Actively Recruiting
pDIFFIR: Geriatric Periprosthetic Distal Femur: Fixation Versus Replacement - A Randomized Controlled Trial Comparing Acute Open Reduction Internal Fixation and Distal Femur Replacement
Led by Unity Health Toronto · Updated on 2025-12-18
148
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
Unity Health Toronto
Lead Sponsor
M
Mount Sinai Hospital, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Periprosthetic distal femur fractures are serious injuries that affect elderly patients and can lead to significant health problems and risk of death. Researchers are studying whether replacing the distal femur and knee joint with an artificial knee prosthesis provides better knee pain relief and function compared to traditional surgical fixation using plates, nails, screws, or wires. This randomized controlled trial aims to compare these two surgical treatments in patients aged 65 and older who have sustained a recent fracture around a stable knee replacement. Participants will be randomly assigned to one of two groups: one receiving a distal femur replacement surgery where the broken bone and knee joint are removed and replaced with an artificial joint, and the other undergoing surgical fixation to stabilize the fracture using hardware such as wires, screws, or plates. The study will enroll a total of 148 patients, with 74 in each treatment group. The trial will monitor outcomes including knee function, mortality, reoperation rates, complications, pain after surgery, and quality of life. During the study, participants will be followed for at least 12 months to assess knee function and up to 24 months to evaluate survival and other secondary outcomes. Researchers will collect data on health economics to understand the cost-effectiveness of each treatment. Patients will undergo regular assessments to monitor their recovery and any complications. The total participation time includes these follow-up periods to provide a comprehensive evaluation of both surgical approaches.
CONDITIONS
Brief Title
pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Acute period around the time of surgery
Participants undergo knee surgery either to replace the distal femur and knee joint with an artificial joint or to fix the fracture using wires, nails, screws, pins, or plates.
1 surgical visit (in-person) and immediate post-operative care visits
Duration - Up to 12 months
Participants are monitored after surgery to assess knee function and recovery over time.
Regular follow-up visits over 12 months to assess knee function
Trial Site Locations
Total: 1 location
1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
Research Team
C
Cassandra Tardif-Theriault
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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