Comparing two implants to one for fixing distal femur fractures
Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)
This study tests whether using two implants instead of one helps people with distal femur fractures heal better after their injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06032299 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using a dual implant versus a single implant for the fixation of distal femur fractures. Patients with femur fractures that can be treated with either method will be enrolled and treated within 72 hours of their injury. The goal is to determine which fixation method provides better outcomes for patients recovering from these types of fractures.
Who should consider this trial
Good fit: Ideal candidates are patients with a distal femur fracture who were previously ambulatory and can consent to the procedure.
Not a fit: Patients with associated major lower extremity fractures, ongoing infections, or severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for patients with distal femur fractures.
How similar studies have performed: Other studies have explored similar fixation methods, but the specific comparison of dual versus single implants for distal femur fractures is less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Femur fracture distal to the femoral diaphysis. * Operative treatment within 72 hours of presenting to the treating hospital. * Patient was previously ambulatory. * Fracture amendable to either single or dual implant fixation. * Informed consent can be obtained from the patient, family member, or power of attorney. Exclusion Criteria: * Associated major lower extremity fracture. * Ongoing infection. * History of metabolic bone disease (Paget's, etc). * Pathologic fracture. * Open fracture. * Severe cognitive impairment (Six Item Screener with 3 or more errors). * Stage 5 Parkinson's disease. * Significant femoral bone loss requiring planned staged bone grafting. * Vascular injury.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Brandon Yuan, MD — Mayo Clinic
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.