Bracing After Ankle Fracture
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
Odense University Hospital
1,400 participants
Apr 23, 2026
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria2
- years or older
- Surgically or non-surgically treated ankle fracture
Exclusion Criteria7
- 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
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Interventions
Ankel stirrups are a patient preferred ankel brace that allow active ankle dorsal and plantar flexion during weightbearing while maintaining lateral stability.
Walkers immobilise and stabilise the ankle during weightbearing.
Locations(16)
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NCT07163091