Physical Recovery During Bracing After Ankle Fracture (Re-BAF): A Multi-Center Superiority Analysis Nested Within a Non-inferiority Randomised Controlled Trial (BAF; NCT07163091)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Daily SENS Motion® accelerometer counts as a measure of daily physical activity during the first 12 weeks following ankle fracture
研究概览
简要总结
Ankle fractures are among the most common fractures and represent the second most frequent fracture type requiring surgery. Many patients experience long-term pain, stiffness, and reduced ankle function, which substantially limits their physical activity. Even five years after injury, more than a third of patients have not regained their pre-injury activity levels.
Standard treatment typically involves immobilisation using a rigid foot-ankle brace (walker). Although effective in protecting fracture healing, these braces may be overly restrictive, contributing to ankle stiffness, swelling, delayed physical recovery and return to daily activities, and reduced quality of life. Patients increasingly express a preference for lighter, movement-permitting ankle supports, such as minimal ankle stirrups. Recent evidence suggests that braces and elastic bands that allow more ankle movement than walkers may enhance faster recovery without increasing complications.
However, high quality evidence is necessary for more robust conclusions. The Scandinavian Bracing after Ankle Fracture (BAF) multicentre randomised controlled trial (NCT07163091) therefore investigates whether an ankle stirrup is non-inferior to a standard walker with respect to patient-reported ankle pain and function, measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The primary hypothesis is that ankle stirrups better align with patients' preferences for less restrictive bracing while providing sufficient stability during fracture healing. Secondarily, ankle stirrups may promote faster recovery and physical activity.
The Re-BAF trial is nested within a larger multicentre non-inferiority trial (Bracing after Ankle Fracture [BAF], ClinicalTrials.gov ID: NCT07163091), aiming to investigate whether an ankle stirrup is non-inferior to a standard foot-ankle brace in improving patient-reported foot and ankle function, as measured by the Manchester-Oxford Foot Questionnaire ([MOXFQ], primary BAF outcome) after ankle fracture.
The aim of the Re-BAF trial is to investigate whether ankle stirrups are superior to standard foot-ankle braces in improving physical activity, assessed using objectively measured thigh-worn accelerometry from baseline (i.e. randomisation) to 12-week follow-up. We hypothesize that early and continuous movement during rehabilitation, enabled by an ankle stirrup, is superior in improving physical activity compared with a foot-ankle brace, without compromising fracture healing.
详细描述
Background: Although patients generally acknowledge the need for immobilisation following ankle fracture, a qualitative study including ten patients found substantial challenges in adhering to immobilisation recommendations. In a randomised controlled trial (RCT) by Smeeing et al. (2020), braces and elastic bandages permitting greater ankle movement than standard walkers were not associated with poorer functional outcomes and were associated with a faster return to work (p = 0.02) without an increased risk of complications. However, the trial was terminated after inclusion of only half of the planned sample, raising concerns regarding statistical power and robustness of the findings. Compared to the walker, ankle stirrups may better align with patient preferences while promoting physical activity and faster recovery.
Aim: The aim of this Re-BAF trial is to investigate if ankle stirrups, allowing active weight-bearing, are superior to rigid foot-ankle braces on patients' daily physical activity levels and physical recovery.
Study design: Superiority trial including 280 adult patients (140 per arm) with surgically or non-surgically treated ankle fractures, nested within a larger Scandinavian randomized multicentre non-inferiority trial (n=1400). Participants will be randomized to four weeks of weight-bearing as tolerated in either an ankle stirrup or a foot-ankle brace.
Eligibility: Inclusion: patients aged ≥18 years with surgically or non-surgically treated ankle fractures. Exclusion: pathological fractures, open fractures, prolonged need for ankle immobilisation (e.g., non-union or poor wound healing), inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder), non-weight bearing treatment, allergy to adhesive tape used for the SENS apparatus, uninterest in participating in the trial, or inability to read Danish.
Recruitment: Patients will be recruited at their one- to two-week follow-up from orthopaedic departments across Denmark. Patient recruitment begins after one to two weeks, as surgically treated patients are typically immobilised in casts or foot-ankle braces and instructed to avoid or minimise weight-bearing during the initial postoperative period to allow swelling to subside and wounds to heal. Likewise, non-surgically treated patients are typically immobilised in a foot-ankle brace. However, weight-bearing recommendations vary between hospitals and surgeons, ranging from weight-bearing as tolerated to limited or non-weight-bearing until fracture stability is confirmed radiographically at the one- to two-week follow-up. The type of immobilisation (e.g., cast or brace) and weight-bearing restrictions during the initial weeks therefore vary across hospitals and treating surgeons.
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
- Double (Investigator, Outcomes Assessor)
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
- •Open fractures (skin perforation)
- •Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)
- •Non-weight bearing treatment
- •Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)
- •Allergy to SENS Motion adhesive patches
- •Inability to read or speak Danish
- •Uninterest in participating
研究组 & 干预措施
Ankle stirrup
Active ankel dorsal and plantar flexion during use of the ankle stirrup
干预措施: Ankle stirrup (Other)
Foot-ankle brace (walker)
Immobilisation during use of the foot-ankle brace
干预措施: Foot-ankle brace (Other)
结局指标
主要结局
Daily SENS Motion® accelerometer counts as a measure of daily physical activity during the first 12 weeks following ankle fracture
时间窗: From baseline (randomisation) to 12 weeks post-fracture.
From baseline (randomisation) until 12 weeks post-fracture, participants will continuously wear a thigh-mounted SENS Motion® accelerometer, a GDPR-compliant medical-grade sensor, to objectively assess physical activity and sleep. The SENS Motion accelerometer is a validated device for use in both younger and older orthopaedic populations. It continuously measures total physical activity (expressed as accelerometer counts per day), time spent resting, standing, and being physically active (including walking, running, and cycling), number of steps, movement intensity, nocturnal activity, and sleep duration. The primary endpoint is the between-group difference in physical activity (accelerometer counts) from baseline (randomisation) to 6 and 12 weeks (primary) post-fracture.
次要结局
- Weekly minutes of moderate-to-vigorous-intensity physical activity (MVPA) in the first 12 weeks following ankle fracture(From baseline (randomisation) to 6 weeks and 12 weeks post-fracture)
- Patient-reported physical activity during the first 12 weeks post-fracture(Between-group differences are evaluated from baseline (randomisation) to 6 weeks and 12 weeks post-fracture)
- Patient-reported weekly pain during the first 12 weeks post-fracture(Between-group differences over time from baseline (randomisation) to 12 weeks post-fracture will be analysed using mixed-effects models with repeated weekly measurements, with results reported at 6 and 12 weeks.)
- Patient-reported weekly analgesic use during the first 12 weeks post-fracture(Between-group differences over time from baseline (randomisation) to 12 weeks post-fracture will be analysed using mixed-effects models with repeated weekly measurements, with results reported at 6 and 12 weeks.)