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pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement | Clinical Trials | Clareo Health

RECRUITINGNA

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femur Replacement (DFR)

NCT05805774•Unity Health Toronto

View on ClinicalTrials.gov

Summary

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

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

October 17, 2025

Primary Completion Date

December 10, 2030

Completion Date

December 10, 2032

Last Updated

December 18, 2025

Enrollment

148

ESTIMATED participants

Conditions

Distal Femur FracturePeriprosthetic Fracture Around Prosthetic Joint Implant KneeKnee Fracture

Interventions

Distal Femur Replacement

PROCEDURE

Surgical fixation

PROCEDURE

Contacts

Cassandra Tardif-Theriault

CONTACT

416-864-6060 cassandra.tardif-theriault@unityhealth.to

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RECRUITINGNA

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Femoral Neck FracturesIntertrochanteric Fractures+20 more

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Inclusion Criteria

Exclusion Criteria

Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures

Opioid-Free Pain Treatment in Trauma Patients

Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series

Locking Plates for Distal Femur Fractures - a Multicenter Case Review

Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Below Knee Fracture Fixation

Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures