A study protocol for a randomised trial of bracing after ankle fracture.
Jonas Ammundsen Ipsen, Anders Holsgaard-Larsen, Charlotte Abrahamsen...
https://pubmed.ncbi.nlm.nih.gov/41978451/Actively Recruiting
Led by Odense University Hospital · Updated on 2026-04-29
1400
Participants Needed
16
Research Sites
52 weeks
Total Duration
Ankle fractures are common injuries that can cause significant pain and limit ankle function. Researchers are evaluating whether using an ankle stirrup, a less restrictive brace allowing active ankle movement, is not worse than the standard foot-ankle brace walker that immobilizes the ankle. This trial aims to determine if the ankle stirrup can reduce pain and improve function measured by the Manchester-Oxford Foot Questionnaire MOXFQ three months after fracture, while also considering patient preferences and recovery speed. The study is a large, pragmatic, randomized controlled trial conducted across multiple orthopedic centers in Scandinavia.
CONDITIONS
Bracing After Ankle Fracture
J
Jonas A Ipsen, phd
B
Bjarke Viberg, Phd
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Odense University Hospital
Lead Sponsor
Aalborg University Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either an ankle stirrup or a foot-ankle brace (walker) to support ankle healing after fracture, with weightbearing unrestricted in both groups.
Baseline visit and follow-up visits at 6 and 12 weeks
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Jonas Ammundsen Ipsen, Anders Holsgaard-Larsen, Charlotte Abrahamsen...
https://pubmed.ncbi.nlm.nih.gov/41978451/Odense University Hospital
Lead Sponsor
Aalborg University Hospital
Collaborating Sponsor