Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by John Scolaro (uci)

Description

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.

Official Title

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

Details

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.

Keywords

Articular Fractures, Distal Femur Fracture, Distal Femur complete articular Fracture, Distal Femur extraarticular Fracture, Distal Femoral Fractures, Single Implant Fixation, Dual Implant Fixation

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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

Locations

  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • University of Texas Medical Branch not yet accepting patients
    Galveston Texas 77555 United States
  • Vanderbilt University Medical Center accepting new patients
    Nashville Tennessee 37232 United States

Lead Scientist at University of California Health

  • John Scolaro (uci)
    Associate Clinical Professor, Orthopaedic Surgery, School of Medicine. Authored (or co-authored) 107 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Wake Forest University Health Sciences
ID
NCT06286670
Study Type
Interventional
Participants
Expecting 144 study participants
Last Updated