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Procedure

Replacement vs Fixation Surgery for Distal Femur Fracture (DIFFIR 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 fracture of the distal femur (Classification 33)

Independent or moderately frail with score of 3 to 6 on the Clinical Frailty Scale

Must not have

Major vascular injuries requiring intervention, compartment syndrome and major neurologic injuries

Previous surgical fixation or total knee replacement of the distal femur or proximal tibia

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

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.

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major blood vessel injuries, severe swelling in limbs, or serious nerve damage needing treatment.

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I have had surgery on my knee or near my knee.

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I have had a fracture due to a disease, not because of osteoporosis.

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I have had a severe injury or major leg injuries.

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I cannot undergo surgery due to medical reasons.

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I have had surgery on my hip, including partial or total replacement.

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I have had an infection near a broken bone.

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I have a broken bone that is exposed through my skin.

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I have fractures in both of my thigh bones.

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I have had issues or surgery on my knee's extensor mechanism.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ our primary outcome is knee pain and function as measured by repeated measures of the oxford knee score at 3, 6, 9 and 12 -months post-surgery to detect a 5 point improvement on the oks with 0.5 correlation between assessments.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~our primary outcome is knee pain and function as measured by repeated measures of the oxford knee score at 3, 6, 9 and 12 -months post-surgery to detect a 5 point improvement on the oks with 0.5 correlation between assessments.

This trial's timeline: 3 weeks for screening, Varies for treatment, and our primary outcome is knee pain and function as measured by repeated measures of the oxford knee score at 3, 6, 9 and 12 -months post-surgery to detect a 5 point improvement on the oks with 0.5 correlation between assessments. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oxford Knee Score (OKS)

Secondary study objectives

Daily morphine equivalent usage while in hospital

Health status and quality of life - EQ-5D questionnaire

Knee Extension lag

+3 more

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

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ascension Providence Rochester HospitalOTHER

Unity Health TorontoLead Sponsor

554 Previous Clinical Trials

454,151 Total Patients Enrolled

Mount Sinai Hospital, CanadaOTHER

200 Previous Clinical Trials

69,016 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

~39 spots leftby Dec 2025

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