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The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

RecruitingNAAges 18 Years - 65 YearsAllOstfold Hospital Trust
NCT06568276 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion criteria; fluent in oral and written Norwegian language * isolated Weber type B fractures and Weber B+ posterior malleolar Mason Molloy class I. * Initial medial clear space (MCS)\>=7mm or weightbearing x-ray evaluated as unstable or primary reposition after fracture dislocation. * Pre-injury walking ability without aids. Exclusion criteria * 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
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What it tests

  • Additional deep deltoid ligament suture
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Where

9 sites
Oestfold Hospital Trust
Grålum, Norway
Ålesund Sjukhehus
Ålesund, Norway
Haukeland University Hospital
Bergen, Norway
Nordlandssykehuset Bodø
Bodø, Norway
Sykehuset Innlandet Elverum
Elverum, Norway
Sykehuset Innlandet Gjøvik
Gjøvik, Norway
Sykehuset Levanger
Levanger, Norway
Oslo University Hospital Ullevål/Aker
Oslo, Norway

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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