-year-old morbidly obese woman, who was pregnant at 12 weeks gestation, was seen in an orthopedic oncology clinic with a 1-month history of a slowly growing, painful posterior thigh mass. She had no history of cancer or bleeding disorder, and denied a history of trauma or constitutional symptoms consistent with malignancy. Coagulation studies were normal. Magnetic resonance imaging (MRI) obtained 2 weeks prior in the emergency room showed a cystic lesion with mass-like components in the posterior compartment of the distal right thigh, measuring 17 cm longitudinally. The lesion was located adjacent to, but not involving, the sciatic nerve and femoral vasculature. On initial examination, the large soft-tissue mass was evident and moderately painful to palpation; no skin changes were noted, and the patient had a normal sensorimotor examination. Fine-needle aspiration was performed, which resulted in amorphous debris consistent with hematoma.

Repeat MRI 2 months later showed increased size of the lesion (9.5×10.5 cm axial, 22.0 cm craniocaudal). Although most findings of a more extensive imaging protocol, including precontrast and postcontrast sequences, were consistent with hematoma, the lesion also had several characteristics that indicated soft-tissue sarcoma. Specifically, findings suggestive of chronic hematoma included the hyperintense short tau inversion recovery (STIR) T1/T2 signal of the cystic component consistent with proteinaceous fluid and the low STIR TI/T2 signal of the periphery consistent with a rim of hemosiderin (Figure 1). Additionally, the cystic component of the lesion had multiple fine septations that are atypical for a hematoma (Figure 1), and several lymph nodes greater than 1.7 cm in short axis were noted in the anterior thigh and hemipelvis that were suspicious of metastatic lymphadenopathy. The encapsulated appearance of the lesion with a sharply defined margin and short transition zone were also reassuring findings for a benign lesion (Figures 1, 2A, 2B). However, several findings were identified that suggested soft-tissue sarcoma, including a nodular soft-tissue component on the medial wall of the lesion that had heterogeneous enhancement with contrast (Figure 2B). We, therefore, proceeded with ultrasound-guided core needle biopsy of the mass and cytologic sampling of the fluid components, which were again consistent with hematoma; no evidence of internal vascular flow was noted on Doppler ultrasound. Ultrasound-guided right inguinal lymph node biopsy was also performed and was negative for malignancy. Because of her large body habitus and pregnancy status, it was agreed that open biopsy should be delayed until after delivery to avoid placing the patient in a prone position.

The patient visited the emergency room several times during the following months because of intermittent exacerbations of her lower extremity pain, swelling, and occasional paresthesias. About 6 months after initial presentation, repeat MRI again showed increased size of the mass (13.5×13.5 cm axial, 28 cm craniocaudal). There was also increased displacement of the adjacent neurovascular structures but no evidence of deep vein thrombosis. Because of concerns about the increased symptomatology of her thigh mass and possible sampling error of the previous biopsies, an elective cesarean section was performed at 35 weeks gestation. One week later, after clearance by her obstetrician, we proceeded with open biopsy of the mass in prone position. Initial sampling was negative for malignancy on frozen section; then, we expressed 1.75 L of brown fluid and solidified blood products, irrigated copiously, and placed a surgical drain. The permanent histologic specimens were again consistent with hematoma, and microbial cultures were negative. A week later, the patient accidentally removed her drain, and she presented with a fever (101°F) on postoperative day (POD) 15. Computed tomography showed reaccumulation of fluid; duplex ultrasound was negative. She was placed on cephalexin and underwent ultrasound-guided replacement of the drain with removal of an additional 750 mL fluid on POD 20. She drained an additional 150 to 200 mL/d for 1 month, with marked improvement in her leg swelling and knee range of motion. The drainage decreased during the next 3 weeks, and the drain was removed on POD 75.

Discussion

The presence of a hematoma in the extremities is usually a straightforward diagnosis. However, the unusual circumstances of this case highlight all the indications for investigation for possible soft-tissue sarcoma when a patient presents with what appears to be a benign condition.

Hematomas are rare in the absence of trauma or coagulopathy, with chronic expansion of hematomas rarer still.^4,7,10-11 The patient had no evidence of coagulopathy because of her ability to have an uncomplicated pregnancy and elective cesarean section. She denied a history of trauma, and the location of her hematoma at the posterior distal thigh is an uncommon site of injury. In this setting, fine-needle aspiration and serial imaging to assess for progressive increase in lesion size were indicated to rule out malignancy.²

MRI is the gold-standard imaging modality for distinguishing soft-tissue masses from hematomas.^5,12-14 Unlike the typical appearance of a hematoma, sarcomas of the soft-tissue extremities are often complex cystic lesions with multiple septations, internal soft-tissue components, and relatively ill-defined margins.^15-17 However, as a hematoma becomes chronic, it can develop a fibrinous capsule, and the contents can manifest an atypical, heterogeneous appearance from scattered, progressive accumulation of blood products that is essentially indistinguishable from sarcomas on imaging.⁵

Because of the expansion of the hematoma and the atypical appearance of the mass on imaging, repeated core biopsy and, eventually, open biopsy were indicated, despite a preliminary negative diagnosis based on fine-needle aspiration. This resulted from the possibility of sampling error that is particularly relevant to cystic sarcomas, because only portions of the mass may be composed of malignant cells.² An unusual aspect of this case is the regional lymphadenopathy noted on MRI, because regional lymphatic spread is a known mechanism of metastasis in soft-tissue sarcomas.¹⁸ However, the inguinal biopsies showed a chronic inflammatory infiltrate and were negative for malignancy, and enlarged nodes were not seen on imaging several months later. It is possible that the lymphadenopathy resulted from an unrelated process; alternatively, it may have been secondary to impaired lymphatic drainage because of mass effect from the hematoma, which also caused temporary lower extremity swelling.

The distal posterior thigh is an unreported location for a chronic expanding hematoma. Our patient developed slowly progressive lower-limb swelling and, eventually, paresthesias because of displacement of the neurovasculature, an unusual sequela that was recently reported in a similar case of an acute spontaneous hematoma in a patient on warfarin.¹⁹ Rupture of a Baker cyst is a possible inciting factor in our patient, although the proximal location of the lesion and the clearly defined tissue plane on MRI between the hematoma and the popliteal region make this unlikely. Finally, the patient’s lesion showed no evidence of vascular flow on Doppler ultrasonography, although giant hematomas secondary to popliteal aneurysm rupture have been reported.^20-22

Conclusion

This case highlights the features of a chronic expanding hematoma that can suggest soft-tissue sarcoma and shows the recommended diagnostic steps to differentiate the 2 conditions. This case also describes an unreported location for a chronic expanding hematoma with resulting progressive neurovascular displacement caused by mass effect. We recommend careful monitoring of patients with similarly expansile lesions in this region for signs of neurovascular compromise.

Fat embolism syndrome (FES) was first described by Von Bergmann in 1873 in a patient with a fractured femur.¹ While fat within the circulation (fat embolism) is relatively common following long-bone fracture, the clinical pattern of symptoms that make up FES is less so, occurring in 1% to 3% of isolated long-bone fractures and 5% to 10% of patients with multiple skeletal trauma.¹ A variety of clinical, laboratory, and imaging criteria has been described, classically by Gurd in 1970 (Table).^1-6 Most commonly, however, it is a diagnosis of exclusion when the classic triad of respiratory difficulty, neurologic abnormalities, and a characteristic petechial rash are present in the appropriate clinical setting.⁶ 

The neurologic sequelae of this syndrome can range from headache, confusion, and agitation to stupor, focal neurologic signs, and, less commonly, coma.⁷ Onset of these symptoms usually occurs between 24 hours and 48 hours (mean, 40 hours) after trauma.¹ While these neurologic manifestations occur in up to 86% of patients with FES, it is rare for them to be present without the pulmonary symptoms of dyspnea, hypoxemia, and tachypnea, which are the most common presenting symptoms of the disease.^1-6 In this case report, we describe severe, rapid-onset neurologic manifestations, without the typical pulmonary involvement, as the primary clinical presentation of FES in a polytrauma patient. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A previously healthy 50-year-old man presented to the emergency room in transfer from an outside hospital after a rollover motor vehicle collision in which he was ejected approximately 50 feet. Injuries included a right proximal humerus fracture/dislocation (Figure 1), right ulnar styloid fracture, L1 compression fracture, and multiple rib fractures. On admission, the patient had an ethanol level of 969 mg/L (.097%) and a urine drug screen positive only for opioids, presumably because of pain medication given that day. He denied a history of alcohol abuse and reported consuming 2 to 3 beers per week. The patient was awake, alert, and oriented with a Glasgow Coma Scale (GCS) of 15. He was tachycardic (heart rate, 126), tachypneic (respiratory rate, 24), and febrile (temperature, 38.6°C [101.5°F]), and his white blood cell count was elevated at 29.5×10⁹/L. On examination, his right arm was found to be neurovascularly intact; it was placed in a sling with a forearm splint, and the patient was admitted to the intermediate special care unit on spine precautions with a plan for right shoulder hemiarthroplasty the following day.

Overnight the patient’s mental status began to deteriorate, and approximately 10 hours after initial assessment, he was not answering questions but was able to respond to some commands. On hospital day 2, approximately 20 hours after initial assessment, the patient had a GCS of 8, was not responding to commands, and moved only in response to painful stimuli. The patient had been prescribed morphine by patient-controlled analgesia and had received intravenous hydromorphone on the day of admission, although the amount of medication delivered was not thought adequate to explain this deterioration. On the morning of hospital day 2, noncontrast brain computed tomography (CT) was normal with no evidence of intracranial hemorrhage or infarct. This was followed by brain magnetic resonance imaging (MRI), with the T2-weighted images showing numerous, small hyperintense lesions in subcortical and periventricular white matter, corpus callosum, basal ganglia, brain stem, and cerebellar hemispheres (Figure 2). The lesions also showed hyperintensity on diffusion-weighted MRI and were interpreted to be consistent with multiple, tiny infarcts (Figure 3). In addition, susceptibility-weighted sequences showed low signal in the same areas, suggesting multiple microhemorrhages, a pattern consistent with FES. Oxygen saturations remained 95% to 99%, and chest radiograph revealed clear lung fields without infiltrate. On hospital day 2, the patient was transferred to the intensive care unit and intubated for airway protection owing to an inability to clear secretions, although arterial blood gas levels remained normal. An echocardiogram revealed no right-to-left shunt, such as a patent foramen ovale (PFO); an electroencephalogram showed no seizure-like activity. No petechial rash was noted on skin examination. The patient was treated with supportive care. Right shoulder hemiarthroplasty was performed on hospital day 7 without complications (Figure 1). On hospital day 13, the patient was following commands and on day 14 he was extubated. His mental status continued to improve, and he was discharged to a rehabilitation facility after 36 days. On last follow-up, 6 months after initial injury, the patient was recovering well with no residual neurologic deficits and only minor limitation in range of motion of the right shoulder.

Discussion

This case presented an interesting diagnostic challenge regarding the patient’s rapid decline in mental status, with a differential diagnosis including diffuse axonal injury (DAI), anoxic brain injury, posttraumatic seizure, other intracranial pathology, such as stroke or hemorrhage, and FES. FES was diagnosed, when other possibilities were ruled out, given the characteristic findings on brain MRI described above in the context of multiple fractures.

Pathophysiology

Despite its recognition in 1873, there is no consensus on the pathophysiological mechanism that causes the clinical symptoms of FES. In the setting of trauma, there are 2 predominant theories. The mechanical theory postulates that fat globules enter the circulation through disrupted venules after the fracture of marrow-containing bones, passing to the arterial circulation through pulmonary vasculature, or paradoxically, by way of a right-to-left shunt, such as a PFO.^1,3 The presence of fat in the heart, visualized as echogenic material in the right and left atria on transesophageal echocardiography, has been confirmed in multiple studies during orthopedic procedures, including total knee arthroplasty and femoral reaming.^8,9 These fat particles can lodge as microembolisms in target organs such as the skin and brain. However, autopsy studies have shown a lack of correlation of the severity of symptoms and the quantity of intravascular fat.¹ In addition, the typical 24- to 72-hour delay in the onset of symptoms after initial trauma would argue against a solely mechanical explanation.¹⁰

Alternatively or concomitantly, the biochemical theory proposes that embolized fat may be degraded to toxic intermediaries, such as free fatty acids and C-reactive protein, which cause end-organ damage.³ This has been shown in an animal model, in which intravascular injection of free fatty acids was associated with endothelial damage and increased capillary permeability in the lung, leading to acute respiratory distress syndrome (ARDS).¹¹ The same mechanism could explain injury to other end organs and is consistent with the delay in onset of symptoms after acute injury. In our patient’s case, the absence of pulmonary involvement, lack of a right-to-left vascular shunt such as a PFO, and presence of a systemic inflammatory response on admission may implicate the production of toxic intermediaries from the metabolism of embolized fat as the source of this patient’s FES.

