Department of Orthopaedics, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.
Int Orthop. 2012 Jul;36(7):1349-54. doi: 10.1007/s00264-012-1502-0. Epub 2012 Feb 22.
Hip resurfacing arthroplasty has gained popularity for treating young and active patients who have arthritis. There are two major data sources for assessing outcome and revision rate after total joint arthroplasty: sample-based clinical trials and national arthroplasty registers. The purpose of this study was to evaluate the outcome of the Birmingham Hip Resurfacing (BHR) arthroplasty in terms of revision rate as reported in clinical studies and recorded by national arthroplasty registers.
A comprehensive literature research was performed from English-language, peer-reviewed journals and annual reports from national joint arthroplasty registers worldwide. Only publications from MEDLINE-listed journals were included. The revision rate was used as the primary outcome parameter. In order to allow for direct comparison of different data sets, calculation was based on revisions per 100 observed component years. For statistical analysis, confidence intervals (CI) were calculated.
A total of 18,708 implants, equivalent to 106,565 observed component years, were analysed in the follow-up studies. The register reports contained 9,806 primary cases corresponding to 44,294 observed component years. Statistical analysis revealed a significant difference in revisions per 100 observed component years between the development team (0.27; CI: 0.14-0.40) and register data (0.74; CI: 0.72-0.76).
The BHR arthroplasty device shows good results in terms of revision rate in register data as well as in clinical studies. However, the excellent results reported by the development team are not reproducible by other surgeons. Based on the results of our study, we believe that comprehensive national arthroplasty registers are the most suitable tool for assessing hip arthroplasty revision rate.
髋关节表面置换术在治疗患有关节炎的年轻和活跃患者方面越来越受欢迎。有两个主要的数据来源可用于评估全关节置换术后的结果和翻修率:基于样本的临床试验和国家关节置换登记处。本研究的目的是评估 Birmingham Hip Resurfacing(BHR)关节置换术在临床研究中报告的翻修率以及在国家关节置换登记处记录的结果。
从英语同行评议期刊和全球国家关节置换登记处的年度报告中进行了全面的文献研究。仅包括来自 MEDLINE 列出的期刊的出版物。翻修率被用作主要的结果参数。为了允许对不同数据集进行直接比较,计算基于每 100 个观察到的部件年的翻修次数。为了进行统计分析,计算了置信区间(CI)。
在随访研究中,共分析了 18708 个植入物,相当于 106565 个观察到的部件年。登记报告包含 9806 例原发性病例,相当于 44294 个观察到的部件年。统计分析显示,开发团队(0.27;CI:0.14-0.40)和登记处数据(0.74;CI:0.72-0.76)之间的每 100 个观察到的部件年的翻修次数存在显著差异。
BHR 关节置换术在登记处数据和临床研究中在翻修率方面均显示出良好的结果。然而,开发团队报告的出色结果无法被其他外科医生复制。基于我们的研究结果,我们认为全面的国家关节置换登记处是评估髋关节置换翻修率的最合适工具。