Ankle Fracture, Malleolus Fracture, Medial Malleolus Fracture, Bimalleolar Fracture, Trimalleolar Fracture
Conditions
Keywords
outcomes, surgical, non-surgical, ankle, malleolus, fracture, tibia, fibula, bimalleolar, trimalleolar
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.
Interventions
PROCEDURENonsurgical
Randomized to nonsurgical: patient will receive surgical treatment of the inside portion (medial malleolus) of the tibia fracture only; the fibula fracture (and posterior malleolus fracture, if present) will be closed reduced (not repaired surgically).
PROCEDURESurgical
Randomized to surgical: patient will receive surgical treatment of both the inside portion (medial malleolus) of the tibia fracture, as well as the fibula fracture (lateral malleolus). Fixation of the posterior side of the tibia (posterior malleolus) may or may not be performed based upon intraoperative x-rays.
Sponsors
Southeastern Fracture Consortium
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical outcomes | one year | Time to union (radiographic healing of the fracture), Time to weight-bearing, Complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| functional outcomes | one year | Measured by the SF-36 Health Survey and the Foot Function Index |
Countries
United States
Outcome results
None listed