Clinical Presentation

The initial presentation of FES usually manifests as respiratory distress and hypoxia.¹⁰ Chest radiographs are often normal, as in our patient, but can show bilateral diffuse interstitial or alveolar infiltrates.^2,6 CT more often has findings, including bilateral ground-glass opacities with interlobar septal thickening.¹² A petechial rash can be found on the head, neck, anterior thorax, axillae, subconjunctiva, and oral mucous membranes, although it occurs in only 20% to 50% of cases.^1,2,13 Neurologic sequelae are present in up to 80% of patients,⁷ with onset typically following pulmonary symptoms.^1,10 These sequelae can range from headache, confusion, and agitation to stupor, focal neurologic signs, and, less commonly, coma.⁷ Onset of symptoms generally occurs between 24 and 48 hours after trauma,¹ although they have been reported as early as 12 hours.¹⁰ This case is an example of an atypical course, with the initial presentation of neurologic symptoms at approximately 14 hours after trauma with rapid progression to coma without classic pulmonary symptoms.

Diagnosis

Owing to the nonspecific clinical features of FES, a variety of clinical, laboratory, and imaging criteria has been described. Of these criteria, the most frequently referenced is by Gurd in 1970,^4,5 who divided the features into major and minor, with 1 major and 4 minor features required to make the diagnosis (Table). In applying these criteria to our patient, we found that he exhibited the major criteria of cerebral involvement and minor criteria of tachycardia, fever, and thrombocytopenia. Respiratory insufficiency and petechial rash, as well as jaundice, renal changes, and anemia were negative features. Retinal changes, elevated erythrocyte sedimentation rate, and fat macroglobulinemia were not tested or examined. Although in our case the clinical and laboratory criteria for the diagnosis of FES as defined by Gurd were not met, the sensitivity of Gurd’s and other criteria is debated.¹⁰

Laboratory tests specific for the disease have not been developed. Although elevated serum levels of lipase, increased blood lipid levels, and fat globules in the urine, sputum, and blood have all been proposed, they are found in trauma patients with and without FES.^2,5,6

The nonspecific nature of the signs and symptoms of FES and the lack of reliable laboratory tests for diagnosis of the syndrome highlight the importance of radiographic evaluation in patients with neurologic symptoms. Brain CT scans are usually negative,¹⁴ although, in some cases, they may show diffuse edema with scattered low attenuating areas and hemorrhage.¹⁵ MRI is more sensitive, and T2-weighted images typically reveal multiple small, nonconfluent hyperintense lesions, usually in the periventricular, subcortical, and deep white matter, sometimes referred to as the “starfield” pattern.^14,16 The differential diagnosis for these findings is broad and, in addition to FES, includes DAI, vasogenic edema with microinfarcts, and demyelinating disease.¹⁴ Sensitivity and specificity may be increased with the addition of diffusion-weighted MRI, which shows scattered bright spots on a dark background in a similar “starfield” pattern as on T2-weighted images.¹⁵ Susceptibility-weighted MRI has recently been introduced as having utility in the diagnosis of FES, with areas of low-signal intensity indicating diffuse microhemorrhages.¹⁷ DAI can show a similar pattern; however, the autopsy-confirmed locations of the abnormalities are distinct, with those of FES being found in cerebral and cerebellar white matter and splenium of the corpus callosum and radiographic abnormalities of DAI being found in the gray-white matter junction, dorsolateral brainstem, and splenium of corpus callosum.¹⁷

Prevention and Treatment

Of primary importance in the prevention of FES is early stabilization of fractures. Several studies have shown a decreased incidence of FES when long-bone fractures are treated with immediate operative fixation.^18,19 However, in the setting of polytrauma, the desire for early definitive treatment must be balanced against the risks for the exaggerated immune response from prolonged surgery.²⁰ The timing of fracture fixation to prevent sequelae of the inflammatory response, such as ARDS and multiple organ dysfunction syndrome, is still debated. In a review article, Pape and colleagues²⁰ suggest classifying the multiply injured patient as stable, borderline, unstable, and in extremis based on clinical and laboratory criteria. They recommend early definitive fixation for stable patients and those patients who are borderline or unstable and responsive to resuscitation, whereas damage-control orthopedics and staged fracture fixation should be considered in the other groups.

Several pharmacologic interventions have been described, although their effects are highly variable and none have clear indications.^1-3,6 The most heavily researched is corticosteroids, with the proposed mechanisms of action including blunting of the inflammatory response, stabilizing the pulmonary capillary membrane to reduce interstitial edema, preventing activation of the complement system, and retarding platelet aggregation.²¹ A recent meta-analysis to assess this intervention examined 6 studies with a total of 386 patients with long-bone fractures who were randomized to treatment with corticosteroids or supportive care only.²² They found a reduced risk for FES in those patients who received corticosteroids, but there was no difference in mortality between groups. Given these results, the utility of corticosteroids is still debated.   

Once FES has occurred, treatment options usually focus on supportive care, with most patients having a full recovery.^1,3 No specific treatments are available, and symptomatic treatment is the suggested approach, including ensuring adequate oxygenation and ventilation and providing hemodynamic support and volume and blood-product resuscitation as needed.^1-3,6  

Conclusion

We have presented a case of FES unique in its rapid onset, an initial presentation with neurologic manifestations without typical pulmonary involvement, and the mechanism of end-organ damage without a right-to-left shunt. This case emphasizes the importance of considering FES in the patient with deteriorating mental status in the setting of multiple fractures, particularly in the absence of other characteristic clinical findings, such as pulmonary distress and the pathognomonic petechial rash. Brain MRI can play an important role in diagnosing those patients presenting with predominantly neurological symptoms. Early recognition of this condition allows for the anticipation of complications of the disease process, such as respiratory distress, and the potential need for mechanical ventilation and hemodynamic support.

Fat embolism syndrome (FES) was first described by Von Bergmann in 1873 in a patient with a fractured femur.¹ While fat within the circulation (fat embolism) is relatively common following long-bone fracture, the clinical pattern of symptoms that make up FES is less so, occurring in 1% to 3% of isolated long-bone fractures and 5% to 10% of patients with multiple skeletal trauma.¹ A variety of clinical, laboratory, and imaging criteria has been described, classically by Gurd in 1970 (Table).^1-6 Most commonly, however, it is a diagnosis of exclusion when the classic triad of respiratory difficulty, neurologic abnormalities, and a characteristic petechial rash are present in the appropriate clinical setting.⁶ 

The neurologic sequelae of this syndrome can range from headache, confusion, and agitation to stupor, focal neurologic signs, and, less commonly, coma.⁷ Onset of these symptoms usually occurs between 24 hours and 48 hours (mean, 40 hours) after trauma.¹ While these neurologic manifestations occur in up to 86% of patients with FES, it is rare for them to be present without the pulmonary symptoms of dyspnea, hypoxemia, and tachypnea, which are the most common presenting symptoms of the disease.^1-6 In this case report, we describe severe, rapid-onset neurologic manifestations, without the typical pulmonary involvement, as the primary clinical presentation of FES in a polytrauma patient. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A previously healthy 50-year-old man presented to the emergency room in transfer from an outside hospital after a rollover motor vehicle collision in which he was ejected approximately 50 feet. Injuries included a right proximal humerus fracture/dislocation (Figure 1), right ulnar styloid fracture, L1 compression fracture, and multiple rib fractures. On admission, the patient had an ethanol level of 969 mg/L (.097%) and a urine drug screen positive only for opioids, presumably because of pain medication given that day. He denied a history of alcohol abuse and reported consuming 2 to 3 beers per week. The patient was awake, alert, and oriented with a Glasgow Coma Scale (GCS) of 15. He was tachycardic (heart rate, 126), tachypneic (respiratory rate, 24), and febrile (temperature, 38.6°C [101.5°F]), and his white blood cell count was elevated at 29.5×10⁹/L. On examination, his right arm was found to be neurovascularly intact; it was placed in a sling with a forearm splint, and the patient was admitted to the intermediate special care unit on spine precautions with a plan for right shoulder hemiarthroplasty the following day.

Overnight the patient’s mental status began to deteriorate, and approximately 10 hours after initial assessment, he was not answering questions but was able to respond to some commands. On hospital day 2, approximately 20 hours after initial assessment, the patient had a GCS of 8, was not responding to commands, and moved only in response to painful stimuli. The patient had been prescribed morphine by patient-controlled analgesia and had received intravenous hydromorphone on the day of admission, although the amount of medication delivered was not thought adequate to explain this deterioration. On the morning of hospital day 2, noncontrast brain computed tomography (CT) was normal with no evidence of intracranial hemorrhage or infarct. This was followed by brain magnetic resonance imaging (MRI), with the T2-weighted images showing numerous, small hyperintense lesions in subcortical and periventricular white matter, corpus callosum, basal ganglia, brain stem, and cerebellar hemispheres (Figure 2). The lesions also showed hyperintensity on diffusion-weighted MRI and were interpreted to be consistent with multiple, tiny infarcts (Figure 3). In addition, susceptibility-weighted sequences showed low signal in the same areas, suggesting multiple microhemorrhages, a pattern consistent with FES. Oxygen saturations remained 95% to 99%, and chest radiograph revealed clear lung fields without infiltrate. On hospital day 2, the patient was transferred to the intensive care unit and intubated for airway protection owing to an inability to clear secretions, although arterial blood gas levels remained normal. An echocardiogram revealed no right-to-left shunt, such as a patent foramen ovale (PFO); an electroencephalogram showed no seizure-like activity. No petechial rash was noted on skin examination. The patient was treated with supportive care. Right shoulder hemiarthroplasty was performed on hospital day 7 without complications (Figure 1). On hospital day 13, the patient was following commands and on day 14 he was extubated. His mental status continued to improve, and he was discharged to a rehabilitation facility after 36 days. On last follow-up, 6 months after initial injury, the patient was recovering well with no residual neurologic deficits and only minor limitation in range of motion of the right shoulder.

Discussion

This case presented an interesting diagnostic challenge regarding the patient’s rapid decline in mental status, with a differential diagnosis including diffuse axonal injury (DAI), anoxic brain injury, posttraumatic seizure, other intracranial pathology, such as stroke or hemorrhage, and FES. FES was diagnosed, when other possibilities were ruled out, given the characteristic findings on brain MRI described above in the context of multiple fractures.

Pathophysiology

Despite its recognition in 1873, there is no consensus on the pathophysiological mechanism that causes the clinical symptoms of FES. In the setting of trauma, there are 2 predominant theories. The mechanical theory postulates that fat globules enter the circulation through disrupted venules after the fracture of marrow-containing bones, passing to the arterial circulation through pulmonary vasculature, or paradoxically, by way of a right-to-left shunt, such as a PFO.^1,3 The presence of fat in the heart, visualized as echogenic material in the right and left atria on transesophageal echocardiography, has been confirmed in multiple studies during orthopedic procedures, including total knee arthroplasty and femoral reaming.^8,9 These fat particles can lodge as microembolisms in target organs such as the skin and brain. However, autopsy studies have shown a lack of correlation of the severity of symptoms and the quantity of intravascular fat.¹ In addition, the typical 24- to 72-hour delay in the onset of symptoms after initial trauma would argue against a solely mechanical explanation.¹⁰

Alternatively or concomitantly, the biochemical theory proposes that embolized fat may be degraded to toxic intermediaries, such as free fatty acids and C-reactive protein, which cause end-organ damage.³ This has been shown in an animal model, in which intravascular injection of free fatty acids was associated with endothelial damage and increased capillary permeability in the lung, leading to acute respiratory distress syndrome (ARDS).¹¹ The same mechanism could explain injury to other end organs and is consistent with the delay in onset of symptoms after acute injury. In our patient’s case, the absence of pulmonary involvement, lack of a right-to-left vascular shunt such as a PFO, and presence of a systemic inflammatory response on admission may implicate the production of toxic intermediaries from the metabolism of embolized fat as the source of this patient’s FES.

