NCT02032966

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

Outcomes Following Surgical Versus Nonsurgical Treatment of Fibular Fractures Following Operative Fixation of Unstable Medial Malleolus Fractures: A Prospective Randomized Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Tennessee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Fracture
• Malleolus Fracture
• Medial Malleolus Fracture
• Bimalleolar Fracture
• Trimalleolar Fracture

Interventions

Type	Name	Description
PROCEDURE	Nonsurgical	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).
PROCEDURE	Surgical	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.

Timeline

• Start date: 2011-04-01
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2014-01-10
• Last updated: 2018-11-28

Locations

1 site across 1 country: United States