A study protocol for a randomised trial of bracing after ankle fracture.
Jonas Ammundsen Ipsen, Anders Holsgaard-Larsen, Charlotte Abrahamsen...
https://pubmed.ncbi.nlm.nih.gov/41978451Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07163091
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
Led by Odense University Hospital · Updated on 2026-04-29
1400
Participants Needed
16
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
A
Aalborg University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Ankle fractures are common injuries that can cause significant pain and limit ankle function. Researchers are evaluating whether using an ankle stirrup, a less restrictive brace allowing active ankle movement, is not worse than the standard foot-ankle brace (walker) that immobilizes the ankle. This trial aims to determine if the ankle stirrup can reduce pain and improve function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after fracture, while also considering patient preferences and recovery speed. The study is a large, pragmatic, randomized controlled trial conducted across multiple orthopedic centers in Scandinavia.
CONDITIONS
Brief Title
Bracing After Ankle Fracture
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Surgically or non-surgically treated ankle fracture
You will not qualify if you...
- Pathological fractures
- Inability 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive either an ankle stirrup or a foot-ankle brace (walker) to support ankle healing after fracture, with weightbearing unrestricted in both groups.
Baseline visit and follow-up visits at 6 and 12 weeks
Trial Site Locations
Total: 16 locations
1
Orthopedic Department, Hospital of Southern Jutland
Aabenraa, Denmark, 6200
Not Yet Recruiting
2
Orthopedic Department, Aalborg Universitets Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
3
Orthopedic Department, Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
4
Orthopedic Department, Bispebjerg Hospital
Copenhagen, Denmark, 2200
Not Yet Recruiting
5
Orthopedic Department, Hospital of South West Jutland
Esbjerg, Denmark, 6700
Not Yet Recruiting
6
Orthopedic Department, Herlev Hospital
Herlev, Denmark, 2730
Not Yet Recruiting
7
Orthopedic Department, North Zealand Hospital
Hillerød, Denmark, 3400
Not Yet Recruiting
8
Orthopedic Department, Hvidovre Hospital
Hvidovre, Denmark, 2650
Not Yet Recruiting
9
Orthopedic Department, Hospital Lillebaelt - Kolding
Kolding, Denmark, 6000
Actively Recruiting
10
Orthopedic Department, Zealand University Hospital - Køge
Køge, Denmark, 4600
Actively Recruiting
11
Orthopedic Department, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
12
Orthopedic Department, Randers Hospital
Randers, Denmark, 5930
Not Yet Recruiting
13
Orthopedic Department, Slagelse Hospital
Slagelse, Denmark, 4200
Not Yet Recruiting
14
Orthopedic Department, Hospital Lillebaelt - Vejle
Vejle, Denmark, 7100
Not Yet Recruiting
15
Orthopedic Department, Viborg Hospital
Viborg, Denmark, 8800
Not Yet Recruiting
16
Surgical Centre, National Hospital of the Faroe Islands
Tórshavn, Faroe Islands
Not Yet Recruiting
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Research Team
J
Jonas A Ipsen, phd
B
Bjarke Viberg, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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