Clinical Presentation

The initial presentation of FES usually manifests as respiratory distress and hypoxia.¹⁰ Chest radiographs are often normal, as in our patient, but can show bilateral diffuse interstitial or alveolar infiltrates.^2,6 CT more often has findings, including bilateral ground-glass opacities with interlobar septal thickening.¹² A petechial rash can be found on the head, neck, anterior thorax, axillae, subconjunctiva, and oral mucous membranes, although it occurs in only 20% to 50% of cases.^1,2,13 Neurologic sequelae are present in up to 80% of patients,⁷ with onset typically following pulmonary symptoms.^1,10 These sequelae can range from headache, confusion, and agitation to stupor, focal neurologic signs, and, less commonly, coma.⁷ Onset of symptoms generally occurs between 24 and 48 hours after trauma,¹ although they have been reported as early as 12 hours.¹⁰ This case is an example of an atypical course, with the initial presentation of neurologic symptoms at approximately 14 hours after trauma with rapid progression to coma without classic pulmonary symptoms.

Diagnosis

Owing to the nonspecific clinical features of FES, a variety of clinical, laboratory, and imaging criteria has been described. Of these criteria, the most frequently referenced is by Gurd in 1970,^4,5 who divided the features into major and minor, with 1 major and 4 minor features required to make the diagnosis (Table). In applying these criteria to our patient, we found that he exhibited the major criteria of cerebral involvement and minor criteria of tachycardia, fever, and thrombocytopenia. Respiratory insufficiency and petechial rash, as well as jaundice, renal changes, and anemia were negative features. Retinal changes, elevated erythrocyte sedimentation rate, and fat macroglobulinemia were not tested or examined. Although in our case the clinical and laboratory criteria for the diagnosis of FES as defined by Gurd were not met, the sensitivity of Gurd’s and other criteria is debated.¹⁰

Laboratory tests specific for the disease have not been developed. Although elevated serum levels of lipase, increased blood lipid levels, and fat globules in the urine, sputum, and blood have all been proposed, they are found in trauma patients with and without FES.^2,5,6

The nonspecific nature of the signs and symptoms of FES and the lack of reliable laboratory tests for diagnosis of the syndrome highlight the importance of radiographic evaluation in patients with neurologic symptoms. Brain CT scans are usually negative,¹⁴ although, in some cases, they may show diffuse edema with scattered low attenuating areas and hemorrhage.¹⁵ MRI is more sensitive, and T2-weighted images typically reveal multiple small, nonconfluent hyperintense lesions, usually in the periventricular, subcortical, and deep white matter, sometimes referred to as the “starfield” pattern.^14,16 The differential diagnosis for these findings is broad and, in addition to FES, includes DAI, vasogenic edema with microinfarcts, and demyelinating disease.¹⁴ Sensitivity and specificity may be increased with the addition of diffusion-weighted MRI, which shows scattered bright spots on a dark background in a similar “starfield” pattern as on T2-weighted images.¹⁵ Susceptibility-weighted MRI has recently been introduced as having utility in the diagnosis of FES, with areas of low-signal intensity indicating diffuse microhemorrhages.¹⁷ DAI can show a similar pattern; however, the autopsy-confirmed locations of the abnormalities are distinct, with those of FES being found in cerebral and cerebellar white matter and splenium of the corpus callosum and radiographic abnormalities of DAI being found in the gray-white matter junction, dorsolateral brainstem, and splenium of corpus callosum.¹⁷

Prevention and Treatment

Of primary importance in the prevention of FES is early stabilization of fractures. Several studies have shown a decreased incidence of FES when long-bone fractures are treated with immediate operative fixation.^18,19 However, in the setting of polytrauma, the desire for early definitive treatment must be balanced against the risks for the exaggerated immune response from prolonged surgery.²⁰ The timing of fracture fixation to prevent sequelae of the inflammatory response, such as ARDS and multiple organ dysfunction syndrome, is still debated. In a review article, Pape and colleagues²⁰ suggest classifying the multiply injured patient as stable, borderline, unstable, and in extremis based on clinical and laboratory criteria. They recommend early definitive fixation for stable patients and those patients who are borderline or unstable and responsive to resuscitation, whereas damage-control orthopedics and staged fracture fixation should be considered in the other groups.

Several pharmacologic interventions have been described, although their effects are highly variable and none have clear indications.^1-3,6 The most heavily researched is corticosteroids, with the proposed mechanisms of action including blunting of the inflammatory response, stabilizing the pulmonary capillary membrane to reduce interstitial edema, preventing activation of the complement system, and retarding platelet aggregation.²¹ A recent meta-analysis to assess this intervention examined 6 studies with a total of 386 patients with long-bone fractures who were randomized to treatment with corticosteroids or supportive care only.²² They found a reduced risk for FES in those patients who received corticosteroids, but there was no difference in mortality between groups. Given these results, the utility of corticosteroids is still debated.   

Once FES has occurred, treatment options usually focus on supportive care, with most patients having a full recovery.^1,3 No specific treatments are available, and symptomatic treatment is the suggested approach, including ensuring adequate oxygenation and ventilation and providing hemodynamic support and volume and blood-product resuscitation as needed.^1-3,6  

Conclusion

We have presented a case of FES unique in its rapid onset, an initial presentation with neurologic manifestations without typical pulmonary involvement, and the mechanism of end-organ damage without a right-to-left shunt. This case emphasizes the importance of considering FES in the patient with deteriorating mental status in the setting of multiple fractures, particularly in the absence of other characteristic clinical findings, such as pulmonary distress and the pathognomonic petechial rash. Brain MRI can play an important role in diagnosing those patients presenting with predominantly neurological symptoms. Early recognition of this condition allows for the anticipation of complications of the disease process, such as respiratory distress, and the potential need for mechanical ventilation and hemodynamic support.

Fat embolism syndrome (FES) was first described by Von Bergmann in 1873 in a patient with a fractured femur.¹ While fat within the circulation (fat embolism) is relatively common following long-bone fracture, the clinical pattern of symptoms that make up FES is less so, occurring in 1% to 3% of isolated long-bone fractures and 5% to 10% of patients with multiple skeletal trauma.¹ A variety of clinical, laboratory, and imaging criteria has been described, classically by Gurd in 1970 (Table).^1-6 Most commonly, however, it is a diagnosis of exclusion when the classic triad of respiratory difficulty, neurologic abnormalities, and a characteristic petechial rash are present in the appropriate clinical setting.⁶ 

The neurologic sequelae of this syndrome can range from headache, confusion, and agitation to stupor, focal neurologic signs, and, less commonly, coma.⁷ Onset of these symptoms usually occurs between 24 hours and 48 hours (mean, 40 hours) after trauma.¹ While these neurologic manifestations occur in up to 86% of patients with FES, it is rare for them to be present without the pulmonary symptoms of dyspnea, hypoxemia, and tachypnea, which are the most common presenting symptoms of the disease.^1-6 In this case report, we describe severe, rapid-onset neurologic manifestations, without the typical pulmonary involvement, as the primary clinical presentation of FES in a polytrauma patient. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A previously healthy 50-year-old man presented to the emergency room in transfer from an outside hospital after a rollover motor vehicle collision in which he was ejected approximately 50 feet. Injuries included a right proximal humerus fracture/dislocation (Figure 1), right ulnar styloid fracture, L1 compression fracture, and multiple rib fractures. On admission, the patient had an ethanol level of 969 mg/L (.097%) and a urine drug screen positive only for opioids, presumably because of pain medication given that day. He denied a history of alcohol abuse and reported consuming 2 to 3 beers per week. The patient was awake, alert, and oriented with a Glasgow Coma Scale (GCS) of 15. He was tachycardic (heart rate, 126), tachypneic (respiratory rate, 24), and febrile (temperature, 38.6°C [101.5°F]), and his white blood cell count was elevated at 29.5×10⁹/L. On examination, his right arm was found to be neurovascularly intact; it was placed in a sling with a forearm splint, and the patient was admitted to the intermediate special care unit on spine precautions with a plan for right shoulder hemiarthroplasty the following day.

Overnight the patient’s mental status began to deteriorate, and approximately 10 hours after initial assessment, he was not answering questions but was able to respond to some commands. On hospital day 2, approximately 20 hours after initial assessment, the patient had a GCS of 8, was not responding to commands, and moved only in response to painful stimuli. The patient had been prescribed morphine by patient-controlled analgesia and had received intravenous hydromorphone on the day of admission, although the amount of medication delivered was not thought adequate to explain this deterioration. On the morning of hospital day 2, noncontrast brain computed tomography (CT) was normal with no evidence of intracranial hemorrhage or infarct. This was followed by brain magnetic resonance imaging (MRI), with the T2-weighted images showing numerous, small hyperintense lesions in subcortical and periventricular white matter, corpus callosum, basal ganglia, brain stem, and cerebellar hemispheres (Figure 2). The lesions also showed hyperintensity on diffusion-weighted MRI and were interpreted to be consistent with multiple, tiny infarcts (Figure 3). In addition, susceptibility-weighted sequences showed low signal in the same areas, suggesting multiple microhemorrhages, a pattern consistent with FES. Oxygen saturations remained 95% to 99%, and chest radiograph revealed clear lung fields without infiltrate. On hospital day 2, the patient was transferred to the intensive care unit and intubated for airway protection owing to an inability to clear secretions, although arterial blood gas levels remained normal. An echocardiogram revealed no right-to-left shunt, such as a patent foramen ovale (PFO); an electroencephalogram showed no seizure-like activity. No petechial rash was noted on skin examination. The patient was treated with supportive care. Right shoulder hemiarthroplasty was performed on hospital day 7 without complications (Figure 1). On hospital day 13, the patient was following commands and on day 14 he was extubated. His mental status continued to improve, and he was discharged to a rehabilitation facility after 36 days. On last follow-up, 6 months after initial injury, the patient was recovering well with no residual neurologic deficits and only minor limitation in range of motion of the right shoulder.

Discussion

This case presented an interesting diagnostic challenge regarding the patient’s rapid decline in mental status, with a differential diagnosis including diffuse axonal injury (DAI), anoxic brain injury, posttraumatic seizure, other intracranial pathology, such as stroke or hemorrhage, and FES. FES was diagnosed, when other possibilities were ruled out, given the characteristic findings on brain MRI described above in the context of multiple fractures.

Pathophysiology

Despite its recognition in 1873, there is no consensus on the pathophysiological mechanism that causes the clinical symptoms of FES. In the setting of trauma, there are 2 predominant theories. The mechanical theory postulates that fat globules enter the circulation through disrupted venules after the fracture of marrow-containing bones, passing to the arterial circulation through pulmonary vasculature, or paradoxically, by way of a right-to-left shunt, such as a PFO.^1,3 The presence of fat in the heart, visualized as echogenic material in the right and left atria on transesophageal echocardiography, has been confirmed in multiple studies during orthopedic procedures, including total knee arthroplasty and femoral reaming.^8,9 These fat particles can lodge as microembolisms in target organs such as the skin and brain. However, autopsy studies have shown a lack of correlation of the severity of symptoms and the quantity of intravascular fat.¹ In addition, the typical 24- to 72-hour delay in the onset of symptoms after initial trauma would argue against a solely mechanical explanation.¹⁰

Alternatively or concomitantly, the biochemical theory proposes that embolized fat may be degraded to toxic intermediaries, such as free fatty acids and C-reactive protein, which cause end-organ damage.³ This has been shown in an animal model, in which intravascular injection of free fatty acids was associated with endothelial damage and increased capillary permeability in the lung, leading to acute respiratory distress syndrome (ARDS).¹¹ The same mechanism could explain injury to other end organs and is consistent with the delay in onset of symptoms after acute injury. In our patient’s case, the absence of pulmonary involvement, lack of a right-to-left vascular shunt such as a PFO, and presence of a systemic inflammatory response on admission may implicate the production of toxic intermediaries from the metabolism of embolized fat as the source of this patient’s FES.

Clinical Presentation

The initial presentation of FES usually manifests as respiratory distress and hypoxia.¹⁰ Chest radiographs are often normal, as in our patient, but can show bilateral diffuse interstitial or alveolar infiltrates.^2,6 CT more often has findings, including bilateral ground-glass opacities with interlobar septal thickening.¹² A petechial rash can be found on the head, neck, anterior thorax, axillae, subconjunctiva, and oral mucous membranes, although it occurs in only 20% to 50% of cases.^1,2,13 Neurologic sequelae are present in up to 80% of patients,⁷ with onset typically following pulmonary symptoms.^1,10 These sequelae can range from headache, confusion, and agitation to stupor, focal neurologic signs, and, less commonly, coma.⁷ Onset of symptoms generally occurs between 24 and 48 hours after trauma,¹ although they have been reported as early as 12 hours.¹⁰ This case is an example of an atypical course, with the initial presentation of neurologic symptoms at approximately 14 hours after trauma with rapid progression to coma without classic pulmonary symptoms.

