About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Additional deep deltoid ligament suture

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

9
Oestfold Hospital TrustN-1714, GrålumPostbox 300, Norway
Ålesund Sjukhehus Ålesund Norway
Haukeland University Hospital Bergen Norway
Nordlandssykehuset Bodø Bodø Norway

Sponsors and collaborators

Ostfold Hospital Trust

Lead sponsor

Sykehuset Innlandet HF

Collaborator

Helse Nord-Trøndelag HF

Collaborator

Helse-Bergen HF

Collaborator

Norwegian Institute of Public Health

Collaborator

Helse Stavanger HF

Collaborator

Trondheim University Hospital

Collaborator

Norwegian University of Science and Technology

Collaborator

Alesund Hospital

Collaborator

Nordlandssykehuset HF

Collaborator