NCT05805774 pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
| NCT ID | NCT05805774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Unity Health Toronto |
| Condition | Distal Femur Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2025-10-17 |
| Primary Completion | 2030-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2025-10-17 with a primary completion date of 2030-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 repair * Poly-trauma status (Injury Severity Score\>15) or any associated major injuries of the lower extremities that may hinder post-operative ambulation * Medical contraindication to surgery
Contact & Investigator
Amir Khoshbin, MD
PRINCIPAL INVESTIGATOR
Unity Health Toronto - St Michael's Hospital
Frequently Asked Questions
Who can join the NCT05805774 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Distal Femur Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05805774 currently recruiting?
Yes, NCT05805774 is actively recruiting participants. Contact the research team at cassandra.tardif-theriault@unityhealth.to for enrollment information.
Where is the NCT05805774 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05805774 clinical trial?
NCT05805774 is sponsored by Unity Health Toronto. The principal investigator is Amir Khoshbin, MD at Unity Health Toronto - St Michael's Hospital. The trial plans to enroll 148 participants.