Diagnosis

Owing to the nonspecific clinical features of FES, a variety of clinical, laboratory, and imaging criteria has been described. Of these criteria, the most frequently referenced is by Gurd in 1970,^4,5 who divided the features into major and minor, with 1 major and 4 minor features required to make the diagnosis (Table). In applying these criteria to our patient, we found that he exhibited the major criteria of cerebral involvement and minor criteria of tachycardia, fever, and thrombocytopenia. Respiratory insufficiency and petechial rash, as well as jaundice, renal changes, and anemia were negative features. Retinal changes, elevated erythrocyte sedimentation rate, and fat macroglobulinemia were not tested or examined. Although in our case the clinical and laboratory criteria for the diagnosis of FES as defined by Gurd were not met, the sensitivity of Gurd’s and other criteria is debated.¹⁰

Laboratory tests specific for the disease have not been developed. Although elevated serum levels of lipase, increased blood lipid levels, and fat globules in the urine, sputum, and blood have all been proposed, they are found in trauma patients with and without FES.^2,5,6

The nonspecific nature of the signs and symptoms of FES and the lack of reliable laboratory tests for diagnosis of the syndrome highlight the importance of radiographic evaluation in patients with neurologic symptoms. Brain CT scans are usually negative,¹⁴ although, in some cases, they may show diffuse edema with scattered low attenuating areas and hemorrhage.¹⁵ MRI is more sensitive, and T2-weighted images typically reveal multiple small, nonconfluent hyperintense lesions, usually in the periventricular, subcortical, and deep white matter, sometimes referred to as the “starfield” pattern.^14,16 The differential diagnosis for these findings is broad and, in addition to FES, includes DAI, vasogenic edema with microinfarcts, and demyelinating disease.¹⁴ Sensitivity and specificity may be increased with the addition of diffusion-weighted MRI, which shows scattered bright spots on a dark background in a similar “starfield” pattern as on T2-weighted images.¹⁵ Susceptibility-weighted MRI has recently been introduced as having utility in the diagnosis of FES, with areas of low-signal intensity indicating diffuse microhemorrhages.¹⁷ DAI can show a similar pattern; however, the autopsy-confirmed locations of the abnormalities are distinct, with those of FES being found in cerebral and cerebellar white matter and splenium of the corpus callosum and radiographic abnormalities of DAI being found in the gray-white matter junction, dorsolateral brainstem, and splenium of corpus callosum.¹⁷

Prevention and Treatment

Of primary importance in the prevention of FES is early stabilization of fractures. Several studies have shown a decreased incidence of FES when long-bone fractures are treated with immediate operative fixation.^18,19 However, in the setting of polytrauma, the desire for early definitive treatment must be balanced against the risks for the exaggerated immune response from prolonged surgery.²⁰ The timing of fracture fixation to prevent sequelae of the inflammatory response, such as ARDS and multiple organ dysfunction syndrome, is still debated. In a review article, Pape and colleagues²⁰ suggest classifying the multiply injured patient as stable, borderline, unstable, and in extremis based on clinical and laboratory criteria. They recommend early definitive fixation for stable patients and those patients who are borderline or unstable and responsive to resuscitation, whereas damage-control orthopedics and staged fracture fixation should be considered in the other groups.

Several pharmacologic interventions have been described, although their effects are highly variable and none have clear indications.^1-3,6 The most heavily researched is corticosteroids, with the proposed mechanisms of action including blunting of the inflammatory response, stabilizing the pulmonary capillary membrane to reduce interstitial edema, preventing activation of the complement system, and retarding platelet aggregation.²¹ A recent meta-analysis to assess this intervention examined 6 studies with a total of 386 patients with long-bone fractures who were randomized to treatment with corticosteroids or supportive care only.²² They found a reduced risk for FES in those patients who received corticosteroids, but there was no difference in mortality between groups. Given these results, the utility of corticosteroids is still debated.   

Once FES has occurred, treatment options usually focus on supportive care, with most patients having a full recovery.^1,3 No specific treatments are available, and symptomatic treatment is the suggested approach, including ensuring adequate oxygenation and ventilation and providing hemodynamic support and volume and blood-product resuscitation as needed.^1-3,6  

Conclusion

We have presented a case of FES unique in its rapid onset, an initial presentation with neurologic manifestations without typical pulmonary involvement, and the mechanism of end-organ damage without a right-to-left shunt. This case emphasizes the importance of considering FES in the patient with deteriorating mental status in the setting of multiple fractures, particularly in the absence of other characteristic clinical findings, such as pulmonary distress and the pathognomonic petechial rash. Brain MRI can play an important role in diagnosing those patients presenting with predominantly neurological symptoms. Early recognition of this condition allows for the anticipation of complications of the disease process, such as respiratory distress, and the potential need for mechanical ventilation and hemodynamic support.

It is thought that, by placing more emphasis on soft-tissue preservation, minimally invasive surgery total hip arthroplasty (MIS-THA) results in less soft-tissue trauma, less blood loss, and earlier recovery.^1-3 Despite these improvements over standard methods, there is a concern that the vigorous retraction needed for proper visualization through smaller incisions could injure soft tissues.^4-7 Single-incision direct anterior THA (DA-THA) has gained in popularity because of the true intermuscular/internervous plane through which the procedure can be performed with relatively minimal muscle dissection using MIS techniques.^8,9 This approach may offer quicker recovery and superior stability in comparison with nonintermuscular methods, which unavoidably cause more muscle damage.^10-12

Although the evidence of these early gains is encouraging, several studies have found high complication rates with DA-THA.^8,13-17 Noted disadvantages include a steep learning curve, lateral femoral cutaneous neurapraxia, need for a specialized table, and higher fracture and wound complication rates. Not surprisingly, with increased surgeon experience, the complication rate decreased substantially.^14,15 However, wound-related complications remained steady, with 2 recent large studies reporting rates of 4.6% and 2.1%.^14,15 The thin anterior skin, high tensional forces along the groin crease and perpendicular to the typical DA incision, and less resilient soft-tissue envelope are postulated reasons for wound-related issues, which are likely magnified in patients who are more obese.^15,16

A novel device designed to lessen tissue damage is the ring retractor (Figure 1). Used initially in general surgery and obstetrics, it consists of 2 semirigid polymer rings connected by a flexible cylindrical polymer membrane.^18-20 The lower ring is tucked and anchored underneath the wound edge, and then the upper ring is rolled down and cinched onto the skin. The resultant tension on the polymer sleeve—imparted by the rigidity of the ring—provides strong, evenly distributed wound-edge retraction. It also provides a physical barrier between the wound edge and the rest of the operative field. Proponents of the ring retractor claim increased wound-edge moisture, less bruising, and reduced local trauma compared with standard metal retractors alone.

Wound-edge retractor forces are doubled during MIS-THA compared with conventional THA.^14-20 This may explain reports of worse scar cosmesis with MIS-THA. Given the theoretical benefits of minimized wound-edge trauma, the ring retractor may improve scar appearance compared with standard retraction alone. Any clinically relevant effect on cosmesis should be readily apparent to justify use of the retractor in this regard. Although some surgeons routinely use the device for primary THA, it has not been the subject of any recent orthopedic studies.

In the present study, we prospectively investigated wound cosmesis with and without use of the ring retractor in patients undergoing DA-THA.

Materials and Methods

This prospective, single-center, randomized study was reviewed and approved by the institutional review board at our facility. Consent was obtained from all participating patients.

We evaluated 50 surgical incisions in 48 patients. Eligible participants were over age 18 years and undergoing primary DA-THA. Exclusion criteria included previous surgery on the affected hip, a pathological hip condition requiring an extensile exposure, systemic inflammatory illness, chronic corticosteroid use, and dermatologic abnormality of the incisional area. One patient was having simultaneous bilateral THAs, and another was having staged bilateral THAs. Each hip in these patients was given its own case number and treated separately. Of the 49 patients who met all the inclusion criteria, only 1 decided not to participate (Figure 2).

Stratified randomization with permuted block size (sex, body mass index [BMI]) was used to assign patients in a 1:1 ratio to either the treatment group or the control group. In the treatment group, the Protractor Incision Protector and Retractor (Gyrus ACMI, Southborough, Massachusetts) was used with standard metal retractors. In the control group, only standard metal retractors were used. Patients were blinded to their group assignments, and surgeons were informed about each assignment only after the initial incision was made.

Clinical research investigators were blinded to the groups’ prospectively collected data. Collection time points were preoperative clinical visit, day of surgery through discharge, and 2-, 6-, and 12-week postoperative follow-ups. Day-of-surgery data included estimated intraoperative blood loss, operative side, operative time, intraoperative complications, and American Society of Anesthesiologists (ASA) physical status classification. Total length of stay, pain scores (range, 0-10), estimated drain output, and blood-transfusion data were also recorded. To evaluate whether the device had any effect on short-term functional outcome, we collected Harris Hip Scores (HHS) and Short Form–12 (SF-12, Version 2) scores at the preoperative and 6-week postoperative visits. We also documented any wound-healing-related issues or complications that occurred up until the final visit.

To account for any effect of nutrition status on wound healing, we obtained pre-albumin and albumin levels and absolute lymphocyte counts from the preoperative electronic records. We used an albumin level under 3.5 g/dL and an absolute lymphocyte count under 1500/µL for our analysis, as these cutoffs have been associated with wound complications after primary THA.²¹ There is no similarly established threshold for pre-albumin level, so we used values under 20 mg/L based on comparable literature.^22,23

At each postoperative visit, standardized high-resolution images were obtained. At the 12-week visit, patients completed 2 Likert scales regarding their overall opinion of their scars and how their scars compared with their expectations. They also ranked 5 separate THA-related outcomes in order of importance (Appendix).

Photographs were evaluated by 2 blinded plastic surgeons (Dr. Friedman and Dr. Jack) using 2 grading systems—the Stony Brook Scar Evaluation Scale (SBSES)²⁴ (Table 1) and a modified Manchester Scar Scale (MSS)²⁵ (Table 2). We used these systems because they were photograph-based, psychometrically studied, and specifically designed to assess surgical incision healing with established validity and reliability.^24-27 A particular advantage, strictly related to cosmetic outcome, is their validity in scoring scars from high-definition photographs in a different place or time. The SBSES, an ordinal wound evaluation scale that measures short-term cosmetic outcomes, consists of 6 items, each receiving 1 or 0 point, yielding a total score between 0 (worst) and 5 (best). The modified MSS includes a visual analog scale (VAS), which has a vertical hash marked on a 10-cm line and is scored between 0 (excellent) and 10 (poor) to 1 decimal point.^26,28 This value is added to grades on color, surface appearance, contour, and distortion, resulting in a score between 4 (best) and 24 (worst). The primary outcome measures were Likert-scale responses obtained at final visit and SBSES/MSS scores for each visit; 12-week scores were the primary end point.

Operative Procedure

Experienced fellowship-trained orthopedic surgeons performed all procedures. A modified Hueter approach was used for exposure.⁹ Mean incision length was about 12 cm. For the treatment group, the ring retractor was inserted at the level of the tensor fascia, with the inferior ring resting between the fascia and the subcutaneous layer and the superior ring cinched over the skin (Figure 3). The device is made in 4 different sizes for incisions from 2.5 to 17 cm; our study population required only 1 size. Otherwise, the surgical protocol was based on that described by Matta and colleagues.⁸ Wound closure (over a drain) was performed according to a standardized protocol—running No. 1 Vicryl suture for the superficial tensor fascia, interrupted 2-0 Vicryl for the deep dermal layer, and subcutaneous 4-0 Monocryl for the skin followed by application of Dermabond (Ethicon, Somerville, New Jersey) and Tegaderm +Pad (3M, St. Paul, Minnesota) for outer dressing, which was replaced on postoperative day 2 and removed at the 2-week visit.

Statistical Methods

An a priori sample-size calculation was performed. Power performed in a base of a prior study that evaluated anterolateral and posterolateral THA scars using a VAS, a component of the MSS, suggested a sample size of 16 per group to detect the minimal clinically important difference of 1.5 cm: SD (σ) = 1.5 cm, α = 0.05, β = 0.20.^29,30 In addition, a general estimate for detecting a 1-unit change on an ordinal scale (σ = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively decided to enroll 25 patients per arm in case of larger true variance.

