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pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
Sponsor: Unity Health Toronto
Summary
Periprosthetic distal femur fractures are a significant source of morbidity and mortality for elderly patients. One treatment option involved a surgical fixation with plates or nails, screws and cables/wires along the side of your fractured bone. The second method consists in replacing your knee joint with an artificial knee prosthesis (artificial knee joint). The primary objective is to determine if acute distal femur replacement improves knee pain and functional outcomes compared to surgical fixation. Secondary outcomes are mortality, reoperation, complications, post-operative pain and quality of life. A health economic analysis will be conducted to assess the cost-effectiveness of both treatments. A total of 148 patients (74/group) will be enrolled in the study.
Official title: pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femur Replacement (DFR)
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2025-10-17
Completion Date
2032-12-10
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Distal Femur Replacement
Knee surgery to remove the lower part of the femur and knee joint (where the broken bones are) and will replace them with an artificial knee joint (prosthesis).
Surgical fixation
Knee surgery to fix the fracture, that can use wires, nails, screws, pins or plates to health and fix the bones together.
Locations (1)
St. Michael's Hospital
Toronto, Ontario, Canada