Stay attentive to cardiovascular disease risk in patients with psoriasis because effective treatment of psoriasis could improve their vascular risk as well, said Jeffrey M. Sobell, MD, of Tufts University in Boston.

Shared risk factors between psoriasis and cardiovascular disease may put psoriasis patients at particular risk for a major cardiac event, he said at the Caribbean Dermatology Symposium.

The metabolic syndrome and its associated cardiovascular risk of myocardial infarction and stroke is significantly more prevalent in psoriasis patients, compared with controls, Dr. Sobell said at the meeting, provided by Global Academy for Medical Education.

ricky_68fr/fotolia

dermnews@frontlinemedcom.com

Stay attentive to cardiovascular disease risk in patients with psoriasis because effective treatment of psoriasis could improve their vascular risk as well, said Jeffrey M. Sobell, MD, of Tufts University in Boston.

Shared risk factors between psoriasis and cardiovascular disease may put psoriasis patients at particular risk for a major cardiac event, he said at the Caribbean Dermatology Symposium.

The metabolic syndrome and its associated cardiovascular risk of myocardial infarction and stroke is significantly more prevalent in psoriasis patients, compared with controls, Dr. Sobell said at the meeting, provided by Global Academy for Medical Education.

ricky_68fr/fotolia

dermnews@frontlinemedcom.com

Stay attentive to cardiovascular disease risk in patients with psoriasis because effective treatment of psoriasis could improve their vascular risk as well, said Jeffrey M. Sobell, MD, of Tufts University in Boston.

Shared risk factors between psoriasis and cardiovascular disease may put psoriasis patients at particular risk for a major cardiac event, he said at the Caribbean Dermatology Symposium.

The metabolic syndrome and its associated cardiovascular risk of myocardial infarction and stroke is significantly more prevalent in psoriasis patients, compared with controls, Dr. Sobell said at the meeting, provided by Global Academy for Medical Education.

ricky_68fr/fotolia

dermnews@frontlinemedcom.com

The PAM50-based risk of recurrence (ROR) score enabled selection of a subset of patients with estrogen receptor (ER)–positive early-stage breast cancer with node-positive or node-negative disease with an estimated 10-year distant recurrence (DR) absolute risk of less than 5%, investigators reported.

This subset of patients with one to three positive lymph nodes presented a sufficiently low risk of disease recurrence and could safely avoid chemotherapy, reported Anne-Vibeke Laenkholm, MD, and her associates. The report was published in the Journal of Clinical Oncology.

The PAM50-based ROR score (Prosigna Score; Nanostring Technologies, Seattle) is a comparative gene expression profile of the tumor, relative to each of the four PAM50 molecular profiles (luminal A, luminal B, basal, and HER2 enriched) to determine the degree of similarity. The Prosigna assay currently has Food and Drug Administration clearance for prognostic use.

Postmenopausal women diagnosed with ER-positive/HER2-negative early-stage breast cancer in Denmark between 2000 and 2003, and who received adjuvant treatment with tamoxifen or an aromatase inhibitor without chemotherapy were eligible for this cohort study.

The primary endpoint was time to DR, defined as the interval from breast cancer surgery until DR or death as a result of breast cancer. Secondary endpoints included overall survival and time to any recurrence. “The median age of patients was 63 years (range, 50-89 years); 45.5% were node negative, and 54.5% had one to three positive nodes. Tumor characteristics including nodal status, tumor size, malignancy grade, and lymphovascular invasion were all associated with DR, whereas treatment adherence was not,” wrote Dr. Laenkholm of the department of surgical pathology, Zealand University Hospital, Denmark, and her colleagues.

“With a median follow-up of approximately 9 years, 26% of the patients with node-positive disease were categorized as having a low ROR score corresponding to a DR of 3.5% at 10 years compared with those with an intermediate ROR score with a DR of 11.5% and those with a high ROR score corresponding to a DR risk of 22%. In the node-negative group, those with a low ROR score had a 10-year DR risk of 5% and those with an intermediate ROR score had a 7.3% 10-year DR risk, compared with a DR of 17.8% in those with a high ROR score,” Dr. Laenkholm and her associates reported.

The data are entirely prognostic and do not address whether chemotherapy might offer some benefit in a node-positive population (i.e., one to three nodes), or whether adjuvant chemotherapy–associated adverse effects may offset the added benefit, if any, the investigators said.

Nonetheless, genomic assay–based scoring tools are an important aid in clinical decision making readily available to the physician at the patient’s bedside, they said.

Nanostring Technologies funded the study. Laboratory work flow was executed at the department of surgical pathology, Zealand University Hospital. Several authors reported ties with Roche and other pharmaceutical companies.
 

op@frontlinemedcom.com

SOURCE: Laenkholm et al. J Clin Oncol. 2018 Jan 25. doi: 10.1200/JCO.2017.74.6586.

The PAM50-based risk of recurrence (ROR) score enabled selection of a subset of patients with estrogen receptor (ER)–positive early-stage breast cancer with node-positive or node-negative disease with an estimated 10-year distant recurrence (DR) absolute risk of less than 5%, investigators reported.

This subset of patients with one to three positive lymph nodes presented a sufficiently low risk of disease recurrence and could safely avoid chemotherapy, reported Anne-Vibeke Laenkholm, MD, and her associates. The report was published in the Journal of Clinical Oncology.

The PAM50-based ROR score (Prosigna Score; Nanostring Technologies, Seattle) is a comparative gene expression profile of the tumor, relative to each of the four PAM50 molecular profiles (luminal A, luminal B, basal, and HER2 enriched) to determine the degree of similarity. The Prosigna assay currently has Food and Drug Administration clearance for prognostic use.

Postmenopausal women diagnosed with ER-positive/HER2-negative early-stage breast cancer in Denmark between 2000 and 2003, and who received adjuvant treatment with tamoxifen or an aromatase inhibitor without chemotherapy were eligible for this cohort study.

The primary endpoint was time to DR, defined as the interval from breast cancer surgery until DR or death as a result of breast cancer. Secondary endpoints included overall survival and time to any recurrence. “The median age of patients was 63 years (range, 50-89 years); 45.5% were node negative, and 54.5% had one to three positive nodes. Tumor characteristics including nodal status, tumor size, malignancy grade, and lymphovascular invasion were all associated with DR, whereas treatment adherence was not,” wrote Dr. Laenkholm of the department of surgical pathology, Zealand University Hospital, Denmark, and her colleagues.

“With a median follow-up of approximately 9 years, 26% of the patients with node-positive disease were categorized as having a low ROR score corresponding to a DR of 3.5% at 10 years compared with those with an intermediate ROR score with a DR of 11.5% and those with a high ROR score corresponding to a DR risk of 22%. In the node-negative group, those with a low ROR score had a 10-year DR risk of 5% and those with an intermediate ROR score had a 7.3% 10-year DR risk, compared with a DR of 17.8% in those with a high ROR score,” Dr. Laenkholm and her associates reported.

The data are entirely prognostic and do not address whether chemotherapy might offer some benefit in a node-positive population (i.e., one to three nodes), or whether adjuvant chemotherapy–associated adverse effects may offset the added benefit, if any, the investigators said.

Nonetheless, genomic assay–based scoring tools are an important aid in clinical decision making readily available to the physician at the patient’s bedside, they said.

Nanostring Technologies funded the study. Laboratory work flow was executed at the department of surgical pathology, Zealand University Hospital. Several authors reported ties with Roche and other pharmaceutical companies.
 

op@frontlinemedcom.com

SOURCE: Laenkholm et al. J Clin Oncol. 2018 Jan 25. doi: 10.1200/JCO.2017.74.6586.

The PAM50-based risk of recurrence (ROR) score enabled selection of a subset of patients with estrogen receptor (ER)–positive early-stage breast cancer with node-positive or node-negative disease with an estimated 10-year distant recurrence (DR) absolute risk of less than 5%, investigators reported.

This subset of patients with one to three positive lymph nodes presented a sufficiently low risk of disease recurrence and could safely avoid chemotherapy, reported Anne-Vibeke Laenkholm, MD, and her associates. The report was published in the Journal of Clinical Oncology.

The PAM50-based ROR score (Prosigna Score; Nanostring Technologies, Seattle) is a comparative gene expression profile of the tumor, relative to each of the four PAM50 molecular profiles (luminal A, luminal B, basal, and HER2 enriched) to determine the degree of similarity. The Prosigna assay currently has Food and Drug Administration clearance for prognostic use.

Postmenopausal women diagnosed with ER-positive/HER2-negative early-stage breast cancer in Denmark between 2000 and 2003, and who received adjuvant treatment with tamoxifen or an aromatase inhibitor without chemotherapy were eligible for this cohort study.

The primary endpoint was time to DR, defined as the interval from breast cancer surgery until DR or death as a result of breast cancer. Secondary endpoints included overall survival and time to any recurrence. “The median age of patients was 63 years (range, 50-89 years); 45.5% were node negative, and 54.5% had one to three positive nodes. Tumor characteristics including nodal status, tumor size, malignancy grade, and lymphovascular invasion were all associated with DR, whereas treatment adherence was not,” wrote Dr. Laenkholm of the department of surgical pathology, Zealand University Hospital, Denmark, and her colleagues.

“With a median follow-up of approximately 9 years, 26% of the patients with node-positive disease were categorized as having a low ROR score corresponding to a DR of 3.5% at 10 years compared with those with an intermediate ROR score with a DR of 11.5% and those with a high ROR score corresponding to a DR risk of 22%. In the node-negative group, those with a low ROR score had a 10-year DR risk of 5% and those with an intermediate ROR score had a 7.3% 10-year DR risk, compared with a DR of 17.8% in those with a high ROR score,” Dr. Laenkholm and her associates reported.

The data are entirely prognostic and do not address whether chemotherapy might offer some benefit in a node-positive population (i.e., one to three nodes), or whether adjuvant chemotherapy–associated adverse effects may offset the added benefit, if any, the investigators said.

Nonetheless, genomic assay–based scoring tools are an important aid in clinical decision making readily available to the physician at the patient’s bedside, they said.

Nanostring Technologies funded the study. Laboratory work flow was executed at the department of surgical pathology, Zealand University Hospital. Several authors reported ties with Roche and other pharmaceutical companies.
 

op@frontlinemedcom.com

SOURCE: Laenkholm et al. J Clin Oncol. 2018 Jan 25. doi: 10.1200/JCO.2017.74.6586.

KAUAI, HAWAII – When certolizumab pegol receives marketing approval for moderate to severe psoriasis – which experts say is a virtual lock – it will offer a singular advantage over current anti–tumor necrosis factor (anti-TNF) biologics: strong evidence of safety in pregnancy.

“Some believe this will make certolizumab the anti-TNF agent of choice in women of childbearing potential, ” Kenneth B. Gordon, MD, observed at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

CRIB was a prospective postmarketing pharmacokinetic study that evaluated placental transfer of certolizumab from 16 pregnant women on the biologic to their infants. All of the mothers received their last dose of certolizumab for rheumatoid arthritis or other approved indications within 35 days of delivery. Blood samples were collected from mothers, newborns, and umbilical cords within 1 hour of delivery, and again from the infants at weeks 4 and 8 after delivery.

Only one infant had a detectable plasma level of certolizumab at birth, and it was barely measurable at 0.042 mcg/mL, as compared with 49.4 mcg/mL in the mother’s plasma. This is consistent with the fact that certolizumab’s pegylated arm allows only minimal or no placental transfer from mother to infant, so there is essentially no third trimester in utero fetal exposure. In contrast, as Dr. Kimball noted, other anti-TNF biologics lack a pegylated arm and thus preferentially cross the placenta, creating a theoretical increased risk of maternal pregnancy complications and/or congenital malformations.

Dr. Kimball, professor of dermatology at Harvard Medical School and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, both in Boston, also has been deeply involved in an ongoing registry (sponsored by certolizumab manufacturer UCB) of several hundred women on certolizumab in pregnancy. The data have reassuringly shown no increased risk of maternal pregnancy complications such as preeclampsia, gestational diabetes, or preterm birth, nor any increase in or pattern of congenital malformations, compared with background rates in the general population.

Dr. Gordon said that while he understands the concerns, he personally doesn’t think the class-wide safety of TNF inhibitors in pregnancy and lactation is a big issue.

“My argument is that anti-TNF agents have been used very frequently in women of childbearing age, and also in women who are pregnant or lactating. And there have not been any side effect signals from that,” he explained.

The prospects of gaining an expanded indication for certolizumab in psoriasis hinge in part on the impressive results of the pivotal phase 3, randomized, double-blind, placebo-controlled CIMPASI-1 and CIMPASI-2 trials. In CIMPASI-1, the week-48 Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response rates were 87.1% and 60.2%, respectively, in patients on the biologic at 400 mg every 2 weeks; among those on certolizumab at 200 mg every 2 weeks, the rates were 67.2% and 42.8%. In CIMPASI-2, the PASI 75 and PASI 90 rates were 81.3% and 62.0% at 400 mg and 78.7% and 59.6% with 200 mg every 2 weeks.

There were no cases of tuberculosis or any other significant safety concerns through 48 weeks, Dr. Gordon said.

“Certolizumab is coming soon for psoriasis,” predicted Craig L. Leonardi, MD, a psoriasis researcher at Saint Louis University. “The data are very impressive. It’s a high-performance drug. There’s no reason why this drug shouldn’t be approved.”

Since Dr. Kimball’s presentation of the CRIB data at the 2017 annual meeting of the European Academy of Dermatology and Venereology, the study has been published (Ann Rheum Dis. 2018 Feb;77[2]:228-33).

Dr. Gordon reported receiving research support from and serving as a paid consultant to numerous pharmaceutical companies developing new psoriasis therapies.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

KAUAI, HAWAII – When certolizumab pegol receives marketing approval for moderate to severe psoriasis – which experts say is a virtual lock – it will offer a singular advantage over current anti–tumor necrosis factor (anti-TNF) biologics: strong evidence of safety in pregnancy.

“Some believe this will make certolizumab the anti-TNF agent of choice in women of childbearing potential, ” Kenneth B. Gordon, MD, observed at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

CRIB was a prospective postmarketing pharmacokinetic study that evaluated placental transfer of certolizumab from 16 pregnant women on the biologic to their infants. All of the mothers received their last dose of certolizumab for rheumatoid arthritis or other approved indications within 35 days of delivery. Blood samples were collected from mothers, newborns, and umbilical cords within 1 hour of delivery, and again from the infants at weeks 4 and 8 after delivery.

Only one infant had a detectable plasma level of certolizumab at birth, and it was barely measurable at 0.042 mcg/mL, as compared with 49.4 mcg/mL in the mother’s plasma. This is consistent with the fact that certolizumab’s pegylated arm allows only minimal or no placental transfer from mother to infant, so there is essentially no third trimester in utero fetal exposure. In contrast, as Dr. Kimball noted, other anti-TNF biologics lack a pegylated arm and thus preferentially cross the placenta, creating a theoretical increased risk of maternal pregnancy complications and/or congenital malformations.

Dr. Kimball, professor of dermatology at Harvard Medical School and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, both in Boston, also has been deeply involved in an ongoing registry (sponsored by certolizumab manufacturer UCB) of several hundred women on certolizumab in pregnancy. The data have reassuringly shown no increased risk of maternal pregnancy complications such as preeclampsia, gestational diabetes, or preterm birth, nor any increase in or pattern of congenital malformations, compared with background rates in the general population.

Dr. Gordon said that while he understands the concerns, he personally doesn’t think the class-wide safety of TNF inhibitors in pregnancy and lactation is a big issue.

“My argument is that anti-TNF agents have been used very frequently in women of childbearing age, and also in women who are pregnant or lactating. And there have not been any side effect signals from that,” he explained.

The prospects of gaining an expanded indication for certolizumab in psoriasis hinge in part on the impressive results of the pivotal phase 3, randomized, double-blind, placebo-controlled CIMPASI-1 and CIMPASI-2 trials. In CIMPASI-1, the week-48 Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response rates were 87.1% and 60.2%, respectively, in patients on the biologic at 400 mg every 2 weeks; among those on certolizumab at 200 mg every 2 weeks, the rates were 67.2% and 42.8%. In CIMPASI-2, the PASI 75 and PASI 90 rates were 81.3% and 62.0% at 400 mg and 78.7% and 59.6% with 200 mg every 2 weeks.

There were no cases of tuberculosis or any other significant safety concerns through 48 weeks, Dr. Gordon said.

“Certolizumab is coming soon for psoriasis,” predicted Craig L. Leonardi, MD, a psoriasis researcher at Saint Louis University. “The data are very impressive. It’s a high-performance drug. There’s no reason why this drug shouldn’t be approved.”

Since Dr. Kimball’s presentation of the CRIB data at the 2017 annual meeting of the European Academy of Dermatology and Venereology, the study has been published (Ann Rheum Dis. 2018 Feb;77[2]:228-33).

Dr. Gordon reported receiving research support from and serving as a paid consultant to numerous pharmaceutical companies developing new psoriasis therapies.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

KAUAI, HAWAII – When certolizumab pegol receives marketing approval for moderate to severe psoriasis – which experts say is a virtual lock – it will offer a singular advantage over current anti–tumor necrosis factor (anti-TNF) biologics: strong evidence of safety in pregnancy.

“Some believe this will make certolizumab the anti-TNF agent of choice in women of childbearing potential, ” Kenneth B. Gordon, MD, observed at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

CRIB was a prospective postmarketing pharmacokinetic study that evaluated placental transfer of certolizumab from 16 pregnant women on the biologic to their infants. All of the mothers received their last dose of certolizumab for rheumatoid arthritis or other approved indications within 35 days of delivery. Blood samples were collected from mothers, newborns, and umbilical cords within 1 hour of delivery, and again from the infants at weeks 4 and 8 after delivery.

Only one infant had a detectable plasma level of certolizumab at birth, and it was barely measurable at 0.042 mcg/mL, as compared with 49.4 mcg/mL in the mother’s plasma. This is consistent with the fact that certolizumab’s pegylated arm allows only minimal or no placental transfer from mother to infant, so there is essentially no third trimester in utero fetal exposure. In contrast, as Dr. Kimball noted, other anti-TNF biologics lack a pegylated arm and thus preferentially cross the placenta, creating a theoretical increased risk of maternal pregnancy complications and/or congenital malformations.

Dr. Kimball, professor of dermatology at Harvard Medical School and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, both in Boston, also has been deeply involved in an ongoing registry (sponsored by certolizumab manufacturer UCB) of several hundred women on certolizumab in pregnancy. The data have reassuringly shown no increased risk of maternal pregnancy complications such as preeclampsia, gestational diabetes, or preterm birth, nor any increase in or pattern of congenital malformations, compared with background rates in the general population.

Dr. Gordon said that while he understands the concerns, he personally doesn’t think the class-wide safety of TNF inhibitors in pregnancy and lactation is a big issue.

“My argument is that anti-TNF agents have been used very frequently in women of childbearing age, and also in women who are pregnant or lactating. And there have not been any side effect signals from that,” he explained.

The prospects of gaining an expanded indication for certolizumab in psoriasis hinge in part on the impressive results of the pivotal phase 3, randomized, double-blind, placebo-controlled CIMPASI-1 and CIMPASI-2 trials. In CIMPASI-1, the week-48 Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response rates were 87.1% and 60.2%, respectively, in patients on the biologic at 400 mg every 2 weeks; among those on certolizumab at 200 mg every 2 weeks, the rates were 67.2% and 42.8%. In CIMPASI-2, the PASI 75 and PASI 90 rates were 81.3% and 62.0% at 400 mg and 78.7% and 59.6% with 200 mg every 2 weeks.

There were no cases of tuberculosis or any other significant safety concerns through 48 weeks, Dr. Gordon said.

“Certolizumab is coming soon for psoriasis,” predicted Craig L. Leonardi, MD, a psoriasis researcher at Saint Louis University. “The data are very impressive. It’s a high-performance drug. There’s no reason why this drug shouldn’t be approved.”

Since Dr. Kimball’s presentation of the CRIB data at the 2017 annual meeting of the European Academy of Dermatology and Venereology, the study has been published (Ann Rheum Dis. 2018 Feb;77[2]:228-33).

Dr. Gordon reported receiving research support from and serving as a paid consultant to numerous pharmaceutical companies developing new psoriasis therapies.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

Total inpatient costs for patients who report being allergic to penicillin are much higher than for those who don’t report an allergy, according to a recent systematic review and meta-analysis.

The review, which eventually included 30 articles, found that total inpatient costs ranged from an average $1,145-$4,254 higher per patient with a reported penicillin allergy compared to nonallergic patients, said T. Joseph Mattingly, PharmD, and his associates. Outpatient prescription costs were also estimated to be steeper, running $14-$93 higher per patient who reported a penicillin allergy.

Spike Mafford/Thinkstock

Although 10%-20% of patients report a penicillin allergy, “[a] majority of patients who report PCN [penicillin] allergy are not truly allergic upon confirmatory testing,” Dr. Mattingly and his colleagues wrote.

This overreporting of penicillin allergies is a problem for the patient and the health care system because “reported antibiotic allergies have been associated with suboptimal antibiotic therapy, increased antimicrobial resistance, increased length of stay, increased antibiotic-related adverse events, increased rates of C. difficile infection, intensive care unit (ICU) admission, death, as well as increased treatment cost,” said Dr. Mattingly and his coauthors.

koakes@frontlinemedcom.com

SOURCE: Mattingly TJ et al. J Allergy Clin Immunol Pract. 2018 Jan 31. doi: 10.1016/j.jaip.2017.12.033.

Total inpatient costs for patients who report being allergic to penicillin are much higher than for those who don’t report an allergy, according to a recent systematic review and meta-analysis.

The review, which eventually included 30 articles, found that total inpatient costs ranged from an average $1,145-$4,254 higher per patient with a reported penicillin allergy compared to nonallergic patients, said T. Joseph Mattingly, PharmD, and his associates. Outpatient prescription costs were also estimated to be steeper, running $14-$93 higher per patient who reported a penicillin allergy.

Spike Mafford/Thinkstock

Although 10%-20% of patients report a penicillin allergy, “[a] majority of patients who report PCN [penicillin] allergy are not truly allergic upon confirmatory testing,” Dr. Mattingly and his colleagues wrote.

This overreporting of penicillin allergies is a problem for the patient and the health care system because “reported antibiotic allergies have been associated with suboptimal antibiotic therapy, increased antimicrobial resistance, increased length of stay, increased antibiotic-related adverse events, increased rates of C. difficile infection, intensive care unit (ICU) admission, death, as well as increased treatment cost,” said Dr. Mattingly and his coauthors.

koakes@frontlinemedcom.com

SOURCE: Mattingly TJ et al. J Allergy Clin Immunol Pract. 2018 Jan 31. doi: 10.1016/j.jaip.2017.12.033.

Total inpatient costs for patients who report being allergic to penicillin are much higher than for those who don’t report an allergy, according to a recent systematic review and meta-analysis.

The review, which eventually included 30 articles, found that total inpatient costs ranged from an average $1,145-$4,254 higher per patient with a reported penicillin allergy compared to nonallergic patients, said T. Joseph Mattingly, PharmD, and his associates. Outpatient prescription costs were also estimated to be steeper, running $14-$93 higher per patient who reported a penicillin allergy.

Spike Mafford/Thinkstock

Although 10%-20% of patients report a penicillin allergy, “[a] majority of patients who report PCN [penicillin] allergy are not truly allergic upon confirmatory testing,” Dr. Mattingly and his colleagues wrote.

This overreporting of penicillin allergies is a problem for the patient and the health care system because “reported antibiotic allergies have been associated with suboptimal antibiotic therapy, increased antimicrobial resistance, increased length of stay, increased antibiotic-related adverse events, increased rates of C. difficile infection, intensive care unit (ICU) admission, death, as well as increased treatment cost,” said Dr. Mattingly and his coauthors.

koakes@frontlinemedcom.com

SOURCE: Mattingly TJ et al. J Allergy Clin Immunol Pract. 2018 Jan 31. doi: 10.1016/j.jaip.2017.12.033.

The Food and Drug Administration has approved a combination drug intended to treat HIV-1 infections – bictegravir, emtricitabine, tenofovir alafenamide – in virologically suppressed (HIV-1 RNA less than 50 copies/mL) adults who have no history of antiretroviral treatment or as a replacement for their current antiretroviral regimen.

The approval of the new combination drug (Biktarvy) was based on four active, randomized, controlled trials comprising three double-blind studies and one open label study. After 48 weeks of treatment in all trials, CD4+ cell count was evaluated to determine the efficacy of bictegravir, emtricitabine, tenofovir alafenamide, compared with other antiretroviral therapies.

ilacy@frontlinemedcom.com

The Food and Drug Administration has approved a combination drug intended to treat HIV-1 infections – bictegravir, emtricitabine, tenofovir alafenamide – in virologically suppressed (HIV-1 RNA less than 50 copies/mL) adults who have no history of antiretroviral treatment or as a replacement for their current antiretroviral regimen.

The approval of the new combination drug (Biktarvy) was based on four active, randomized, controlled trials comprising three double-blind studies and one open label study. After 48 weeks of treatment in all trials, CD4+ cell count was evaluated to determine the efficacy of bictegravir, emtricitabine, tenofovir alafenamide, compared with other antiretroviral therapies.

ilacy@frontlinemedcom.com

The Food and Drug Administration has approved a combination drug intended to treat HIV-1 infections – bictegravir, emtricitabine, tenofovir alafenamide – in virologically suppressed (HIV-1 RNA less than 50 copies/mL) adults who have no history of antiretroviral treatment or as a replacement for their current antiretroviral regimen.

The approval of the new combination drug (Biktarvy) was based on four active, randomized, controlled trials comprising three double-blind studies and one open label study. After 48 weeks of treatment in all trials, CD4+ cell count was evaluated to determine the efficacy of bictegravir, emtricitabine, tenofovir alafenamide, compared with other antiretroviral therapies.

ilacy@frontlinemedcom.com

A substantial portion of older adults with epilepsy who are on Medicare receive prescriptions for antiepileptic drugs (AEDs) and nonepilepsy drugs (NEDs) that can interact to alter their effectiveness or induce toxicity, according to a retrospective analysis of a claims database.

Up to a quarter of all patients had potential interactions between AED and non-AED prescriptions, and these were more likely to occur for patients with comorbid conditions or those who were eligible for Part D Low Income Subsidy, reported Raymond Edward Faught Jr., MD, a professor in the department of neurology at Emory University, Atlanta, and his colleagues. The study was published in Epilepsia.

©Thinkstock.com

ilacy@frontlinemedcom.com

SOURCE: Faught E et al. Epilepsia. 2008 Feb 7. doi: 10.1111/epi.14010.

