SuspendedNot Applicable

Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

Stopped: Partly due to financial issues and changes in study staff work placements

Finland126 participantsStarted 2012-02

Plain-language summary

A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Weber B bi- or trimalleolar ankle fracture (fracture of the lateral and medial malleolus +/- posterior malleolus sized under 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs) * Age: 16 years or older * Voluntary * Operated within 7 days of the trauma * Able to walk unaided before the current trauma Exclusion Criteria: * Peripheral neuropathy * Pilon fracture * Bilateral ankle fracture * Concomitant tibial fracture * Pathological fracture * Active infection around the ankle * A previous ankle fracture on either side * In trimalleolar fractures, posterior malleolus fracture sized over 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs * Inadequate co-operation * Permanent residence outside the catchment area of the study hospital

What they're measuring

Olerud-Molander Ankle Score

Timeframe: 2 years

Trial details

NCT IDNCT01757951

SponsorUniversity of Oulu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12