目的比较不同种植体组合用于初次全髋关节置换术(THR)的存活情况。设计系统评价和网络荟萃分析。数据源Medline,Embase,科克伦图书馆,ClinicalTrials.gov,世卫组织国际临床试验注册平台,和欧盟临床试验注册。综述方法公布的随机对照试验比较不同的植入物组合。植入物组合由轴承表面材料定义(聚乙烯上的金属,聚乙烯上的陶瓷,陶瓷对陶瓷,或金属对金属),头部尺寸(大尺寸≥36mm或小尺寸<36mm),和固定技术(水泥,未固定,混合动力车,或反向混合)。我们的参考植入物组合是聚乙烯上的金属(非高度交联),小脑袋,和水泥。主要结果是原发性THR后0-2年和2-10年的翻修手术。次要结果是临床医生报告的Harris髋关节评分。结果77项研究纳入系统评价,15项研究(3177例髋关节)在网络荟萃分析中进行修订。与参考植入物组合相比,没有证据表明其他植入物组合可降低翻修手术的风险。虽然估计不精确,金属对金属,小脑袋,与参考植入物组合相比,胶结植入物(风险比4.4,95%可信区间1.6至16.6)和表面置换(12.1,2.1至120.3)增加了初次THR后0-2年的翻修风险。在2-10年期间观察到类似的结果。31项研究(2888例患者)纳入Harris髋关节评分分析。没有植入物组合具有比参考植入物组合更好的评分。结论未发现较新的植入物组合优于参考植入物组合(聚乙烯上金属(非高度交联),小脑袋,骨水泥)在翻修手术风险或Harris髋关节评分方面。金属对金属,小脑袋,与参考植入物组合相比,胶结植入物和表面置换增加了翻修手术的风险。结果与观察证据一致,并在敏感性分析中重复,但由于研究报告不佳而受到限制。系统审查注册PROSPEROCRD42015019435。
Objective To compare the survival of different implant combinations for primary total hip replacement (THR). Design Systematic
review and network meta-analysis. Data sources Medline, Embase, The Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and the EU Clinical Trials Register.Review methods Published randomised controlled trials comparing different implant combinations. Implant combinations were defined by bearing surface materials (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or metal-on-metal), head size (large ≥36 mm or small <36 mm), and fixation technique (cemented, uncemented, hybrid, or reverse hybrid). Our reference implant combination was metal-on-polyethylene (not highly cross linked), small head, and cemented. The primary outcome was revision surgery at 0-2 years and 2-10 years after primary THR. The secondary outcome was the Harris hip score reported by clinicians.Results 77 studies were included in the systematic
review, and 15 studies (3177 hips) in the network meta-analysis for revision. There was no evidence that the risk of revision surgery was reduced by other implant combinations compared with the reference implant combination. Although estimates are imprecise, metal-on-metal, small head, cemented implants (hazard ratio 4.4, 95% credible interval 1.6 to 16.6) and resurfacing (12.1, 2.1 to 120.3) increase the risk of revision at 0-2 years after primary THR compared with the reference implant combination. Similar results were observed for the 2-10 years period. 31 studies (2888 patients) were included in the analysis of Harris hip score. No implant combination had a better score than the reference implant combination.Conclusions Newer implant combinations were not found to be better than the reference implant combination (metal-on-polyethylene (not highly cross linked), small head, cemented) in terms of risk of revision surgery or Harris hip score. Metal-on-metal, small head, cemented implants and resurfacing increased the risk of revision surgery compared with the reference implant combination. The results were consistent with observational evidence and were replicated in sensitivity analysis but were limited by poor reporting across studies.Systematic
review registration PROSPERO CRD42015019435.