pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUnity Health Toronto

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

Qualifiers

• 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

Treatments tested in this trial

  • Distal Femur Replacement
  • Surgical fixation

Treatment groups

148 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Unity Health Toronto

Lead sponsor

Mount Sinai Hospital, Canada

Collaborator