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Joint Replacement

Group A - DFR for Knee Fracture (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

pDIFFIR Trial 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.

pDIFFIR Trial 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.

pDIFFIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

pDIFFIR Trial Design

2Treatment groups

Active Control

Group I: Group A - DFRActive Control1 Intervention

Group II: Group B - ORIFActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

540 Previous Clinical Trials

447,632 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently accepting new participants?

"Indeed, as indicated on clinicaltrials.gov, this trial is currently actively seeking eligible participants. It was first published on February 1st, 2024 and has been recently updated on January 26th, 2024."

Answered by AI

What is the total number of participants being recruited for this research study?

"Indeed, the details available on clinicaltrials.gov indicate that this trial is presently seeking eligible participants. The initial posting for the trial was made on February 1st, 2024 and it underwent its most recent update on January 26th, 2024. To complete the study successfully, a total of 148 individuals will be recruited from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Amir Khoshbin 2024. "pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05805774.