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单期翻修治疗髋关节假体关节感染不优于两期翻修
作者:小柯机器人 发布时间:2022/11/6 19:01:12

英国布里斯托大学医学院Ashley W Blom团队比较了单期与两期翻修治疗髋关节假体关节感染的临床效果及成本效益。该研究于2022年10月31日发表在《英国医学杂志》上。

为了确定髋关节假体感染的单期翻修手术与两期翻修术后患者报告的预后是否有所改善,并确定这些手术的成本效益,研究组在英国(n=12)和瑞典(n=3)的大量三级转诊中心或骨科单位进行了一项实用、平行组、开放标签、随机对照试验,招募时间为2015年3月1日至2018年12月19日。

共有140名成年人(年龄≥18岁)入组,髋关节假体感染需要翻修,采用计算机生成的按医院分层的1:1随机列表将其随机分配,65例接受单期翻修,75例接受两期翻修。意向治疗主要结局是随机分组18个月后疼痛、僵硬和功能限制,通过西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分进行评定。次要结局包括手术并发症和关节感染。经济评估(仅在英国参与者中进行评估)比较了随机分组之间的质量校正寿命和成本。

参与者的平均年龄为71岁(标准差9),女性51名(36%)。18个月时,各组间WOMAC评分无差异(平均差0.13);然而,单期手术在三个月时更好(11.53),但在六个月后效果不佳。单期组有5名(8%)参与者发生术中事件,显著少于两期组的20名(27%)。18个月时,单期组的9名(14%)参与者和两期组的8名(11%)参与者至少有一个可能持续感染的标志物。从医疗保健提供者和个人社会服务的角度来看,单期翻修术具有成本效益,在£20000/质量校正寿命年阈值中,增量净货币收益为£11167。

研究结果表明,18个月时,根据患者报告的结果,单期翻修治疗髋关节假体关节感染与两期翻修相比没有优势。单期翻修术在三个月时效果更好,术中并发症更少,且成本效益高。患者更喜欢早期恢复功能,因此,在决定治疗时,外科医生应考虑患者的偏好和单期手术的成本效益。

附:英文原文

Title: Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial

Author: Ashley W Blom, Erik Lenguerrand, Simon Strange, Sian M Noble, Andrew D Beswick, Amanda Burston, Kirsty Garfield, Rachael Gooberman-Hill, Shaun R S Harris, Setor K Kunutsor, J Athene Lane, Alasdair MacGowan, Sanchit Mehendale, Andrew J Moore, Ola Rolfson, Jason C J Webb, Matthew Wilson, Michael R Whitehouse

Issue&Volume: 2022/10/31

Abstract:

Objectives To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures.

Design Pragmatic, parallel group, open label, randomised controlled trial.

Setting High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018.

Participants 140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision).

Interventions A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure.

Main outcome measures The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups.

Results The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval 8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11167 (95% confidence interval £638 to £21696) at a £20000 per quality adjusted life years threshold (£1.0; $1.1; €1.4).

Conclusions At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery.

DOI: 10.1136/bmj-2022-071281

Source: https://www.bmj.com/content/379/bmj-2022-071281

期刊信息

BMJ-British Medical Journal:《英国医学杂志》,创刊于1840年。隶属于BMJ出版集团,最新IF:27.604
官方网址:http://www.bmj.com/
投稿链接:https://mc.manuscriptcentral.com/bmj