The Wilcoxon rank sum test was used for comparisons of continuous data between groups. Differences between means were analyzed with 2-sided t tests. Categorical data were compared with the Pearson χ² test or the Fisher exact test, as indicated. Ordinal ranking scores were compared with the Mantel-Haenszel test. Multivariate logistic regression was applied to identify the significant independent predictors of better scar grades for each surgeon by considering candidate variables with Ps < .20 in the univariate analysis.

Results

We found no differences in demographic or perioperative characteristics between treatment and control groups (Tables 3, 4). The groups showed similar mean improvements in their respective 6-week HHS (38.7 and 36.4 points; P = .65), SF-12 physical component summary scores (11.8 and 14.5 points; P = .37), and SF-12 mental component summary scores (5.1 and 3.7; P = .70).

Patient questionnaire outcomes are listed in Table 5. For the control group, 25/25 image sets were obtained at the 2-week visit, 25/25 at the 6-week visit, and 24/25 at the 12-week visit. For the treatment group, there were 23/25, 24/25, and 23/25 images sets, respectively.

When surgeon scoring was analyzed separately, SBSES and MSS scores were similar between treatment and control groups, with 1 exception: 2-week MSS scores were better for the treatment group according to surgeon A (P = .026). When grades were averaged, SBSES scores were again similar at all time points (Figure 4A); MSS scores were better for the treatment group at 2 weeks (P = .036) and equivalent at all other time points (Figure 4B). For the SBSES, Spearman correlation coefficient ρ with 95% confidence interval (CI) was 0.37
(95% CI, 0.08-0.66) at 2 weeks, 0.48 (95% CI, 0.20-0.76) at 6 weeks, and 0.62 (95% CI, 0.33-0.91) at 12 weeks. Following the same pattern for the MSS, ρ was 0.20 (95% CI, –0.09 to 0.49), 0.51 (95% CI, 0.23-0.79), and 0.32 (95% CI, 0.03-0.61).

Independent multivariate analysis revealed that age over 65 years was a significant predictor of worse scores. On SBSES, the odds ratio (OR) was 1.15 (95% CI, 1.07-1.24) for surgeon A and 1.11 (95% CI, 1.05-1.18) for surgeon B. On MSS, the OR was 0.89 (95% CI, 0.84-0.94) for surgeon A and 0.95 (95% CI, 0.91-0.99) for surgeon B. The likelihood of having worse SBSES scores according to surgeon A was 4.72 times higher if the pre-albumin level was under 20 mg/L (95% CI, 1.15-19.36). Albumin level under 3.5 g/dL and absolute lymphocyte count under 1500 cells/µL were not found to be independent predictors of poorer scores.

Patients’ overall opinion (P = .63) and assessment of their scars relative to expectations (P = .25) on the Likert scales were not different between groups. More scars exceeded patients’ expectations and had more excellent ratings in the control group. The 2 groups were similar with regard to relative importance of various patient-related outcomes. Factors most important to overall outcome were relief of hip pain, followed by implant longevity and length of recovery. Least important were incision-related variables.

There were only 3 minor noninfectious wound complications (6%), 2 in the treatment group and 1 in the control group. In the treatment group, a 67-year-old man with diabetes (ASA class III; BMI, 32.1 kg/m²; received transfusion) had 2 small areas (<5 mm) of superficial ulceration at 6-week follow-up—one at the proximal aspect of the incision and the other near the midpoint along the flexion crease. Both lesions resolved by 12-week follow-up. Also in the treatment group, a 77-year-old woman (ASA class II; BMI, 24.9 kg/m²; received transfusion) at 6 weeks had a spitting suture, which was removed in clinic without further issue. In the control group, a 55-year-old woman (ASA class II; BMI, 27.4 kg/m²) had a suture reaction near the proximal aspect of her incision 3 weeks after surgery. This reaction, which presented as a mild, localized erythema without pain, tenderness, or drainage, resolved by 6-week follow-up. None of these wound complications required intervention beyond observation.

Discussion

This study was designed to provide a bipartisan measure of wound-healing cosmesis after DA-THA. Scar evaluation by blinded plastic surgeons served as a standardized, clinical assessment, whereas the patient questionnaire offered a more subjective appraisal. The modified MMS²⁵ and the SBSES²⁴ are the only 2 wound-grading systems designed and validated for photographic assessment of postsurgical scars. Most scar evaluation schemes pertain to burn or traumatic scars.^26,27,31 As a result, many earlier studies intending to compare incisional scars used poorly suited evaluation systems.

The current literature includes reports on 3 studies with scoring-based scar assessment in THA; all used grading systems designed for either burns or traumatic wounds, but 2 also used a VAS.^32-34 VASs have been validated for measuring wound cosmesis but are entirely subjective and without structure and provide no feedback as to why a scar was rated good or bad.²⁴ Mow and colleagues³² prospectively compared scars after standard posterior or MIS approaches and found no differences according to a scoring system intended for burn scars. In our study population, we found no group differences in patients’ cosmesis of their scars.

Although scars can take a year or longer to fully mature, researchers from the University of Michigan discovered that scar appearance at 1 year correlates highly with cosmesis 12 weeks after closure, though poorly with cosmesis 10 days after closure.³⁵ Therefore, any observed differences in scar cosmesis between groups at 12-week follow-up would likely persist, whereas differences at 2-week follow-up would have little bearing on ultimate appearance. For this reason, our primary outcome measure was healing process and cosmesis at 12 weeks. High wound complication rates have been reported for MIS-DA-THA.^8,14-16 Jewett and Collis¹⁵ noted a 4.6% wound complication rate (3% noninfectious ulcerative dehiscence, 1.6% superficial infection), which is comparable to the 6% rate found in this study. However, there likely is some variability across studies in what constitutes a wound complication or superficial infection. Of our 3 wound complications—stitch reaction, spitting suture, small noninfectious ulceration—only the ulceration was of a severity similar to that reported by Jewett and Collis.¹⁵ Matta and colleagues⁸ reported only 3 wound complications (in 494 patients), all severe enough to require operative intervention. One explanation for this low complication rate is use of a ring retractor, as it is routinely depicted in their technique paper. However, no specific reference is made to gauge how often the device was used.

Rates of superficial infection after DA-THA range from 0.6% to 1.6% in 3 large observational studies (combined deep infection rate, 0.43%).^8,14,15 In 2 of these studies, all patients with superficial infection underwent formal débridement, though none developed deep infection. A prospective randomized study of 221 patients who underwent colorectal surgery—where perioperative infectious morbidity ranges from 25% to 50%—found that ring retractor use significantly reduced superficial wound infection rates (8.1% vs 0%). A significant reduction in wound infection was shown in a similarly designed study involving 48 patients who had open appendectomy (14.6% vs 1.6%). The device had no effect on deep infection in either general surgery study. The wound infection rates reported in these general surgery studies are markedly higher than those in our study population. As a result, the effect of the ring retractor on wound infection in DA-THA may be less. Regardless of the effect on deep infection, fewer superficial infections, which often require operative intervention, would be of considerable benefit.

Below-threshold albumin level and absolute lymphocyte count have been associated with wound-healing complications after hip replacement.²¹ In the present study, pre-albumin level under 20 mg/L was the only nutritional marker predictive of poor wound appearance, but this finding was seen only in SBSES scores from surgeon A. Subgroup analysis did not reveal any relationship between wound appearance and any of the recorded demographic or perioperative variables, but for a small predictive influence with age over 65 years.

This study had some limitations. Our findings cannot be generalized to all patients who undergo THA, as only DA incisions were studied. Results also may not be generalizable to non-fellowship-trained orthopedists. In addition, selection bias likely resulted from including patients already selected for the DA approach. Using digital images for evaluation (vs real-life evaluation) may have affected reliability as well. Last, by not incorporating texture, we omitted a potentially informative feature from scoring.

It is paramount that surgeons undergo diligent training before undertaking this approach for minimizing unwanted results; furthermore, higher early complication rates level off with increased surgeon experience.^14,36,37 We recommend meticulous soft-tissue handling, cautious retraction, and careful patient selection (relative contraindication for patients with an abdominal pannus overlying the incision) as primary measures for minimizing incisional trauma and potential wound-healing complications.³⁸ Preservation of the tensor fascia is also crucial,³⁹ as it is the only closable layer separating deep and superficial compartments. Without good closure of the tensor fascia, there is no containment or tamponade of deep bleeding, which can facilitate hematoma formation.

In the population studied, we found no significant long-term differences in cosmetic appearance (based on clinician or patient evaluation) between wounds managed with and without the ring retractor. Our data do not support routine use of the ring retractor, during DA-THA, for improved wound cosmesis. Whether the device has any significant role in reducing the number of wound complications in THA is yet to be determined. Last, the ring retractor may have a role in other areas of orthopedic surgery, such as hip fractures in the elderly or orthopedic oncology. In situations like these, where adequate nutrition and immunocompetency may be lacking, the added protection provided by the device may translate into a more notable benefit than in elective THA.

It is thought that, by placing more emphasis on soft-tissue preservation, minimally invasive surgery total hip arthroplasty (MIS-THA) results in less soft-tissue trauma, less blood loss, and earlier recovery.^1-3 Despite these improvements over standard methods, there is a concern that the vigorous retraction needed for proper visualization through smaller incisions could injure soft tissues.^4-7 Single-incision direct anterior THA (DA-THA) has gained in popularity because of the true intermuscular/internervous plane through which the procedure can be performed with relatively minimal muscle dissection using MIS techniques.^8,9 This approach may offer quicker recovery and superior stability in comparison with nonintermuscular methods, which unavoidably cause more muscle damage.^10-12

Although the evidence of these early gains is encouraging, several studies have found high complication rates with DA-THA.^8,13-17 Noted disadvantages include a steep learning curve, lateral femoral cutaneous neurapraxia, need for a specialized table, and higher fracture and wound complication rates. Not surprisingly, with increased surgeon experience, the complication rate decreased substantially.^14,15 However, wound-related complications remained steady, with 2 recent large studies reporting rates of 4.6% and 2.1%.^14,15 The thin anterior skin, high tensional forces along the groin crease and perpendicular to the typical DA incision, and less resilient soft-tissue envelope are postulated reasons for wound-related issues, which are likely magnified in patients who are more obese.^15,16

A novel device designed to lessen tissue damage is the ring retractor (Figure 1). Used initially in general surgery and obstetrics, it consists of 2 semirigid polymer rings connected by a flexible cylindrical polymer membrane.^18-20 The lower ring is tucked and anchored underneath the wound edge, and then the upper ring is rolled down and cinched onto the skin. The resultant tension on the polymer sleeve—imparted by the rigidity of the ring—provides strong, evenly distributed wound-edge retraction. It also provides a physical barrier between the wound edge and the rest of the operative field. Proponents of the ring retractor claim increased wound-edge moisture, less bruising, and reduced local trauma compared with standard metal retractors alone.

Wound-edge retractor forces are doubled during MIS-THA compared with conventional THA.^14-20 This may explain reports of worse scar cosmesis with MIS-THA. Given the theoretical benefits of minimized wound-edge trauma, the ring retractor may improve scar appearance compared with standard retraction alone. Any clinically relevant effect on cosmesis should be readily apparent to justify use of the retractor in this regard. Although some surgeons routinely use the device for primary THA, it has not been the subject of any recent orthopedic studies.

In the present study, we prospectively investigated wound cosmesis with and without use of the ring retractor in patients undergoing DA-THA.

Materials and Methods

This prospective, single-center, randomized study was reviewed and approved by the institutional review board at our facility. Consent was obtained from all participating patients.

We evaluated 50 surgical incisions in 48 patients. Eligible participants were over age 18 years and undergoing primary DA-THA. Exclusion criteria included previous surgery on the affected hip, a pathological hip condition requiring an extensile exposure, systemic inflammatory illness, chronic corticosteroid use, and dermatologic abnormality of the incisional area. One patient was having simultaneous bilateral THAs, and another was having staged bilateral THAs. Each hip in these patients was given its own case number and treated separately. Of the 49 patients who met all the inclusion criteria, only 1 decided not to participate (Figure 2).

Stratified randomization with permuted block size (sex, body mass index [BMI]) was used to assign patients in a 1:1 ratio to either the treatment group or the control group. In the treatment group, the Protractor Incision Protector and Retractor (Gyrus ACMI, Southborough, Massachusetts) was used with standard metal retractors. In the control group, only standard metal retractors were used. Patients were blinded to their group assignments, and surgeons were informed about each assignment only after the initial incision was made.

