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RECRUITING
NCT05805774
NA

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Sponsor: 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.

Official 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)

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2025-10-17

Completion Date

2032-12-10

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

PROCEDURE

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).

PROCEDURE

Surgical fixation

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

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada