Bracing After Ankle Fracture

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.

NCT Number	NCT07163091
Lead Sponsor	Odense University Hospital Collaborators: Aalborg University Hospital, Randers Regional Hospital, Aarhus University Hospital, Viborg Regional Hospital, Hospital of Southern Jutland, Slagelse Hospital, Bispebjerg Hospital, Hvidovre University Hospital, Herlev Hospital, National Hospital of the Faroe Islands, Hospital of South West Jutland, Esbjerg, Denmark, Køge Hospital, Denmark, Sygehus Lillebaelt
Conditions	Ankle Fracture, Rehabilitation, Recovery
Enrollment	1,400 participants
Start Date	2026-04-23
Primary Completion	2028-09-30 (estimated)
Study Completion	2029-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-29