Bracing After Ankle Fracture (BAF): a Randomised Multicenter Non-inferiority Trial Comparing Ankle Stirrups to Walkers on Pain, Function and Social Interaction for Adults After Ankle Fracture - Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,400
- 试验地点
- 31
- 主要终点
- Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ)
研究概览
简要总结
Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority remains limited and inconclusive. Thus, the aim is assess if an ankle stirrup is non-inferior to a standard walker in reducing pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The hypothesis is that ankel stirrups align better with patients preferenes for less immobilising braces and offer sufficient stability while the fracture heals. Secondarily it may lead to faster recovery of function, return to work and reduced cost. The sample size of a maximum of 1400 patients allow us to assess non-inferiority in age and sex specific subgroups and treatment (surgical or non-sugical). Non-inferiority will be assessed in a pragmatic, multicenter, randomised controlled trial involving Scandinavian orthopedic departments.
详细描述
Ankle fractures are the third most occuring fracture. After an ankle fracture, patients experience reduced ankle function and pain [3]. Also, evidence with moderate to high risk of bias indicate that immobilisation prolong patients recovery. However, high quality evidence are necessary for finite conclusions.
In Scandinavia, foot-ankle braces (walkers) are used to immobilise the fracture while healing. Even though patients acknowledge the need for immobilisation, a qualitative study of ten patients found that patients experienced difficulties in adhering to the recommendation of immobilisation after ankle fracture. A randomised controlled trial (RCT) by Smeeing et al. 2020 found that braces and elastic bands that allow more ankle movement than walkers did not lead to poorer functional outcomes (p=0.56), but may lead to a faster return to work (p = 0.02) without increased complications (p=0.63). The RCT was terminated when half the sample had been included, thus questioning the statistical power of the findings. Based on patient interviews completed during trial preparations we learned that patients preferred ankle stirrups as they allowed movement during use. The same patients also expressed an aversion to the walker, while being hesitant that ankle-supporting elastic bandages provided sufficient support.
Compared to the walker, ankle stirrups may better align with patient preferences while remaining non-inferior in restoring ankle-related outcomes such as pain and function.
Patients will be included in the orthopedic outpatient departments and randomised to a walker or an ankle stirrup. Randomisation will be in blocks to ensure that surgically and non-surgically patients are evenly distributed between groups and that each center will have an equal amount of intervention and control patients. Weightbearing will be unrestricted in both groups so the difference will be the brace (ankel stirrup or walker). Other variation will be a reflection of usual practice. The primary outcome is a validated score including pain, function and social interaction 12 weeks after ankel fracture. The sample size is calculated to 140 patients per each of six subgroups (males 18-39, females 18-39, males 40-59, females 40-59, males 60+, females 60+) randomisation stop when the smallest subgroup (females 18-39 years) reaches 140 or a maximum of 1400 has been included. Patients have been involved in designing the trial and a former ankle fracture patient serves a member of the steering committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The data collection is blinded at baseline assessment for the local project managers. The researchers will be blinded to treatment allocation until reporting.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Surgically or non-surgically treated ankle fracture
排除标准
- •Pathological fractures
- •Inadequacy to read or speak danish
- •Open fractures
- •Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)
- •Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)
- •Restricted weightbearing
- •Uninterest in participating
结局指标
主要结局
Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ)
时间窗: Measured as the change from baseline and after 6 and 12 weeks
The index score of the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after randomisation is chosen as the primary outcome. Patients prefer MOXFQ, and it is a valid and reliable self-administered 16-item patient-reported outcome (PRO) divided into three dimensions (walking/standing seven items, pain five items and social interaction four items). MOXFQ will be summarised as an index score covering the most important dimensions patients indicated after ankle fracture (e.g. pain, function and social interaction). Response options consist of a 5-point Likert scale ranging from zero to four. The MOXFQ index score will be calculated by summing the raw scores of the 16 items of the MOXFQ to a index score ranging from a minimum of 0 to a maximum of 100, where 100 represents the most severe health state.
次要结局
- Physical activity(Measured as the change from baseline and after 6 and 12 weeks)
- Health-related Quality Of Life (HRQOL)(Measured as the change from baseline and after 6 and 12 weeks)
- Ankle dorsiflexion(Measured as the change from baseline and after 6 and 12 weeks)
- Ankle strength(Measured as the change from baseline and after 6 and 12 weeks)
- Hospital costs(Measured as the total cost from baseline and after 12 weeks)
- Return to work(From fracture and until date of return to work.)
- Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ) in subgroups(Measured as the change from baseline after 6 and 12 weeks.)
- Adverse Events (AE) and Serious Adverse Events (SAE)(Safety reporting for each patient will begin at baseline and after 6 and twelve weeks)