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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Distal Femur Replacement

    Procedure/Surgery

    Knee 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/Surgery

    Knee surgery to fix the fracture, that can use wires, nails, screws, pins or plates to health and fix the bones together.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Group A - DFRActive comparator 1 intervention
Group B: Group B - ORIFActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

Mortality

Track patient's death.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

Mount Sinai Hospital, Canada

Collaborator