pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
NCT ID: NCT05805774
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
148 participants
INTERVENTIONAL
2025-10-17
2032-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A - DFR
Distal Femur Replacement
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).
Group B - ORIF
Surgical fixation
Knee surgery to fix the fracture, that can use wires, nails, screws, pins or plates to health and fix the bones together.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Distal Femur Replacement
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
Knee surgery to fix the fracture, that can use wires, nails, screws, pins or plates to health and fix the bones together.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mount Sinai Hospital, Canada
OTHER
Unity Health Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amir Khoshbin, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto - St Michael's Hospital
Jesse Wolfstadt, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Health Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Cassandra Tardif-Theriault
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-001
Identifier Type: -
Identifier Source: org_study_id