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RSA 和注册研究:新植入物分阶段引入的探索。

RSA and registries: the quest for phased introduction of new implants.

机构信息

Biomechanics and Imaging Group, Department of Orthopaedics, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands. Nelissen:

出版信息

J Bone Joint Surg Am. 2011 Dec 21;93 Suppl 3:62-5. doi: 10.2106/JBJS.K.00907.

Abstract

INTRODUCTION

Although the overall survival of knee and hip prostheses at ten years averages 90%, recent problems with several hip and knee prostheses have illustrated that the orthopaedic community, industry, and regulators can still further improve patient safety. Given the early predictive properties of roentgen stereophotogrammetric analysis (RSA) and the meticulous follow-up of national joint registries, these two methods are ideal tools for such a phased clinical introduction. In this paper, we elaborate on the predictive power of RSA within a two-year follow-up after arthroplasty and its relationship to national joint registries. The association between RSA prosthesis-migration data and registry data is evaluated.

METHODS

The five-year rate of revision of RSA-tested total knee replacements was compared with that of non-RSA-tested total knee replacements. Data were extracted from the published results of the national joint registries of Sweden, Australia, and New Zealand.

RESULTS

There was a 22% to 35% reduction in the number of revisions of RSA-tested total knee replacements as compared with non-RSA-tested total knee replacements in the national joint registries. Assuming that the total cost of total knee arthroplasty is $37,000 in the United States, a 22% to 35% reduction in the number of revisions (currently close to 55,000 annually) could lead to an estimated annual savings of over $400 million to the health-care system.

CONCLUSION

The phased clinical introduction of new prostheses with two-year RSA results as a qualitative tool could lead to better patient care and could reduce the costs associated with revision total knee arthroplasty. Follow-up in registries is necessary to substantiate these results and to improve post-market surveillance.

摘要

简介

尽管膝关节和髋关节假体的十年总体存活率平均为 90%,但最近几种髋关节和膝关节假体出现的问题表明,矫形外科界、工业界和监管机构仍可以进一步提高患者安全性。鉴于射线立体摄影分析(RSA)具有早期预测性能,以及国家关节登记处的细致随访,这两种方法是进行这种分阶段临床引入的理想工具。在本文中,我们详细阐述了 RSA 在关节置换后两年随访中的预测能力及其与国家关节登记处的关系。评估了 RSA 假体迁移数据与登记处数据之间的相关性。

方法

比较了 RSA 测试的全膝关节置换与非 RSA 测试的全膝关节置换的五年翻修率。数据从瑞典、澳大利亚和新西兰的国家关节登记处发表的结果中提取。

结果

与非 RSA 测试的全膝关节置换相比,国家关节登记处中 RSA 测试的全膝关节置换的翻修数量减少了 22%至 35%。假设全膝关节置换的总成本为 37000 美元,那么翻修数量减少 22%至 35%(目前接近每年 55000 例)可能会导致医疗保健系统每年节省超过 4 亿美元。

结论

使用两年 RSA 结果作为定性工具对新假体进行分阶段临床引入,可以改善患者护理,并降低与翻修全膝关节置换相关的成本。需要在登记处进行随访,以证实这些结果并改善上市后监测。

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