Clinical research investigators were blinded to the groups’ prospectively collected data. Collection time points were preoperative clinical visit, day of surgery through discharge, and 2-, 6-, and 12-week postoperative follow-ups. Day-of-surgery data included estimated intraoperative blood loss, operative side, operative time, intraoperative complications, and American Society of Anesthesiologists (ASA) physical status classification. Total length of stay, pain scores (range, 0-10), estimated drain output, and blood-transfusion data were also recorded. To evaluate whether the device had any effect on short-term functional outcome, we collected Harris Hip Scores (HHS) and Short Form–12 (SF-12, Version 2) scores at the preoperative and 6-week postoperative visits. We also documented any wound-healing-related issues or complications that occurred up until the final visit.

To account for any effect of nutrition status on wound healing, we obtained pre-albumin and albumin levels and absolute lymphocyte counts from the preoperative electronic records. We used an albumin level under 3.5 g/dL and an absolute lymphocyte count under 1500/µL for our analysis, as these cutoffs have been associated with wound complications after primary THA.²¹ There is no similarly established threshold for pre-albumin level, so we used values under 20 mg/L based on comparable literature.^22,23

At each postoperative visit, standardized high-resolution images were obtained. At the 12-week visit, patients completed 2 Likert scales regarding their overall opinion of their scars and how their scars compared with their expectations. They also ranked 5 separate THA-related outcomes in order of importance (Appendix).

Photographs were evaluated by 2 blinded plastic surgeons (Dr. Friedman and Dr. Jack) using 2 grading systems—the Stony Brook Scar Evaluation Scale (SBSES)²⁴ (Table 1) and a modified Manchester Scar Scale (MSS)²⁵ (Table 2). We used these systems because they were photograph-based, psychometrically studied, and specifically designed to assess surgical incision healing with established validity and reliability.^24-27 A particular advantage, strictly related to cosmetic outcome, is their validity in scoring scars from high-definition photographs in a different place or time. The SBSES, an ordinal wound evaluation scale that measures short-term cosmetic outcomes, consists of 6 items, each receiving 1 or 0 point, yielding a total score between 0 (worst) and 5 (best). The modified MSS includes a visual analog scale (VAS), which has a vertical hash marked on a 10-cm line and is scored between 0 (excellent) and 10 (poor) to 1 decimal point.^26,28 This value is added to grades on color, surface appearance, contour, and distortion, resulting in a score between 4 (best) and 24 (worst). The primary outcome measures were Likert-scale responses obtained at final visit and SBSES/MSS scores for each visit; 12-week scores were the primary end point.

Operative Procedure

Experienced fellowship-trained orthopedic surgeons performed all procedures. A modified Hueter approach was used for exposure.⁹ Mean incision length was about 12 cm. For the treatment group, the ring retractor was inserted at the level of the tensor fascia, with the inferior ring resting between the fascia and the subcutaneous layer and the superior ring cinched over the skin (Figure 3). The device is made in 4 different sizes for incisions from 2.5 to 17 cm; our study population required only 1 size. Otherwise, the surgical protocol was based on that described by Matta and colleagues.⁸ Wound closure (over a drain) was performed according to a standardized protocol—running No. 1 Vicryl suture for the superficial tensor fascia, interrupted 2-0 Vicryl for the deep dermal layer, and subcutaneous 4-0 Monocryl for the skin followed by application of Dermabond (Ethicon, Somerville, New Jersey) and Tegaderm +Pad (3M, St. Paul, Minnesota) for outer dressing, which was replaced on postoperative day 2 and removed at the 2-week visit.

Statistical Methods

An a priori sample-size calculation was performed. Power performed in a base of a prior study that evaluated anterolateral and posterolateral THA scars using a VAS, a component of the MSS, suggested a sample size of 16 per group to detect the minimal clinically important difference of 1.5 cm: SD (σ) = 1.5 cm, α = 0.05, β = 0.20.^29,30 In addition, a general estimate for detecting a 1-unit change on an ordinal scale (σ = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively decided to enroll 25 patients per arm in case of larger true variance.

The Wilcoxon rank sum test was used for comparisons of continuous data between groups. Differences between means were analyzed with 2-sided t tests. Categorical data were compared with the Pearson χ² test or the Fisher exact test, as indicated. Ordinal ranking scores were compared with the Mantel-Haenszel test. Multivariate logistic regression was applied to identify the significant independent predictors of better scar grades for each surgeon by considering candidate variables with Ps < .20 in the univariate analysis.

Results

We found no differences in demographic or perioperative characteristics between treatment and control groups (Tables 3, 4). The groups showed similar mean improvements in their respective 6-week HHS (38.7 and 36.4 points; P = .65), SF-12 physical component summary scores (11.8 and 14.5 points; P = .37), and SF-12 mental component summary scores (5.1 and 3.7; P = .70).

Patient questionnaire outcomes are listed in Table 5. For the control group, 25/25 image sets were obtained at the 2-week visit, 25/25 at the 6-week visit, and 24/25 at the 12-week visit. For the treatment group, there were 23/25, 24/25, and 23/25 images sets, respectively.

When surgeon scoring was analyzed separately, SBSES and MSS scores were similar between treatment and control groups, with 1 exception: 2-week MSS scores were better for the treatment group according to surgeon A (P = .026). When grades were averaged, SBSES scores were again similar at all time points (Figure 4A); MSS scores were better for the treatment group at 2 weeks (P = .036) and equivalent at all other time points (Figure 4B). For the SBSES, Spearman correlation coefficient ρ with 95% confidence interval (CI) was 0.37
(95% CI, 0.08-0.66) at 2 weeks, 0.48 (95% CI, 0.20-0.76) at 6 weeks, and 0.62 (95% CI, 0.33-0.91) at 12 weeks. Following the same pattern for the MSS, ρ was 0.20 (95% CI, –0.09 to 0.49), 0.51 (95% CI, 0.23-0.79), and 0.32 (95% CI, 0.03-0.61).

Independent multivariate analysis revealed that age over 65 years was a significant predictor of worse scores. On SBSES, the odds ratio (OR) was 1.15 (95% CI, 1.07-1.24) for surgeon A and 1.11 (95% CI, 1.05-1.18) for surgeon B. On MSS, the OR was 0.89 (95% CI, 0.84-0.94) for surgeon A and 0.95 (95% CI, 0.91-0.99) for surgeon B. The likelihood of having worse SBSES scores according to surgeon A was 4.72 times higher if the pre-albumin level was under 20 mg/L (95% CI, 1.15-19.36). Albumin level under 3.5 g/dL and absolute lymphocyte count under 1500 cells/µL were not found to be independent predictors of poorer scores.

Patients’ overall opinion (P = .63) and assessment of their scars relative to expectations (P = .25) on the Likert scales were not different between groups. More scars exceeded patients’ expectations and had more excellent ratings in the control group. The 2 groups were similar with regard to relative importance of various patient-related outcomes. Factors most important to overall outcome were relief of hip pain, followed by implant longevity and length of recovery. Least important were incision-related variables.

There were only 3 minor noninfectious wound complications (6%), 2 in the treatment group and 1 in the control group. In the treatment group, a 67-year-old man with diabetes (ASA class III; BMI, 32.1 kg/m²; received transfusion) had 2 small areas (<5 mm) of superficial ulceration at 6-week follow-up—one at the proximal aspect of the incision and the other near the midpoint along the flexion crease. Both lesions resolved by 12-week follow-up. Also in the treatment group, a 77-year-old woman (ASA class II; BMI, 24.9 kg/m²; received transfusion) at 6 weeks had a spitting suture, which was removed in clinic without further issue. In the control group, a 55-year-old woman (ASA class II; BMI, 27.4 kg/m²) had a suture reaction near the proximal aspect of her incision 3 weeks after surgery. This reaction, which presented as a mild, localized erythema without pain, tenderness, or drainage, resolved by 6-week follow-up. None of these wound complications required intervention beyond observation.

Discussion

This study was designed to provide a bipartisan measure of wound-healing cosmesis after DA-THA. Scar evaluation by blinded plastic surgeons served as a standardized, clinical assessment, whereas the patient questionnaire offered a more subjective appraisal. The modified MMS²⁵ and the SBSES²⁴ are the only 2 wound-grading systems designed and validated for photographic assessment of postsurgical scars. Most scar evaluation schemes pertain to burn or traumatic scars.^26,27,31 As a result, many earlier studies intending to compare incisional scars used poorly suited evaluation systems.

The current literature includes reports on 3 studies with scoring-based scar assessment in THA; all used grading systems designed for either burns or traumatic wounds, but 2 also used a VAS.^32-34 VASs have been validated for measuring wound cosmesis but are entirely subjective and without structure and provide no feedback as to why a scar was rated good or bad.²⁴ Mow and colleagues³² prospectively compared scars after standard posterior or MIS approaches and found no differences according to a scoring system intended for burn scars. In our study population, we found no group differences in patients’ cosmesis of their scars.

Although scars can take a year or longer to fully mature, researchers from the University of Michigan discovered that scar appearance at 1 year correlates highly with cosmesis 12 weeks after closure, though poorly with cosmesis 10 days after closure.³⁵ Therefore, any observed differences in scar cosmesis between groups at 12-week follow-up would likely persist, whereas differences at 2-week follow-up would have little bearing on ultimate appearance. For this reason, our primary outcome measure was healing process and cosmesis at 12 weeks. High wound complication rates have been reported for MIS-DA-THA.^8,14-16 Jewett and Collis¹⁵ noted a 4.6% wound complication rate (3% noninfectious ulcerative dehiscence, 1.6% superficial infection), which is comparable to the 6% rate found in this study. However, there likely is some variability across studies in what constitutes a wound complication or superficial infection. Of our 3 wound complications—stitch reaction, spitting suture, small noninfectious ulceration—only the ulceration was of a severity similar to that reported by Jewett and Collis.¹⁵ Matta and colleagues⁸ reported only 3 wound complications (in 494 patients), all severe enough to require operative intervention. One explanation for this low complication rate is use of a ring retractor, as it is routinely depicted in their technique paper. However, no specific reference is made to gauge how often the device was used.

Rates of superficial infection after DA-THA range from 0.6% to 1.6% in 3 large observational studies (combined deep infection rate, 0.43%).^8,14,15 In 2 of these studies, all patients with superficial infection underwent formal débridement, though none developed deep infection. A prospective randomized study of 221 patients who underwent colorectal surgery—where perioperative infectious morbidity ranges from 25% to 50%—found that ring retractor use significantly reduced superficial wound infection rates (8.1% vs 0%). A significant reduction in wound infection was shown in a similarly designed study involving 48 patients who had open appendectomy (14.6% vs 1.6%). The device had no effect on deep infection in either general surgery study. The wound infection rates reported in these general surgery studies are markedly higher than those in our study population. As a result, the effect of the ring retractor on wound infection in DA-THA may be less. Regardless of the effect on deep infection, fewer superficial infections, which often require operative intervention, would be of considerable benefit.

Below-threshold albumin level and absolute lymphocyte count have been associated with wound-healing complications after hip replacement.²¹ In the present study, pre-albumin level under 20 mg/L was the only nutritional marker predictive of poor wound appearance, but this finding was seen only in SBSES scores from surgeon A. Subgroup analysis did not reveal any relationship between wound appearance and any of the recorded demographic or perioperative variables, but for a small predictive influence with age over 65 years.

This study had some limitations. Our findings cannot be generalized to all patients who undergo THA, as only DA incisions were studied. Results also may not be generalizable to non-fellowship-trained orthopedists. In addition, selection bias likely resulted from including patients already selected for the DA approach. Using digital images for evaluation (vs real-life evaluation) may have affected reliability as well. Last, by not incorporating texture, we omitted a potentially informative feature from scoring.

It is paramount that surgeons undergo diligent training before undertaking this approach for minimizing unwanted results; furthermore, higher early complication rates level off with increased surgeon experience.^14,36,37 We recommend meticulous soft-tissue handling, cautious retraction, and careful patient selection (relative contraindication for patients with an abdominal pannus overlying the incision) as primary measures for minimizing incisional trauma and potential wound-healing complications.³⁸ Preservation of the tensor fascia is also crucial,³⁹ as it is the only closable layer separating deep and superficial compartments. Without good closure of the tensor fascia, there is no containment or tamponade of deep bleeding, which can facilitate hematoma formation.

