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组织块分析和植入物登记对于进一步提高患者安全性都是必要的。

Explant analysis and implant registries are both needed to further improve patient safety.

作者信息

Morlock M M, Gomez-Barrena E, Wirtz D C, Hart A, Kretzer J P

机构信息

Institute of Biomechanics, TUHH Hamburg University of Technology, Hamburg, Germany.

Department of Orthopaedic Surgery and Traumatology, Universidad Autónoma de Madrid, Madrid, Spain.

出版信息

EFORT Open Rev. 2022 May 31;7(6):344-348. doi: 10.1530/EOR-22-0033.

Abstract

In the early days of total joint replacement, implant fracture, material problems and wear presented major problems for the long-term success of the operation. Today, failures directly related to the implant comprise only 2-3% of the reasons for revision surgeries, which is a result of the material and design improvements in combination with the standardization of pre-clinical testing methods and the post-market surveillance required by the legal regulation. Arthroplasty registers are very effective tools to document the long-term clinical performance of implants and implantation techniques such as fixation methods in combination with patient characteristics. Revisions due to implant failure are initially not reflected by the registries due to their small number. Explant analysis including patient, clinical and imaging documentation is crucial to identify failure mechanisms early enough to prevent massive failures detectable in the registries. In the past, early reaction was not always successful, since explant analysis studies have either been performed late or the results did not trigger preventive measures until clinical failures affected a substantial number of patients. The identification of implant-related problems is only possible if all failures are reported and related to the number of implantations. A system that analyses all explants from revisions attributed to implant failure is mandatory to reduce failures, allowing improvement of risk assessment in the regulatory process.

摘要

在全关节置换术的早期,植入物骨折、材料问题和磨损是手术长期成功面临的主要问题。如今,与植入物直接相关的失败仅占翻修手术原因的2%-3%,这是材料和设计改进,以及临床前测试方法标准化和法律法规要求的上市后监测相结合的结果。关节成形术登记是记录植入物和植入技术(如固定方法与患者特征相结合)长期临床性能的非常有效的工具。由于因植入物失败导致的翻修数量较少,登记处最初并未反映出来。包括患者、临床和影像记录在内的取出物分析对于尽早识别失败机制至关重要,以便预防登记处中可检测到的大量失败情况。过去,早期反应并不总是成功的,因为取出物分析研究要么进行得很晚,要么直到临床失败影响大量患者时结果才引发预防措施。只有报告所有失败情况并将其与植入数量相关联,才有可能识别与植入物相关的问题。一个分析因植入物失败导致翻修的所有取出物的系统对于减少失败情况是必不可少的,这有助于在监管过程中改进风险评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c3f/9257736/19bd83148f58/EOR-22-0033fig1.jpg

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