Clinical Trial

The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

Recruiting
View on ClinicalTrials.gov →
Summary
Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-20; most recent amendment 2025-08-12.
Status change: Not Yet Recruiting → Recruiting 2025-08-04
Trial Details
NCT Number NCT06568276
Lead Sponsor Ostfold Hospital Trust
Collaborators: Sykehuset Innlandet HF, Helse Nord-Trøndelag HF, Helse-Bergen HF, Norwegian Institute of Public Health, Helse Stavanger HF, Trondheim University Hospital, Norwegian University of Science and Technology, Alesund Hospital, Nordlandssykehuset HF
Conditions Ankle Fractures, Deltoid Ligament; Sprain (Strain) (Ankle)
Enrollment 120 participants
Start Date 2024-09-20
Primary Completion 2026-12-31 (estimated)
Study Completion 2032-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-13