Bracing After Ankle Fracture

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.

Conditions

• Ankle Fracture
• Rehabilitation
• Recovery

Interventions

OTHER

ankel stirrup

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

OTHER

Foot-ankel brace (walker)

Walkers immobilise and stabilise the ankle during weightbearing.

Sponsors & Collaborators

• Aalborg University Hospital

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Hospital of Southern Jutland, Aabenraa, Denmark

  collaborator UNKNOWN

• Slagelse Hospital

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• National Hospital of the Faroe Islands

  collaborator OTHER_GOV

• Hospital of South West Jutland, Esbjerg, Denmark

  collaborator UNKNOWN

• Køge Hospital, Denmark

  collaborator UNKNOWN

• Sygehus Lillebaelt

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Bjarke Viberg, Phd · Odense Universitetshospital Ortopaedkirurgisk Afdeling

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-23

Primary Completion

2028-09-30

Completion

2029-09-30

Countries

• Denmark
• Faroe Islands

Study Locations