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Procedure

Replacement vs Fixation Surgery for Distal Femur Fracture (DIFFIR Trial)

N/A
Recruiting
Led By Amir Khoshbin, 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 fracture of the distal femur (Classification 33)
Fracture is amendable to both treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up test will be completed at each follow up visit at 3, 6,12 and 24 months post surgery
Awards & highlights

DIFFIR Trial Summary

This trial will help determine which surgical technique is best for geriatric patients with distal femur fracture.

Who is the study for?
This trial is for geriatric patients aged 65 or older who have recently suffered a distal femur fracture. They must be able to understand English, French, or Spanish and were walking before the injury, even if they needed aids. The patient should not have had previous major surgeries on the affected leg, no severe dementia, and must consent to participate.Check my eligibility
What is being tested?
The study compares two treatments for elderly patients with knee fractures: surgical fixation using plates and screws versus knee replacement surgery. It aims to determine which method offers better function outcomes, fewer complications, and lower costs.See study design
What are the potential side effects?
Surgical fixation may lead to non-union of bones, infections, need for more surgery and requires long immobilization that can cause disability. Knee replacement allows immediate walking but carries risks like infection or prosthesis issues.

DIFFIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a specific type of broken thigh bone near the knee.
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My fracture can be treated in more than one way.
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I am mostly independent but may need some help with daily activities.
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My fracture happened within the last 2 weeks.
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I am 65 years old or older.
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I or someone who makes decisions for me can sign the study consent form.
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I was able to walk on my own or with help before my injury.
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I am either male or female.

DIFFIR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~test will be completed at each follow up visit at 3, 6, 12 and 24 months post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and test will be completed at each follow up visit at 3, 6, 12 and 24 months post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oxford Knee Score (OKS)
Secondary outcome measures
Daily morphine equivalent usage while in hospital
Health status and quality of life - EQ-5D questionnaire
Knee Extension lag
+3 more

DIFFIR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Distal femoral replacement (DFR)Experimental Treatment1 Intervention
Distal femoral replacement will be performed by excising the distal portion of the femur (up to two thirds) and replacing with a prosthesis incorporating a hinged total knee replacement. Surgical approach and implant selection will be at the discretion of the treating surgeon and within the standard of care. Surgeons performing this procedure will be qualified by training and experience in arthroplasty.
Group II: Surgical Fixation (ORIF)Active Control1 Intervention
Surgical fixation of the distal femoral fracture will be performed with the goals of obtaining and maintaining anatomic reduction and stable fixation of the distal portion of the femur. Surgical approach and implant selection for the surgical fixation (ORIF) will be at the discretion of the treating surgeon and within the standard of care. Surgeons performing this procedure will be qualified by training and experience in trauma of the knee.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Distal femoral replacement
2018
N/A
~30

Find a Location

Who is running the clinical trial?

Ascension HealthIndustry Sponsor
24 Previous Clinical Trials
2,896 Total Patients Enrolled
Hospital for Special Surgery, New YorkOTHER
242 Previous Clinical Trials
61,762 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
967 Previous Clinical Trials
6,845,536 Total Patients Enrolled

Media Library

Distal femoral replacement (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04076735 — N/A
Distal Femur Fracture Research Study Groups: Distal femoral replacement (DFR), Surgical Fixation (ORIF)
Distal Femur Fracture Clinical Trial 2023: Distal femoral replacement Highlights & Side Effects. Trial Name: NCT04076735 — N/A
Distal femoral replacement (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04076735 — N/A

Frequently Asked Questions

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

Are there still vacancies for participants in this trial?

"This clinical trial, originally posted on October 1st 2021, is still actively searching for participants; the details were recently updated on May 16th 2022."

Answered by AI

What is the cap on participants for this experiment?

"Affirmative. Clinicaltrials.gov's data suggests that this trial is currently seeking participants, having been initially posted on October 1st 2021 and last updated May 16th 2022. 140 patients are needed to enrol at a single site."

Answered by AI
~56 spots leftby Dec 2025