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. 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. 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%. 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). National Institute for Health and Care Research (NIHR), NIHR Barts Biomedical Research Centre, and NIHR Applied Research Collaboration Oxford and Thames Valley.

中文翻译：

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手术治疗踝关节骨折 (WAX) 后早期负重与延迟负重：一项非劣效性、多中心、随机对照试验


踝关节骨折手术后，患者通常会被告知 6 周内避免行走（延迟负重）。手术后两周步行（早期负重）可能是一种安全且优选的康复策略。本研究旨在确定早期负重策略与延迟负重策略相比的临床和成本效益。这是一项务实、多中心、随机、非劣效性试验，纳入了 561 名参与者（年龄≥18 岁），他们在 23 家英国国民医疗服务 (NHS) 医院接受了因不稳定踝关节骨折而进行的急性手术，这些参与者被分配到延迟体重组或体重组组。负重（n=280）或早期负重康复策略（n=281）。使用后足钉治疗的患者、那些没有保护性踝关节感觉（例如周围神经病变）、没有能力同意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没有对治疗蒙蔽。主要结果是在随机分组后 4 个月时使用 Olerud 和 Molander 踝关节评分 (OMAS) 在符合方案人群中测量踝关节功能。预先指定的非劣效性 OMAS 界限为 –6 分，如果出现非劣效性，则将优效性测试纳入意向治疗人群中。该试验已在 ISRCTN 登记处前瞻性注册，ISRCTN12883981，并且该试验不对新参与者开放。主要结果数据收集自 561 名参与者中的 480 名（86%）。招聘于2020年1月13日至2021年10月29日期间进行。 随机分组后 4 个月，早期负重组的平均 OMAS 评分为 65·9，延迟负重组的平均 OMAS 评分为 61·2，调整后的平均差异为 4·47（95% CI 0·58 至 8·37） ，p=0·024；优效性测试调整差异4·42，95% CI 0·53 至8·32，p=0·026）有利于早期负重。早期负重组中有 46 名 (16%) 参与者和延迟负重组有 39 名 (14%) 参与者出现一种或多种并发症（调整比值比 1·18，95% CI 0·80 至 1·75， p=0·40）。从 NHS 和个人社会服务的角度来看，早期负重组和延迟负重组的平均成本分别为 725 英镑和 785 英镑（平均差 – 60 英镑 [95% CI –342 至 232]）。早期负重具有成本效益的概率超过80%。研究发现，与当前的护理标准（延迟负重）相比，早期负重策略在临床上并不逊色，并且很可能具有成本效益。国家健康与护理研究所 (NIHR)、NIHR 巴茨生物医学研究中心以及 NIHR 牛津和泰晤士河谷应用研究合作中心。