NCT01757951

Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2012-12-31
• Last updated: 2022-11-02

Locations

1 site across 1 country: Finland