Trauma
Conditions
Keywords
Ankle, Fracture, medial malleolus, Osteosynthesis
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.
Interventions
PROCEDUREUnimalleolar 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.
PROCEDUREBimalleolar 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.
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications and Harms | At two, four and 12 weeks, and at 2 years | Treatment related complications and harms (i.e. wound infection, re-operations, deep vein trombhosis, plaster sore, wound healing problems) |
Countries
Finland
Outcome results
None listed