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The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study completion date: Dec 31, 2031 to Jul 1, 2032v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 1 to 9
    • Start date changed from estimate of Sep 1, 2024 to Sep 20, 2024
    • Collaborators: 8 to 9
    • Eligibility criteria expanded, about 4 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Ankle Fractures, Deltoid Ligament; Sprain (Strain) (Ankle)
Related terms Ankle Fractures, Sprains and Strains
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov