Comparing single and dual implant methods for fixing distal femur fractures
Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 16 sites (Birmingham, Alabama and 15 other locations) |
| Trial ID | NCT06286670 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have sustained displaced distal femur fractures requiring surgical treatment.
Not a fit: Patients with certain injury characteristics that prevent dual implant treatment or those with multisystem injuries may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham, Alabama and 15 other locations
- 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)
- Louisiana State University — New Orleans, Louisiana, United States (Not_yet_recruiting)
- University of Maryland, Shock Trauma Center — Baltimore, Maryland, United States (Recruiting)
- NYC Health and Hospital/Bellevue — New York, New York, United States (Not_yet_recruiting)
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- 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)
- University of Texas Medical Branch — Galveston, Texas, United States (Not_yet_recruiting)
- Inova — Fairfax, Virginia, United States (Recruiting)
- Valley Health — Winchester, Virginia, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.