RecruitingNot ApplicableNCT07163091

Bracing After Ankle Fracture

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 - Study Protocol


Sponsor

Odense University Hospital

Enrollment

1,400 participants

Start Date

Apr 23, 2026

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • years or older
  • Surgically or non-surgically treated ankle fracture

Exclusion Criteria7

  • 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

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Interventions

OTHERankel stirrup

Ankel stirrups are a patient preferred ankel brace that allow active ankle dorsal and plantar flexion during weightbearing while maintaining lateral stability.

OTHERFoot-ankel brace (walker)

Walkers immobilise and stabilise the ankle during weightbearing.


Locations(16)

Orthopedic Department, Hospital of Southern Jutland

Aabenraa, Denmark

Orthopedic Department, Aalborg Universitets Hospital

Aalborg, Denmark

Orthopedic Department, Aarhus University Hospital

Aarhus, Denmark

Orthopedic Department, Bispebjerg Hospital

Copenhagen, Denmark

Orthopedic Department, Hospital of South West Jutland

Esbjerg, Denmark

Orthopedic Department, Herlev Hospital

Herlev, Denmark

Orthopedic Department, North Zealand Hospital

Hillerød, Denmark

Orthopedic Department, Hvidovre Hospital

Hvidovre, Denmark

Orthopedic Department, Hospital Lillebaelt - Kolding

Kolding, Denmark

Orthopedic Department, Zealand University Hospital - Køge

Køge, Denmark

Orthopedic Department, Odense University Hospital

Odense, Denmark

Orthopedic Department, Randers Hospital

Randers, Denmark

Orthopedic Department, Slagelse Hospital

Slagelse, Denmark

Orthopedic Department, Hospital Lillebaelt - Vejle

Vejle, Denmark

Orthopedic Department, Viborg Hospital

Viborg, Denmark

Surgical Centre, National Hospital of the Faroe Islands

Tórshavn, Faroe Islands

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NCT07163091