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

NCT ID: NCT02032966

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2019-12-31

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.

Conditions

Ankle Fracture; Malleolus Fracture; Medial Malleolus Fracture; Bimalleolar Fracture; Trimalleolar Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Nonsurgical

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

Surgical

Intervention Type: PROCEDURE

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.

syndesmotic injury

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.

Group Type: OTHER

Surgical

Intervention Type: PROCEDURE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeastern Fracture Consortium

UNKNOWN

Sponsor Role: collaborator

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk W Kiner, M.D.

Role: PRINCIPAL_INVESTIGATOR

UTCOM Chattanooga/Erlanger Health System

Locations

Erlanger Health System

Chattanooga, Tennessee, United States

Countries

United States

Other Identifiers

11-010

Identifier Type: -

Identifier Source: org_study_id