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pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

NCT05805774 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-12-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Amir Khoshbin, MD · Unity Health Toronto - St Michael's Hospital

  • Jesse Wolfstadt, MD · Mount Sinai Health Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-17
Primary Completion
2030-12-10
Completion
2032-12-10

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05805774 on ClinicalTrials.gov