NCT07521696: Re-BAF

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

Not yet recruiting NA Last updated 13 April 2026

What this trial tests

NA trial testing Ankle stirrup in Ankle Fracture in 280 participants. Not yet recruiting.

Timeline

1 April 2026

Primary endpoint
30 September 2028

30 September 2029

Quick facts

Lead sponsor	Odense University Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	280
Start date	1 April 2026
Primary completion	30 September 2028
Estimated completion	30 September 2029
Sites	1 location across Denmark

Drugs / interventions tested

• Ankle stirrup
• Foot-ankle brace

Conditions studied

• Ankle Fracture — all drugs for Ankle Fracture →
• Recovery — all drugs for Recovery →
• Physical Activity — all drugs for Physical Activity →
• Rehabilitation — all drugs for Rehabilitation →

Sponsor

Odense University Hospital

Who can join

18 and older, any sex, with Ankle Fracture or Recovery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.