RecruitingNot ApplicableNCT06286670

Single Versus Dual Implant Fixation of Distal Femur Fractures

Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP


Sponsor

Wake Forest University Health Sciences

Enrollment

144 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Age greater than or equal to 18 years
  • Surgically treated displaced distal femur extra articular or complete articular fractures

Exclusion Criteria8

  • 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

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Interventions

PROCEDURESingle Implant Fixation

Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail.

PROCEDUREDual Implant Fixation

Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate.


Locations(16)

University of Alabama Birmingham

Birmingham, Alabama, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Emory University, Grady Memorial Research Hospital

Atlanta, Georgia, United States

Atrium Health Navicent

Macon, Georgia, United States

Louisiana State University

New Orleans, Louisiana, United States

University of Maryland, Shock Trauma Center

Baltimore, Maryland, United States

NYC Health and Hospital/Bellevue

New York, New York, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

Atrium Health Cabarrus

Concord, North Carolina, United States

Pennsylvania State University

Hershey, Pennsylvania, United States

Prisma Health- Upstate

Greenville, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Medical Branch

Galveston, Texas, United States

Inova

Fairfax, Virginia, United States

Valley Health

Winchester, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06286670