Bracing After Ankle Fracture

Recruiting now · Not applicable

Conditions studied: Ankle Fracture, Rehabilitation, Recovery

In brief

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.

Key facts

Study ID

NCT07163091

Run by

Odense University Hospital

People needed

1400

Starts

2026-04-23

Expected to finish

2029-09-30

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 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

Where it is running

• Orthopedic Department, Hospital Lillebaelt - Kolding — Kolding, Denmark (enrolling)
• Orthopedic Department, Zealand University Hospital - Køge — Køge, Denmark (enrolling)
• Orthopedic Department, Odense University Hospital — Odense, Denmark (enrolling)
• Orthopedic Department, Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Orthopedic Department, Herlev Hospital — Herlev, Denmark
• Orthopedic Department, North Zealand Hospital — Hillerød, Denmark
• Orthopedic Department, Hvidovre Hospital — Hvidovre, 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
• Orthopedic Department, Hospital of Southern Jutland — Aabenraa, Denmark
• Surgical Centre, National Hospital of the Faroe Islands — Tórshavn, Faroe Islands
• Orthopedic Department, Aalborg Universitets Hospital — Aalborg, Denmark
• Orthopedic Department, Bispebjerg Hospital — Copenhagen, Denmark
• Orthopedic Department, Hospital of South West Jutland — Esbjerg, Denmark

Full record on ClinicalTrials.gov

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