Blood Metal Ion Thresholds to Identify Patients with Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris An External Multicenter Validation Study of Birmingham Hip Resurfacing and Corail-Pinnacle Implants
Blood Metal Ion Thresholds to Identify Patients with Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris An External Multicenter Validation Study of Birmingham Hip Resurfacing and Corail-Pinnacle Implants
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DOI：
10.2106/jbjs.16.01568
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发表时间：
2017-09-20
影响因子：
5.3
通讯作者：
Murray, David W.
中科院分区：
文献类型：
--
作者：
Matharu, Gulraj S.;Berryman, Fiona;Murray, David W.
背景：最近研究的作者报告了新设计的植入物特异性血液金属离子阈值，用于预测接受单侧或双侧金属对金属（MoM）髋关节置换术的患者对金属碎片（ARMD）的不良反应。这些阈值对于识别 ARMD 低风险患者最有效。我们研究了这些新设计的血液金属离子阈值是否能够在外部患者队列中有效识别 MoM 髋关节置换术后存在 ARMD 风险的患者。 方法：我们进行了一项验证研究，涉及 3 个欧洲中心的 710 名患者进行的 803 例 MoM 髋关节置换术（323 例单侧伯明翰髋关节置换术 [BHR]、93 例双侧 BHR 和 294 例单侧 Corail-Pinnacle 植入物）。所有患者均接受全血金属离子采样，并分为 2 组：患有 ARMD 的组（导致翻修或通过影像学识别；n = 75）和无 ARMD 的组（n = 635）。先前设计的植入物特异性血液金属离子阈值（单侧 BHR 为 2.15 μg/L 钴；双侧 BHR 钴或铬最大值为 5.5 μg/L；单侧 Corail-Pinnacle 植入物为 3.57 μg/L）应用于验证队列，并使用接受者操作特征曲线分析来建立每个阈值的区分特征。 结果：对于单侧 BHR，每个种植体特异性阈值区分患有和不患有 ARMD 的患者的曲线、灵敏度、特异性以及阳性和阴性预测值分别为 89.4%（95% 置信区间 [CI] = 82.8% 至 96.0%）、78.9%、86.7%、44.1% 和 96.9%；双侧 BHR 为 89.2%（CI = 81.3% 至 97.1%）、70.6%、86.8%、54.5% 和 93.0%；对于单侧 Corail-Pinnacle 种植体，分别为 76.9%（CI = 63.9% 至 90.0%）、65.0%、85.4%、24.5% 和 97.1%。使用种植体特定阈值，我们漏掉了 20 名 ARMD 患者（占本系列患者的 2.8%）。当我们使用监管机构提出的固定阈值时，我们漏掉了更多的ARMD患者：当我们使用英国钴和铬阈值7μg/L时，漏检了35例（4.9%），当我们使用美国钴和铬阈值3μg/L（p = 1.0）时，漏检了21例（3.0%），以及46例（6.5%）。当我们使用美国钴和铬阈值 10 μg/L (p < 0.0001) 时。结论：这项外部多中心验证研究证实，血液金属离子水平低于新的植入物特定阈值的患者在 MoM 髋关节置换术后发生 ARMD 的风险较低。与使用监管机构目前提出的阈值相比，使用这些特定于植入物的阈值，我们错过的 ARMD 患者更少。因此，我们建议在管理接受 MoM 髋关节置换术的患者时使用植入物特定的血液金属离子阈值。
Background: The authors of recent studies have reported newly devised implant-specific blood metal ion thresholds to predict adverse reactions to metal debris (ARMD) in patients who have undergone unilateral or bilateral metal-on-metal (MoM) hip arthroplasty. These thresholds were most effective for identifying patients at low risk of ARMD. We investigated whether these newly devised blood metal ion thresholds could effectively identify patients at risk of ARMD after MoM hip arthroplasty in an external cohort of patients.Methods: We performed a validation study involving 803 MoM hip arthroplasties (323 unilateral Birmingham Hip Resurfacing [BHR], 93 bilateral BHR, and 294 unilateral Corail-Pinnacle implants) performed in 710 patients at 3 European centers. All patients underwent whole-blood metal ion sampling, and were divided into 2 groups: those with ARMD (leading to revision or identified on imaging; n = 75) and those without ARMD (n = 635). Previously devised implant-specific blood metal ion thresholds (2.15 mu g/L of cobalt for unilateral BHR; 5.5 mu g/L for the maximum of either cobalt or chromium for bilateral BHR; and 3.57 mu g/L of cobalt for unilateral Corail-Pinnacle implants) were applied to the validation cohort, and receiver operating characteristic curve analysis was used to establish the discriminatory characteristics of each threshold.Results: The area under the curve, sensitivity, specificity, and positive and negative predictive values for the ability of each implant-specific threshold to distinguish between patients with and without ARMD were, respectively, 89.4% (95% confidence interval [CI] = 82.8% to 96.0%), 78.9%, 86.7%, 44.1%, and 96.9% for unilateral BHR; 89.2% (CI = 81.3% to 97.1%), 70.6%, 86.8%, 54.5%, and 93.0% for bilateral BHR; and 76.9% (CI = 63.9% to 90.0%), 65.0%, 85.4%, 24.5%, and 97.1% for unilateral Corail-Pinnacle implants. Using the implant-specific thresholds, we missed 20 patients with ARMD (2.8% of the patients in this series). We missed more patients with ARMD when we used the fixed thresholds proposed by regulatory authorities: 35 (4.9%) when we used the U.K. threshold of 7 mu g/L for both cobalt and chromium p = 0.0003), 21 (3.0%) when we used the U.S. threshold of 3 mu g/L for both cobalt and chromium (p = 1.0), and 46 (6.5%) when we used the U.S. threshold of 10 mu g/L for both cobalt and chromium (p < 0.0001).Conclusions: This external multicenter validation study confirmed that patients with blood metal ion levels below new implant-specific thresholds have a low risk of ARMD after MoM hip arthroplasty. Using these implant-specific thresholds, we missed fewer patients with ARMD compared with when the thresholds currently proposed by regulatory authorities were used. We therefore recommend using implant-specific blood metal ion thresholds when managing patients who have undergone MoM hip arthroplasty.