Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

Study Overview
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Brief Summary
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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.

Official Title
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Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial

Conditions
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Trauma

Intervention / Treatment
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* Procedure: Unimalleolar fixation
* Procedure: Bimalleolar fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unimalleolar Fixation<br>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. | Procedure: Unimalleolar fixation<br>* 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.<br>|
| Active Comparator: Bimalleolar Fixation<br>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. | Procedure: Bimalleolar fixation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olerud-Molander Ankle Score | A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Foot and Ankle Outcome Score (FAOS) | FAOS, 5 subscales from 0-100, with higher scores indicating better function | 2 years | 
| A 100 mm Visual Analogue Scale for function and pain (VAS) | Range from 0 to 100, with higher scores indicating more severe pain | 2 years | 
| The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36) | 8 subscales from 0-100, with higher scores indicating better health-related quality of life | 2 years | 
| Talocrural joint congruence | 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. | At two, four and 12 weeks, and at 2 years | 
| Fracture healing | Fracture union is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture, medial malleolus, Osteosynthesis, Ankle