A substantial portion of older adults with epilepsy who are on Medicare receive prescriptions for antiepileptic drugs (AEDs) and nonepilepsy drugs (NEDs) that can interact to alter their effectiveness or induce toxicity, according to a retrospective analysis of a claims database.

Up to a quarter of all patients had potential interactions between AED and non-AED prescriptions, and these were more likely to occur for patients with comorbid conditions or those who were eligible for Part D Low Income Subsidy, reported Raymond Edward Faught Jr., MD, a professor in the department of neurology at Emory University, Atlanta, and his colleagues. The study was published in Epilepsia.

©Thinkstock.com

ilacy@frontlinemedcom.com

SOURCE: Faught E et al. Epilepsia. 2008 Feb 7. doi: 10.1111/epi.14010.

A substantial portion of older adults with epilepsy who are on Medicare receive prescriptions for antiepileptic drugs (AEDs) and nonepilepsy drugs (NEDs) that can interact to alter their effectiveness or induce toxicity, according to a retrospective analysis of a claims database.

Up to a quarter of all patients had potential interactions between AED and non-AED prescriptions, and these were more likely to occur for patients with comorbid conditions or those who were eligible for Part D Low Income Subsidy, reported Raymond Edward Faught Jr., MD, a professor in the department of neurology at Emory University, Atlanta, and his colleagues. The study was published in Epilepsia.

©Thinkstock.com

ilacy@frontlinemedcom.com

SOURCE: Faught E et al. Epilepsia. 2008 Feb 7. doi: 10.1111/epi.14010.

ABSTRACT

Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be encountered in the primary setting (degenerative, congenital, post-traumatic), severe glenoid bone loss is encountered in most revision total shoulder arthroplasties. Severe glenoid bone loss is treated with various techniques including hemiarthroplasty, eccentric reaming, and glenoid reconstruction with bone autografts and allografts. Despite encouraging short- to mid-term results reported with these reconstruction techniques, the clinical and radiographic outcomes remain inconsistent and the high number of complications is a concern. To overcome this problem, more recently augmented components and patient specific implants were introduced. Using the computer-aided design and computer-aided manufacturing technology patient-specific implants have been created to reconstruct the glenoid vault in cases of severe glenoid bone loss.

In this article we describe a patient specific glenoid implant, its indication, technical aspects and surgical technique, based on the author's experience as well as a review of the current literature on custom glenoid implants.

Continue to: Total shoulder arthroplasty...

Total shoulder arthroplasty (TSA) is an effective operation for providing pain relief and improving function in patients with end-stage degenerative shoulder disease that is nonresponsive to nonoperative treatments.^1-4 With the increasing number of arthroplasties performed, and the expanding indication for shoulder arthroplasty, the number of revision shoulder arthroplasties is also increasing.^5-14 Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered mostly in revision TSAs.

Historically, patients with severe glenoid bone loss were treated with a hemiarthroplasty.^15-17 However, due to inferior outcomes associated with the use of shoulder hemiarthroplasties compared with TSA in these cases,^18-20 various techniques were developed with the aim of realigning the glenoid axis and securing the implants into the deficient glenoid vault.^21-25 Options have included eccentric reaming, glenoid reconstruction with bone autografts and allografts, and more recently augmented components and patient-specific implants. Studies with eccentric reaming and reconstruction with bone graft during complex shoulder arthroplasty have reported encouraging short- to mid-term results, but the clinical and radiographic outcomes remain inconsistent, and the high number of complications is a concern.^25-28

Complications with these techniques include component loosening, graft resorption, nonunion, failure of graft incorporation, infection, and instability.^25-28

Computer-aided design and computer-aided manufacturing (CAD/CAM) of patient-specific implants have been used successfully by hip arthroplasty surgeons to deal with complex acetabular reconstructions in the setting of severe bone loss. More recently, the same technology has been used to reconstruct the glenoid vault in cases of severe glenoid bone loss.

In this article, we describe a patient-specific glenoid implant, its indication, and both technical aspects and the surgical technique, based on the authors’ experience as well as a review of the current literature on custom glenoid implants.

Continue to: PATIENT-SPECIFIC GLENOID COMPONENT

The Vault Reconstruction System ([VRS], Zimmer Biomet) is a patient-specific glenoid vault reconstruction system developed with the use of CAD/CAM to address severe glenoid bone loss encountered during shoulder arthroplasty. For several years, the VRS was available only as a custom implant according to the US Food and Drug Administration rules, and therefore its use was limited to a few cases per year. Recently, a 510(k) envelope clearance was granted to use the VRS in reverse TSA to address significant glenoid bone defects.

The VRS is made of porous plasma spray titanium to provide high strength and flexibility, and allows for biologic fixation. This system can accommodate a restricted bone loss envelope of about 50 mm × 50 mm × 35 mm according to the previous experience of the manufacturer in the custom scenario, covering 96% of defects previously addressed. One 6.5-mm nonlocking central screw and a minimum of four 4.75-mm nonlocking or locking peripheral screws are required for optimal fixation of the implant in the native scapula. A custom boss can be added in to enhance fixation in the native scapula when the bone is sufficient. To facilitate the surgical procedure, a trial implant, a bone model of the scapula, and a custom boss reaming guide are 3-dimensional (3-D) and printed in sterilizable material. These are all provided as single-use disposable instruments and can be available for surgeons during both the initial plan review and surgery.

PREOPERATIVE PLANNING

Patients undergo a preoperative fine-cut 2-dimensional computed tomography scan of the scapula and adjacent humerus following a predefined protocol with a slice thickness of 2 mm to 3 mm. An accurate 3-D bone model of the scapula is obtained using a 3-D image processing software system (Figure 1). The 3-D scapular model is used to create a patient-specific glenoid implant proposal that is approved by the surgeon (Figure 2). Implant position, orientation, size, screw trajectory, and recommended bone removal, if necessary, are determined to create a more normal glenohumeral center of rotation and to secure a glenoid implant in severely deficient glenoid bone (Figure 3). Once the implant design is approved by the surgeon, the final patient-specific implant is manufactured.

SURGICAL TECHNIQUE

The exposure of the glenoid is a critical step for the successful implantation of the patient-specific glenoid implant. Soft tissue and scar tissue around the glenoid must be removed to allow for optimal fit of the custom-made reaming guide. Also, removal of the entire capsulolabral complex on the anteroinferior rim of the glenoid is essential to both enhance glenoid exposure and to allow a perfect fit of the guide to the pathologic bone stock. Attention should be paid during débridement and/or implant removal in case of revision, to make sure that no excessive bone is removed because the patient-specific guide is referenced to this anatomy. Excessive bone removal can change the orientation of the patient-specific guide and ultimately the fixation of the implant. Once the custom-made patient-specific guide is positioned, a 3.2-mm Steinmann pin is placed through the inserter for temporary fixation. The pin should engage or perforate the medial cortical wall to ensure that the subsequent reamer has a stable cannula over which to ream. After the glenoid is reamed, the final implant can be placed in the ideal position according to the preoperative planning. A central 6.5-mm nonlocking central screw and 4.75-mm nonlocking or locking peripheral screws are required to complete the fixation of the implant in the native scapula. Once the patient-specific glenoid component is positioned and strongly fixed to the bone, the glenosphere can be positioned according to the preoperative planning, and the reverse shoulder arthroplasty can be completed in the usual fashion.

CASE EXAMPLES

A 68-year-old woman underwent a TSA for end-stage osteoarthritis in 2000. The implant failed due to a cuff failure. The patient underwent several surgeries, including an open cuff repair, with no success. She had no active elevation preoperatively. Because of the significant glenoid bone loss, a patient-specific glenoid reconstruction was planned. Within 24 months after this surgery, the patient was able to get her hand to her head and elevate to 90º (Figures 4A-4F).

Continue to: In October 2013...

In October 2013, a 68-year-old man underwent a TSA for end-stage osteoarthritis. After 18 months, the implant failed due to active Propionibacterium acnes infection, which required excisional arthroplasty with insertion of an antibiotic spacer. Significant glenoid bone loss (Figure 5) and global soft-tissue deficiency caused substantial disability and led to an indication for a reverse TSA with a patient-specific glenoid vault reconstruction (Figures 6A-6D) after infection eradication. Within 20 months after this surgery, the patient had resumed a satisfactory range of motion (130º forward elevation, 20º external rotation) and outcome.

DISCUSSION

Although glenoid bone loss is often seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered in most revision TSAs. The best treatment method for massive glenoid bone defects during complex shoulder arthroplasty remains uncertain. Options have included eccentric reaming, glenoid reconstruction with bone allograft and autograft, and more recently augmented components and patient-specific implants.^21-25 The advent and availability of CAD/CAM technology have enabled shoulder surgeons to create patient-specific metal solutions to these challenging cases. Currently, only a few reports exist in the literature on patient-specific glenoid components in the setting of severe bone loss.^29-32

Chammaa and colleagues²⁹ reported the outcomes of 37 patients with a hip-inspired glenoid component (Total Shoulder Replacement, Stanmore Implants Worldwide). The 5-year results with this implant were promising, with a 16% revision rate and only 1 case of glenoid loosening.

Stoffelen and colleagues³⁰ recently described the successful use of a patient-specific anatomic metal-backed glenoid component for the management of severe glenoid bone loss with excellent results at 2.5 years of follow-up. A different approach was pursued by Gunther and Lynch,³¹ who reported on 7 patients with a custom inset glenoid implant for deficient glenoid vaults. These circular anatomic, custom-made glenoid components were created with the intention of placing the implants partially inside the glenoid vault and relying partially on sclerotic cortical bone. Despite excellent results at 3 years of follow-up, their use is limited to specific defect geometries and cannot be used in cases of extreme bone loss.

CONCLUSION

We have described the use of a patient-specific glenoid component in 2 patients with severe glenoid bone loss. Despite the satisfactory clinical and short-term radiographic results, we acknowledge that longer-term follow-up is needed to confirm the efficacy of this type of reconstruction. We believe that patient-specific glenoid components represent a valuable addition to the armamentarium of shoulder surgeons who address complex glenoid bone deformities.

ABSTRACT

Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be encountered in the primary setting (degenerative, congenital, post-traumatic), severe glenoid bone loss is encountered in most revision total shoulder arthroplasties. Severe glenoid bone loss is treated with various techniques including hemiarthroplasty, eccentric reaming, and glenoid reconstruction with bone autografts and allografts. Despite encouraging short- to mid-term results reported with these reconstruction techniques, the clinical and radiographic outcomes remain inconsistent and the high number of complications is a concern. To overcome this problem, more recently augmented components and patient specific implants were introduced. Using the computer-aided design and computer-aided manufacturing technology patient-specific implants have been created to reconstruct the glenoid vault in cases of severe glenoid bone loss.

In this article we describe a patient specific glenoid implant, its indication, technical aspects and surgical technique, based on the author's experience as well as a review of the current literature on custom glenoid implants.

Continue to: Total shoulder arthroplasty...

Total shoulder arthroplasty (TSA) is an effective operation for providing pain relief and improving function in patients with end-stage degenerative shoulder disease that is nonresponsive to nonoperative treatments.^1-4 With the increasing number of arthroplasties performed, and the expanding indication for shoulder arthroplasty, the number of revision shoulder arthroplasties is also increasing.^5-14 Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered mostly in revision TSAs.

Historically, patients with severe glenoid bone loss were treated with a hemiarthroplasty.^15-17 However, due to inferior outcomes associated with the use of shoulder hemiarthroplasties compared with TSA in these cases,^18-20 various techniques were developed with the aim of realigning the glenoid axis and securing the implants into the deficient glenoid vault.^21-25 Options have included eccentric reaming, glenoid reconstruction with bone autografts and allografts, and more recently augmented components and patient-specific implants. Studies with eccentric reaming and reconstruction with bone graft during complex shoulder arthroplasty have reported encouraging short- to mid-term results, but the clinical and radiographic outcomes remain inconsistent, and the high number of complications is a concern.^25-28

Complications with these techniques include component loosening, graft resorption, nonunion, failure of graft incorporation, infection, and instability.^25-28

Computer-aided design and computer-aided manufacturing (CAD/CAM) of patient-specific implants have been used successfully by hip arthroplasty surgeons to deal with complex acetabular reconstructions in the setting of severe bone loss. More recently, the same technology has been used to reconstruct the glenoid vault in cases of severe glenoid bone loss.

In this article, we describe a patient-specific glenoid implant, its indication, and both technical aspects and the surgical technique, based on the authors’ experience as well as a review of the current literature on custom glenoid implants.

Continue to: PATIENT-SPECIFIC GLENOID COMPONENT

The Vault Reconstruction System ([VRS], Zimmer Biomet) is a patient-specific glenoid vault reconstruction system developed with the use of CAD/CAM to address severe glenoid bone loss encountered during shoulder arthroplasty. For several years, the VRS was available only as a custom implant according to the US Food and Drug Administration rules, and therefore its use was limited to a few cases per year. Recently, a 510(k) envelope clearance was granted to use the VRS in reverse TSA to address significant glenoid bone defects.

The VRS is made of porous plasma spray titanium to provide high strength and flexibility, and allows for biologic fixation. This system can accommodate a restricted bone loss envelope of about 50 mm × 50 mm × 35 mm according to the previous experience of the manufacturer in the custom scenario, covering 96% of defects previously addressed. One 6.5-mm nonlocking central screw and a minimum of four 4.75-mm nonlocking or locking peripheral screws are required for optimal fixation of the implant in the native scapula. A custom boss can be added in to enhance fixation in the native scapula when the bone is sufficient. To facilitate the surgical procedure, a trial implant, a bone model of the scapula, and a custom boss reaming guide are 3-dimensional (3-D) and printed in sterilizable material. These are all provided as single-use disposable instruments and can be available for surgeons during both the initial plan review and surgery.