In the population studied, we found no significant long-term differences in cosmetic appearance (based on clinician or patient evaluation) between wounds managed with and without the ring retractor. Our data do not support routine use of the ring retractor, during DA-THA, for improved wound cosmesis. Whether the device has any significant role in reducing the number of wound complications in THA is yet to be determined. Last, the ring retractor may have a role in other areas of orthopedic surgery, such as hip fractures in the elderly or orthopedic oncology. In situations like these, where adequate nutrition and immunocompetency may be lacking, the added protection provided by the device may translate into a more notable benefit than in elective THA.

It is thought that, by placing more emphasis on soft-tissue preservation, minimally invasive surgery total hip arthroplasty (MIS-THA) results in less soft-tissue trauma, less blood loss, and earlier recovery.^1-3 Despite these improvements over standard methods, there is a concern that the vigorous retraction needed for proper visualization through smaller incisions could injure soft tissues.^4-7 Single-incision direct anterior THA (DA-THA) has gained in popularity because of the true intermuscular/internervous plane through which the procedure can be performed with relatively minimal muscle dissection using MIS techniques.^8,9 This approach may offer quicker recovery and superior stability in comparison with nonintermuscular methods, which unavoidably cause more muscle damage.^10-12

Although the evidence of these early gains is encouraging, several studies have found high complication rates with DA-THA.^8,13-17 Noted disadvantages include a steep learning curve, lateral femoral cutaneous neurapraxia, need for a specialized table, and higher fracture and wound complication rates. Not surprisingly, with increased surgeon experience, the complication rate decreased substantially.^14,15 However, wound-related complications remained steady, with 2 recent large studies reporting rates of 4.6% and 2.1%.^14,15 The thin anterior skin, high tensional forces along the groin crease and perpendicular to the typical DA incision, and less resilient soft-tissue envelope are postulated reasons for wound-related issues, which are likely magnified in patients who are more obese.^15,16

A novel device designed to lessen tissue damage is the ring retractor (Figure 1). Used initially in general surgery and obstetrics, it consists of 2 semirigid polymer rings connected by a flexible cylindrical polymer membrane.^18-20 The lower ring is tucked and anchored underneath the wound edge, and then the upper ring is rolled down and cinched onto the skin. The resultant tension on the polymer sleeve—imparted by the rigidity of the ring—provides strong, evenly distributed wound-edge retraction. It also provides a physical barrier between the wound edge and the rest of the operative field. Proponents of the ring retractor claim increased wound-edge moisture, less bruising, and reduced local trauma compared with standard metal retractors alone.

Wound-edge retractor forces are doubled during MIS-THA compared with conventional THA.^14-20 This may explain reports of worse scar cosmesis with MIS-THA. Given the theoretical benefits of minimized wound-edge trauma, the ring retractor may improve scar appearance compared with standard retraction alone. Any clinically relevant effect on cosmesis should be readily apparent to justify use of the retractor in this regard. Although some surgeons routinely use the device for primary THA, it has not been the subject of any recent orthopedic studies.

In the present study, we prospectively investigated wound cosmesis with and without use of the ring retractor in patients undergoing DA-THA.

Materials and Methods

This prospective, single-center, randomized study was reviewed and approved by the institutional review board at our facility. Consent was obtained from all participating patients.

We evaluated 50 surgical incisions in 48 patients. Eligible participants were over age 18 years and undergoing primary DA-THA. Exclusion criteria included previous surgery on the affected hip, a pathological hip condition requiring an extensile exposure, systemic inflammatory illness, chronic corticosteroid use, and dermatologic abnormality of the incisional area. One patient was having simultaneous bilateral THAs, and another was having staged bilateral THAs. Each hip in these patients was given its own case number and treated separately. Of the 49 patients who met all the inclusion criteria, only 1 decided not to participate (Figure 2).

Stratified randomization with permuted block size (sex, body mass index [BMI]) was used to assign patients in a 1:1 ratio to either the treatment group or the control group. In the treatment group, the Protractor Incision Protector and Retractor (Gyrus ACMI, Southborough, Massachusetts) was used with standard metal retractors. In the control group, only standard metal retractors were used. Patients were blinded to their group assignments, and surgeons were informed about each assignment only after the initial incision was made.

Clinical research investigators were blinded to the groups’ prospectively collected data. Collection time points were preoperative clinical visit, day of surgery through discharge, and 2-, 6-, and 12-week postoperative follow-ups. Day-of-surgery data included estimated intraoperative blood loss, operative side, operative time, intraoperative complications, and American Society of Anesthesiologists (ASA) physical status classification. Total length of stay, pain scores (range, 0-10), estimated drain output, and blood-transfusion data were also recorded. To evaluate whether the device had any effect on short-term functional outcome, we collected Harris Hip Scores (HHS) and Short Form–12 (SF-12, Version 2) scores at the preoperative and 6-week postoperative visits. We also documented any wound-healing-related issues or complications that occurred up until the final visit.

To account for any effect of nutrition status on wound healing, we obtained pre-albumin and albumin levels and absolute lymphocyte counts from the preoperative electronic records. We used an albumin level under 3.5 g/dL and an absolute lymphocyte count under 1500/µL for our analysis, as these cutoffs have been associated with wound complications after primary THA.²¹ There is no similarly established threshold for pre-albumin level, so we used values under 20 mg/L based on comparable literature.^22,23

At each postoperative visit, standardized high-resolution images were obtained. At the 12-week visit, patients completed 2 Likert scales regarding their overall opinion of their scars and how their scars compared with their expectations. They also ranked 5 separate THA-related outcomes in order of importance (Appendix).

Photographs were evaluated by 2 blinded plastic surgeons (Dr. Friedman and Dr. Jack) using 2 grading systems—the Stony Brook Scar Evaluation Scale (SBSES)²⁴ (Table 1) and a modified Manchester Scar Scale (MSS)²⁵ (Table 2). We used these systems because they were photograph-based, psychometrically studied, and specifically designed to assess surgical incision healing with established validity and reliability.^24-27 A particular advantage, strictly related to cosmetic outcome, is their validity in scoring scars from high-definition photographs in a different place or time. The SBSES, an ordinal wound evaluation scale that measures short-term cosmetic outcomes, consists of 6 items, each receiving 1 or 0 point, yielding a total score between 0 (worst) and 5 (best). The modified MSS includes a visual analog scale (VAS), which has a vertical hash marked on a 10-cm line and is scored between 0 (excellent) and 10 (poor) to 1 decimal point.^26,28 This value is added to grades on color, surface appearance, contour, and distortion, resulting in a score between 4 (best) and 24 (worst). The primary outcome measures were Likert-scale responses obtained at final visit and SBSES/MSS scores for each visit; 12-week scores were the primary end point.

Operative Procedure

Experienced fellowship-trained orthopedic surgeons performed all procedures. A modified Hueter approach was used for exposure.⁹ Mean incision length was about 12 cm. For the treatment group, the ring retractor was inserted at the level of the tensor fascia, with the inferior ring resting between the fascia and the subcutaneous layer and the superior ring cinched over the skin (Figure 3). The device is made in 4 different sizes for incisions from 2.5 to 17 cm; our study population required only 1 size. Otherwise, the surgical protocol was based on that described by Matta and colleagues.⁸ Wound closure (over a drain) was performed according to a standardized protocol—running No. 1 Vicryl suture for the superficial tensor fascia, interrupted 2-0 Vicryl for the deep dermal layer, and subcutaneous 4-0 Monocryl for the skin followed by application of Dermabond (Ethicon, Somerville, New Jersey) and Tegaderm +Pad (3M, St. Paul, Minnesota) for outer dressing, which was replaced on postoperative day 2 and removed at the 2-week visit.

Statistical Methods

An a priori sample-size calculation was performed. Power performed in a base of a prior study that evaluated anterolateral and posterolateral THA scars using a VAS, a component of the MSS, suggested a sample size of 16 per group to detect the minimal clinically important difference of 1.5 cm: SD (σ) = 1.5 cm, α = 0.05, β = 0.20.^29,30 In addition, a general estimate for detecting a 1-unit change on an ordinal scale (σ = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively decided to enroll 25 patients per arm in case of larger true variance.

The Wilcoxon rank sum test was used for comparisons of continuous data between groups. Differences between means were analyzed with 2-sided t tests. Categorical data were compared with the Pearson χ² test or the Fisher exact test, as indicated. Ordinal ranking scores were compared with the Mantel-Haenszel test. Multivariate logistic regression was applied to identify the significant independent predictors of better scar grades for each surgeon by considering candidate variables with Ps < .20 in the univariate analysis.

Results

We found no differences in demographic or perioperative characteristics between treatment and control groups (Tables 3, 4). The groups showed similar mean improvements in their respective 6-week HHS (38.7 and 36.4 points; P = .65), SF-12 physical component summary scores (11.8 and 14.5 points; P = .37), and SF-12 mental component summary scores (5.1 and 3.7; P = .70).

Patient questionnaire outcomes are listed in Table 5. For the control group, 25/25 image sets were obtained at the 2-week visit, 25/25 at the 6-week visit, and 24/25 at the 12-week visit. For the treatment group, there were 23/25, 24/25, and 23/25 images sets, respectively.

When surgeon scoring was analyzed separately, SBSES and MSS scores were similar between treatment and control groups, with 1 exception: 2-week MSS scores were better for the treatment group according to surgeon A (P = .026). When grades were averaged, SBSES scores were again similar at all time points (Figure 4A); MSS scores were better for the treatment group at 2 weeks (P = .036) and equivalent at all other time points (Figure 4B). For the SBSES, Spearman correlation coefficient ρ with 95% confidence interval (CI) was 0.37
(95% CI, 0.08-0.66) at 2 weeks, 0.48 (95% CI, 0.20-0.76) at 6 weeks, and 0.62 (95% CI, 0.33-0.91) at 12 weeks. Following the same pattern for the MSS, ρ was 0.20 (95% CI, –0.09 to 0.49), 0.51 (95% CI, 0.23-0.79), and 0.32 (95% CI, 0.03-0.61).

Independent multivariate analysis revealed that age over 65 years was a significant predictor of worse scores. On SBSES, the odds ratio (OR) was 1.15 (95% CI, 1.07-1.24) for surgeon A and 1.11 (95% CI, 1.05-1.18) for surgeon B. On MSS, the OR was 0.89 (95% CI, 0.84-0.94) for surgeon A and 0.95 (95% CI, 0.91-0.99) for surgeon B. The likelihood of having worse SBSES scores according to surgeon A was 4.72 times higher if the pre-albumin level was under 20 mg/L (95% CI, 1.15-19.36). Albumin level under 3.5 g/dL and absolute lymphocyte count under 1500 cells/µL were not found to be independent predictors of poorer scores.

Patients’ overall opinion (P = .63) and assessment of their scars relative to expectations (P = .25) on the Likert scales were not different between groups. More scars exceeded patients’ expectations and had more excellent ratings in the control group. The 2 groups were similar with regard to relative importance of various patient-related outcomes. Factors most important to overall outcome were relief of hip pain, followed by implant longevity and length of recovery. Least important were incision-related variables.

There were only 3 minor noninfectious wound complications (6%), 2 in the treatment group and 1 in the control group. In the treatment group, a 67-year-old man with diabetes (ASA class III; BMI, 32.1 kg/m²; received transfusion) had 2 small areas (<5 mm) of superficial ulceration at 6-week follow-up—one at the proximal aspect of the incision and the other near the midpoint along the flexion crease. Both lesions resolved by 12-week follow-up. Also in the treatment group, a 77-year-old woman (ASA class II; BMI, 24.9 kg/m²; received transfusion) at 6 weeks had a spitting suture, which was removed in clinic without further issue. In the control group, a 55-year-old woman (ASA class II; BMI, 27.4 kg/m²) had a suture reaction near the proximal aspect of her incision 3 weeks after surgery. This reaction, which presented as a mild, localized erythema without pain, tenderness, or drainage, resolved by 6-week follow-up. None of these wound complications required intervention beyond observation.

Discussion

This study was designed to provide a bipartisan measure of wound-healing cosmesis after DA-THA. Scar evaluation by blinded plastic surgeons served as a standardized, clinical assessment, whereas the patient questionnaire offered a more subjective appraisal. The modified MMS²⁵ and the SBSES²⁴ are the only 2 wound-grading systems designed and validated for photographic assessment of postsurgical scars. Most scar evaluation schemes pertain to burn or traumatic scars.^26,27,31 As a result, many earlier studies intending to compare incisional scars used poorly suited evaluation systems.

