About this trial
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.
Eligibility criteria
Qualifiers
18 years or older
Surgically or non-surgically treated ankle fracture
Disqualifiers
Pathological fractures
Inadequacy to read or speak danish
Open fractures
Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)
Trial design
Treatments tested in this trial
- ankel stirrup
- Foot-ankel brace (walker)
Treatment groups
Sponsors and collaborators
Odense University Hospital
Lead sponsor
Aalborg University Hospital
Collaborator
Randers Regional Hospital
Collaborator
Aarhus University Hospital
Collaborator
Viborg Regional Hospital
Collaborator
Hospital of Southern Jutland, Aabenraa, Denmark
Collaborator
Slagelse Hospital
Collaborator
Bispebjerg Hospital
Collaborator
Hvidovre University Hospital
Collaborator
Herlev Hospital
Collaborator
National Hospital of the Faroe Islands
Collaborator
Hospital of South West Jutland, Esbjerg, Denmark
Collaborator
Køge Hospital, Denmark
Collaborator
Sygehus Lillebaelt
Collaborator