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

Ankle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02032966
• Other study ID #: 11-010
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2011
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Bimalleolar Fracture
• Fractures, Bone
• Malleolus Fracture
• Medial Malleolus Fracture
• Trimalleolar Fracture

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Erlanger Health System	Chattanooga	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	Southeastern Fracture Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcomes	Time to union (radiographic healing of the fracture), Time to weight-bearing, Complications	one year
Secondary	functional outcomes	Measured by the SF-36 Health Survey and the Foot Function Index	one year