The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
Recruiting now · Not applicable
Conditions studied: Ankle Fractures, Deltoid Ligament; Sprain (Strain) (Ankle)
In brief
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.
Key facts
- Study ID
- NCT06568276
- Run by
- Ostfold Hospital Trust
- People needed
- 120
- Starts
- 2024-09-20
- Expected to finish
- 2032-07-01
- Last updated by the study team
- 2025-08-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
- previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery.
- open fx Gustilo Anderson II or more, multi-trauma and pathologic fracture.
- neuropathies and generalized joint disease such as Rheumatoid Arthritis or other more severe condition in same extremity
- fixation of tibial fragment or syndesmotic screw or suture button planned prior to surgery
Where it is running
- Oestfold Hospital Trust — Grålum, Postbox 300, Norway (enrolling)
- Ålesund Sjukhehus — Ålesund, Norway (enrolling)
- Haukeland University Hospital — Bergen, Norway (enrolling)
- Nordlandssykehuset Bodø — Bodø, Norway (enrolling)
- Sykehuset Innlandet Elverum — Elverum, Norway (enrolling)
- Sykehuset Innlandet Gjøvik — Gjøvik, Norway (enrolling)
- Sykehuset Levanger — Levanger, Norway (enrolling)
- Oslo University Hospital Ullevål/Aker — Oslo, Norway (enrolling)
- Stavanger University Hospital — Stavanger, Norway (enrolling)
Full record on ClinicalTrials.gov
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