pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Launched by UNITY HEALTH TORONTO · Mar 28, 2023

Keywords

ClinConnect Summary

The pDIFFIR clinical trial is studying two different treatment options for elderly patients who have suffered a specific type of knee fracture called a periprosthetic distal femur fracture. This type of fracture occurs around a knee joint that has already been replaced with an artificial implant. The trial will compare two approaches: one involves using surgical methods to fix the broken bone with plates, nails, and screws, while the other option is to replace the knee joint entirely with a new artificial knee. The main goal is to see which method helps reduce knee pain and improves the ability to move around after surgery.

To participate in this study, individuals must be 65 years or older and have an acute fracture that occurred within a week of the injury. They should have been able to walk independently or with assistance before the injury. Participants will be monitored for various outcomes, including pain levels, overall health, and quality of life. The study aims to enroll 148 patients, and it's currently looking for participants. It's important to note that certain conditions, like infections or previous knee surgeries, may exclude someone from joining the trial.

Gender

ALL

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