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Joint Replacement

Replacement vs Fixation for Distal Femur Fractures (pDIFFIR Trial)

N/A
Recruiting
Led By Jesse Wolfstadt, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2)
Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial aims to compare two treatment options for elderly patients with fractures in the lower part of the thigh bone. One option involves surgery to fix the fracture with plates, nails, screws, and cables/w

Who is the study for?
This trial is for individuals aged 65 or older who have a specific type of knee fracture (periprosthetic distal femur fracture) around a stable knee replacement. Candidates must have been able to walk before the injury, even if they needed help, and not be severely frail. They should understand the consent form or have an interpreter available.Check my eligibility
What is being tested?
The pDIFFIR study compares two treatments for elderly patients with certain knee fractures: surgical fixation using hardware like plates or nails versus replacing the damaged bone with an artificial joint. The goal is to see which method better improves pain and function.See study design
What are the potential side effects?
Potential side effects may include complications from surgery such as infection, increased pain, issues with wound healing, reoperation needs, and possibly reduced mobility compared to pre-injury levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a fracture near my knee replacement but the implant is stable.
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I was able to walk on my own or with help before my injury.
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I can give or have someone who can give consent for me to join the study.
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I am 65 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee function
Secondary outcome measures
Mortality

Trial Design

2Treatment groups
Active Control
Group I: Group A - DFRActive Control1 Intervention
Group II: Group B - ORIFActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
549 Previous Clinical Trials
450,926 Total Patients Enrolled
Jesse Wolfstadt, MDPrincipal InvestigatorMount Sinai Health Hospital
3 Previous Clinical Trials
290 Total Patients Enrolled
Amir Khoshbin, MDPrincipal InvestigatorUnity Health Toronto - St Michael's Hospital
2 Previous Clinical Trials
244 Total Patients Enrolled
~99 spots leftby Dec 2030
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