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

2天前 来源:Lancet

本文由小咖机器人翻译整理

期刊来源:Lancet

原文链接:https://doi.org/10.1016/S0140-6736(24)00710-4

摘要内容如下:

背景

踝关节骨折手术后,患者通常被要求在6周内避免行走(延迟负重)。术后2周步行(早期负重)可能是一种安全和更好的康复策略。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。

方法

这是一项实用、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(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(n=280)或早期负重康复策略(n=281)。使用后足钉治疗的患者、没有保护性踝关节感觉(如周围神经病变)、没有同意能力或没有能力坚持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进行掩蔽。主要结果是在随机分组后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。预先指定的非劣效性OMAS界值为-6分,在非劣效性的情况下,优效性检验包括在意向治疗人群中。该试验在ISRCTN Registry(ISRCTN12883981)进行了前瞻性注册,并且该试验不对新参与者开放。

调查结果

从561名参与者中的480名(86%)收集了主要结果数据。招募时间为2020年1月13日至2021年10月29日。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,校正平均差异为4.47(95%CI 0.58~8.37,P=0.024;优势检验调整差异4.42,95%CI 0.53~8.32,P=0.026)有利于早期负重。早期负重组46例(16%)和延迟负重组39例(14%)患者出现一种或多种并发症(调整后的比值比为1.18,95%CI为0.80~1.75,P=0.40)。从英国国民健康保险制度(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])。早期负重划算的概率超过80%。

解释

研究发现,与目前的标准护理(延迟负重)相比,早期负重策略在临床上并不差,并且极有可能具有成本效益。

英文原文如下:

Abstracts

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).

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