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

Not Applicable

• Conditions: Ankle Fracture; Malleolus Fracture; Medial Malleolus Fracture; Bimalleolar Fracture; Trimalleolar Fracture

• Registration Number: NCT02032966
• Lead Sponsor: University of Tennessee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-28
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical outcomes	one year	Time to union (radiographic healing of the fracture), Time to weight-bearing, Complications

Secondary Outcome Measures

Name	Time	Method
functional outcomes	one year	Measured by the SF-36 Health Survey and the Foot Function Index

Trial Locations

Locations (1)

Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States