RECRUITING

Single Versus Dual Implant Fixation of Distal Femur Fractures

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Conditions

Articular FracturesDistal Femur FractureDistal Femur complete articular FractureDistal Femur extraarticular Fracture

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-09-16
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06286670

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to 18 years
  2. * Surgically treated displaced distal femur extra articular or complete articular fractures
  1. * Patients with injury features that preclude treatment with 2 implants
  2. * Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
  3. * Body Mass Index (BMI) \> 40
  4. * Injury due to ground level fall
  5. * Patient that speaks neither English or Spanish
  6. * Patients with multisystem injuries that could preclude return to work
  7. * \< 18 years of age
  8. * Prisoner

Contacts and Locations

Study Contact

Rachel Seymour, PhD
CONTACT
704.355.2000
Rachel.Seymour@atriumhealth.org
Christine Churchill, MA
CONTACT
704.355.2000
Christine.Churchill@atriumhealth.org

Principal Investigator

Laurence Kempton, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35233
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Yale School of Medicine
New Haven, Connecticut, 06520
United States
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637
United States
Atrium Health Navicent
Macon, Georgia, 31201
United States
Louisiana State University
New Orleans, Louisiana, 70112
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
Duke University
Durham, North Carolina, 27710
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
Inova
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Laurence Kempton, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Distal Femur Fracture
  • Distal Femur complete articular Fracture
  • Distal Femur extraarticular Fracture

Additional Relevant MeSH Terms

  • Articular Fractures