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 range18 Years – 80 Years
SexALL
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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).
What they're measuring
1
Between-groups difference in Manchester-Oxford Foot and Ankle Questionnaire score at 2 years