Department of Community Health Sciences, University of Calgary, Health Research Innovation Centre, Calgary, AB, Canada,
Clin Orthop Relat Res. 2014 Jul;472(7):2217-30. doi: 10.1007/s11999-014-3556-3. Epub 2014 Apr 4.
Metal-on-metal hip resurfacing was developed for younger, active patients as an alternative to THA, but it remains controversial. Study heterogeneity, inconsistent outcome definitions, and unstandardized outcome measures challenge our ability to compare arthroplasty outcomes studies.
QUESTIONS/PURPOSES: We asked how early revisions or reoperations (within 5 years of surgery) and overall revisions, adverse events, and postoperative component malalignment compare among studies of metal-on-metal hip resurfacing with THA among patients with hip osteoarthritis. Secondarily, we compared the revision frequency identified in the systematic review with revisions reported in four major joint replacement registries.
We conducted a systematic review of English language studies published after 1996. Adverse events of interest included rates of early failure, time to revision, revision, reoperation, dislocation, infection/sepsis, femoral neck fracture, mortality, and postoperative component alignment. Revision rates were compared with those from four national joint replacement registries. Results were reported as adverse event rates per 1000 person-years stratified by device market status (in use and discontinued). Comparisons between event rates of metal-on-metal hip resurfacing and THA are made using a quasilikelihood generalized linear model. We identified 7421 abstracts, screened and reviewed 384 full-text articles, and included 236. The most common study designs were prospective cohort studies (46.6%; n = 110) and retrospective studies (36%; n = 85). Few randomized controlled trials were included (7.2%; n = 17).
The average time to revision was 3.0 years for metal-on-metal hip resurfacing (95% CI, 2.95-3.1) versus 7.8 for THA (95% CI, 7.2-8.3). For all devices, revisions and reoperations were more frequent with metal-on-metal hip resurfacing than THA based on point estimates and CIs: 10.7 (95% CI, 10.1-11.3) versus 7.1 (95% CI, 6.7-7.6; p = 0.068), and 7.9 (95% CI, 5.4-11.3) versus 1.8 (95% CI, 1.3-2.2; p = 0.084) per 1000 person-years, respectively. This difference was consistent with three of four national joint replacement registries, but overall national joint replacement registries revision rates were lower than those reported in the literature. Dislocations were more frequent with THA than metal-on-metal hip resurfacing: 4.4 (95% CI, 4.2-4.6) versus 0.9 (95% CI, 0.6-1.2; p = 0.008) per 1000 person-years, respectively. Adverse event rates change when discontinued devices were included.
Revisions and reoperations are more frequent and occur earlier with metal-on-metal hip resurfacing, except when discontinued devices are removed from the analyses. Results from the literature may be misleading without consistent definitions, standardized outcome metrics, and accounting for device market status. This is important when clinicians are assessing and communicating patient risk and when selecting which device is most appropriate for individual patients.
金属对金属髋关节表面置换术是为年轻、活跃的患者开发的,作为全髋关节置换术的替代方案,但仍存在争议。研究的异质性、不一致的结果定义和非标准化的结果测量方法,使我们难以比较关节置换术结果研究。
问题/目的:我们询问了在髋关节骨关节炎患者中,金属对金属髋关节表面置换术与全髋关节置换术相比,早期翻修或再次手术(术后 5 年内)和总体翻修、不良事件以及术后组件对线不良的情况如何。其次,我们比较了系统评价中确定的翻修频率与四个主要关节置换登记处报告的翻修频率。
我们对 1996 年后发表的英文文献进行了系统评价。感兴趣的不良事件包括早期失败率、翻修时间、翻修、再次手术、脱位、感染/败血症、股骨颈骨折、死亡率和术后组件对线。翻修率与四个国家关节置换登记处的数据进行了比较。结果以每 1000 人年的不良事件发生率报告,按设备市场状况(使用中和已停产)分层。使用拟似然广义线性模型比较金属对金属髋关节表面置换术和全髋关节置换术的事件发生率。我们确定了 7421 篇摘要,筛选并回顾了 384 篇全文文章,并纳入了 236 篇。最常见的研究设计是前瞻性队列研究(46.6%;n=110)和回顾性研究(36%;n=85)。纳入的随机对照试验较少(7.2%;n=17)。
金属对金属髋关节表面置换术的平均翻修时间为 3.0 年(95%CI,2.95-3.1),而全髋关节置换术为 7.8 年(95%CI,7.2-8.3)。基于点估计值和置信区间,所有装置的翻修和再次手术都比全髋关节置换术更为频繁:10.7(95%CI,10.1-11.3)与 7.1(95%CI,6.7-7.6;p=0.068),7.9(95%CI,5.4-11.3)与 1.8(95%CI,1.3-2.2;p=0.084)每 1000 人年,分别。这一差异与四个国家关节置换登记处中的三个一致,但总体国家关节置换登记处的翻修率低于文献报告。与金属对金属髋关节表面置换术相比,全髋关节置换术后脱位更为常见:4.4(95%CI,4.2-4.6)与 0.9(95%CI,0.6-1.2;p=0.008)每 1000 人年,分别。当包括已停产的设备时,不良事件发生率会发生变化。
除了在分析中排除已停产的设备外,金属对金属髋关节表面置换术的翻修和再次手术更为频繁,且发生时间更早。如果没有一致的定义、标准化的结果指标以及设备市场状况的考虑,文献中的结果可能会产生误导。当临床医生评估和交流患者风险以及选择最适合个别患者的设备时,这一点很重要。