Single Versus Dual Implant Fixation of Distal Femur Fractures

Last updated: April 28, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Dual Implant Fixation

Single Implant Fixation

Clinical Study ID

NCT06286670
IRB00108312
HT94252311075
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age greater than or equal to 18 years

  • Surgically treated displaced distal femur extra articular or complete articularfractures

Exclusion

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 anotherinstitution

  • 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

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Dual Implant Fixation
Phase:
Study Start date:
September 16, 2024
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • University of Alabama Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • University of Florida Gainesville

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Florida Orthopaedic Institute

    Temple Terrace, Florida 33637
    United States

    Site Not Available

  • Emory University, Grady Memorial Research Hospital

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Atrium Health Navicent

    Macon, Georgia 31201
    United States

    Active - Recruiting

  • Louisiana State University

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Atrium Health Musculoskeletal Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Atrium Health Cabarrus

    Concord, North Carolina 28025
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Pennsylvania State University

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Prisma Health- Upstate

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • Inova

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Valley Health

    Winchester, Virginia 22601
    United States

    Site Not Available

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