Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Surgically or non-surgically treated ankle fracture
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
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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
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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