RecruitingNot ApplicableNCT06568276

The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-reported Functional Outcome and Radiological Stability Measurements


Sponsor

Ostfold Hospital Trust

Enrollment

120 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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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Interventions

PROCEDUREAdditional deep deltoid ligament suture

The deep deltoid ligament will be sutured through a curved incision lifting the tibialis posterior tendon out to be sutured back after tying the ligament to an anchor in the talus.


Locations(9)

Oestfold Hospital Trust

Grålum, Postbox 300, 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

Stavanger University Hospital

Stavanger, Norway

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NCT06568276


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