Physical Recovery During Bracing After Ankle Fracture (Re-BAF)

Starting soon · Not applicable

Conditions studied: Ankle Fracture, Recovery, Physical Activity, Rehabilitation

In brief

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.

Key facts

Study ID

NCT07521696

Run by

Odense University Hospital

People needed

280

Starts

2026-04-01

Expected to finish

2029-09-30

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Surgically or non-surgically treated ankle fracture

You may not qualify if…

• 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

Where it is running

• Odense University Hospital — Odense, Region Syddanmark, Denmark

Full record on ClinicalTrials.gov

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