PREOPERATIVE PLANNING

Patients undergo a preoperative fine-cut 2-dimensional computed tomography scan of the scapula and adjacent humerus following a predefined protocol with a slice thickness of 2 mm to 3 mm. An accurate 3-D bone model of the scapula is obtained using a 3-D image processing software system (Figure 1). The 3-D scapular model is used to create a patient-specific glenoid implant proposal that is approved by the surgeon (Figure 2). Implant position, orientation, size, screw trajectory, and recommended bone removal, if necessary, are determined to create a more normal glenohumeral center of rotation and to secure a glenoid implant in severely deficient glenoid bone (Figure 3). Once the implant design is approved by the surgeon, the final patient-specific implant is manufactured.

SURGICAL TECHNIQUE

The exposure of the glenoid is a critical step for the successful implantation of the patient-specific glenoid implant. Soft tissue and scar tissue around the glenoid must be removed to allow for optimal fit of the custom-made reaming guide. Also, removal of the entire capsulolabral complex on the anteroinferior rim of the glenoid is essential to both enhance glenoid exposure and to allow a perfect fit of the guide to the pathologic bone stock. Attention should be paid during débridement and/or implant removal in case of revision, to make sure that no excessive bone is removed because the patient-specific guide is referenced to this anatomy. Excessive bone removal can change the orientation of the patient-specific guide and ultimately the fixation of the implant. Once the custom-made patient-specific guide is positioned, a 3.2-mm Steinmann pin is placed through the inserter for temporary fixation. The pin should engage or perforate the medial cortical wall to ensure that the subsequent reamer has a stable cannula over which to ream. After the glenoid is reamed, the final implant can be placed in the ideal position according to the preoperative planning. A central 6.5-mm nonlocking central screw and 4.75-mm nonlocking or locking peripheral screws are required to complete the fixation of the implant in the native scapula. Once the patient-specific glenoid component is positioned and strongly fixed to the bone, the glenosphere can be positioned according to the preoperative planning, and the reverse shoulder arthroplasty can be completed in the usual fashion.

CASE EXAMPLES

A 68-year-old woman underwent a TSA for end-stage osteoarthritis in 2000. The implant failed due to a cuff failure. The patient underwent several surgeries, including an open cuff repair, with no success. She had no active elevation preoperatively. Because of the significant glenoid bone loss, a patient-specific glenoid reconstruction was planned. Within 24 months after this surgery, the patient was able to get her hand to her head and elevate to 90º (Figures 4A-4F).

Continue to: In October 2013...

In October 2013, a 68-year-old man underwent a TSA for end-stage osteoarthritis. After 18 months, the implant failed due to active Propionibacterium acnes infection, which required excisional arthroplasty with insertion of an antibiotic spacer. Significant glenoid bone loss (Figure 5) and global soft-tissue deficiency caused substantial disability and led to an indication for a reverse TSA with a patient-specific glenoid vault reconstruction (Figures 6A-6D) after infection eradication. Within 20 months after this surgery, the patient had resumed a satisfactory range of motion (130º forward elevation, 20º external rotation) and outcome.

DISCUSSION

Although glenoid bone loss is often seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered in most revision TSAs. The best treatment method for massive glenoid bone defects during complex shoulder arthroplasty remains uncertain. Options have included eccentric reaming, glenoid reconstruction with bone allograft and autograft, and more recently augmented components and patient-specific implants.^21-25 The advent and availability of CAD/CAM technology have enabled shoulder surgeons to create patient-specific metal solutions to these challenging cases. Currently, only a few reports exist in the literature on patient-specific glenoid components in the setting of severe bone loss.^29-32

Chammaa and colleagues²⁹ reported the outcomes of 37 patients with a hip-inspired glenoid component (Total Shoulder Replacement, Stanmore Implants Worldwide). The 5-year results with this implant were promising, with a 16% revision rate and only 1 case of glenoid loosening.

Stoffelen and colleagues³⁰ recently described the successful use of a patient-specific anatomic metal-backed glenoid component for the management of severe glenoid bone loss with excellent results at 2.5 years of follow-up. A different approach was pursued by Gunther and Lynch,³¹ who reported on 7 patients with a custom inset glenoid implant for deficient glenoid vaults. These circular anatomic, custom-made glenoid components were created with the intention of placing the implants partially inside the glenoid vault and relying partially on sclerotic cortical bone. Despite excellent results at 3 years of follow-up, their use is limited to specific defect geometries and cannot be used in cases of extreme bone loss.

CONCLUSION

We have described the use of a patient-specific glenoid component in 2 patients with severe glenoid bone loss. Despite the satisfactory clinical and short-term radiographic results, we acknowledge that longer-term follow-up is needed to confirm the efficacy of this type of reconstruction. We believe that patient-specific glenoid components represent a valuable addition to the armamentarium of shoulder surgeons who address complex glenoid bone deformities.

ABSTRACT

Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be encountered in the primary setting (degenerative, congenital, post-traumatic), severe glenoid bone loss is encountered in most revision total shoulder arthroplasties. Severe glenoid bone loss is treated with various techniques including hemiarthroplasty, eccentric reaming, and glenoid reconstruction with bone autografts and allografts. Despite encouraging short- to mid-term results reported with these reconstruction techniques, the clinical and radiographic outcomes remain inconsistent and the high number of complications is a concern. To overcome this problem, more recently augmented components and patient specific implants were introduced. Using the computer-aided design and computer-aided manufacturing technology patient-specific implants have been created to reconstruct the glenoid vault in cases of severe glenoid bone loss.

In this article we describe a patient specific glenoid implant, its indication, technical aspects and surgical technique, based on the author's experience as well as a review of the current literature on custom glenoid implants.

Continue to: Total shoulder arthroplasty...

Total shoulder arthroplasty (TSA) is an effective operation for providing pain relief and improving function in patients with end-stage degenerative shoulder disease that is nonresponsive to nonoperative treatments.^1-4 With the increasing number of arthroplasties performed, and the expanding indication for shoulder arthroplasty, the number of revision shoulder arthroplasties is also increasing.^5-14 Complex glenoid bone deformities present the treating surgeon with a complex reconstructive challenge. Although glenoid bone loss can be seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered mostly in revision TSAs.

Historically, patients with severe glenoid bone loss were treated with a hemiarthroplasty.^15-17 However, due to inferior outcomes associated with the use of shoulder hemiarthroplasties compared with TSA in these cases,^18-20 various techniques were developed with the aim of realigning the glenoid axis and securing the implants into the deficient glenoid vault.^21-25 Options have included eccentric reaming, glenoid reconstruction with bone autografts and allografts, and more recently augmented components and patient-specific implants. Studies with eccentric reaming and reconstruction with bone graft during complex shoulder arthroplasty have reported encouraging short- to mid-term results, but the clinical and radiographic outcomes remain inconsistent, and the high number of complications is a concern.^25-28

Complications with these techniques include component loosening, graft resorption, nonunion, failure of graft incorporation, infection, and instability.^25-28

Computer-aided design and computer-aided manufacturing (CAD/CAM) of patient-specific implants have been used successfully by hip arthroplasty surgeons to deal with complex acetabular reconstructions in the setting of severe bone loss. More recently, the same technology has been used to reconstruct the glenoid vault in cases of severe glenoid bone loss.

In this article, we describe a patient-specific glenoid implant, its indication, and both technical aspects and the surgical technique, based on the authors’ experience as well as a review of the current literature on custom glenoid implants.

Continue to: PATIENT-SPECIFIC GLENOID COMPONENT

The Vault Reconstruction System ([VRS], Zimmer Biomet) is a patient-specific glenoid vault reconstruction system developed with the use of CAD/CAM to address severe glenoid bone loss encountered during shoulder arthroplasty. For several years, the VRS was available only as a custom implant according to the US Food and Drug Administration rules, and therefore its use was limited to a few cases per year. Recently, a 510(k) envelope clearance was granted to use the VRS in reverse TSA to address significant glenoid bone defects.

The VRS is made of porous plasma spray titanium to provide high strength and flexibility, and allows for biologic fixation. This system can accommodate a restricted bone loss envelope of about 50 mm × 50 mm × 35 mm according to the previous experience of the manufacturer in the custom scenario, covering 96% of defects previously addressed. One 6.5-mm nonlocking central screw and a minimum of four 4.75-mm nonlocking or locking peripheral screws are required for optimal fixation of the implant in the native scapula. A custom boss can be added in to enhance fixation in the native scapula when the bone is sufficient. To facilitate the surgical procedure, a trial implant, a bone model of the scapula, and a custom boss reaming guide are 3-dimensional (3-D) and printed in sterilizable material. These are all provided as single-use disposable instruments and can be available for surgeons during both the initial plan review and surgery.

PREOPERATIVE PLANNING

Patients undergo a preoperative fine-cut 2-dimensional computed tomography scan of the scapula and adjacent humerus following a predefined protocol with a slice thickness of 2 mm to 3 mm. An accurate 3-D bone model of the scapula is obtained using a 3-D image processing software system (Figure 1). The 3-D scapular model is used to create a patient-specific glenoid implant proposal that is approved by the surgeon (Figure 2). Implant position, orientation, size, screw trajectory, and recommended bone removal, if necessary, are determined to create a more normal glenohumeral center of rotation and to secure a glenoid implant in severely deficient glenoid bone (Figure 3). Once the implant design is approved by the surgeon, the final patient-specific implant is manufactured.

SURGICAL TECHNIQUE

The exposure of the glenoid is a critical step for the successful implantation of the patient-specific glenoid implant. Soft tissue and scar tissue around the glenoid must be removed to allow for optimal fit of the custom-made reaming guide. Also, removal of the entire capsulolabral complex on the anteroinferior rim of the glenoid is essential to both enhance glenoid exposure and to allow a perfect fit of the guide to the pathologic bone stock. Attention should be paid during débridement and/or implant removal in case of revision, to make sure that no excessive bone is removed because the patient-specific guide is referenced to this anatomy. Excessive bone removal can change the orientation of the patient-specific guide and ultimately the fixation of the implant. Once the custom-made patient-specific guide is positioned, a 3.2-mm Steinmann pin is placed through the inserter for temporary fixation. The pin should engage or perforate the medial cortical wall to ensure that the subsequent reamer has a stable cannula over which to ream. After the glenoid is reamed, the final implant can be placed in the ideal position according to the preoperative planning. A central 6.5-mm nonlocking central screw and 4.75-mm nonlocking or locking peripheral screws are required to complete the fixation of the implant in the native scapula. Once the patient-specific glenoid component is positioned and strongly fixed to the bone, the glenosphere can be positioned according to the preoperative planning, and the reverse shoulder arthroplasty can be completed in the usual fashion.

CASE EXAMPLES

A 68-year-old woman underwent a TSA for end-stage osteoarthritis in 2000. The implant failed due to a cuff failure. The patient underwent several surgeries, including an open cuff repair, with no success. She had no active elevation preoperatively. Because of the significant glenoid bone loss, a patient-specific glenoid reconstruction was planned. Within 24 months after this surgery, the patient was able to get her hand to her head and elevate to 90º (Figures 4A-4F).

Continue to: In October 2013...

In October 2013, a 68-year-old man underwent a TSA for end-stage osteoarthritis. After 18 months, the implant failed due to active Propionibacterium acnes infection, which required excisional arthroplasty with insertion of an antibiotic spacer. Significant glenoid bone loss (Figure 5) and global soft-tissue deficiency caused substantial disability and led to an indication for a reverse TSA with a patient-specific glenoid vault reconstruction (Figures 6A-6D) after infection eradication. Within 20 months after this surgery, the patient had resumed a satisfactory range of motion (130º forward elevation, 20º external rotation) and outcome.

DISCUSSION

Although glenoid bone loss is often seen in the primary setting (degenerative, congenital, and post-traumatic), severe glenoid bone loss is encountered in most revision TSAs. The best treatment method for massive glenoid bone defects during complex shoulder arthroplasty remains uncertain. Options have included eccentric reaming, glenoid reconstruction with bone allograft and autograft, and more recently augmented components and patient-specific implants.^21-25 The advent and availability of CAD/CAM technology have enabled shoulder surgeons to create patient-specific metal solutions to these challenging cases. Currently, only a few reports exist in the literature on patient-specific glenoid components in the setting of severe bone loss.^29-32

Chammaa and colleagues²⁹ reported the outcomes of 37 patients with a hip-inspired glenoid component (Total Shoulder Replacement, Stanmore Implants Worldwide). The 5-year results with this implant were promising, with a 16% revision rate and only 1 case of glenoid loosening.

Stoffelen and colleagues³⁰ recently described the successful use of a patient-specific anatomic metal-backed glenoid component for the management of severe glenoid bone loss with excellent results at 2.5 years of follow-up. A different approach was pursued by Gunther and Lynch,³¹ who reported on 7 patients with a custom inset glenoid implant for deficient glenoid vaults. These circular anatomic, custom-made glenoid components were created with the intention of placing the implants partially inside the glenoid vault and relying partially on sclerotic cortical bone. Despite excellent results at 3 years of follow-up, their use is limited to specific defect geometries and cannot be used in cases of extreme bone loss.

