Actively Recruiting
Repairing the Deltoid Ligament in Unstable Ankle Fractures to Improve Function and Joint Stability
Led by Ostfold Hospital Trust · Updated on 2025-08-13
120
Participants Needed
9
Research Sites
287 weeks
Total Duration
AI-Summary
What this Trial Is About
Ankle fractures are common injuries occurring in about 1 in 800 people each year. This research evaluates whether repairing the deltoid ligament in unstable ankle fractures improves joint stability, functional outcomes, and may help prevent long-term osteoarthritis. The study focuses on patients with severe ankle fractures, as these injuries can significantly reduce daily function and affect the ability to work, potentially increasing community healthcare costs. Participants will be randomly assigned to one of two groups one receiving standard treatment involving plate and screw fixation of the lateral malleolus only, and the other receiving the same standard treatment plus an additional surgical repair suture of the deep deltoid ligament. The ligament repair involves a specific surgical technique where the ligament is reattached to an anchor in the talus. This multicenter randomized controlled study aims to compare these approaches in unstable Weber B ankle fractures. During the study, participants will be evaluated through patient-reported functional outcomes and radiological stability measurements at 1 and 2 years after injury, with functional outcome data also collected at 5 years. Additional assessments include general health, pain levels, ankle arthritis development, and foot and ankle function scores collected at various intervals up to 5 years. Researchers will monitor the long-term effects of ligament repair on ankle stability and function, with follow-up visits planned to assess recovery and outcomes.
CONDITIONS
Brief Title
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
Research Team
E
Esten Konstad Haanæs, MD
M
Marius Molund, MD, PhD
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