Bracing After Ankle Fracture
BAF
2 other identifiers
interventional
1,400
2 countries
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
September 9, 2025
CompletedStudy Start
First participant enrolled
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
April 29, 2026
April 1, 2026
2.4 years
August 20, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Index score (0-100) of the Manchester-Oxford Foot Questionnaire (MOXFQ)
The index score of the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after randomisation is chosen as the primary outcome. Patients prefer MOXFQ, and it is a valid and reliable self-administered 16-item patient-reported outcome (PRO) divided into three dimensions (walking/standing seven items, pain five items and social interaction four items). MOXFQ will be summarised as an index score covering the most important dimensions patients indicated after ankle fracture (e.g. pain, function and social interaction). Response options consist of a 5-point Likert scale ranging from zero to four. The MOXFQ index score will be calculated by summing the raw scores of the 16 items of the MOXFQ to a index score ranging from a minimum of 0 to a maximum of 100, where 100 represents the most severe health state.
Measured as the change from baseline and after 6 and 12 weeks
Secondary Outcomes (8)
Physical activity
Measured as the change from baseline and after 6 and 12 weeks
Health-related Quality Of Life (HRQOL)
Measured as the change from baseline and after 6 and 12 weeks
Ankle dorsiflexion
Measured as the change from baseline and after 6 and 12 weeks
Ankle strength
Measured as the change from baseline and after 6 and 12 weeks
Hospital costs
Measured as the total cost from baseline and after 12 weeks
- +3 more secondary outcomes
Other Outcomes (8)
The index score of the Manchester-Oxford Foot Questionnaire (MOXFQ)
Change from baseline to 6 and 12 months follow-up
Physical activity long term
Change from baseline and after 6 and 12 months
Health-related Quality Of Life (HRQOL) long term
Baseline and after 6 and 12 months
- +5 more other outcomes
Study Arms (2)
foot ankel brace (walker)
ACTIVE COMPARATORWalker: immobilisation during use
Ankel stirrup
EXPERIMENTALAnkel stirrup: active ankel dorsal and plantar flextion during use
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.
Eligibility Criteria
You may qualify if:
- years or older
- Surgically or non-surgically treated ankle fracture
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Aalborg University Hospitalcollaborator
- Randers Regional Hospitalcollaborator
- Aarhus University Hospitalcollaborator
- Viborg Regional Hospitalcollaborator
- Slagelse Hospitalcollaborator
- Hospital of Southern Jutland, Aabenraa, Denmarkcollaborator
- Bispebjerg Hospitalcollaborator
- Hvidovre University Hospitalcollaborator
- Herlev Hospitalcollaborator
- National Hospital of the Faroe Islandscollaborator
- Hospital of South West Jutland, Esbjerg, Denmarkcollaborator
- Køge Hospital, Denmarkcollaborator
- Sygehus Lillebaeltcollaborator
Study Sites (16)
Orthopedic Department, Hospital of Southern Jutland
Aabenraa, 6200, Denmark
Orthopedic Department, Aalborg Universitets Hospital
Aalborg, 9000, Denmark
Orthopedic Department, Aarhus University Hospital
Aarhus, 8200, Denmark
Orthopedic Department, Bispebjerg Hospital
Copenhagen, 2200, Denmark
Orthopedic Department, Hospital of South West Jutland
Esbjerg, 6700, Denmark
Orthopedic Department, Herlev Hospital
Herlev, 2730, Denmark
Orthopedic Department, North Zealand Hospital
Hillerød, 3400, Denmark
Orthopedic Department, Hvidovre Hospital
Hvidovre, 2650, Denmark
Orthopedic Department, Hospital Lillebaelt - Kolding
Kolding, 6000, Denmark
Orthopedic Department, Zealand University Hospital - Køge
Køge, 4600, Denmark
Orthopedic Department, Odense University Hospital
Odense, 5000, Denmark
Orthopedic Department, Randers Hospital
Randers, 5930, Denmark
Orthopedic Department, Slagelse Hospital
Slagelse, 4200, Denmark
Orthopedic Department, Hospital Lillebaelt - Vejle
Vejle, 7100, Denmark
Orthopedic Department, Viborg Hospital
Viborg, 8800, Denmark
Surgical Centre, National Hospital of the Faroe Islands
Tórshavn, Faroe Islands
Related Publications (1)
Ipsen JA, Holsgaard-Larsen A, Abrahamsen C, Gundtoft PH, Costa M, Mikkelsen SS, Hrobjartsson A, Viberg B. A study protocol for a randomised trial of bracing after ankle fracture. Dan Med J. 2026 Mar 19;73(4):A09250748. doi: 10.61409/A09250748.
PMID: 41978451DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bjarke Viberg, Phd
Odense Universitetshospital Ortopaedkirurgisk Afdeling
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The data collection is blinded at baseline assessment for the local project managers. The researchers will be blinded to treatment allocation until reporting.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2025
First Posted
September 9, 2025
Study Start
April 23, 2026
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Immediately following publication, no end date.
- Access Criteria
- Any researcher, affiliated to an established institution
Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.