Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B Ankle Fractures (NCT05412693) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B Ankle Fractures
Norway110 participantsStarted 2022-05-15
Plain-language summary
Stability dictates treatment choice for trans-syndesmotic fibula fractures. Optimal treatment for partially unstable fractures remains a topic of debate. The purpose of this study is to evaluate possible outcome non-inferior of functional orthosis treatment versus cast immobilization for these fractures.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients:
* With isolated Weber type B fractures that are deemed stable on weightbearing radiographs (MCS injured ankle - MCS uninjured ankle \< 1 mm).
* With concomitant gravity stress test evaluated as unstable (MCS injured ankle - MCS uninjured ankle \< 1 mm)
* Presenting to one of the participating hospitals, and that are available for stability evaluation within 14 days after injury.
* 18-80 years of age
* With pre-injury walking ability without aids.
Exclusion Criteria:
* Patients:
* with fracture of the medial malleolus, pre-hospital closed fracture reduction, open fracture, fracture resulting from high-energy trauma or multi-trauma or pathologic fracture.
* with fracture of the posterior malleolus involving 25% or more of the joint surface or with a step of the intraarticular surface. (non-displaced fractures smaller than 25% can be included)
* with neuropathies and generalized joint disease such as Rheumatoid Arthritis.
* that are assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
* with previous history of ipsilateral ankle fracture.
* with previous history of ipsilateral major ankle-/foot surgery.
* who live outside one of the participating hospitals catchment areas (not available for follow-up).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Between-groups difference in Manchester-Oxford Foot and Ankle Questionnaire score at 2 years