英国牛津大学Christopher Patrick Bretherton团队比较了脚踝骨折手术后患者进行早期和延迟负重对预后以及成本效益的影响。2024年6月4日出版的《柳叶刀》杂志发表了这项成果。

脚踝骨折手术后，患者通常被要求在6周内避免行走（延迟负重）。手术后2周步行（早期负重）可能是一种安全且可取的康复策略。该研究旨在确定早期负重策略与延迟负重策略的临床和成本效益。

研究组进行了一项实用、多中心、随机、非劣效性试验，包括561名参与者（年龄≥18岁），他们在23家英国国家医疗服务体系（NHS）医院接受了不稳定踝关节骨折的急性手术，被分配到延迟负重组（n=280）或早期负重康复策略组（n=281）。接受后脚钉治疗、无保护性踝关节感觉（如周围神经病变）、没有同意能力或没有能力遵守试验程序的患者被排除在外。参与者和临床医生都对治疗方式知情。主要结局是在随机分组后4个月，在符合方案的人群中使用Olerud和Molander踝关节评分（OMAS）测量踝关节功能。预先规定的非劣效性OMAS限值为-6分，在非劣效的情况下，优效性测试包括在意向治疗人群中。

主要结果数据收集自561名参与者中的480人（86%）。招募于2020年1月13日至2021年10月29日进行。随机分组后4个月，早期负重组和延迟负重组的平均OMAS评分分别为65.9和61.2分，校正后的平均差异为4.47（95%CI 0.58至8.37，p=0.024；优势测试校正后的差异为4.42，95%CI 0.53至8.32，p=0.026），有利于早期负重。早期负重组的46名（16%）参与者和延迟负重组的39名（14%）参与者有一种或多种并发症（校正后的比值比为1.18，95%CI为0.80-1.75，p=0.40）。从NHS和个人社会服务的角度来看，早期和延迟负重组的平均成本分别为725英镑和785英镑（平均差异–60英镑[95%CI–342至232]）。早期承重具有成本效益的概率超过80%。

研究研究表明，早期负重策略在临床上并不逊于目前的护理标准（延迟负重），而且很可能具有成本效益。

附：英文原文

Title: Early versus delayed weight-bearing following operatively treated ankle fracture (WAX): a non-inferiority, multicentre, randomised controlled trial

Author: Christopher Patrick Bretherton, Juul Achten, Vidoushee Jogarah, Stavros Petrou, Nicholas Peckham, Felix Achana, Duncan Appelbe, Rebecca Kearney, Harry Claireux, Philip Bell, Xavier L Griffin, Andrew McAndrew, Neal Jacobs, Justin Forder, Thomas Hester, Charlotte Cross, Tony Bateman, Will Kieffer, Tristan Barton, Richard Walter, Nick Savva, Daniel Marsland, Barry Rose, Zine Beech, Togay Koc, Bethany Armstead, Ben Ollivere, Owen Diamond, Kar Teoh, Paul Magill, Jitendra Mangwani, Paul Hodgson, Robbie Ray, Baljinder Dhinsa, Haroon Majeed, John Wong-Chung, Jonathan Young, Agnes Lagare, Akash Soogumbur, Albina Morozova, Alexander Hunt, Amanda Adamson, Angie Dempster, Ann McCormack, Azra Arif, Bethany Armstead, Charlotte Vye, Chetan Dojode, Chloe Brown, Christina Haines, Christopher To, Ciaran Brennan, Dan Winson, Elizabeth McGough, Ellen Jessup-Dunton, Fiona Bintcliffe, Fiona Thompson, Gabriel Omogra, Georgia Scott, Helen Samuel, Hossam Fraig, Ina Burokiene, Isabel Odysseos-Beaumont, James Rand, Janet Edkins, Joe Barrett-Lee, John McFall, Karim Wahed, Kate Herbert, Kelly Death, Laura Beddard, Leanne Dupley, Leeann Bryce, Lianne Wright, Lucy Bailey, Lucy Maling, Marjan Raad, Matt Morris, Matthew Williams, May Labidi, Natalie Holmes, Nikki Staines, Paul A Matthews, Philip McCormac, Rashmi Easow, Scott Matthews, Smriti Kapoor, Sophie Harris, Susan Wagland, Timothy Cobb, Tracey White

Issue&Volume: 2024-06-04

Abstract:

Background

After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early weight-bearing) might be a safe and preferable rehabilitation strategy. This study aimed to determine the clinical and cost effectiveness of an early weight-bearing strategy compared with a delayed weight-bearing strategy.

Methods

This was a pragmatic, multicentre, randomised, non-inferiority trial including 561 participants (aged ≥18 years) who received acute surgery for an unstable ankle fracture in 23 UK National Health Service (NHS) hospitals who were assigned to either a delayed weight-bearing (n=280) or an early weight-bearing rehabilitation strategy (n=281). Patients treated with a hindfoot nail, those who did not have protective ankle sensation (eg, peripheral neuropathy), did not have the capacity to consent, or did not have the ability to adhere to trial procedures were excluded. Neither participants nor clinicians were masked to the treatment. The primary outcome was ankle function measured using the Olerud and Molander Ankle Score (OMAS) at 4 months after randomisation, in the per-protocol population. The pre-specified non-inferiority OMAS margin was –6 points and superiority testing was included in the intention-to-treat population in the event of non-inferiority. The trial was prospectively registered with ISRCTN Registry, ISRCTN12883981, and the trial is closed to new participants.

Findings

Primary outcome data were collected from 480 (86%) of 561 participants. Recruitment was conducted between Jan 13, 2020, and Oct 29, 2021. At 4 months after randomisation, the mean OMAS score was 65·9 in the early weight-bearing and 61·2 in the delayed weight-bearing group and adjusted mean difference was 4·47 (95% CI 0·58 to 8·37, p=0·024; superiority testing adjusted difference 4·42, 95% CI 0·53 to 8·32, p=0·026) in favour of early weight-bearing. 46 (16%) participants in the early weight-bearing group and 39 (14%) in the delayed weight-bearing group had one or more complications (adjusted odds ratio 1·18, 95% CI 0·80 to 1·75, p=0·40). The mean costs from the perspective of the NHS and personal social services in the early and delayed weight-bearing groups were ￡725 and ￡785, respectively (mean difference –￡60 [95% CI –342 to 232]). The probability that early weight-bearing is cost-effective exceeded 80%.

Interpretation

An early weight-bearing strategy was found to be clinically non-inferior and highly likely to be cost-effective compared with the current standard of care (delayed weight-bearing).

DOI: 10.1016/S0140-6736(24)00710-4

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00710-4/abstract