CONCLUSION

We have described the use of a patient-specific glenoid component in 2 patients with severe glenoid bone loss. Despite the satisfactory clinical and short-term radiographic results, we acknowledge that longer-term follow-up is needed to confirm the efficacy of this type of reconstruction. We believe that patient-specific glenoid components represent a valuable addition to the armamentarium of shoulder surgeons who address complex glenoid bone deformities.

In a rare show of bipartisanship for the mostly polarized 115th Congress, Republican and Democratic Senate leaders announced a 2-year budget deal that would increase federal spending for defense as well as key domestic priorities, including many health programs.

Not in the deal, for which the path to the president’s desk remains unclear, is any bipartisan legislation aimed at shoring up the Affordable Care Act’s individual health insurance marketplaces. Senate Majority Leader Mitch McConnell (R-Ky.) promised Sen. Susan Collins (R-Maine) a vote on health legislation in exchange for her vote for the GOP tax bill in December. So far, that vote has not materialized.

The deal does appear to include almost every other health priority Democrats have been pushing the past several months, including 2 years of renewed funding for community health centers and a series of other health programs Congress failed to provide for before they technically expired last year.

“I believe we have reached a budget deal that neither side loves but both sides can be proud of,” Senate Minority Leader Chuck Schumer (D-N.Y.) said on the Senate floor. “That’s compromise. That’s governing.”

Said McConnell, “This bill represents a significant bipartisan step forward.”

Senate leaders are still negotiating last details of the accord, including the size of a cut to the ACA’s Prevention and Public Health Fund, which would help offset the costs of this legislation.

According to documents circulating on Capitol Hill, the deal includes $6 billion in funding for treatment of mental health issues and opioid addiction, $2 billion in extra funding for the National Institutes of Health, and an additional 4-year extension of the Children’s Health Insurance Program (CHIP), which builds on the 6 years approved by Congress in January.

In the Medicare program, the deal would accelerate the closing of the “doughnut hole” in Medicare drug coverage that requires seniors to pay thousands of dollars out-of-pocket before catastrophic coverage kicks in. It would also repeal the controversial Medicare Independent Payment Advisory Board (IPAB), which is charged with holding down Medicare spending for the federal government if it exceeds a certain level. Members have never been appointed to the board, however, and its use has not so far been triggered by Medicare spending. Both the closure of the doughnut hole and creation of the IPAB were part of the ACA.

The agreement would also fund a host of more limited health programs – some of which are known as “extenders” because they often ride along with other, larger health or spending bills.

Those programs include more than $7 billion in funding for the nation’s federally funded community health centers. The clinics serve 27 million low-income people and saw their funding lapse last fall – a delay advocates said had already complicated budgeting and staffing decisions for many clinics.

And in a victory for the physical therapy industry and patient advocates, the accord would permanently repeal a limit on Medicare’s coverage of physical therapy, speech-language pathology and outpatient treatment. Previously, the program capped coverage after $2,010 worth of occupational therapy and another $2,010 for speech-language therapy and physical therapy combined. But Congress had long taken action to delay those caps or provide exemptions – meaning they had never actually taken effect.

According to an analysis by the nonpartisan Congressional Budget Office, permanently repealing the caps would cost about $6.47 billion over the next decade.

Lawmakers would also forestall cuts mandated by the ACA to reduce the payments made to so-called Disproportionate Share Hospitals, which serve high rates of low-income patients. Those cuts have been delayed continuously since the law’s 2010 passage.

Limited programs are also affected. The deal would fund for 5 years the Maternal, Infant and Early Childhood Home Visiting Program, a program that helps guide low-income, at-risk mothers in parenting. It served about 160,000 families in fiscal year 2016.

“We are relieved that there is a deal for a 5-year reauthorization of MIECHV,” Lori Freeman, CEO of the Association of Maternal & Child Health Programs – an advocacy group – said in an emailed statement. “States, home visitors, and families have been in limbo for the past several months, and this news will bring the stability they need to continue this successful program.”

And the budget deal funds programs that encourage doctors to practice in medically underserved areas, providing just under $500 million over the next 2 years for the National Health Service Corps and another $363 million over 2 years to the Teaching Health Center Graduate Medical Education program, which places medical residents in Community Health Centers.
 

Kaiser Health News correspondent Emmarie Huetteman contributed to this article. KHN’s coverage of these topics is supported by Heising-Simons Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In a rare show of bipartisanship for the mostly polarized 115th Congress, Republican and Democratic Senate leaders announced a 2-year budget deal that would increase federal spending for defense as well as key domestic priorities, including many health programs.

Not in the deal, for which the path to the president’s desk remains unclear, is any bipartisan legislation aimed at shoring up the Affordable Care Act’s individual health insurance marketplaces. Senate Majority Leader Mitch McConnell (R-Ky.) promised Sen. Susan Collins (R-Maine) a vote on health legislation in exchange for her vote for the GOP tax bill in December. So far, that vote has not materialized.

The deal does appear to include almost every other health priority Democrats have been pushing the past several months, including 2 years of renewed funding for community health centers and a series of other health programs Congress failed to provide for before they technically expired last year.

“I believe we have reached a budget deal that neither side loves but both sides can be proud of,” Senate Minority Leader Chuck Schumer (D-N.Y.) said on the Senate floor. “That’s compromise. That’s governing.”

Said McConnell, “This bill represents a significant bipartisan step forward.”

Senate leaders are still negotiating last details of the accord, including the size of a cut to the ACA’s Prevention and Public Health Fund, which would help offset the costs of this legislation.

According to documents circulating on Capitol Hill, the deal includes $6 billion in funding for treatment of mental health issues and opioid addiction, $2 billion in extra funding for the National Institutes of Health, and an additional 4-year extension of the Children’s Health Insurance Program (CHIP), which builds on the 6 years approved by Congress in January.

In the Medicare program, the deal would accelerate the closing of the “doughnut hole” in Medicare drug coverage that requires seniors to pay thousands of dollars out-of-pocket before catastrophic coverage kicks in. It would also repeal the controversial Medicare Independent Payment Advisory Board (IPAB), which is charged with holding down Medicare spending for the federal government if it exceeds a certain level. Members have never been appointed to the board, however, and its use has not so far been triggered by Medicare spending. Both the closure of the doughnut hole and creation of the IPAB were part of the ACA.

The agreement would also fund a host of more limited health programs – some of which are known as “extenders” because they often ride along with other, larger health or spending bills.

Those programs include more than $7 billion in funding for the nation’s federally funded community health centers. The clinics serve 27 million low-income people and saw their funding lapse last fall – a delay advocates said had already complicated budgeting and staffing decisions for many clinics.

And in a victory for the physical therapy industry and patient advocates, the accord would permanently repeal a limit on Medicare’s coverage of physical therapy, speech-language pathology and outpatient treatment. Previously, the program capped coverage after $2,010 worth of occupational therapy and another $2,010 for speech-language therapy and physical therapy combined. But Congress had long taken action to delay those caps or provide exemptions – meaning they had never actually taken effect.

According to an analysis by the nonpartisan Congressional Budget Office, permanently repealing the caps would cost about $6.47 billion over the next decade.

Lawmakers would also forestall cuts mandated by the ACA to reduce the payments made to so-called Disproportionate Share Hospitals, which serve high rates of low-income patients. Those cuts have been delayed continuously since the law’s 2010 passage.

Limited programs are also affected. The deal would fund for 5 years the Maternal, Infant and Early Childhood Home Visiting Program, a program that helps guide low-income, at-risk mothers in parenting. It served about 160,000 families in fiscal year 2016.

“We are relieved that there is a deal for a 5-year reauthorization of MIECHV,” Lori Freeman, CEO of the Association of Maternal & Child Health Programs – an advocacy group – said in an emailed statement. “States, home visitors, and families have been in limbo for the past several months, and this news will bring the stability they need to continue this successful program.”

And the budget deal funds programs that encourage doctors to practice in medically underserved areas, providing just under $500 million over the next 2 years for the National Health Service Corps and another $363 million over 2 years to the Teaching Health Center Graduate Medical Education program, which places medical residents in Community Health Centers.
 

Kaiser Health News correspondent Emmarie Huetteman contributed to this article. KHN’s coverage of these topics is supported by Heising-Simons Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In a rare show of bipartisanship for the mostly polarized 115th Congress, Republican and Democratic Senate leaders announced a 2-year budget deal that would increase federal spending for defense as well as key domestic priorities, including many health programs.

Not in the deal, for which the path to the president’s desk remains unclear, is any bipartisan legislation aimed at shoring up the Affordable Care Act’s individual health insurance marketplaces. Senate Majority Leader Mitch McConnell (R-Ky.) promised Sen. Susan Collins (R-Maine) a vote on health legislation in exchange for her vote for the GOP tax bill in December. So far, that vote has not materialized.

The deal does appear to include almost every other health priority Democrats have been pushing the past several months, including 2 years of renewed funding for community health centers and a series of other health programs Congress failed to provide for before they technically expired last year.

“I believe we have reached a budget deal that neither side loves but both sides can be proud of,” Senate Minority Leader Chuck Schumer (D-N.Y.) said on the Senate floor. “That’s compromise. That’s governing.”

Said McConnell, “This bill represents a significant bipartisan step forward.”

Senate leaders are still negotiating last details of the accord, including the size of a cut to the ACA’s Prevention and Public Health Fund, which would help offset the costs of this legislation.

According to documents circulating on Capitol Hill, the deal includes $6 billion in funding for treatment of mental health issues and opioid addiction, $2 billion in extra funding for the National Institutes of Health, and an additional 4-year extension of the Children’s Health Insurance Program (CHIP), which builds on the 6 years approved by Congress in January.

In the Medicare program, the deal would accelerate the closing of the “doughnut hole” in Medicare drug coverage that requires seniors to pay thousands of dollars out-of-pocket before catastrophic coverage kicks in. It would also repeal the controversial Medicare Independent Payment Advisory Board (IPAB), which is charged with holding down Medicare spending for the federal government if it exceeds a certain level. Members have never been appointed to the board, however, and its use has not so far been triggered by Medicare spending. Both the closure of the doughnut hole and creation of the IPAB were part of the ACA.

The agreement would also fund a host of more limited health programs – some of which are known as “extenders” because they often ride along with other, larger health or spending bills.

Those programs include more than $7 billion in funding for the nation’s federally funded community health centers. The clinics serve 27 million low-income people and saw their funding lapse last fall – a delay advocates said had already complicated budgeting and staffing decisions for many clinics.

And in a victory for the physical therapy industry and patient advocates, the accord would permanently repeal a limit on Medicare’s coverage of physical therapy, speech-language pathology and outpatient treatment. Previously, the program capped coverage after $2,010 worth of occupational therapy and another $2,010 for speech-language therapy and physical therapy combined. But Congress had long taken action to delay those caps or provide exemptions – meaning they had never actually taken effect.

According to an analysis by the nonpartisan Congressional Budget Office, permanently repealing the caps would cost about $6.47 billion over the next decade.

Lawmakers would also forestall cuts mandated by the ACA to reduce the payments made to so-called Disproportionate Share Hospitals, which serve high rates of low-income patients. Those cuts have been delayed continuously since the law’s 2010 passage.

Limited programs are also affected. The deal would fund for 5 years the Maternal, Infant and Early Childhood Home Visiting Program, a program that helps guide low-income, at-risk mothers in parenting. It served about 160,000 families in fiscal year 2016.

“We are relieved that there is a deal for a 5-year reauthorization of MIECHV,” Lori Freeman, CEO of the Association of Maternal & Child Health Programs – an advocacy group – said in an emailed statement. “States, home visitors, and families have been in limbo for the past several months, and this news will bring the stability they need to continue this successful program.”

And the budget deal funds programs that encourage doctors to practice in medically underserved areas, providing just under $500 million over the next 2 years for the National Health Service Corps and another $363 million over 2 years to the Teaching Health Center Graduate Medical Education program, which places medical residents in Community Health Centers.
 

Kaiser Health News correspondent Emmarie Huetteman contributed to this article. KHN’s coverage of these topics is supported by Heising-Simons Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

ABSTRACT

Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. The purpose of this study was to demonstrate the feasibility of revisions with a completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.

Between 2003 and 2011, 104 primary total shoulder arthroplasties (TSAs) were performed with an uncemented glenoid component in our group. Of these patients, 13 (average age, 64 years) were revised to reverse shoulder arthroplasty (RSA) using a modular convertible platform system and were included in this study. Average follow-up after revision was 22 months. Outcome measures included pain, range of motion, Constant-Murley scores, Simple Shoulder Tests, and subjective shoulder values. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021), and active external rotation increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°). Mean pain scores significantly improved from 4.2 to 13.3 points. The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90). Subjectively, 12 patients rated their shoulder as better or much better than preoperatively. This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function.

Continue to: Polyethylene glenoid components...

Polyethylene glenoid components are the gold standard in anatomic total shoulder arthroplasty (TSA). However, even though TSA survivorship exceeds 95% at 10-year follow-up,¹ glenoid component loosening remains the main complication and the weak link in these implants. This complication accounts for 25% of all complications related to TSA in the literature.² In most cases, glenoid component loosening is not isolated but combined with a rotator cuff tear, glenohumeral instability, or component malposition.^3-5 Therefore, revision of TSA to reverse shoulder arthroplasty (RSA) often requires the removal of both the humeral stem and glenoid component. Removal of the humeral stem can be challenging and can necessitate removal of the cement and osteotomy of the diaphysis, risking fracture and extensive damage to the soft tissue (Figures 1A, 1B).^6-8 Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. Allografts and specific designs with a longer post can be mandatory to obtain a stable fixation of the new baseplate.^9-12

We hypothesized that a completely convertible platform system on both the humeral and the glenoid side could facilitate the revision of a failed TSA to a RSA. This would enable the surgeon to leave the humeral stem and the glenoid baseplate in place, avoiding the difficulty of stem removal and the reimplantation of a glenoid component, especially in osteoporotic glenoid bone and elderly patients. The revision procedure would then only consist of replacing the humeral head by a metallic tray and polyethylene bearing on the humeral side and by impacting a glenosphere on the glenoid baseplate (Figures 2A, 2B).

