Musculoskeletal Research Unit, Bristol Medical School, University of Bristol, Southmead Hospital, Bristol, United Kingdom.
National Institute for Health Research, Biomedical Research Centre Bristol, University of Bristol, Bristol, United Kingdom.
J Bone Joint Surg Am. 2018 Feb 7;100(3):189-196. doi: 10.2106/JBJS.17.00039.
New medical technologies are often used widely without adequate supporting data, a practice that can lead to widespread catastrophic failure such as occurred with metal-on-metal (MoM) hip replacements. We determined both how revision rates would have differed if, instead of receiving MoM hip replacements, patients had received existing alternatives and the subsequent cumulative re-revision rates of the patients who did receive MoM hip replacements compared with alternatives.
This study is a population-based longitudinal cohort study of patient data recorded in the National Joint Registry (NJR) for England, Wales and Northern Ireland between April 2003 and December 2014. We ascertained implant failure rates separately among stemmed MoM total hip replacement (THR) and hip-resurfacing procedures and, using flexible parametric survival modeling, compared them with the failure rates that would have been expected had existing alternatives been used. We used Kaplan-Meier survivorship analysis to compare cumulative re-revision of patients who received stemmed MoM primary replacements that failed and of those who underwent hip resurfacing that failed with those whose non-MoM THRs had failed.
In all, 37,555 patients underwent MoM hip resurfacing, with a 10-year revision rate of 12.6% (95% confidence interval [CI]: 12.2% to 13.1%) compared with a predicted revision rate of 4.8% if alternative implants had been used. The 32,024 stemmed MoM THRs had a 19.8% (95% CI: 18.9% to 20.8%) 10-year failure rate compared with an expected rate of 3.9% if alternatives had been used. For every 100 MoM hip-resurfacing procedures, there were 7.8 excess revisions by 10 years, and for every 100 stemmed MoM THR procedures, there were 15.9, which equates to 8,021 excess first revisions. Seven-year re-revision rates were 14.9% (95% CI: 13.8% to 16.2%) for stemmed non-MoM THRs, 18.0% (95% CI: 15.7% to 20.7%) for MoM hip resurfacing, and 19.8% (95% CI: 17.0% to 23.0%) for stemmed MoM THRs.
This study highlights the consequences of widespread and poorly monitored adoption of a medical technology. Over 1 million MoM hip prostheses were implanted worldwide. The excess failure on a global scale will be enormous. This practice of adopting new technologies without adequate supporting data must not be repeated.
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
新的医疗技术在缺乏充分支持数据的情况下广泛应用，这种做法可能导致广泛的灾难性失败，就像金属对金属（MoM）髋关节置换术那样。我们确定了如果患者接受现有的替代方案而不是 MoM 髋关节置换术，那么修订率会有何不同，以及随后接受 MoM 髋关节置换术的患者与接受替代方案的患者的累积再次修订率。
这是一项基于人群的纵向队列研究，对英格兰、威尔士和北爱尔兰国家联合登记处（NJR）在 2003 年 4 月至 2014 年 12 月期间记录的患者数据进行了研究。我们分别确定了带柄 MoM 全髋关节置换术（THR）和髋关节表面置换术的植入物失败率，并使用灵活的参数生存模型，将其与使用现有替代方案时预期的失败率进行比较。我们使用 Kaplan-Meier 生存分析比较了接受失败的带柄 MoM 初次置换的患者和接受失败的髋关节表面置换的患者与接受非 MoM THR 失败的患者的累积再次修订率。
共有 37555 名患者接受了 MoM 髋关节表面置换术，10 年的修订率为 12.6%（95%置信区间[CI]：12.2%至 13.1%），而如果使用替代植入物，预计修订率为 4.8%。32024 例带柄 MoM THR 的 10 年失败率为 19.8%（95%CI：18.9%至 20.8%），而如果使用替代物，预计失败率为 3.9%。每 100 例 MoM 髋关节表面置换术，10 年内会有 7.8 例额外的翻修，而每 100 例带柄 MoM THR 手术，会有 15.9 例，相当于 8021 例额外的初次翻修。7 年的再次修订率分别为：非 MoM THR 的带柄 MoM 14.9%（95%CI：13.8%至 16.2%），MoM 髋关节表面置换的 18.0%（95%CI：15.7%至 20.7%），带柄 MoM THR 的 19.8%（95%CI：17.0%至 23.0%）。
这项研究强调了广泛且监测不佳的医疗技术采用所带来的后果。全球范围内植入了超过 100 万例 MoM 髋关节假体。全球范围内的过度失败将是巨大的。这种在缺乏充分支持数据的情况下采用新技术的做法绝不能再重复。
治疗水平 III。请参阅作者说明，以获取完整的证据水平描述。
