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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 16 sites (Birmingham, Alabama and 15 other locations) |
| Status | Recruiting |
| Started | September 16, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT06286670 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
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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
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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
- Principal investigator: Laurence Kempton, MD — Wake Forest University Health Sciences
- Study coordinator: Rachel Seymour, PhD
- Email: Rachel.Seymour@advocatehealth.org
- Phone: 704.355.2000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Two ways to fix distal femur fractures in older adults
This trial tests whether a single implant or two implants help older adults with distal femur fractures return to work and daily activities sooner.
-
Smart Crutch Tips to guide weight-bearing after extra-articular proximal tibia fracture surgery
This study will test whether personalized weight-bearing plans using Smart Crutch Tips help adults with extra-articular proximal tibia fractures heal faster, return to full weight-bearing sooner, and feel less fear of movement.
-
Comparing elbow hemiarthroplasty and ORIF for treating distal humeral fractures in older adults
This study is testing whether surgery to fix elbow fractures with plates and screws works better than replacing part of the elbow in older adults with these types of injuries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.