pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Knee function — 12 months
Compare knee pain between the two groups using the Oxford Knee Score - which is a patient reported outcome measure. It assess knee function and gives a rating from 0 to 48 - being 0 bad knee function and 48 - excellent knee function.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | Recruiting |
More Unity Health Toronto trials in Canada
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05805774 on ClinicalTrials.gov ↗ ← All trials in Canada