pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

NCT05805774 | Recruiting

• 1 other identifier: 23-001
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Fracture; Distal Femur Fracture; Periprosthetic Fracture Around Prosthetic Joint Implant Knee

Keywords

Periprosthetic Distal Femur fracture; Knee replacement; Surgical fixation; Geriatric patients

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

• Mortality

  24 months

Study Arms (2)

Group A - DFR

ACTIVE COMPARATOR

Procedure: Distal Femur Replacement

Group B - ORIF

ACTIVE COMPARATOR

Procedure: Surgical fixation

Interventions

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).

Group A - DFR

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.

Group B - ORIF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Femoral Fractures, Distal; Knee Fractures

Interventions

Surgical Fixation Devices

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries; Knee Injuries

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Amir Khoshbin, MD

  Unity Health Toronto - St Michael's Hospital

  PRINCIPAL INVESTIGATOR

• Jesse Wolfstadt, MD

  Mount Sinai Health Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Tardif-Theriault

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: October 17, 2025
• Primary Completion (Estimated): December 10, 2030
• Study Completion (Estimated): December 10, 2032
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CA (1)