Status:
ENROLLING_BY_INVITATION
Dual Implant Versus Single Implant Distal End of Femur
Lead Sponsor:
University of Utah
Conditions:
Distal Femur Fracture
Eligibility:
All Genders
60-100 years
Phase:
NA
Brief Summary
The investigators overall study objective is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (d...
Detailed Description
The incidence of distal femur fractures in elderly patients continues to increase, most recently having an incidence of 8.7/100,000/year. This trend likely accompanies the aging population and the inc...
Eligibility Criteria
Inclusion
- Patient age 60 years or greater,
- 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 :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05292313
Start Date
March 14 2022
End Date
February 1 2027
Last Update
October 31 2025
Active Locations (1)
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1
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84112