Clinical trial Recruiting at 13 sites Interventional Ages 18 and up

Comparing single and dual implant methods for fixing distal femur fractures

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

Run by Wake Forest University Health Sciences · NCT06286670 · Data updated 2026-11-12

This study is testing whether using one or two implants to fix certain types of thigh bone fractures helps patients heal better and get back to their daily activities faster.

More Articular Fractures trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment144 (estimated)
SponsorWake Forest University Health Sciences
Academic / other
Locations16 sites (Birmingham, Alabama and 15 other locations)
StatusRecruiting
StartedSeptember 16, 2024
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedApril 7, 2026
Trial IDNCT06286670 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who have sustained displaced distal femur fractures requiring surgical treatment.

Probably not a fit

Patients with certain injury characteristics that prevent dual implant treatment or those with multisystem injuries may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of single versus dual implant fixation techniques in patients with specific types of distal femur fractures. The study focuses on understanding which surgical approach leads to better healing outcomes and a quicker return to daily activities for patients. Given the high rate of nonunion in these fractures, the research seeks to identify a method that could enhance recovery and reduce the need for additional surgeries. Participants will be monitored for their recovery progress and functional return post-surgery.

Why it matters

Potential benefit: If successful, this study could lead to improved healing rates and faster recovery times for patients with distal femur fractures.

How similar studies have gone: Previous studies have explored various fixation methods for fractures, but this specific comparison of single versus dual implant fixation in distal femur fractures is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Alabama Birmingham
    Birmingham, Alabama, United States
    Recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
    Recruiting
  • Emory University, Grady Memorial Research Hospital
    Atlanta, Georgia, United States
    Recruiting
  • Atrium Health Navicent
    Macon, Georgia, United States
    Recruiting
  • University of Maryland, Shock Trauma Center
    Baltimore, Maryland, United States
    Recruiting
  • University of North Carolina Chapel Hill
    Chapel Hill, North Carolina, United States
    Recruiting
Show 10 more locations
  • Atrium Health Carolinas Medical Center
    Charlotte, North Carolina, United States
    Recruiting
  • Atrium Health Cabarrus
    Concord, North Carolina, United States
    Recruiting
  • Pennsylvania State University
    Hershey, Pennsylvania, United States
    Recruiting
  • Prisma Health- Upstate
    Greenville, South Carolina, United States
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting
  • Inova
    Fairfax, Virginia, United States
    Recruiting
  • Valley Health
    Winchester, Virginia, United States
    Recruiting
  • Louisiana State University
    New Orleans, Louisiana, United States
    Not yet recruiting
  • NYC Health and Hospital/Bellevue
    New York, New York, United States
    Not yet recruiting
  • University of Texas Medical Branch
    Galveston, Texas, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.