Bracing options after an ankle fracture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized non-inferiority trial compares an ankle stirrup to a standard foot-ankle brace (walker) in adults with surgically or non-surgically treated ankle fractures. The primary outcome is pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) at three months, with a planned sample of up to 1,400 participants to enable subgroup analyses by age, sex, and treatment type. Secondary outcomes include time to return to work, complication rates, and cost, and participants will be followed for recovery and adverse events. The trial aims to determine whether the less restrictive stirrup offers similar clinical outcomes while improving patient experience and recovery speed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years or older
* Surgically or non-surgically treated ankle fracture

Exclusion Criteria:

* 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's running

• Orthopedic Department, Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Orthopedic Department, Hospital Lillebaelt - Kolding
  Kolding, Denmark Recruiting
• Orthopedic Department, Zealand University Hospital - Køge
  Køge, Denmark Recruiting
• Orthopedic Department, Odense University Hospital
  Odense, Denmark Recruiting
• Orthopedic Department, Hospital of Southern Jutland
  Aabenraa, Denmark Not yet recruiting
• Orthopedic Department, Aalborg Universitets Hospital
  Aalborg, Denmark Not yet recruiting

Study contacts

• Study coordinator: Jonas A Ipsen, phd
• Email: Jonas.Ammundsen.Ipsen@rsyd.dk
• Phone: +4523925264

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.