About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
• 65 years and older
Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2)
Fracture is acute (within 1 week from time of injury)
Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury
Disqualifiers
• Active infection around the fracture (soft tissue or bone)
Open fracture
Bilateral femur fractures
Major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries
Trial design
Parallel
Treatments tested in this trial
Distal Femur Replacement
Procedure/SurgeryKnee 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
Procedure/SurgeryKnee surgery to fix the fracture, that can use wires, nails, screws, pins or plates to health and fix the bones together.
Treatment groups
Trial outcomes
Primary outcomes
Knee function
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.
Secondary outcomes
Mortality
Track patient's death.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Unity Health Toronto
Lead sponsor
Mount Sinai Hospital, Canada
Collaborator