Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Nuffield Department of Primary Care, University of Oxford, Oxford, UK.
BMC Musculoskelet Disord. 2021 Aug 9;22(1):672. doi: 10.1186/s12891-021-04560-7.
Unstable ankle fractures represent a substantial burden of disease, accounting for a mean hospital stay of nine days, a mean cost of £4,491 per patient and 20,000 operations per year. There is variation in UK practice around weight-bearing instructions after operatively managed ankle fracture. Early weight-bearing may reduce reliance on health services, time off work, and improve functional outcomes. However, concerns remain about the potential for complications such as implant failure. This is the protocol of a multicentre randomised non-inferiority clinical trial of weight-bearing following operatively treated ankle fracture.
Adults aged 18 years and over who have been managed operatively for ankle fracture will be assessed for eligibility. Baseline function (Olerud and Molander Ankle Score [OMAS]), health-related quality of life (EQ-5D-5L), and complications will be collected after informed consent has been obtained. A randomisation sequence has been prepared by a trial statistician to allow for 1:1 allocation to receive either instruction to weight-bear as pain allows from the point of randomisation, two weeks after the time of surgery ('early weight-bearing' group) or to not weight-bear for a further four weeks ('delayed weight -bearing' group). All other treatment will be as per the guidance of the treating clinician. Participants will be asked about their weight-bearing status weekly until four weeks post-randomisation. At four weeks post-randomisation complications will be collected. At six weeks, four months, and 12 months post-randomisation, the OMAS, EQ-5D-5L, complications, physiotherapy input, and resource use will be collected. The primary outcome measure is ankle function (OMAS) at four months post-randomisation. A minimum of 436 participants will be recruited to obtain 80% power to detect a non-inferiority margin of -6 points on the OMAS 4 months post-randomisation. A within-trial health economic evaluation will be conducted to estimate the cost-effectiveness of the treatment options.
The results of this study will inform national guidance with regards to the most clinically and cost-effective strategy for weight-bearing after surgery for unstable ankle fractures.
ISRCTN12883981 , Registered 02 December 2019.
不稳定踝关节骨折是一种严重的疾病，其平均住院时间为 9 天，每位患者的平均治疗费用为 4491 英镑，每年手术量为 2 万例。英国在术后管理踝关节骨折方面的负重指导存在差异。早期负重可以减少对卫生服务的依赖、减少误工时间并改善功能结局。然而，人们仍然担心潜在的并发症，如植入物失败。这是一项多中心随机非劣效性临床试验的方案，旨在研究术后治疗踝关节骨折后的负重情况。
年龄在 18 岁及以上且已接受手术治疗踝关节骨折的成年人将接受入选评估。在获得知情同意后，将收集基线功能（Olerud 和 Molander 踝关节评分[OMAS]）、健康相关生活质量（EQ-5D-5L）和并发症数据。试验统计学家已经制定了随机序列，允许 1:1 分配接受从随机分组时起疼痛允许负重的指导（早期负重组）或再负重 4 周（延迟负重组）。所有其他治疗将根据治疗医生的指导进行。参与者将在随机分组后 4 周内每周报告其负重状态。在随机分组后 4 周时收集并发症数据。在随机分组后 6 周、4 个月和 12 个月时，将收集 OMAS、EQ-5D-5L、并发症、物理治疗情况和资源使用情况。主要结局测量指标是随机分组后 4 个月时的踝关节功能（OMAS）。将招募至少 436 名参与者，以获得 80%的效力来检测随机分组后 4 个月时 OMAS 的非劣效性边界为-6 分。将进行一项试验内卫生经济学评估，以估算治疗方案的成本效益。
这项研究的结果将为国家指南提供信息，以确定不稳定踝关节骨折手术后最具临床和成本效益的负重策略。
ISRCTN82222005，注册于 2019 年 12 月 2 日。
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