NCT05805774

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-17
• Primary completion: 2030-12-10
• Completion: 2032-12-10
• First posted: 2023-04-10
• Last updated: 2025-12-18

Locations

1 site across 1 country: Canada