Clarke Aileen, Pulikottil-Jacob Ruth, Grove Amy, Freeman Karoline, Mistry Hema, Tsertsvadze Alexander, Connock Martin, Court Rachel, Kandala Ngianga-Bakwin, Costa Matthew, Suri Gaurav, Metcalfe David, Crowther Michael, Morrow Sarah, Johnson Samantha, Sutcliffe Paul
Warwick Evidence, Warwick Medical School, University of Warwick, Coventry, UK.
Warwick Orthopaedics, University Hospitals Coventry and Warwickshire, Coventry, UK.
Health Technol Assess. 2015 Jan;19(10):1-668, vii-viii. doi: 10.3310/hta19100.
Total hip replacement (THR) involves the replacement of a damaged hip joint with an artificial hip prosthesis. Resurfacing arthroplasty (RS) involves replacement of the joint surface of the femoral head with a metal surface covering.
To undertake clinical effectiveness and cost-effectiveness analysis of different types of THR and RS for the treatment of pain and disability in people with end-stage arthritis of the hip, in particular to compare the clinical effectiveness and cost-effectiveness of (1) different types of primary THR and RS for people in whom both procedures are suitable and (2) different types of primary THR for people who are not suitable for hip RS.
Electronic databases including MEDLINE, EMBASE, The Cochrane Library, Current Controlled Trials and UK Clinical Research Network (UKCRN) Portfolio Database were searched in December 2012, with searches limited to publications from 2008 and sample sizes of ≥ 100 participants. Reference lists and websites of manufacturers and professional organisations were also screened.
Systematic reviews of the literature were undertaken to appraise the clinical effectiveness and cost-effectiveness of different types of THR and RS for people with end-stage arthritis of the hip. Included randomised controlled trials (RCTs) and systematic reviews were data extracted and risk of bias and methodological quality were independently assessed by two reviewers using the Cochrane Collaboration risk of bias tool and the Assessment of Multiple Systematic Reviews (AMSTAR) tool. A Markov multistate model was developed for the economic evaluation of the technologies. Sensitivity analyses stratified by sex and controlled for age were carried out to assess the robustness of the results.
A total of 2469 records were screened of which 37 were included, representing 16 RCTs and eight systematic reviews. The mean post-THR Harris Hip Score measured at different follow-up times (from 6 months to 10 years) did not differ between THR groups, including between cross-linked polyethylene and traditional polyethylene cup liners (pooled mean difference 2.29, 95% confidence interval -0.88 to 5.45). Five systematic reviews reported evidence on different types of THR (cemented vs. cementless cup fixation and implant articulation materials) but these reviews were inconclusive. Eleven cost-effectiveness studies were included; four provided relevant cost and utility data for the model. Thirty registry studies were included, with no studies reporting better implant survival for RS than for all types of THR. For all analyses, mean costs for RS were higher than those for THR and mean quality-adjusted life-years (QALYs) were lower. The incremental cost-effectiveness ratio for RS was dominated by THR, that is, THR was cheaper and more effective than RS (for a lifetime horizon in the base-case analysis, the incremental cost of RS was £11,284 and the incremental QALYs were -0.0879). For all age and sex groups RS remained clearly dominated by THR. Cost-effectiveness acceptability curves showed that, for all patients, THR was almost 100% cost-effective at any willingness-to-pay level. There were age and sex differences in the populations with different types of THR and variations in revision rates (from 1.6% to 3.5% at 9 years). For the base-case analysis, for all age and sex groups and a lifetime horizon, mean costs for category E (cemented components with a polyethylene-on-ceramic articulation) were slightly lower and mean QALYs for category E were slightly higher than those for all other THR categories in both deterministic and probabilistic analyses. Hence, category E dominated the other four categories. Sensitivity analysis using an age- and sex-adjusted log-normal model demonstrated that, over a lifetime horizon and at a willingness-to-pay threshold of £20,000 per QALY, categories A and E were equally likely (50%) to be cost-effective.
A large proportion of the included studies were inconclusive because of poor reporting, missing data, inconsistent results and/or great uncertainty in the treatment effect estimates. This warrants cautious interpretation of the findings. The evidence on complications was scarce, which may be because of the absence or rarity of these events or because of under-reporting. The poor reporting meant that it was not possible to explore contextual factors that might have influenced study results and also reduced the applicability of the findings to routine clinical practice in the UK. The scope of the review was limited to evidence published in English in 2008 or later, which could be interpreted as a weakness; however, systematic reviews would provide summary evidence for studies published before 2008.
Compared with THR, revision rates for RS were higher, mean costs for RS were higher and mean QALYs gained were lower; RS was dominated by THR. Similar results were obtained in the deterministic and probabilistic analyses and for all age and sex groups THR was almost 100% cost-effective at any willingness-to-pay level. Revision rates for all types of THR were low. Category A THR (cemented components with a polyethylene-on-metal articulation) was more cost-effective for older age groups. However, across all age-sex groups combined, the mean cost for category E THR (cemented components with a polyethylene-on-ceramic articulation) was slightly lower and the mean QALYs gained were slightly higher. Category E therefore dominated the other four categories. Certain types of THR appeared to confer some benefit, including larger femoral head sizes, use of a cemented cup, use of a cross-linked polyethylene cup liner and a ceramic-on-ceramic as opposed to a metal-on-polyethylene articulation. Further RCTs with long-term follow-up are needed.
