Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study

Status unconfirmed · Not applicable

Conditions studied: Ankle Fracture, Malleolus Fracture, Medial Malleolus Fracture, Bimalleolar Fracture, Trimalleolar Fracture

In brief

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.

Key facts

Study ID

NCT02032966

Run by

University of Tennessee

People needed

30

Starts

2011-04-01

Expected to finish

2019-12-01

Last updated by the study team

2018-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Erlanger Health System — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.