The purpose of this study was to demonstrate the feasibility of revisions with this completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.

MATERIALS AND METHODS

PATIENT SELECTION

Between 2003 and 2011, 104 primary TSAs were performed with an uncemented glenoid component in our group. Of these patients, 18 underwent revision (17.3%). Among these 18 patients, 13 were revised to RSA using a modular convertible platform system and were included in this study, while 5 patients were revised to another TSA (2 dissociations of the polyethylene glenoid implant, 2 excessively low implantations of the glenoid baseplate, and 1 glenoid loosening). The mean age of the 13 patients (9 women, 4 men) included in this retrospective study at the time of revision was 64 years (range, 50-75 years). The reasons for revision surgery were rotator cuff tear (5, among which 2 were posterosuperior tears, and 3 were tears of the subscapularis), dislocations (5 posterior and 1 anterior, among which 4 had a B2 or C glenoid), suprascapular nerve paralysis (1), and dissociation of the polyethylene (1). The initial TSA was indicated for primary osteoarthritis with a normal cuff (9), primary osteoarthritis with a reparable cuff tear (2), posttraumatic osteoarthritis (1), and chronic dislocation (1). The right dominant shoulder was involved in 10 cases. The mean time interval between the primary TSA and the revision was 15 months (range, 1-61 months).

OPERATIVE TECHNIQUE

PREOPERATIVE PLANNING

Revision of a failed TSA is always a difficult challenge, and evaluation of bone loss on both the humeral and the glenoid sides, as well as the status of the cuff, is mandatory, even with a completely convertible arthroplasty system. The surgeon must be prepared to remove the humeral stem in case reduction of the joint is impossible. We systematically performed standard radiographs (anteroposterior, axillary, and outlet views) and computed tomography (CT) scans in order to assess both the version and positioning, as well as potential signs of loosening of the implants and the status of the cuff (continuity, degree of muscle trophicity, and fatty infiltration). A preoperative leucocyte count, sedimentation rate, and C-reactive protein rates were requested in every revision case, even if a mechanical etiology was strongly suspected.

Continue to: REVISION PROCEDURE

All the implants that had been used in the primary TSAs were Arrow Universal Shoulder Prostheses (FH Orthopedics). All revisions were performed through the previous deltopectoral approach in the beach chair position under general anesthesia with an interscalene block. Adhesions of the deep part of the deltoid were carefully released. The conjoint tendon was released, and the location of the musculocutaneous and axillary nerves was identified before any retractor was placed. In the 10 cases where the subscapularis was intact, it was peeled off the medial border of the bicipital groove to obtain sufficient length for a tension-free reinsertion.

The anatomical head of the humeral implant was disconnected from the stem and removed. All stems were found to be well fixed; there were no cases of loosening or evidence of infection. A circumferential capsular release was systematically carried out. The polyethylene glenoid onlay was then unlocked from the baseplate.

The quality of the fixation of the glenoid baseplate was systematically evaluated; no screw was found to be loose, and the fixation of all baseplates was stable. Therefore, there was no need to revise the glenoid baseplate, even when its position was considered excessively retroverted (Glenoid B2) or high. A glenosphere was impacted on the baseplate, and a polyethylene humeral bearing was then implanted on the humeral stem. The thinnest polyethylene bearing available (number 0) was chosen in all cases, and a size 36 glenosphere was chosen in 12 out of 13 cases. Intraoperative stability of the implant was satisfactory, and no impingement was found posteriorly, anteriorly, or inferiorly.

In one case, the humeral stem was a first-generation humeral implant which was not compatible with the new-generation humeral bearing, and the humeral stem had to be replaced.

In 2 cases, reduction of the RSA was either impossible or felt to be too tight, even after extensive soft-tissue release and resection of the remaining supraspinatus. The main reason for this was an excessively proud humeral stem because of an onlay polyethylene humeral bearing instead of an inlay design. However, removal of the uncemented humeral stem was always possible with no osteotomy or cortical window of the humeral shaft as the humeral stem has been designed with a bone ingrowth surface only on the metaphyseal part with a smooth surface on diaphyseal part. After removal of the stem, a small amount of humeral metaphysis was cut, and a new humeral stem was press-fit in a lower position. This allowed restoration of an appropriate tension of the soft tissue and, therefore, an easier reduction. The subscapularis was medialized and reinserted transosseously when possible with a double-row repair. In 3 cases, the subscapularis was torn and retracted at the level of the glenoid, or impossible to identify to allow its reinsertion.

Continue to: According to our infectious disease department...

According to our infectious disease department, we made a minimum of 5 cultures for each revision case looking for a possible low-grade infection. All cultures in our group are held for 14 days to assess for Propionibacterium acnes.

POSTOPERATIVE MANAGEMENT

A shoulder splint in neutral rotation was used for the first 4 weeks. Passive range of motion (ROM) was started immediately with pendulum exercises and passive anterior elevation. Active assisted and active ROM were allowed after 4 weeks, and physiotherapy was continued for 6 months. Elderly patients were referred to a center of rehabilitation. We found only 1 or 2 positive cultures (Propionibacterium acnes) for 4 patients, and we decided to consider them as a contamination. None of the patients were treated with antibiotics.

CLINICAL AND RADIOLOGICAL ASSESSMENT

Clinical evaluation included pre- and postoperative pain scores (visual analog scale [VAS]), ROM, the Constant-Murley¹³ score, the Simple Shoulder Test (SST),¹⁴ and the subjective shoulder value.¹⁵ Subjective satisfaction was assessed by asking the patients at follow-up how they felt compared with before surgery and was graded using a 4-point scale: 1, much better; 2, better; 3, the same; and 4, worse. Radiographic evaluation was performed on pre- and postoperative standard anteroposterior, outlet, and axillary views. Radiographs were reviewed to determine the presence of glenohumeral subluxation, periprosthetic lucency, component shift in position, and scapular notching.

STATISTICAL ANALYSIS

Descriptive statistics are reported as mean (range) for continuous measures and number (percentage) for discrete variables. The Wilcoxon signed-rank test was used for preoperative vs postoperative changes. The alpha level for all tests was set at 0.05 for statistical significance.

RESULTS

CLINICAL OUTCOME

At a mean of 22 months (range, 7-38 months) follow-up after revision, active ROM was significantly improved. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021). Active external rotation with the elbow on the side increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°) (P = 0.034), and increased with the arm held at 90° abduction from 13° (range, 0°-20°) to 49° (range, 0°-80°) (P = 0.025). Mean pain scores improved from 4.2 to 13.3 points (P < 0.001). VAS improved significantly from 9 to 1 (P < 0.0001). The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90) (P = 0.006). The final SST was 7 per 12. Subjectively, 4 patients rated their shoulder as much better, 8 as better, and 1 as the same as preoperatively. No intra- or postoperative complications, including infections, were observed. The mean duration of the procedure was 60 minutes (range, 30-75 minutes).

Continue to: RADIOLOGICAL OUTCOME

No periprosthetic lucency or shift in component was observed at the last follow-up. There was no scapular notching. No resorption of the tuberosities, and no fractures of the acromion or the scapular spine were observed.

DISCUSSION

In this retrospective study, failure of TSA with a metal-backed glenoid implant was successfully revised to RSA. In 10 patients, the use of a universal platform system allowed an easier conversion without removal of the humeral stem or the glenoid component (Figures 3A-3D). Twelve of the 13 patients were satisfied or very satisfied at the last follow-up. None of the patients were in pain, and the mean Constant score was 63. In all the cases, the glenoid baseplate was not changed. In 3 cases the humeral stem was changed without any fracture of the tuberosities of need for an osteotomy. This greatly simplified the revision procedure, as glenoid revisions can be very challenging. Indeed, it is often difficult to assess precisely preoperatively the remaining glenoid bone stock after removal of the glenoid component and the cement. Many therapeutic options to deal with glenoid loosening have been reported in the literature: glenoid bone reconstruction after glenoid component removal and revision to a hemiarthroplasty (HA),^10,16-18 glenoid bone reconstruction after glenoid component removal and revision to a new TSA with a cemented glenoid implant,^16,17,19,20 and glenoid reconstruction after glenoid component removal and revision to a RSA.^12,21 These authors reported that glenoid reconstruction frequently necessitates an iliac bone graft associated with a special design of the baseplate with a long post fixed into the native glenoid bone. However, sometimes implantation of an uncemented glenoid component can be unstable with a high risk of early mobilization of the implant, and 2 steps may be necessary. Conversion to a HA,^10,16-18 or a TSA^16,17,19,20 with a new cemented implant have both been associated with poor clinical outcome, with a high rate of recurrent glenoid loosening for the TSAs.

In our retrospective study, we reported no intra- or postoperative complications. Flury and colleagues²² reported a complication rate of 38% in 21 patients after conversion from a TSA to a RSA with a mean follow-up of 46 months. They removed all the components of the prosthesis with a crack or fracture of the humerus and/or the glenoid. Ortmaier and colleagues²³ reported a rate of complication of 22.7% during the conversion of TSA to RSA. They did an osteotomy of the humeral diaphysis to extract the stem in 40% of cases and had to remove the glenoid cement in 86% of cases with severe damage of the glenoid bone in 10% of cases. Fewer complications were found in our study, as we did not need any procedure such as humeral osteotomy, cerclage, bone grafting, and/or reconstruction of the glenoid. The short operative time and the absence of extensive soft-tissue dissection, thanks to a standard deltopectoral approach, could explain the absence of infection in our series.

Other authors shared our strategy of a universal convertible system and reported their results in the literature. Castagna and colleagues²⁴ in 2013 reported the clinical and radiological results of conversions of HA or TSA to RSA using a modular, convertible system (SMR Shoulder System, Lima Corporate). In their series, only 8 cases of TSAs were converted to RSA. They preserved, in each case, the humeral stem and the glenoid baseplate. There were no intra- or postoperative complications. The mean VAS score decreased from 8 to 2. Weber-Spickschen and colleague²⁵ reported recently in 2015 the same experience with the same system (SMR Shoulder System). They reviewed 15 conversions of TSAs to RSAs without any removal of the implants at a mean 43-month follow-up. They reported excellent pain relief (VAS decreased from 8 to 1) and improvement in shoulder function with a low rate of complications.

Kany and colleagues²⁶ in 2015 had already reported the advantages of a shoulder platform system for revisions. In their series, the authors included cases of failure of HAs and TSAs with loose cemented glenoids and metal-backed glenoids. The clinical and radiological results were similar, with a final Constant score of 60 (range, 42-85) and a similar rate of humeral stems which had to be changed (24%). These stems were replaced either because they were too proud or because there was not enough space to add an onlay polyethylene socket.

Continue to: Despite the encouraging results...

Despite the encouraging results reported in this study, there are some limitations. Firstly, no control group was used. Attempting to address this issue, we compared our results with the literature. Secondly, the number of patients in our study was small. Finally, the follow-up duration (mean 22 months) did not provide long-term outcomes.

CONCLUSION

This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function. A platform system on both the humeral and the glenoid side reduces the operative time of the conversion with a low risk of complications.

ABSTRACT

Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. The purpose of this study was to demonstrate the feasibility of revisions with a completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.

Between 2003 and 2011, 104 primary total shoulder arthroplasties (TSAs) were performed with an uncemented glenoid component in our group. Of these patients, 13 (average age, 64 years) were revised to reverse shoulder arthroplasty (RSA) using a modular convertible platform system and were included in this study. Average follow-up after revision was 22 months. Outcome measures included pain, range of motion, Constant-Murley scores, Simple Shoulder Tests, and subjective shoulder values. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021), and active external rotation increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°). Mean pain scores significantly improved from 4.2 to 13.3 points. The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90). Subjectively, 12 patients rated their shoulder as better or much better than preoperatively. This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function.

Continue to: Polyethylene glenoid components...

Polyethylene glenoid components are the gold standard in anatomic total shoulder arthroplasty (TSA). However, even though TSA survivorship exceeds 95% at 10-year follow-up,¹ glenoid component loosening remains the main complication and the weak link in these implants. This complication accounts for 25% of all complications related to TSA in the literature.² In most cases, glenoid component loosening is not isolated but combined with a rotator cuff tear, glenohumeral instability, or component malposition.^3-5 Therefore, revision of TSA to reverse shoulder arthroplasty (RSA) often requires the removal of both the humeral stem and glenoid component. Removal of the humeral stem can be challenging and can necessitate removal of the cement and osteotomy of the diaphysis, risking fracture and extensive damage to the soft tissue (Figures 1A, 1B).^6-8 Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. Allografts and specific designs with a longer post can be mandatory to obtain a stable fixation of the new baseplate.^9-12

We hypothesized that a completely convertible platform system on both the humeral and the glenoid side could facilitate the revision of a failed TSA to a RSA. This would enable the surgeon to leave the humeral stem and the glenoid baseplate in place, avoiding the difficulty of stem removal and the reimplantation of a glenoid component, especially in osteoporotic glenoid bone and elderly patients. The revision procedure would then only consist of replacing the humeral head by a metallic tray and polyethylene bearing on the humeral side and by impacting a glenosphere on the glenoid baseplate (Figures 2A, 2B).

