Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture
- Conditions
- Trauma
- Interventions
- Procedure: Bimalleolar fixationProcedure: Unimalleolar fixation
- Registration Number
- NCT01757951
- Lead Sponsor
- University of Oulu
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bimalleolar Fixation Bimalleolar fixation Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed. Unimalleolar Fixation Unimalleolar fixation Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.
- Primary Outcome Measures
Name Time Method Olerud-Molander Ankle Score 2 years A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function
- Secondary Outcome Measures
Name Time Method A 100 mm Visual Analogue Scale for function and pain (VAS) 2 years Range from 0 to 100, with higher scores indicating more severe pain
The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36) 2 years 8 subscales from 0-100, with higher scores indicating better health-related quality of life
Talocrural joint congruence At two, four and 12 weeks, and at 2 years Medial clear space \< 4 mm and ≤ 1 mm wider than the superior clear space as measured between the lateral border of the medial malleolus and the medial border of the talus at the level of the talar dome.
The Foot and Ankle Outcome Score (FAOS) 2 years FAOS, 5 subscales from 0-100, with higher scores indicating better function
Fracture healing 2 years Fracture union is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions.
Trial Locations
- Locations (1)
Oulu University Hospital
🇫🇮Oulu, Finland