Bracing options after an 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
This trial will test whether a less rigid ankle stirrup works as well as a standard walker to reduce pain and improve function three months after an ankle fracture in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 16 sites (Aabenraa and 15 other locations) |
| Trial ID | NCT07163091 on ClinicalTrials.gov |
What this trial studies
This randomized non-inferiority trial compares an ankle stirrup to a standard foot-ankle brace (walker) in adults with surgically or non-surgically treated ankle fractures. The primary outcome is pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) at three months, with a planned sample of up to 1,400 participants to enable subgroup analyses by age, sex, and treatment type. Secondary outcomes include time to return to work, complication rates, and cost, and participants will be followed for recovery and adverse events. The trial aims to determine whether the less restrictive stirrup offers similar clinical outcomes while improving patient experience and recovery speed.
Who should consider this trial
Good fit: Adults aged 18 or older with a recent ankle fracture treated surgically or non-surgically who can adhere to follow-up and read Danish are ideal candidates.
Not a fit: Patients with open or pathological fractures, those who need prolonged immobilisation or restricted weightbearing, or those unable to adhere to procedures (for example severe neuropathy or major psychiatric disorders) are unlikely to benefit from the less restrictive stirrup.
Why it matters
Potential benefit: If successful, patients could have a less restrictive brace option that may speed recovery, improve comfort, and shorten time off work without increasing complications.
How similar studies have performed: A prior randomized trial (Smeeing et al. 2020) indicated similar functional outcomes and faster return to work with less restrictive devices but was terminated early and underpowered, so evidence remains limited and inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Surgically or non-surgically treated ankle fracture Exclusion Criteria: * 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
Where this trial is running
Aabenraa and 15 other locations
- Orthopedic Department, Hospital of Southern Jutland — Aabenraa, Denmark (Not_yet_recruiting)
- Orthopedic Department, Aalborg Universitets Hospital — Aalborg, Denmark (Not_yet_recruiting)
- Orthopedic Department, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Orthopedic Department, Bispebjerg Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Orthopedic Department, Hospital of South West Jutland — Esbjerg, Denmark (Not_yet_recruiting)
- Orthopedic Department, Herlev Hospital — Herlev, Denmark (Not_yet_recruiting)
- Orthopedic Department, North Zealand Hospital — Hillerød, Denmark (Not_yet_recruiting)
- Orthopedic Department, Hvidovre Hospital — Hvidovre, Denmark (Not_yet_recruiting)
- Orthopedic Department, Hospital Lillebaelt - Kolding — Kolding, Denmark (Recruiting)
- Orthopedic Department, Zealand University Hospital - Køge — Køge, Denmark (Recruiting)
- Orthopedic Department, Odense University Hospital — Odense, Denmark (Recruiting)
- Orthopedic Department, Randers Hospital — Randers, Denmark (Not_yet_recruiting)
- Orthopedic Department, Slagelse Hospital — Slagelse, Denmark (Not_yet_recruiting)
- Orthopedic Department, Hospital Lillebaelt - Vejle — Vejle, Denmark (Not_yet_recruiting)
- Orthopedic Department, Viborg Hospital — Viborg, Denmark (Not_yet_recruiting)
- Surgical Centre, National Hospital of the Faroe Islands — Tórshavn, Faroe Islands (Not_yet_recruiting)
Study contacts
- Study coordinator: Jonas A Ipsen, phd
- Email: Jonas.Ammundsen.Ipsen@rsyd.dk
- Phone: +4523925264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.