This study is registered as PROSPERO CRD42013003924.
The National Institute for Health Research Health Technology Assessment programme.
全髋关节置换术(THR)是用人工髋关节假体替换受损的髋关节。表面置换术(RS)是用金属表面覆盖物替换股骨头的关节表面。
对不同类型的全髋关节置换术和表面置换术治疗终末期髋关节关节炎患者的疼痛和残疾情况进行临床有效性和成本效益分析,尤其要比较(1)两种手术均适用的患者中不同类型的初次全髋关节置换术和表面置换术的临床有效性和成本效益,以及(2)不适合髋关节表面置换术的患者中不同类型的初次全髋关节置换术的临床有效性和成本效益。
2012年12月检索了电子数据库,包括MEDLINE、EMBASE、Cochrane图书馆、当前受控试验和英国临床研究网络(UKCRN)组合数据库,检索限于2008年以来的出版物且样本量≥100名参与者。还筛选了制造商和专业组织的参考文献列表及网站。
对文献进行系统综述,以评估不同类型的全髋关节置换术和表面置换术治疗终末期髋关节关节炎患者的临床有效性和成本效益。纳入的随机对照试验(RCT)和系统综述进行数据提取,两名评价者使用Cochrane协作偏倚风险工具和多重系统综述评估(AMSTAR)工具独立评估偏倚风险和方法学质量。开发了马尔可夫多状态模型用于技术的经济评估。进行了按性别分层并控制年龄的敏感性分析以评估结果的稳健性。
共筛选了2469条记录,其中37条被纳入,代表16项随机对照试验和8篇系统综述。在不同随访时间(6个月至10年)测量的全髋关节置换术后Harris髋关节评分均值在全髋关节置换术组之间无差异,包括交联聚乙烯和传统聚乙烯杯衬之间(合并均值差异2.29,95%置信区间-0.88至5.45)。5篇系统综述报告了不同类型全髋关节置换术(骨水泥固定与非骨水泥杯固定及植入物关节材料)的证据,但这些综述尚无定论。纳入了11项成本效益研究;4项为模型提供了相关成本和效用数据。纳入了30项登记研究,没有研究报告表面置换术的植入物生存率优于所有类型的全髋关节置换术。对于所有分析,表面置换术的平均成本高于全髋关节置换术,平均质量调整生命年(QALY)较低。表面置换术的增量成本效益比被全髋关节置换术主导,即全髋关节置换术比表面置换术更便宜且更有效(在基础案例分析中,终身视角下,表面置换术的增量成本为11,284英镑,增量QALY为-0.0879)。对于所有年龄和性别组,表面置换术仍明显被全髋关节置换术主导。成本效益可接受性曲线表明,对于所有患者,在任何支付意愿水平下,全髋关节置换术几乎100%具有成本效益。不同类型全髋关节置换术的人群存在年龄和性别差异,翻修率也有变化(9年时从1.6%至3.5%)。对于基础案例分析,对于所有年龄和性别组以及终身视角,在确定性和概率性分析中,E类(骨水泥组件搭配聚乙烯对陶瓷关节)的平均成本略低,平均QALY略高于所有其他全髋关节置换术类别。因此,E类优于其他四类。使用年龄和性别调整的对数正态模型进行的敏感性分析表明,在终身视角下且支付意愿阈值为每QALY 20,000英镑时,A类和E类具有成本效益的可能性相同(50%)。
由于报告不佳、数据缺失、结果不一致和/或治疗效果估计存在很大不确定性,纳入的研究中有很大一部分尚无定论。这需要对研究结果进行谨慎解读。关于并发症的证据很少,这可能是因为这些事件不存在或罕见,或者是因为报告不足。报告不佳意味着无法探讨可能影响研究结果的背景因素,也降低了研究结果在英国常规临床实践中的适用性。综述范围限于2008年或以后以英文发表的证据,这可被视为一个弱点;然而,系统综述将为2008年以前发表的研究提供汇总证据。
与全髋关节置换术相比,表面置换术的翻修率更高,平均成本更高,获得的平均QALY更低;表面置换术被全髋关节置换术主导。在确定性和概率性分析中均获得了类似结果,对于所有年龄和性别组,在任何支付意愿水平下,全髋关节置换术几乎100%具有成本效益。所有类型全髋关节置换术的翻修率都很低。A类全髋关节置换术(骨水泥组件搭配聚乙烯对金属关节)对老年组更具成本效益。然而,综合所有年龄 - 性别组来看,E类全髋关节置换术(骨水泥组件搭配聚乙烯对陶瓷关节)的平均成本略低,获得的平均QALY略高。因此,E类优于其他四类。某些类型的全髋关节置换术似乎有一些益处,包括更大的股骨头尺寸、使用骨水泥杯、使用交联聚乙烯杯衬以及陶瓷对陶瓷而非金属对聚乙烯关节。需要进一步进行长期随访的随机对照试验。
本研究注册为PROSPERO CRD42013003924。
英国国家卫生研究院卫生技术评估项目。