采用无水泥 Spotorno（CLS）系统的全髋关节置换术的汇总结果：临床研究与全球关节置换登记数据的对比分析。
Pooled outcome of total hip arthroplasty with the CementLess Spotorno (CLS) system: a comparative analysis of clinical studies and worldwide arthroplasty register data.
机构信息
Department of Orthopaedic Surgery, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.
出版信息
Int Orthop. 2013 Jun;37(6):995-9. doi: 10.1007/s00264-013-1867-8. Epub 2013 Mar 24.
Abstract
PURPOSE
Our aim was to elucidate the pooled outcome of the CementLess Spotorno (CLS) system in total hip arthroplasty (THA).
METHODS
We compared the outcome of clinical inventor studies, independent clinical studies, and worldwide register data. The main endpoints for analysis were revision rates.
RESULTS
Twenty clinical studies were evaluated and, with one exception, overall found revision rates largely in line with register data. Revision rates (revisions per 100 observed component years) range from 0.15 (inventor study) to 0.28 (independent studies) and 0.43 (register datasets).
CONCLUSION
Data of journal publications and register datasets using the CLS system do not differ significantly with respect to revision rates. Only the initial inventor study reports a revision rate three times lower than in pooled worldwide register datasets.
摘要
目的
本研究旨在阐明无水泥 Sporotorno（CLS）系统在全髋关节置换术（THA）中的综合结果。
方法
我们比较了临床原始研究、独立临床研究和全球注册数据的结果。分析的主要终点是翻修率。
结果
共评估了 20 项临床研究，除了一项研究外，其余研究的总体翻修率与注册数据基本一致。翻修率（每 100 个观察到的部件年的翻修率）范围为 0.15（原始研究）至 0.28（独立研究）和 0.43（注册数据集）。
结论
使用 CLS 系统的期刊出版物和注册数据集的数据在翻修率方面没有显著差异。只有最初的原始研究报告的翻修率比汇总的全球注册数据集低三倍。
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