Status:
ACTIVE_NOT_RECRUITING
Dual Implant Versus Single Implant Distal End of Femur
Lead Sponsor:
Mayo Clinic
Conditions:
Femur Fracture
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06032299
Start Date
April 29 2024
End Date
February 1 2026
Last Update
October 20 2025
Active Locations (1)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905