López-López José A, Humphriss Rachel L, Beswick Andrew D, Thom Howard H Z, Hunt Linda P, Burston Amanda, Fawsitt Christopher G, Hollingworth William, Higgins Julian P T, Welton Nicky J, Blom Ashley W, Marques Elsa M R
Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Musculoskeletal Research Unit, University of Bristol, Southmead Hospital, Learning and Research Building (Level 1), Bristol BS10 5NB, UK.
BMJ. 2017 Nov 2;359:j4651. doi: 10.1136/bmj.j4651.
To compare the survival of different implant combinations for primary total hip replacement (THR). Systematic review and network meta-analysis. Medline, Embase, The Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and the EU Clinical Trials Register. 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. 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. 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. PROSPERO CRD42015019435.
比较初次全髋关节置换（THR）中不同植入物组合的生存率。系统评价和网状Meta分析。检索了Medline、Embase、Cochrane图书馆、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台和欧盟临床试验注册库。纳入比较不同植入物组合的已发表随机对照试验。植入物组合由承重表面材料（金属对聚乙烯、陶瓷对聚乙烯、陶瓷对陶瓷或金属对金属）、股骨头大小（大≥36mm或小<36mm）和固定技术（骨水泥固定、非骨水泥固定、混合固定或反向混合固定）定义。我们的参考植入物组合是金属对聚乙烯（非高度交联）、小头和骨水泥固定。主要结局是初次THR后0至2年和2至10年的翻修手术。次要结局是临床医生报告的Harris髋关节评分。系统评价纳入77项研究，网状Meta分析纳入15项研究（3177个髋关节）用于翻修分析。没有证据表明与参考植入物组合相比，其他植入物组合能降低翻修手术风险。尽管估计值不精确，但与参考植入物组合相比，金属对金属、小头、骨水泥固定植入物（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）在初次THR后0至2年增加了翻修风险。在2至10年期间观察到类似结果。31项研究（2888例患者）纳入Harris髋关节评分分析。没有植入物组合比参考植入物组合得分更高。在翻修手术风险或Harris髋关节评分方面，未发现新的植入物组合优于参考植入物组合（金属对聚乙烯（非高度交联）、小头、骨水泥固定）。与参考植入物组合相比，金属对金属、小头、骨水泥固定植入物和表面置换增加了翻修手术风险。结果与观察性证据一致，并在敏感性分析中得到重复，但受各研究报告质量差的限制。国际前瞻性系统评价注册编号：CRD42015019435。
