Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07163091

Bracing After Ankle Fracture

Led by Odense University Hospital · Updated on 2026-04-29

1400

Participants Needed

16

Research Sites

179 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

A

Aalborg University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Bracing After Ankle Fracture

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Surgically or non-surgically treated ankle fracture
Not Eligible

You will not qualify if you...

  • Pathological fractures
  • Inability to read or speak Danish
  • Open fractures
  • Prolonged need for immobilisation such as non-union or insufficient wound healing
  • Inability to adhere to trial procedures due to conditions like neuropathy or severe psychiatric disorder
  • Restricted weightbearing
  • Uninterest in participating

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Orthopedic Department, Hospital of Southern Jutland

Aabenraa, Denmark, 6200

Not Yet Recruiting

2

Orthopedic Department, Aalborg Universitets Hospital

Aalborg, Denmark, 9000

Not Yet Recruiting

3

Orthopedic Department, Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

4

Orthopedic Department, Bispebjerg Hospital

Copenhagen, Denmark, 2200

Not Yet Recruiting

5

Orthopedic Department, Hospital of South West Jutland

Esbjerg, Denmark, 6700

Not Yet Recruiting

6

Orthopedic Department, Herlev Hospital

Herlev, Denmark, 2730

Not Yet Recruiting

7

Orthopedic Department, North Zealand Hospital

Hillerød, Denmark, 3400

Not Yet Recruiting

8

Orthopedic Department, Hvidovre Hospital

Hvidovre, Denmark, 2650

Not Yet Recruiting

9

Orthopedic Department, Hospital Lillebaelt - Kolding

Kolding, Denmark, 6000

Actively Recruiting

10

Orthopedic Department, Zealand University Hospital - Køge

Køge, Denmark, 4600

Actively Recruiting

11

Orthopedic Department, Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

12

Orthopedic Department, Randers Hospital

Randers, Denmark, 5930

Not Yet Recruiting

13

Orthopedic Department, Slagelse Hospital

Slagelse, Denmark, 4200

Not Yet Recruiting

14

Orthopedic Department, Hospital Lillebaelt - Vejle

Vejle, Denmark, 7100

Not Yet Recruiting

15

Orthopedic Department, Viborg Hospital

Viborg, Denmark, 8800

Not Yet Recruiting

16

Surgical Centre, National Hospital of the Faroe Islands

Tórshavn, Faroe Islands

Not Yet Recruiting

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Research Team

J

Jonas A Ipsen, phd

CONTACT

B

Bjarke Viberg, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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