The current literature includes reports on 3 studies with scoring-based scar assessment in THA; all used grading systems designed for either burns or traumatic wounds, but 2 also used a VAS.^32-34 VASs have been validated for measuring wound cosmesis but are entirely subjective and without structure and provide no feedback as to why a scar was rated good or bad.²⁴ Mow and colleagues³² prospectively compared scars after standard posterior or MIS approaches and found no differences according to a scoring system intended for burn scars. In our study population, we found no group differences in patients’ cosmesis of their scars.

Although scars can take a year or longer to fully mature, researchers from the University of Michigan discovered that scar appearance at 1 year correlates highly with cosmesis 12 weeks after closure, though poorly with cosmesis 10 days after closure.³⁵ Therefore, any observed differences in scar cosmesis between groups at 12-week follow-up would likely persist, whereas differences at 2-week follow-up would have little bearing on ultimate appearance. For this reason, our primary outcome measure was healing process and cosmesis at 12 weeks. High wound complication rates have been reported for MIS-DA-THA.^8,14-16 Jewett and Collis¹⁵ noted a 4.6% wound complication rate (3% noninfectious ulcerative dehiscence, 1.6% superficial infection), which is comparable to the 6% rate found in this study. However, there likely is some variability across studies in what constitutes a wound complication or superficial infection. Of our 3 wound complications—stitch reaction, spitting suture, small noninfectious ulceration—only the ulceration was of a severity similar to that reported by Jewett and Collis.¹⁵ Matta and colleagues⁸ reported only 3 wound complications (in 494 patients), all severe enough to require operative intervention. One explanation for this low complication rate is use of a ring retractor, as it is routinely depicted in their technique paper. However, no specific reference is made to gauge how often the device was used.

Rates of superficial infection after DA-THA range from 0.6% to 1.6% in 3 large observational studies (combined deep infection rate, 0.43%).^8,14,15 In 2 of these studies, all patients with superficial infection underwent formal débridement, though none developed deep infection. A prospective randomized study of 221 patients who underwent colorectal surgery—where perioperative infectious morbidity ranges from 25% to 50%—found that ring retractor use significantly reduced superficial wound infection rates (8.1% vs 0%). A significant reduction in wound infection was shown in a similarly designed study involving 48 patients who had open appendectomy (14.6% vs 1.6%). The device had no effect on deep infection in either general surgery study. The wound infection rates reported in these general surgery studies are markedly higher than those in our study population. As a result, the effect of the ring retractor on wound infection in DA-THA may be less. Regardless of the effect on deep infection, fewer superficial infections, which often require operative intervention, would be of considerable benefit.

Below-threshold albumin level and absolute lymphocyte count have been associated with wound-healing complications after hip replacement.²¹ In the present study, pre-albumin level under 20 mg/L was the only nutritional marker predictive of poor wound appearance, but this finding was seen only in SBSES scores from surgeon A. Subgroup analysis did not reveal any relationship between wound appearance and any of the recorded demographic or perioperative variables, but for a small predictive influence with age over 65 years.

This study had some limitations. Our findings cannot be generalized to all patients who undergo THA, as only DA incisions were studied. Results also may not be generalizable to non-fellowship-trained orthopedists. In addition, selection bias likely resulted from including patients already selected for the DA approach. Using digital images for evaluation (vs real-life evaluation) may have affected reliability as well. Last, by not incorporating texture, we omitted a potentially informative feature from scoring.

It is paramount that surgeons undergo diligent training before undertaking this approach for minimizing unwanted results; furthermore, higher early complication rates level off with increased surgeon experience.^14,36,37 We recommend meticulous soft-tissue handling, cautious retraction, and careful patient selection (relative contraindication for patients with an abdominal pannus overlying the incision) as primary measures for minimizing incisional trauma and potential wound-healing complications.³⁸ Preservation of the tensor fascia is also crucial,³⁹ as it is the only closable layer separating deep and superficial compartments. Without good closure of the tensor fascia, there is no containment or tamponade of deep bleeding, which can facilitate hematoma formation.

In the population studied, we found no significant long-term differences in cosmetic appearance (based on clinician or patient evaluation) between wounds managed with and without the ring retractor. Our data do not support routine use of the ring retractor, during DA-THA, for improved wound cosmesis. Whether the device has any significant role in reducing the number of wound complications in THA is yet to be determined. Last, the ring retractor may have a role in other areas of orthopedic surgery, such as hip fractures in the elderly or orthopedic oncology. In situations like these, where adequate nutrition and immunocompetency may be lacking, the added protection provided by the device may translate into a more notable benefit than in elective THA.

A majority of healthy, youth baseball players report some baseline arm pain and fatigue, and many players suffer adverse psychosocial effects from this pain, according to a study published online ahead of print November 3 in the American Journal of Sports Medicine.

“Both nationally and internationally, we’re witnessing a troubling increase of elbow and shoulder injuries in young baseball players,” said study leader Christopher S. Ahmad, MD, Chief of Sports Medicine and Professor of Orthopedic Surgery at New York-Presbyterian/Columbia and head team physician for the New York Yankees.

Dr. Ahmad and his research colleagues designed a questionnaire to learn more about the frequency, severity, and psychosocial effects of arm pain among active adolescent baseball payers. The questionnaire was completed by 203 players from New York and New Jersey, who were between the ages of 8 and 18. All of the surveys were completed without input from parents or coaches.

Among the survey’s findings was that 74% of players reported having arm pain while throwing. Just 26% said they “never” had arm pain while throwing.

The study also found that:

• 54% reported that arm pain limited the number of innings they could play.

• 75% reported that arm pain limited how hard they could throw.

• 80% reported having arm pain the day after throwing.

• 82% reported arm fatigue during a game or practice.

Pitchers, compared with infielders and outfielders, were especially likely to have played with pain. One-quarter of pitchers reported that they “often” or “always” had pain the day after throwing. “These pitchers likely represent one of the higher-risk groups for incurring a future overuse injury and thus warrant particularly high monitoring,” said Dr. Ahmad.

Almost half (47%) of players reported that they had been encouraged to continue playing in a practice or game even though they were having pain. One in eight players ages 17 to 18 reported that they “always” felt encouraged to continue playing despite having arm pain. A majority of players reported that arm pain caused them to experience less enjoyment while playing and that it was responsible for holding them back from being a better player.

“It’s alarming that so many young baseball players are encouraged to play with pain,” said Dr. Ahmad. “Years ago, prior to concussion protocols, we observed something similar in football, where players who suffered a concussion were routinely sent back into the game after ‘recovering’ for a few minutes. The initial concussion lowered the threshold for another concussion, and the repeated concussions put the player at risk for permanent damage. I think we’re seeing a similar problem in baseball, where playing with arm pain is setting the stage for more serious injury.”

Dr. Ahmad suspects that this phenomenon has contributed to the recent rise in “Tommy John” surgeries among college and professional baseball players. According to Dr. Ahmad, current precautions and guidelines are inadequate for preventing injury. “It’s not enough to set pitch counts based on a player’s age,” he said. “While some 14 year olds are already quite mature, in terms of their skeletal structure, others haven’t even started their growth spurt yet. We need to come up with more individualized throwing programs and better ways to detect which players are at risk for injury.”

Dr. Ahmad is currently investigating the use of ultrasound for correlating arm pain with tissue damage.

A majority of healthy, youth baseball players report some baseline arm pain and fatigue, and many players suffer adverse psychosocial effects from this pain, according to a study published online ahead of print November 3 in the American Journal of Sports Medicine.

“Both nationally and internationally, we’re witnessing a troubling increase of elbow and shoulder injuries in young baseball players,” said study leader Christopher S. Ahmad, MD, Chief of Sports Medicine and Professor of Orthopedic Surgery at New York-Presbyterian/Columbia and head team physician for the New York Yankees.

Dr. Ahmad and his research colleagues designed a questionnaire to learn more about the frequency, severity, and psychosocial effects of arm pain among active adolescent baseball payers. The questionnaire was completed by 203 players from New York and New Jersey, who were between the ages of 8 and 18. All of the surveys were completed without input from parents or coaches.

Among the survey’s findings was that 74% of players reported having arm pain while throwing. Just 26% said they “never” had arm pain while throwing.

The study also found that:

• 54% reported that arm pain limited the number of innings they could play.

• 75% reported that arm pain limited how hard they could throw.

• 80% reported having arm pain the day after throwing.

• 82% reported arm fatigue during a game or practice.

Pitchers, compared with infielders and outfielders, were especially likely to have played with pain. One-quarter of pitchers reported that they “often” or “always” had pain the day after throwing. “These pitchers likely represent one of the higher-risk groups for incurring a future overuse injury and thus warrant particularly high monitoring,” said Dr. Ahmad.

Almost half (47%) of players reported that they had been encouraged to continue playing in a practice or game even though they were having pain. One in eight players ages 17 to 18 reported that they “always” felt encouraged to continue playing despite having arm pain. A majority of players reported that arm pain caused them to experience less enjoyment while playing and that it was responsible for holding them back from being a better player.

“It’s alarming that so many young baseball players are encouraged to play with pain,” said Dr. Ahmad. “Years ago, prior to concussion protocols, we observed something similar in football, where players who suffered a concussion were routinely sent back into the game after ‘recovering’ for a few minutes. The initial concussion lowered the threshold for another concussion, and the repeated concussions put the player at risk for permanent damage. I think we’re seeing a similar problem in baseball, where playing with arm pain is setting the stage for more serious injury.”

Dr. Ahmad suspects that this phenomenon has contributed to the recent rise in “Tommy John” surgeries among college and professional baseball players. According to Dr. Ahmad, current precautions and guidelines are inadequate for preventing injury. “It’s not enough to set pitch counts based on a player’s age,” he said. “While some 14 year olds are already quite mature, in terms of their skeletal structure, others haven’t even started their growth spurt yet. We need to come up with more individualized throwing programs and better ways to detect which players are at risk for injury.”

Dr. Ahmad is currently investigating the use of ultrasound for correlating arm pain with tissue damage.

A majority of healthy, youth baseball players report some baseline arm pain and fatigue, and many players suffer adverse psychosocial effects from this pain, according to a study published online ahead of print November 3 in the American Journal of Sports Medicine.

“Both nationally and internationally, we’re witnessing a troubling increase of elbow and shoulder injuries in young baseball players,” said study leader Christopher S. Ahmad, MD, Chief of Sports Medicine and Professor of Orthopedic Surgery at New York-Presbyterian/Columbia and head team physician for the New York Yankees.

Dr. Ahmad and his research colleagues designed a questionnaire to learn more about the frequency, severity, and psychosocial effects of arm pain among active adolescent baseball payers. The questionnaire was completed by 203 players from New York and New Jersey, who were between the ages of 8 and 18. All of the surveys were completed without input from parents or coaches.

Among the survey’s findings was that 74% of players reported having arm pain while throwing. Just 26% said they “never” had arm pain while throwing.

The study also found that:

• 54% reported that arm pain limited the number of innings they could play.

• 75% reported that arm pain limited how hard they could throw.

• 80% reported having arm pain the day after throwing.

• 82% reported arm fatigue during a game or practice.

Pitchers, compared with infielders and outfielders, were especially likely to have played with pain. One-quarter of pitchers reported that they “often” or “always” had pain the day after throwing. “These pitchers likely represent one of the higher-risk groups for incurring a future overuse injury and thus warrant particularly high monitoring,” said Dr. Ahmad.

Almost half (47%) of players reported that they had been encouraged to continue playing in a practice or game even though they were having pain. One in eight players ages 17 to 18 reported that they “always” felt encouraged to continue playing despite having arm pain. A majority of players reported that arm pain caused them to experience less enjoyment while playing and that it was responsible for holding them back from being a better player.

“It’s alarming that so many young baseball players are encouraged to play with pain,” said Dr. Ahmad. “Years ago, prior to concussion protocols, we observed something similar in football, where players who suffered a concussion were routinely sent back into the game after ‘recovering’ for a few minutes. The initial concussion lowered the threshold for another concussion, and the repeated concussions put the player at risk for permanent damage. I think we’re seeing a similar problem in baseball, where playing with arm pain is setting the stage for more serious injury.”

Dr. Ahmad suspects that this phenomenon has contributed to the recent rise in “Tommy John” surgeries among college and professional baseball players. According to Dr. Ahmad, current precautions and guidelines are inadequate for preventing injury. “It’s not enough to set pitch counts based on a player’s age,” he said. “While some 14 year olds are already quite mature, in terms of their skeletal structure, others haven’t even started their growth spurt yet. We need to come up with more individualized throwing programs and better ways to detect which players are at risk for injury.”

Dr. Ahmad is currently investigating the use of ultrasound for correlating arm pain with tissue damage.