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Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 16, 2024
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2027
Last Updated
February 4, 2026
144
ESTIMATED participants
Single Implant Fixation
PROCEDURE
Dual Implant Fixation
PROCEDURE
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT06028971
NCT01230931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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