Outcomes Following Surgical Versus Nonsurgical Treatment of Fibular Fractures Following Operative Fixation of Unstable Medial Malleolus Fractures: A Prospective Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankle Fracture
- Sponsor
- University of Tennessee
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- clinical outcomes
- Last Updated
- 7 years ago
Overview
Brief Summary
Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an ankle fracture in which both the tibia and the fibula are broken. This would alleviate the need for another incision, plate, and screws to repair the fibula. The purpose of this study is to help determine if surgically repairing only the tibia fracture will lead to equivalent clinical outcomes when compared with surgical repair of both bones.
The hypothesis of this study is that operative stabilization of the medial malleolus fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the ankle, will lead to equivalent clinical outcomes and functional scores as those treated with operative stabilization of both malleoli and/or all malleoli.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Skeletally mature patients ≥ 18 years of age with acute, closed bimalleolar and/or trimalleolar ankle fractures
- •Operative fixation of the ankle fracture is within 3 weeks from date of injury
- •Bimalleolar and/or trimalleolar ankle fractures in which the medial malleolus fragment is greater than 1.7cm wide on lateral x-ray imaging
- •Bimalleolar and/or trimalleolar ankle fractures in which the posterior malleolus fragment is less than 20% of the depth of the tibial articular surface
Exclusion Criteria
- •Skeletally immature patients \< 18 years of age
- •Single malleolar ankle fractures
- •Open fractures
- •Operative fixation of the ankle fracture is more than 3 weeks from date of injury
- •Bimalleolar and/or trimalleolar fractures in which the medial malleolar fragment is less than or equal to 1.7cm wide on lateral x-ray imaging
- •Bimalleolar and/or trimalleolar ankle fractures in which the posterior malleolus fragment is greater than or equal to 20% of the depth of the tibial articular surface
- •Ankles with previous fractures of the medial and/or lateral malleolus requiring operative intervention
Outcomes
Primary Outcomes
clinical outcomes
Time Frame: one year
Time to union (radiographic healing of the fracture), Time to weight-bearing, Complications
Secondary Outcomes
- functional outcomes(one year)