University Hospital Carl Gustav Carus Dresden, University Centre for Orthopaedics and Trauma Surgery, Dresden, Germany.
PLoS One. 2013 Aug 7;8(8):e70359. doi: 10.1371/journal.pone.0070359. eCollection 2013.
The use of metal-on-metal (MoM) total hip arthroplasty (THA) increased in the last decades. A release of metal products (i.e. particles, ions, metallo-organic compounds) in these implants may cause local and/or systemic adverse reactions. Metal ion concentrations in body fluids are surrogate measures of metal exposure.
To systematically summarize and critically appraise published studies concerning metal ion concentrations after MoM THA.
Systematic review of clinical trials (RCTs) and epidemiological studies with assessment of metal ion levels (cobalt, chromium, titanium, nickel, molybdenum) in body fluids after implantation of metalliferous hip replacements. Systematic search in PubMed and Embase in January 2012 supplemented by hand search. Standardized abstraction of pre- and postoperative metal ion concentrations stratified by type of bearing (primary explanatory factor), patient characteristics as well as study quality characteristics (secondary explanatory factors).
Overall, 104 studies (11 RCTs, 93 epidemiological studies) totaling 9.957 patients with measurement of metal ions in body fluids were identified and analyzed. Consistently, median metal ion concentrations were persistently elevated after implantation of MoM-bearings in all investigated mediums (whole blood, serum, plasma, erythrocytes, urine) irrespective of patient characteristics and study characteristics. In several studies very high serum cobalt concentrations above 50 µg/L were measured (detection limit typically 0.3 µg/L). Highest metal ion concentrations were observed after treatment with stemmed large-head MoM-implants and hip resurfacing arthroplasty.
Due to the risk of local and systemic accumulation of metallic products after treatment with MoM-bearing, risk and benefits should be carefully balanced preoperatively. The authors support a proposed "time out" for stemmed large-head MoM-THA and recommend a restricted indication for hip resurfacing arthroplasty. Patients with implanted MoM-bearing should receive regular and standardized monitoring of metal ion concentrations. Further research is indicated especially with regard to potential systemic reactions due to accumulation of metal products.
在过去几十年中,金属对金属(MoM)全髋关节置换术(THA)的使用有所增加。这些植入物中金属制品(例如颗粒、离子、金属有机化合物)的释放可能会引起局部和/或全身不良反应。体液中的金属离子浓度是金属暴露的替代指标。
系统总结和批判性评价有关 MoM-THA 后金属离子浓度的已发表研究。
对临床研究(RCT)和流行病学研究进行系统综述,评估植入含金属髋关节置换物后体液中的金属离子水平(钴、铬、钛、镍、钼)。2012 年 1 月在 PubMed 和 Embase 进行系统检索,并辅以手工检索。标准化摘录术前和术后金属离子浓度,按轴承类型(主要解释因素)、患者特征以及研究质量特征(次要解释因素)分层。
总共确定并分析了 104 项研究(11 项 RCT、93 项流行病学研究),共纳入 9957 例患者,测量了体液中的金属离子。一致的是,无论患者特征和研究特征如何,MoM 轴承植入后所有研究介质(全血、血清、血浆、红细胞、尿液)中的金属离子浓度中位数均持续升高。在一些研究中,测量到非常高的血清钴浓度超过 50μg/L(通常检测限为 0.3μg/L)。最大金属离子浓度出现在使用带柄大头 MoM 植入物和髋关节表面置换术治疗后。
由于 MoM 轴承治疗后金属制品的局部和全身蓄积风险增加,术前应仔细权衡风险和获益。作者支持对带柄大头 MoM-THA 进行“暂停”,并建议对髋关节表面置换术进行限制。植入 MoM 轴承的患者应定期接受标准化的金属离子浓度监测。需要进一步研究,特别是在金属制品蓄积引起潜在全身反应方面。