pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
Canada148 participantsStarted 2025-10-17
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • 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
* Independent or moderately frail with score of 3 to 6 on the validated Clinical Frailty Scale
* Patient is able to read and understand the consent form document, or an interpreter is available to the patient at the time of consent and follow-up
* Patient or substitute decision maker is able to provide written informed consent to participate in the study
Exclusion Criteria:
* • 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
* Pathological fracture excluding osteoporosis
* Ipsilateral total knee arthroplasty using revision components (varus/valgus constraint, stemmed femoral components)
* Periprosthetic distal femur fracture around a loose or failing primary total knee arthroplasty (Lewis and Rorabeck Type III)
* Ipsilateral primary partial knee or patellofemoral arthroplasty
* Previous ORIF of the distal femur or proximal tibia or patella
* Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or rep…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.