Recruiting

Single vs. Dual

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06286670

Conditions

Articular Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single Implant Fixation

Dual Implant Fixation

Study Details

Brief 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.

Conditions

Articular Fractures

Study ID

NCT06286670

Start date

Sep 16, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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 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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single Implant Fixation

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

other: Dual 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.

Interventions

Single Implant Fixation

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

Dual 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.

Primary outcome measure

  • Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [ Time Frame: Week 6 ]
  • Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [ Time Frame: Month 3 ]
  • Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [ Time Frame: Month 6 ]
  • Return to Work - International Physical Activity Questionnaire (IPAQ) Scores [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Rachel Seymour, PhD

704.355.2000Rachel.Seymour@advocatehealth.org

Christine Churchill, MA

704.355.2000Christine.Churchill@advocatehealth.org

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Clay Spitler, MD

caspitler@uabmc.edu

Principal Investigator:

Clay Spitler, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Joel Arnold

joel.arnold@cshs.org

Principal Investigator:

Geoffrey Marecek, MD

Emory University, Grady Memorial Research Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Morgan Fuller

morgan.renae.fuller@emory.edu

Jason Barron

jason.barron@emory.edu

Principal Investigator:

Thomas Large, MD

Atrium Health Navicent

Recruiting

Macon, Georgia, United States, 31201

Contacts

Adithi Shyam

Adithi.Shyam@Advocatehealth.org

Principal Investigator:

Jarrod Dumpe, MD

University of Maryland, Shock Trauma Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Casey Loudermilk

CLoudermilk@som.umaryland.edu

Principal Investigator:

Mark Gage, MD

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Atrium Health Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Christine Churchill

christine.churchill@atriumhealth.org

Principal Investigator:

Laurence Kempton, MD

Atrium Health Cabarrus

Recruiting

Concord, North Carolina, United States, 28025

Contacts

Erica Grochowski

erica.grochowski@atriumhealth.org

Principal Investigator:

Luke Harmer, MD

Pennsylvania State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Andrea Myers

amyers1@pennstatehealth.psu.edu

Principal Investigator:

Jana Davis, MD

Prisma Health- Upstate

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Kyle Adams, MS

kyle.adams@prismahealth.org

Principal Investigator:

Kyle Jeray, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Karen Trochez

karen.m.trochez@vumc.org

Principal Investigator:

Phillip Mitchell, MD

Inova

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Greg Gaski, MD

greg.gaski@inova.org

Principal Investigator:

Greg Gaski, MD

Valley Health

Recruiting

Winchester, Virginia, United States, 22601

Contacts

Ashley Zelaski

540-536-7542azelaski2@valleyhealthlink.com

Principal Investigator:

Kenneth Nelson, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 7, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-07.