Blood Metal Ion Thresholds to Identify Patients with Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris
Blood Metal Ion Thresholds to Identify Patients with Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris
复制标题
血液金属离子阈值可识别金属对金属髋关节植入物患者存在金属碎片不良反应风险的患者
DOI：
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
D. Murray
中科院分区：
文献类型：
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作者：
G. Matharu;F. Berryman;A. Judge;A. Reito;J. McConnell;Olli Lainiala;S. Young;A. Eskelinen;H. Pandit;D. Murray
背景：最近研究的作者报道了新设计的植入物特异性血液金属离子阈值，用于预测单侧或双侧金属对金属（MoM）髋关节置换术患者金属碎片（ARMD）的不良反应。这些阈值对于识别ARMD低风险患者是最有效的。我们研究了这些新设计的血液金属离子阈值是否可以有效识别体外队列患者中MoM髋关节置换术后ARMD风险的患者。方法：我们在3个欧洲中心对710名患者进行了803例MoM髋关节置换术（323例单侧Birmingham髋关节置换术[BHR]， 93例双侧BHR， 294例单侧Corail-Pinnacle植入物）。所有患者均行全血金属离子取样，并分为两组：ARMD组（导致翻修或影像学确诊）和无ARMD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为钴2.15 g/L；双侧BHR为钴或铬的最大值5.5 g/L；单侧Corail-Pinnacle植入物为钴3.57 g/L）应用于验证队列，并使用受试者工作特征曲线分析来建立每个阈值的歧视性特征。结果：各植入物特异性阈值区分ARMD患者的曲线下面积、敏感性、特异性和阳性、阴性预测值分别为89.4%（95%可信区间[CI] = 82.8% ~ 96.0%）、78.9%、86.7%、44.1%和96.9%；双侧BHR分别为89.2% （CI = 81.3% ~ 97.1%）、70.6%、86.8%、54.5%、93.0%；单侧Corail-Pinnacle种植体为76.9% （CI = 63.9% ~ 90.0%）、65.0%、85.4%、24.5%、97.1%。使用植入物特异性阈值，我们错过了20例ARMD患者（占该系列患者的2.8%）。当我们使用监管机构提出的固定阈值时，我们错过了更多的ARMD患者：当我们使用英国阈值7时，我们错过了35例（4.9%）；g/L的钴和铬（p = 0.0003）， 21(3.0%)，当我们使用美国阈值3 &mgr；对于钴和铬（p = 1.0）和46(6.5%)，当我们使用美国的阈值10 &mgr；钴和铬均为g/L （p < 0.0001）。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植入物特异性阈值的患者在MoM髋关节置换术后发生ARMD的风险较低。使用这些植入物特异性阈值，与目前使用监管机构建议的阈值相比，我们错过的ARMD患者更少。因此，我们建议在处理接受MoM髋关节置换术的患者时使用植入物特异性血液金属离子阈值。证据等级：诊断级III。有关证据水平的完整描述，请参见作者说明。
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 &mgr;g/L of cobalt for unilateral BHR; 5.5 &mgr;g/L for the maximum of either cobalt or chromium for bilateral BHR; and 3.57 &mgr;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 &mgr;g/L for both cobalt and chromium (p = 0.0003), 21 (3.0%) when we used the U.S. threshold of 3 &mgr;g/L for both cobalt and chromium (p = 1.0), and 46 (6.5%) when we used the U.S. threshold of 10 &mgr;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. Level of Evidence: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.
影响因子：
105.7
作者：
Altman, Douglas G.;Vergouwe, Yvonne;Moons, Karel G. M.
通讯作者：
Moons, Karel G. M.