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NCT06286670NARecruiting

Single Versus Dual Implant Fixation of Distal Femur Fractures

Wake Forest University Health Sciences

Start Date

9/16/2024

Completion Date

12/1/2027

Summary

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

Detailed Description

Fractures of the distal femur are severe and common injuries sustained by Wounded Warriors in combat. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to duty often beyond one year after injury. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age greater than or equal to 18 years * Surgically treated displaced distal femur extra articular or complete articular fractures Exclusion Criteria: * Patients with injury features that preclude treatment with 2 implants * Patients unlikely to follow-up due to homelessness, or planning follow up at another institution * Body Mass Index (BMI) \> 40 * Injury due to ground level fall * Patient that speaks neither English or Spanish * Patients with multisystem injuries that could preclude return to work * \< 18 years of age * Prisoner

Interventions

PROCEDURE

Single Implant Fixation

PROCEDURE

Dual Implant Fixation

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Conditions

Articular Fractures

Locations

University of Alabama Birmingham

Birmingham, Alabama 35233

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Emory University, Grady Memorial Research Hospital

Atlanta, Georgia 30303

United States

Atrium Health Navicent

Macon, Georgia 31201

United States

Louisiana State University

New Orleans, Louisiana 70112

United States

University of Maryland, Shock Trauma Center

Baltimore, Maryland 21201

United States

NYC Health and Hospital/Bellevue

New York, New York 10016

United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina 27514

United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina 28204

United States

Atrium Health Cabarrus

Concord, North Carolina 28025

United States

Pennsylvania State University

Hershey, Pennsylvania 17033

United States

Prisma Health- Upstate

Greenville, South Carolina 29605

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

University of Texas Medical Branch

Galveston, Texas 77555

United States

Inova

Fairfax, Virginia 22031

United States

Valley Health

Winchester, Virginia 22601

United States