The purpose of this study was to demonstrate the feasibility of revisions with this completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.

MATERIALS AND METHODS

PATIENT SELECTION

Between 2003 and 2011, 104 primary TSAs were performed with an uncemented glenoid component in our group. Of these patients, 18 underwent revision (17.3%). Among these 18 patients, 13 were revised to RSA using a modular convertible platform system and were included in this study, while 5 patients were revised to another TSA (2 dissociations of the polyethylene glenoid implant, 2 excessively low implantations of the glenoid baseplate, and 1 glenoid loosening). The mean age of the 13 patients (9 women, 4 men) included in this retrospective study at the time of revision was 64 years (range, 50-75 years). The reasons for revision surgery were rotator cuff tear (5, among which 2 were posterosuperior tears, and 3 were tears of the subscapularis), dislocations (5 posterior and 1 anterior, among which 4 had a B2 or C glenoid), suprascapular nerve paralysis (1), and dissociation of the polyethylene (1). The initial TSA was indicated for primary osteoarthritis with a normal cuff (9), primary osteoarthritis with a reparable cuff tear (2), posttraumatic osteoarthritis (1), and chronic dislocation (1). The right dominant shoulder was involved in 10 cases. The mean time interval between the primary TSA and the revision was 15 months (range, 1-61 months).

OPERATIVE TECHNIQUE

PREOPERATIVE PLANNING

Revision of a failed TSA is always a difficult challenge, and evaluation of bone loss on both the humeral and the glenoid sides, as well as the status of the cuff, is mandatory, even with a completely convertible arthroplasty system. The surgeon must be prepared to remove the humeral stem in case reduction of the joint is impossible. We systematically performed standard radiographs (anteroposterior, axillary, and outlet views) and computed tomography (CT) scans in order to assess both the version and positioning, as well as potential signs of loosening of the implants and the status of the cuff (continuity, degree of muscle trophicity, and fatty infiltration). A preoperative leucocyte count, sedimentation rate, and C-reactive protein rates were requested in every revision case, even if a mechanical etiology was strongly suspected.

Continue to: REVISION PROCEDURE

All the implants that had been used in the primary TSAs were Arrow Universal Shoulder Prostheses (FH Orthopedics). All revisions were performed through the previous deltopectoral approach in the beach chair position under general anesthesia with an interscalene block. Adhesions of the deep part of the deltoid were carefully released. The conjoint tendon was released, and the location of the musculocutaneous and axillary nerves was identified before any retractor was placed. In the 10 cases where the subscapularis was intact, it was peeled off the medial border of the bicipital groove to obtain sufficient length for a tension-free reinsertion.

The anatomical head of the humeral implant was disconnected from the stem and removed. All stems were found to be well fixed; there were no cases of loosening or evidence of infection. A circumferential capsular release was systematically carried out. The polyethylene glenoid onlay was then unlocked from the baseplate.

The quality of the fixation of the glenoid baseplate was systematically evaluated; no screw was found to be loose, and the fixation of all baseplates was stable. Therefore, there was no need to revise the glenoid baseplate, even when its position was considered excessively retroverted (Glenoid B2) or high. A glenosphere was impacted on the baseplate, and a polyethylene humeral bearing was then implanted on the humeral stem. The thinnest polyethylene bearing available (number 0) was chosen in all cases, and a size 36 glenosphere was chosen in 12 out of 13 cases. Intraoperative stability of the implant was satisfactory, and no impingement was found posteriorly, anteriorly, or inferiorly.

In one case, the humeral stem was a first-generation humeral implant which was not compatible with the new-generation humeral bearing, and the humeral stem had to be replaced.

In 2 cases, reduction of the RSA was either impossible or felt to be too tight, even after extensive soft-tissue release and resection of the remaining supraspinatus. The main reason for this was an excessively proud humeral stem because of an onlay polyethylene humeral bearing instead of an inlay design. However, removal of the uncemented humeral stem was always possible with no osteotomy or cortical window of the humeral shaft as the humeral stem has been designed with a bone ingrowth surface only on the metaphyseal part with a smooth surface on diaphyseal part. After removal of the stem, a small amount of humeral metaphysis was cut, and a new humeral stem was press-fit in a lower position. This allowed restoration of an appropriate tension of the soft tissue and, therefore, an easier reduction. The subscapularis was medialized and reinserted transosseously when possible with a double-row repair. In 3 cases, the subscapularis was torn and retracted at the level of the glenoid, or impossible to identify to allow its reinsertion.

Continue to: According to our infectious disease department...

According to our infectious disease department, we made a minimum of 5 cultures for each revision case looking for a possible low-grade infection. All cultures in our group are held for 14 days to assess for Propionibacterium acnes.

POSTOPERATIVE MANAGEMENT

A shoulder splint in neutral rotation was used for the first 4 weeks. Passive range of motion (ROM) was started immediately with pendulum exercises and passive anterior elevation. Active assisted and active ROM were allowed after 4 weeks, and physiotherapy was continued for 6 months. Elderly patients were referred to a center of rehabilitation. We found only 1 or 2 positive cultures (Propionibacterium acnes) for 4 patients, and we decided to consider them as a contamination. None of the patients were treated with antibiotics.

CLINICAL AND RADIOLOGICAL ASSESSMENT

Clinical evaluation included pre- and postoperative pain scores (visual analog scale [VAS]), ROM, the Constant-Murley¹³ score, the Simple Shoulder Test (SST),¹⁴ and the subjective shoulder value.¹⁵ Subjective satisfaction was assessed by asking the patients at follow-up how they felt compared with before surgery and was graded using a 4-point scale: 1, much better; 2, better; 3, the same; and 4, worse. Radiographic evaluation was performed on pre- and postoperative standard anteroposterior, outlet, and axillary views. Radiographs were reviewed to determine the presence of glenohumeral subluxation, periprosthetic lucency, component shift in position, and scapular notching.

STATISTICAL ANALYSIS

Descriptive statistics are reported as mean (range) for continuous measures and number (percentage) for discrete variables. The Wilcoxon signed-rank test was used for preoperative vs postoperative changes. The alpha level for all tests was set at 0.05 for statistical significance.

RESULTS

CLINICAL OUTCOME

At a mean of 22 months (range, 7-38 months) follow-up after revision, active ROM was significantly improved. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021). Active external rotation with the elbow on the side increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°) (P = 0.034), and increased with the arm held at 90° abduction from 13° (range, 0°-20°) to 49° (range, 0°-80°) (P = 0.025). Mean pain scores improved from 4.2 to 13.3 points (P < 0.001). VAS improved significantly from 9 to 1 (P < 0.0001). The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90) (P = 0.006). The final SST was 7 per 12. Subjectively, 4 patients rated their shoulder as much better, 8 as better, and 1 as the same as preoperatively. No intra- or postoperative complications, including infections, were observed. The mean duration of the procedure was 60 minutes (range, 30-75 minutes).

Continue to: RADIOLOGICAL OUTCOME

No periprosthetic lucency or shift in component was observed at the last follow-up. There was no scapular notching. No resorption of the tuberosities, and no fractures of the acromion or the scapular spine were observed.

DISCUSSION

In this retrospective study, failure of TSA with a metal-backed glenoid implant was successfully revised to RSA. In 10 patients, the use of a universal platform system allowed an easier conversion without removal of the humeral stem or the glenoid component (Figures 3A-3D). Twelve of the 13 patients were satisfied or very satisfied at the last follow-up. None of the patients were in pain, and the mean Constant score was 63. In all the cases, the glenoid baseplate was not changed. In 3 cases the humeral stem was changed without any fracture of the tuberosities of need for an osteotomy. This greatly simplified the revision procedure, as glenoid revisions can be very challenging. Indeed, it is often difficult to assess precisely preoperatively the remaining glenoid bone stock after removal of the glenoid component and the cement. Many therapeutic options to deal with glenoid loosening have been reported in the literature: glenoid bone reconstruction after glenoid component removal and revision to a hemiarthroplasty (HA),^10,16-18 glenoid bone reconstruction after glenoid component removal and revision to a new TSA with a cemented glenoid implant,^16,17,19,20 and glenoid reconstruction after glenoid component removal and revision to a RSA.^12,21 These authors reported that glenoid reconstruction frequently necessitates an iliac bone graft associated with a special design of the baseplate with a long post fixed into the native glenoid bone. However, sometimes implantation of an uncemented glenoid component can be unstable with a high risk of early mobilization of the implant, and 2 steps may be necessary. Conversion to a HA,^10,16-18 or a TSA^16,17,19,20 with a new cemented implant have both been associated with poor clinical outcome, with a high rate of recurrent glenoid loosening for the TSAs.

In our retrospective study, we reported no intra- or postoperative complications. Flury and colleagues²² reported a complication rate of 38% in 21 patients after conversion from a TSA to a RSA with a mean follow-up of 46 months. They removed all the components of the prosthesis with a crack or fracture of the humerus and/or the glenoid. Ortmaier and colleagues²³ reported a rate of complication of 22.7% during the conversion of TSA to RSA. They did an osteotomy of the humeral diaphysis to extract the stem in 40% of cases and had to remove the glenoid cement in 86% of cases with severe damage of the glenoid bone in 10% of cases. Fewer complications were found in our study, as we did not need any procedure such as humeral osteotomy, cerclage, bone grafting, and/or reconstruction of the glenoid. The short operative time and the absence of extensive soft-tissue dissection, thanks to a standard deltopectoral approach, could explain the absence of infection in our series.

Other authors shared our strategy of a universal convertible system and reported their results in the literature. Castagna and colleagues²⁴ in 2013 reported the clinical and radiological results of conversions of HA or TSA to RSA using a modular, convertible system (SMR Shoulder System, Lima Corporate). In their series, only 8 cases of TSAs were converted to RSA. They preserved, in each case, the humeral stem and the glenoid baseplate. There were no intra- or postoperative complications. The mean VAS score decreased from 8 to 2. Weber-Spickschen and colleague²⁵ reported recently in 2015 the same experience with the same system (SMR Shoulder System). They reviewed 15 conversions of TSAs to RSAs without any removal of the implants at a mean 43-month follow-up. They reported excellent pain relief (VAS decreased from 8 to 1) and improvement in shoulder function with a low rate of complications.

Kany and colleagues²⁶ in 2015 had already reported the advantages of a shoulder platform system for revisions. In their series, the authors included cases of failure of HAs and TSAs with loose cemented glenoids and metal-backed glenoids. The clinical and radiological results were similar, with a final Constant score of 60 (range, 42-85) and a similar rate of humeral stems which had to be changed (24%). These stems were replaced either because they were too proud or because there was not enough space to add an onlay polyethylene socket.

Continue to: Despite the encouraging results...

Despite the encouraging results reported in this study, there are some limitations. Firstly, no control group was used. Attempting to address this issue, we compared our results with the literature. Secondly, the number of patients in our study was small. Finally, the follow-up duration (mean 22 months) did not provide long-term outcomes.

CONCLUSION

This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function. A platform system on both the humeral and the glenoid side reduces the operative time of the conversion with a low risk of complications.

ABSTRACT

Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. The purpose of this study was to demonstrate the feasibility of revisions with a completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.

Between 2003 and 2011, 104 primary total shoulder arthroplasties (TSAs) were performed with an uncemented glenoid component in our group. Of these patients, 13 (average age, 64 years) were revised to reverse shoulder arthroplasty (RSA) using a modular convertible platform system and were included in this study. Average follow-up after revision was 22 months. Outcome measures included pain, range of motion, Constant-Murley scores, Simple Shoulder Tests, and subjective shoulder values. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021), and active external rotation increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°). Mean pain scores significantly improved from 4.2 to 13.3 points. The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90). Subjectively, 12 patients rated their shoulder as better or much better than preoperatively. This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function.

Continue to: Polyethylene glenoid components...

Polyethylene glenoid components are the gold standard in anatomic total shoulder arthroplasty (TSA). However, even though TSA survivorship exceeds 95% at 10-year follow-up,¹ glenoid component loosening remains the main complication and the weak link in these implants. This complication accounts for 25% of all complications related to TSA in the literature.² In most cases, glenoid component loosening is not isolated but combined with a rotator cuff tear, glenohumeral instability, or component malposition.^3-5 Therefore, revision of TSA to reverse shoulder arthroplasty (RSA) often requires the removal of both the humeral stem and glenoid component. Removal of the humeral stem can be challenging and can necessitate removal of the cement and osteotomy of the diaphysis, risking fracture and extensive damage to the soft tissue (Figures 1A, 1B).^6-8 Removal of a cemented glenoid component often leads to massive glenoid bone loss, which makes it difficult to implant a new glenoid baseplate. Allografts and specific designs with a longer post can be mandatory to obtain a stable fixation of the new baseplate.^9-12

We hypothesized that a completely convertible platform system on both the humeral and the glenoid side could facilitate the revision of a failed TSA to a RSA. This would enable the surgeon to leave the humeral stem and the glenoid baseplate in place, avoiding the difficulty of stem removal and the reimplantation of a glenoid component, especially in osteoporotic glenoid bone and elderly patients. The revision procedure would then only consist of replacing the humeral head by a metallic tray and polyethylene bearing on the humeral side and by impacting a glenosphere on the glenoid baseplate (Figures 2A, 2B).

