Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

University of Oulu126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Trauma

Interventions

Unimalleolar fixationPROCEDURE

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.

Bimalleolar fixationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Oulu University Hospital

Oulu, Finland

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

The Foot and Ankle Outcome Score (FAOS)

FAOS, 5 subscales from 0-100, with higher scores indicating better function

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

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