Status:
ACTIVE_NOT_RECRUITING
Functional Orthosis Versus Cast Immobilization for Partially Unstable Weber B Ankle Fractures
Lead Sponsor:
Ostfold Hospital Trust
Collaborating Sponsors:
Alesund Hospital
Sykehuset Innlandet HF
Conditions:
Ankle Fractures
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 possi...
Detailed Description
Evidence suggests that Weber B ankle fractures should be treated nonoperatively if the ankle mortise is stable. Stability is maintained if the deltoid ligament is intact, also known as a Weber B/SER2 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05412693
Start Date
May 15 2022
End Date
December 31 2025
Last Update
August 3 2025
Active Locations (3)
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1
Ålesund Hospital
Ålesund, Norway
2
Sykehuset Innlandet, Gjøvik
Gjøvik, Norway
3
Østfold Hospital Trust
Sarpsborg, Østfold fylke, Norway, 1714