Revision Risk Following Primary Anatomic and Reverse TSA with an Exactech Equinoxe Compared with Other Devices: A U.S.-Based Cohort Study.

IF 4.5 1区医学 Q1 ORTHOPEDICS

Journal of Bone and Joint Surgery, American Volume Pub Date : 2026-09-15 DOI:10.2106/JBJS.25.01594

Heather A Prentice, Richard N Chang, Edward Yian, Ronald A Navarro, Anshuman Singh, Danny P Chan, David Ding, Josie A Elwell, Jessica Degrasse, Chris Roche, Elizabeth W Paxton

{"title":"Revision Risk Following Primary Anatomic and Reverse TSA with an Exactech Equinoxe Compared with Other Devices: A U.S.-Based Cohort Study.","authors":"Heather A Prentice, Richard N Chang, Edward Yian, Ronald A Navarro, Anshuman Singh, Danny P Chan, David Ding, Josie A Elwell, Jessica Degrasse, Chris Roche, Elizabeth W Paxton","doi":"10.2106/JBJS.25.01594","DOIUrl":null,"url":null,"abstract":"Background: In 2024, Exactech issued a voluntary recall of Equinoxe devices after finding that some devices had been packaged in bags that were non-conforming because a secondary oxygen barrier layer of ethylene vinyl alcohol was missing. We sought to evaluate the revision risk following shoulder arthroplasty using an Exactech Equinoxe device compared with other eligible devices.Methods: We conducted a cohort study using data from a U.S. health-care system's shoulder arthroplasty registry. The study included 13,901 adult patients who had undergone primary elective anatomic total shoulder arthroplasty (ATSA), elective reverse total shoulder arthroplasty (RTSA), or RTSA for fracture (2005 to 2023). The mean age for the ATSA cohort (N = 8,707) was 68 years, 53.3% were male, and 84.7% were White. Corresponding values for the elective RTSA cohort (N = 4,374) were 74 years, 41.2% male, and 79.9% White, and those for the RTSA for fracture cohort (N = 820) were 73 years, 16.3% male, and 78.4% White. Multivariable Cox regression with covariate adjustment was used to evaluate all-cause revision risk for Equinoxe devices compared with other devices.Results: In adjusted analyses, a higher revision risk was observed for ATSAs with Equinoxe versus other devices (hazard ratio [HR] = 1.87, 95% confidence interval [CI] = 1.33 to 2.62). The higher revision risk was also observed in a subanalysis restricted to ATSAs with Equinoxe devices packaged in non-conforming bags (HR = 1.91, 95% CI = 1.34 to 2.72). No differences were observed in elective RTSAs (HR = 0.71, 95% CI = 0.33 to 1.49) or RTSAs for fracture (HR = 2.30, 95% CI = 0.84 to 6.28) with Equinoxe compared with other devices.Conclusions: We observed a higher revision risk with the use of Equinoxe devices in ATSA, but no difference for Equinoxe devices in elective RTSA compared with other devices. While all Equinoxe devices packaged in non-conforming bags were recalled worldwide in 2024, clinicians should be mindful of these findings when a patient had previously received an Equinoxe ATSA device.Level of evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":""},"PeriodicalIF":4.5000,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Bone and Joint Surgery, American Volume","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2106/JBJS.25.01594","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}

引用次数: 0

Abstract

Background: In 2024, Exactech issued a voluntary recall of Equinoxe devices after finding that some devices had been packaged in bags that were non-conforming because a secondary oxygen barrier layer of ethylene vinyl alcohol was missing. We sought to evaluate the revision risk following shoulder arthroplasty using an Exactech Equinoxe device compared with other eligible devices.

Methods: We conducted a cohort study using data from a U.S. health-care system's shoulder arthroplasty registry. The study included 13,901 adult patients who had undergone primary elective anatomic total shoulder arthroplasty (ATSA), elective reverse total shoulder arthroplasty (RTSA), or RTSA for fracture (2005 to 2023). The mean age for the ATSA cohort (N = 8,707) was 68 years, 53.3% were male, and 84.7% were White. Corresponding values for the elective RTSA cohort (N = 4,374) were 74 years, 41.2% male, and 79.9% White, and those for the RTSA for fracture cohort (N = 820) were 73 years, 16.3% male, and 78.4% White. Multivariable Cox regression with covariate adjustment was used to evaluate all-cause revision risk for Equinoxe devices compared with other devices.

Results: In adjusted analyses, a higher revision risk was observed for ATSAs with Equinoxe versus other devices (hazard ratio [HR] = 1.87, 95% confidence interval [CI] = 1.33 to 2.62). The higher revision risk was also observed in a subanalysis restricted to ATSAs with Equinoxe devices packaged in non-conforming bags (HR = 1.91, 95% CI = 1.34 to 2.72). No differences were observed in elective RTSAs (HR = 0.71, 95% CI = 0.33 to 1.49) or RTSAs for fracture (HR = 2.30, 95% CI = 0.84 to 6.28) with Equinoxe compared with other devices.

Conclusions: We observed a higher revision risk with the use of Equinoxe devices in ATSA, but no difference for Equinoxe devices in elective RTSA compared with other devices. While all Equinoxe devices packaged in non-conforming bags were recalled worldwide in 2024, clinicians should be mindful of these findings when a patient had previously received an Equinoxe ATSA device.

Level of evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

查看原文本刊更多论文

与其他器械相比，使用Exactech equinox进行初始解剖和反向TSA后的翻修风险：一项基于美国的队列研究。

背景：2024年，Exactech发现一些设备包装在不符合标准的袋子中，因为乙基乙烯醇的二次氧屏障层缺失，随后主动召回了equinox设备。我们试图评估肩关节置换术后使用Exactech Equinoxe器械与其他符合条件的器械的翻修风险。方法：我们使用美国卫生保健系统肩关节置换术登记处的数据进行了一项队列研究。该研究包括13901名接受过原发性选择性解剖全肩关节置换术（ATSA）、选择性反向全肩关节置换术（RTSA）或骨折RTSA的成年患者（2005年至2023年）。ATSA队列（N = 8707）的平均年龄为68岁，53.3%为男性，84.7%为白人。选择性RTSA队列（N = 4,374）的相应值为74岁，男性41.2%，白人79.9%，骨折RTSA队列（N = 820）的相应值为73岁，男性16.3%，白人78.4%。采用多变量Cox回归和协变量调整来评估equinox设备与其他设备的全因修订风险。结果：在校正分析中，与其他装置相比，使用equinox的atsa的修订风险更高（风险比[HR] = 1.87, 95%可信区间[CI] = 1.33至2.62）。在一项亚分析中也观察到更高的修订风险，该亚分析仅限于将equinox器械包装在不符合标准的袋子中的atsa （HR = 1.91, 95% CI = 1.34至2.72）。在选择性RTSAs （HR = 0.71, 95% CI = 0.33 ~ 1.49）和骨折RTSAs （HR = 2.30, 95% CI = 0.84 ~ 6.28）中，使用equinox与其他装置相比无差异。结论：我们观察到在ATSA中使用equinox器械有更高的修改风险，但在选择性RTSA中使用equinox器械与其他器械相比没有差异。虽然2024年全球召回了所有包装在不合格袋子中的equinox设备，但当患者之前接受过equinox ATSA设备时，临床医生应该注意这些发现。证据等级：治疗性III级。有关证据水平的完整描述，请参见作者说明。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Bone and Joint Surgery, American Volume 医学-外科

CiteScore

8.90

自引率

7.50%

发文量

660

审稿时长

1 months

期刊介绍： The Journal of Bone & Joint Surgery (JBJS) has been the most valued source of information for orthopaedic surgeons and researchers for over 125 years and is the gold standard in peer-reviewed scientific information in the field. A core journal and essential reading for general as well as specialist orthopaedic surgeons worldwide, The Journal publishes evidence-based research to enhance the quality of care for orthopaedic patients. Standards of excellence and high quality are maintained in everything we do, from the science of the content published to the customer service we provide. JBJS is an independent, non-profit journal.