关于解剖学分级组件全膝关节置换术的已发表结果数据的有效性：一项包括关节置换登记数据的结构化文献回顾。
Validity of published outcome data concerning Anatomic Graduated Component total knee arthroplasty: a structured literature review including arthroplasty register data.
机构信息
Department of Orthopaedic Surgery, Innsbruck Medical University, Anichstr 35, 6020 Innsbruck, Austria.
出版信息
Int Orthop. 2012 Jan;36(1):51-6. doi: 10.1007/s00264-011-1255-1. Epub 2011 Apr 13.
PURPOSE
Total knee arthroplasty (TKA) as a treatment for end-stage osteoarthritis of the knee shows good results in terms of patient satisfaction. For the assessment of outcome and revision rate after total joint arthroplasty, there are two major data sources: clinical studies and national arthroplasty registers. The purpose of this study was to analyse the outcome of Anatomic Graduated Component (AGC) TKA reported in clinical studies and to perform a comparison with the outcome reported by national arthroplasty registers.
METHODS
A systematic literature review was performed using standardised methodology in order to determine the outcome and revision rate of AGC TKA. In a comprehensive meta-analysis of clinical studies and worldwide register results we examined the quality of the basic data and the occurrence and influence of potential bias factors. Confidence intervals were calculated to determine the statistical significance of differences.
RESULTS
We found significant differences as regards the revision rate measured in revisions per 100 observed component years. Compared to worldwide register data it turned out to be significantly lower in clinical studies published by the implant development team. Actually, they reported a revision rate of 0.18 revisions per 100 observed component years, whereas annual reports of national arthroplasty registers report 0.74 revisions per 100 observed component years. A comparison of the results from national arthroplasty registers of different countries revealed a significantly higher revision rate for Denmark in relation to worldwide register data.
CONCLUSIONS
A conventional meta-analysis of clinical studies is affected by the influence of the development team and therefore subject to bias. For the assessment of outcome arthroplasty register data should be rated as superior and, being used as reference data for the detection of potential bias factors in the clinical literature, could make an essential contribution to the quality of scientific meta-analysis.
目的
全膝关节置换术（TKA）作为膝关节终末期骨关节炎的治疗方法，在患者满意度方面取得了良好的效果。为了评估全关节置换术后的结果和翻修率，有两个主要的数据来源：临床研究和国家关节置换登记处。本研究的目的是分析临床研究中报告的解剖学分级组件（AGC）TKA 的结果，并与国家关节置换登记处报告的结果进行比较。
方法
采用标准化方法进行系统文献回顾，以确定 AGC TKA 的结果和翻修率。在对临床研究和全球登记处结果的综合荟萃分析中，我们检查了基本数据的质量以及潜在偏倚因素的发生和影响。置信区间用于确定差异的统计学意义。
结果
我们发现，在每 100 个观察到的组件年的翻修率方面，存在显著差异。与全球登记处数据相比，发表于植入物开发团队的临床研究中的翻修率明显较低。实际上，他们报告的每 100 个观察到的组件年的翻修率为 0.18 次，而国家关节置换登记处的年度报告则为每 100 个观察到的组件年 0.74 次翻修。对不同国家的国家关节置换登记处结果进行比较，发现丹麦的翻修率明显高于全球登记处数据。
结论
对临床研究进行常规荟萃分析会受到开发团队的影响，因此存在偏倚。为了评估结果，关节置换登记处的数据应被评为优于临床文献中潜在偏倚因素的检测参考数据，并为科学荟萃分析的质量做出重要贡献。
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