撤回的 ASR™ THR 和髋关节表面置换系统：我们的患者在 1 至 6 年内的情况如何？
The withdrawn ASR™ THA and hip resurfacing systems: how have our patients fared over 1 to 6 years?
机构信息
Department of Orthopaedic Surgery, Duke University Medical Center, Box 3269, Durham, NC 27710, USA.
出版信息
Clin Orthop Relat Res. 2013 Feb;471(2):430-8. doi: 10.1007/s11999-012-2547-5.
BACKGROUND
The Articular Surface Replacement™ (ASR™) metal-on-metal hip arthroplasty system (DePuy Orthopaedics, Inc, Warsaw, IN, USA) reportedly has a higher than anticipated early failure rate leading to a voluntary recall. This prompted us to evaluate all ASR™ components implanted at our center.
QUESTIONS/PURPOSES: In all ASR™ components, we reported (1) revision rate, (2) blood metal ion levels, and (3) intraoperative findings for revisions related to adverse reaction to metal debris (ARMD).
METHODS
We retrospectively reviewed all 172 patients (190 hips) who underwent THA (149 hips) or hip resurfacing (41 hips) with the ASR™ system. We determined failure rates. We obtained blood metal ion concentrations from 93 patients at last followup. We evaluated MRI studies and intraoperative histopathology. Minimum followup was 12 months (mean, 40 months; range, 12-74 months).
RESULTS
At latest followup, we had revised 24 of 190 hips (13%): in 18 patients with THA and five patients with resurfacing. Mean time to revision was 45 months (range, 12-75 months). Mean blood concentrations were 13 μg/L (range, 0-150 μg/L) for cobalt and 6 μg/L (range, 0-87 μg/L) for chromium. Mean prerevision blood metal ion levels were higher in the revised group (cobalt: 48 μg/L; chromium: 18 μg/L) than in the nonrevised group (cobalt: 5 μg/L; chromium: 2 μg/L). ARMD was present in 14 of the 24 hips revised in this study.
CONCLUSIONS
Surgeons must have a low threshold for concern for ARMD in patients with ASR™ systems. Blood metal ion levels and MRI can be used to evaluate patients with underperforming implants. Intraoperative histopathologic analysis and joint fluid cytology can help diagnose ARMD at the time of revision.
LEVEL OF EVIDENCE
Level III, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.
背景
Articular Surface Replacement™（ASR™）金属对金属髋关节置换系统（美国德培医疗保健公司，华沙，印第安纳州）的早期失败率高于预期，导致该系统被自愿召回。这促使我们评估了我们中心植入的所有 ASR™组件。
问题/目的：在所有 ASR™组件中，我们报告了（1）翻修率，（2）血液金属离子水平，以及（3）与金属屑不良反应相关的翻修术中的发现。
方法
我们回顾性分析了 172 例接受 ASR™系统全髋关节置换术（THA）（149 髋）或髋关节表面置换术（41 髋）的患者。我们确定了失败率。我们从 93 例患者的最后一次随访中获得了血液金属离子浓度。我们评估了 MRI 研究和术中组织病理学。最低随访时间为 12 个月（平均 40 个月；范围 12-74 个月）。
结果
在最新随访时，我们对 190 髋中的 24 髋（13%）进行了翻修：18 例患者接受了 THA，5 例患者接受了髋关节表面置换术。翻修的平均时间为 45 个月（范围 12-75 个月）。平均血液浓度分别为钴 13μg/L（范围 0-150μg/L）和铬 6μg/L（范围 0-87μg/L）。修订组的术前血液金属离子水平较高（钴：48μg/L；铬：18μg/L），而非修订组的术前血液金属离子水平较低（钴：5μg/L；铬：2μg/L）。在本研究中接受翻修的 24 髋中，有 14 髋存在 ARMD。
结论
外科医生必须对 ASR™系统患者的 ARMD 保持低警惕。血液金属离子水平和 MRI 可用于评估植入物性能不佳的患者。术中组织病理学分析和关节液细胞学检查可帮助诊断翻修时的 ARMD。
证据水平
III 级，治疗性研究。有关证据水平的完整描述，请参见作者说明。
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