Bracing after Ankle Fracture (BAF)

Abstract Background Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace, which restricts movement and may delay recovery. Evidence suggests continuous active ankle movement during weight-bearing may reduce recovery time without increasing complications. Also, patients prefer less restrictive devices, such as ankle stirrups, but evidence on non-inferiority are limited and uncertain. Aim To assess if an ankle stirrup allowing active movement during weight-bearing is non-inferior to a standard foot-ankle brace in reducing pain, restoring function, and social interaction, measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months post-randomisation. Secondary objectives will be to assess if the ankle stirrup leads to faster recovery, faster return to work and reduced hospital costs across age groups, gender and treatment (surgical and non-surgical). Methods The BAF trial will be a two-phase, multicentre, pragmatic, non-inferiority randomised controlled trial including patients ≥18 years with surgically or non-surgically treated ankle fractures. Patients are randomised 1:1 to either an ankle stirrup or a standard foot-ankle brace with stratification to ensure an even distribution of genders surgical and non-surgical treatment and recruitment centers. The pilot phase (September–December 2025) will assess recruitment and logistics. The full trial (January 2026–August 2028) will include a miximum of 1400 patients. The sample size is estimated to be sufficient to assess non-inferiority on a population level and to explore non-inferiority pending on surgical and non-surgical treatment, males and females and patients ages 18-39 years, 40-59 years and 60+ years. Patients was involved in designing the trial and a patient representative is a member of the steering committee. Conclusion: The BAF trial will determine whether less restrictive ankle stirrups are a non-inferior alternative to the foot-ankle brace. Secondarily, if the ankle stirrup leads to faster recovery, return to work, reduced health care costs and non-inferiority across prespecified subgroups. Findings will support evidence-based decision making with respect to patients preferences and recovery outcomes.