Bracing After Ankle Fracture

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

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

1,400 Participants
are divided into 2 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