The purpose of this study was to demonstrate the feasibility of revisions with this completely convertible system and to report clinical and radiographic results of a retrospective review of 13 cases.

MATERIALS AND METHODS

PATIENT SELECTION

Between 2003 and 2011, 104 primary TSAs were performed with an uncemented glenoid component in our group. Of these patients, 18 underwent revision (17.3%). Among these 18 patients, 13 were revised to RSA using a modular convertible platform system and were included in this study, while 5 patients were revised to another TSA (2 dissociations of the polyethylene glenoid implant, 2 excessively low implantations of the glenoid baseplate, and 1 glenoid loosening). The mean age of the 13 patients (9 women, 4 men) included in this retrospective study at the time of revision was 64 years (range, 50-75 years). The reasons for revision surgery were rotator cuff tear (5, among which 2 were posterosuperior tears, and 3 were tears of the subscapularis), dislocations (5 posterior and 1 anterior, among which 4 had a B2 or C glenoid), suprascapular nerve paralysis (1), and dissociation of the polyethylene (1). The initial TSA was indicated for primary osteoarthritis with a normal cuff (9), primary osteoarthritis with a reparable cuff tear (2), posttraumatic osteoarthritis (1), and chronic dislocation (1). The right dominant shoulder was involved in 10 cases. The mean time interval between the primary TSA and the revision was 15 months (range, 1-61 months).

OPERATIVE TECHNIQUE

PREOPERATIVE PLANNING

Revision of a failed TSA is always a difficult challenge, and evaluation of bone loss on both the humeral and the glenoid sides, as well as the status of the cuff, is mandatory, even with a completely convertible arthroplasty system. The surgeon must be prepared to remove the humeral stem in case reduction of the joint is impossible. We systematically performed standard radiographs (anteroposterior, axillary, and outlet views) and computed tomography (CT) scans in order to assess both the version and positioning, as well as potential signs of loosening of the implants and the status of the cuff (continuity, degree of muscle trophicity, and fatty infiltration). A preoperative leucocyte count, sedimentation rate, and C-reactive protein rates were requested in every revision case, even if a mechanical etiology was strongly suspected.

Continue to: REVISION PROCEDURE

All the implants that had been used in the primary TSAs were Arrow Universal Shoulder Prostheses (FH Orthopedics). All revisions were performed through the previous deltopectoral approach in the beach chair position under general anesthesia with an interscalene block. Adhesions of the deep part of the deltoid were carefully released. The conjoint tendon was released, and the location of the musculocutaneous and axillary nerves was identified before any retractor was placed. In the 10 cases where the subscapularis was intact, it was peeled off the medial border of the bicipital groove to obtain sufficient length for a tension-free reinsertion.

The anatomical head of the humeral implant was disconnected from the stem and removed. All stems were found to be well fixed; there were no cases of loosening or evidence of infection. A circumferential capsular release was systematically carried out. The polyethylene glenoid onlay was then unlocked from the baseplate.

The quality of the fixation of the glenoid baseplate was systematically evaluated; no screw was found to be loose, and the fixation of all baseplates was stable. Therefore, there was no need to revise the glenoid baseplate, even when its position was considered excessively retroverted (Glenoid B2) or high. A glenosphere was impacted on the baseplate, and a polyethylene humeral bearing was then implanted on the humeral stem. The thinnest polyethylene bearing available (number 0) was chosen in all cases, and a size 36 glenosphere was chosen in 12 out of 13 cases. Intraoperative stability of the implant was satisfactory, and no impingement was found posteriorly, anteriorly, or inferiorly.

In one case, the humeral stem was a first-generation humeral implant which was not compatible with the new-generation humeral bearing, and the humeral stem had to be replaced.

In 2 cases, reduction of the RSA was either impossible or felt to be too tight, even after extensive soft-tissue release and resection of the remaining supraspinatus. The main reason for this was an excessively proud humeral stem because of an onlay polyethylene humeral bearing instead of an inlay design. However, removal of the uncemented humeral stem was always possible with no osteotomy or cortical window of the humeral shaft as the humeral stem has been designed with a bone ingrowth surface only on the metaphyseal part with a smooth surface on diaphyseal part. After removal of the stem, a small amount of humeral metaphysis was cut, and a new humeral stem was press-fit in a lower position. This allowed restoration of an appropriate tension of the soft tissue and, therefore, an easier reduction. The subscapularis was medialized and reinserted transosseously when possible with a double-row repair. In 3 cases, the subscapularis was torn and retracted at the level of the glenoid, or impossible to identify to allow its reinsertion.

Continue to: According to our infectious disease department...

According to our infectious disease department, we made a minimum of 5 cultures for each revision case looking for a possible low-grade infection. All cultures in our group are held for 14 days to assess for Propionibacterium acnes.

POSTOPERATIVE MANAGEMENT

A shoulder splint in neutral rotation was used for the first 4 weeks. Passive range of motion (ROM) was started immediately with pendulum exercises and passive anterior elevation. Active assisted and active ROM were allowed after 4 weeks, and physiotherapy was continued for 6 months. Elderly patients were referred to a center of rehabilitation. We found only 1 or 2 positive cultures (Propionibacterium acnes) for 4 patients, and we decided to consider them as a contamination. None of the patients were treated with antibiotics.

CLINICAL AND RADIOLOGICAL ASSESSMENT

Clinical evaluation included pre- and postoperative pain scores (visual analog scale [VAS]), ROM, the Constant-Murley¹³ score, the Simple Shoulder Test (SST),¹⁴ and the subjective shoulder value.¹⁵ Subjective satisfaction was assessed by asking the patients at follow-up how they felt compared with before surgery and was graded using a 4-point scale: 1, much better; 2, better; 3, the same; and 4, worse. Radiographic evaluation was performed on pre- and postoperative standard anteroposterior, outlet, and axillary views. Radiographs were reviewed to determine the presence of glenohumeral subluxation, periprosthetic lucency, component shift in position, and scapular notching.

STATISTICAL ANALYSIS

Descriptive statistics are reported as mean (range) for continuous measures and number (percentage) for discrete variables. The Wilcoxon signed-rank test was used for preoperative vs postoperative changes. The alpha level for all tests was set at 0.05 for statistical significance.

RESULTS

CLINICAL OUTCOME

At a mean of 22 months (range, 7-38 months) follow-up after revision, active ROM was significantly improved. Active flexion increased significantly from a mean of 93° (range, 30°-120°) to 138° (range, 95°-170°) (P = 0.021). Active external rotation with the elbow on the side increased significantly from 8° (range, −20°-15°) to 25° (range, −10°-60°) (P = 0.034), and increased with the arm held at 90° abduction from 13° (range, 0°-20°) to 49° (range, 0°-80°) (P = 0.025). Mean pain scores improved from 4.2 to 13.3 points (P < 0.001). VAS improved significantly from 9 to 1 (P < 0.0001). The mean Constant Scores improved from 21 (range, 18-32) to 63 (range, 43-90) (P = 0.006). The final SST was 7 per 12. Subjectively, 4 patients rated their shoulder as much better, 8 as better, and 1 as the same as preoperatively. No intra- or postoperative complications, including infections, were observed. The mean duration of the procedure was 60 minutes (range, 30-75 minutes).

Continue to: RADIOLOGICAL OUTCOME

No periprosthetic lucency or shift in component was observed at the last follow-up. There was no scapular notching. No resorption of the tuberosities, and no fractures of the acromion or the scapular spine were observed.

DISCUSSION

In this retrospective study, failure of TSA with a metal-backed glenoid implant was successfully revised to RSA. In 10 patients, the use of a universal platform system allowed an easier conversion without removal of the humeral stem or the glenoid component (Figures 3A-3D). Twelve of the 13 patients were satisfied or very satisfied at the last follow-up. None of the patients were in pain, and the mean Constant score was 63. In all the cases, the glenoid baseplate was not changed. In 3 cases the humeral stem was changed without any fracture of the tuberosities of need for an osteotomy. This greatly simplified the revision procedure, as glenoid revisions can be very challenging. Indeed, it is often difficult to assess precisely preoperatively the remaining glenoid bone stock after removal of the glenoid component and the cement. Many therapeutic options to deal with glenoid loosening have been reported in the literature: glenoid bone reconstruction after glenoid component removal and revision to a hemiarthroplasty (HA),^10,16-18 glenoid bone reconstruction after glenoid component removal and revision to a new TSA with a cemented glenoid implant,^16,17,19,20 and glenoid reconstruction after glenoid component removal and revision to a RSA.^12,21 These authors reported that glenoid reconstruction frequently necessitates an iliac bone graft associated with a special design of the baseplate with a long post fixed into the native glenoid bone. However, sometimes implantation of an uncemented glenoid component can be unstable with a high risk of early mobilization of the implant, and 2 steps may be necessary. Conversion to a HA,^10,16-18 or a TSA^16,17,19,20 with a new cemented implant have both been associated with poor clinical outcome, with a high rate of recurrent glenoid loosening for the TSAs.

In our retrospective study, we reported no intra- or postoperative complications. Flury and colleagues²² reported a complication rate of 38% in 21 patients after conversion from a TSA to a RSA with a mean follow-up of 46 months. They removed all the components of the prosthesis with a crack or fracture of the humerus and/or the glenoid. Ortmaier and colleagues²³ reported a rate of complication of 22.7% during the conversion of TSA to RSA. They did an osteotomy of the humeral diaphysis to extract the stem in 40% of cases and had to remove the glenoid cement in 86% of cases with severe damage of the glenoid bone in 10% of cases. Fewer complications were found in our study, as we did not need any procedure such as humeral osteotomy, cerclage, bone grafting, and/or reconstruction of the glenoid. The short operative time and the absence of extensive soft-tissue dissection, thanks to a standard deltopectoral approach, could explain the absence of infection in our series.

Other authors shared our strategy of a universal convertible system and reported their results in the literature. Castagna and colleagues²⁴ in 2013 reported the clinical and radiological results of conversions of HA or TSA to RSA using a modular, convertible system (SMR Shoulder System, Lima Corporate). In their series, only 8 cases of TSAs were converted to RSA. They preserved, in each case, the humeral stem and the glenoid baseplate. There were no intra- or postoperative complications. The mean VAS score decreased from 8 to 2. Weber-Spickschen and colleague²⁵ reported recently in 2015 the same experience with the same system (SMR Shoulder System). They reviewed 15 conversions of TSAs to RSAs without any removal of the implants at a mean 43-month follow-up. They reported excellent pain relief (VAS decreased from 8 to 1) and improvement in shoulder function with a low rate of complications.

Kany and colleagues²⁶ in 2015 had already reported the advantages of a shoulder platform system for revisions. In their series, the authors included cases of failure of HAs and TSAs with loose cemented glenoids and metal-backed glenoids. The clinical and radiological results were similar, with a final Constant score of 60 (range, 42-85) and a similar rate of humeral stems which had to be changed (24%). These stems were replaced either because they were too proud or because there was not enough space to add an onlay polyethylene socket.

Continue to: Despite the encouraging results...

Despite the encouraging results reported in this study, there are some limitations. Firstly, no control group was used. Attempting to address this issue, we compared our results with the literature. Secondly, the number of patients in our study was small. Finally, the follow-up duration (mean 22 months) did not provide long-term outcomes.

CONCLUSION

This retrospective study shows that a complete convertible system facilitates conversion of TSAs to RSAs with excellent pain relief and a significant improvement in shoulder function. A platform system on both the humeral and the glenoid side reduces the operative time of the conversion with a low risk of complications.

WASHINGTON – The Medicare Hospital Readmissions Reduction Program is working, according to an original analysis of Medicare claims data presented at a meeting of the Medicare Payment Advisory Commission.

“First, readmissions declined,” MedPAC staff member Jeff Stensland, PhD, said during a congressionally mandated staff report to the commissioners. “Second, while observation stays increased, they did not fully offset the decrease in readmissions. Third, while [emergency department] visits also increased, those increases appear to largely be due to factors other than the readmission program. And fourth, in addition, all the evidence we examined suggests that the readmissions program did not result in increased mortality.”

Copyright Kimberly Pack/Thinkstock

gtwachtman@frontlinemedcom.com

WASHINGTON – The Medicare Hospital Readmissions Reduction Program is working, according to an original analysis of Medicare claims data presented at a meeting of the Medicare Payment Advisory Commission.

“First, readmissions declined,” MedPAC staff member Jeff Stensland, PhD, said during a congressionally mandated staff report to the commissioners. “Second, while observation stays increased, they did not fully offset the decrease in readmissions. Third, while [emergency department] visits also increased, those increases appear to largely be due to factors other than the readmission program. And fourth, in addition, all the evidence we examined suggests that the readmissions program did not result in increased mortality.”

Copyright Kimberly Pack/Thinkstock

gtwachtman@frontlinemedcom.com

WASHINGTON – The Medicare Hospital Readmissions Reduction Program is working, according to an original analysis of Medicare claims data presented at a meeting of the Medicare Payment Advisory Commission.

“First, readmissions declined,” MedPAC staff member Jeff Stensland, PhD, said during a congressionally mandated staff report to the commissioners. “Second, while observation stays increased, they did not fully offset the decrease in readmissions. Third, while [emergency department] visits also increased, those increases appear to largely be due to factors other than the readmission program. And fourth, in addition, all the evidence we examined suggests that the readmissions program did not result in increased mortality.”

Copyright Kimberly Pack/Thinkstock

gtwachtman@frontlinemedcom.com