Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05805774

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Distal Femur Fracture Femoral Fractures Femoral Fractures, Distal Fractures, Bone Knee Fracture Knee Fractures Knee Injuries Leg Injuries Periprosthetic Fracture Around Prosthetic Joint Implant Knee Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location status: Recruiting

Location contact

Amir Khoshbin, MD

PRINCIPAL_INVESTIGATOR

Cassandra Tardif-Theriault

CONTACT

[email protected]

416-864-6060 ext. 77117

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Distal Femur Replacement

Procedure

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

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

Primary outcomes

  1. Knee function

    Time frame: 12 months

    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.

Secondary outcomes

  1. Mortality

    Time frame: 24 months

    Track patient's death.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandra Tardif-Theriault

CONTACT

[email protected]

416-864-6060 ext. 77117

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Mount Sinai Hospital, Canada

Registry information

Official study title

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

Acronym: pDIFFIR

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Apr 10, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.