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关节置换登记系统中植入物异常值的识别。

Identification of implant outliers in joint replacement registries.

作者信息

de Steiger Richard N, Hallstrom Brian R, Lübbeke Anne, Paxton Elizabeth W, van Steenbergen Liza N, Wilkinson Mark

机构信息

Australian Orthopaedic Association National Joint Replacement Registry, SAHMRI, Adelaide, Australia.

Michigan Arthroplasty Registry Collaborative Quality Initiative University of Michigan, Department of Orthopaedic Surgery, Ann Arbor, Michigan, USA.

出版信息

EFORT Open Rev. 2023 Jan 27;8(1):11-17. doi: 10.1530/EOR-22-0058.

Abstract

Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace. Implant post-market surveillance remains important, and joint replacement registries are ideally placed to perform this role. This review examined if and how joint replacement registries identified outlier prostheses, outlined problems and suggested solutions to improve post-market surveillance. A search was performed of all joint replacement registries that had electronic or published reports detailing the outcomes of joint replacement. These reports were examined for registry identification of outlier prostheses. Five registries publicly identified outlier prostheses in their reports and the methods by which this was performed, and three others had internal reports. Identification of outlier prostheses is one area that may improve overall joint replacement outcomes; however, further research is needed to determine the optimum methods for identification, including the threshold, the comparator and the numbers required for notification of devices. Co-operation of registries at a global level may lead to earlier identification of devices and thereby further improve the results of joint replacement.

摘要

近期,围绕翻修率高于预期的关节置换产品引发了诸多担忧,监管机构因此对新设备进入市场实施了更严格的管控。植入物上市后监测依然重要,而关节置换登记处是履行这一职责的理想机构。本综述探讨了关节置换登记处是否以及如何识别异常假体,概述了相关问题,并提出了改进上市后监测的解决方案。对所有拥有详细记录关节置换结果的电子报告或已发表报告的关节置换登记处进行了检索。对这些报告进行审查,以确定登记处对异常假体的识别情况。有五个登记处在其报告中公开识别了异常假体及其识别方法,另外三个有内部报告。识别异常假体是一个可能改善整体关节置换效果的领域;然而,需要进一步研究以确定最佳识别方法,包括阈值、比较对象以及设备通报所需数量。全球范围内登记处的合作可能会更早地识别出相关设备,从而进一步改善关节置换的效果。

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