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
• Interventions: Procedure: Surgical; Procedure: Nonsurgical

• 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

Arm && Interventions

Group	Intervention	Description
Surgical	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.
Nonsurgical	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).
syndesmotic injury	Surgical	Non-randomized / "syndesmotic injury": patients who have a positive ligament stress test (signifying a syndesmotic injury) during surgery will require surgical treatment of both the tibia and the fibula and cannot be randomized to either arm ("nonsurgical" versus "surgical"). Patients in this arm will still be included in the study for the collection of clinical and functional outcomes.

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