Comparing knee replacement to surgical fixation for elderly patients with distal femur fractures
Official title: DIFFIR: Geriatric Distal Femur Fixation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femoral Replacement (DFR)
Run by Unity Health Toronto · NCT04076735 · Data updated 2026-11-12
This study is trying to see if knee replacement or surgical fixation works better for older patients with certain types of thigh bone fractures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | October 1, 2021 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT04076735 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 65 and older with closed, displaced, comminuted distal femur fractures who were ambulatory prior to their injury.
✕Probably not a fit
Patients with active infections, open fractures, or those who have had previous surgeries on the affected area may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study is a prospective, randomized controlled trial that aims to compare two treatment options for geriatric patients with distal femur fractures: acute distal femoral replacement and surgical fixation. Patients aged 65 and older with specific types of fractures will be randomly assigned to receive either treatment. The study will assess outcomes such as function, range of motion, general health status, pain levels, and complications associated with each approach. The goal is to determine which method provides better overall results for this vulnerable population.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and quality of life for elderly patients suffering from distal femur fractures.
How similar studies have gone: Other studies have explored similar surgical approaches, but this specific comparison of distal femoral replacement versus surgical fixation in geriatric patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients * 65 years and older * Isolated fracture of the distal femur (Classification 33) * Fracture is amendable to both treatments * Fracture is acute (within 2 weeks from time of injury) * Patient was ambulatory (with or without walking aids) prior to the injury * Independent or moderately frail with score of 3 to 6 on the Clinical Frailty Scale * Patient is able to read and understand English, French, or Spanish * Patient or substitute decision maker is able to provide written informed consent to participate in the study Exclusion Criteria: * Active or previous infection around the fracture (soft tissue or bone) * Open fracture * Bilateral femur fractures * Major vascular injuries requiring intervention, compartment syndrome and major neurologic injuries * Pathological fracture excluding osteoporosis * Previous surgical fixation or total knee replacement of the distal femur or proximal tibia * Previous surgical fixation or hemi/total replacement of the hip * Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair * Polytrauma (Injury Severity Score \> 15) or any associated major injuries of the lower extremities * Previous medical diagnosis of dementia * Medical or surgical contra-indication to surgery
Where it's running
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St Michael's Hospital - Unity Health Toronto
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Amir Khoshbin, MD — St Michael's Hospital - Unity Health Toronto
- Study coordinator: Cassandra Tardif-Theriault, BKin
- Email: cassandra.tardif-theriault@unityhealth.to
- Phone: +1416-864-6060
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Carbon‑fiber lateral plate versus plate-and-nail repair for distal femur fractures
This trial will see if a carbon-fiber (CarboFix) lateral femur plate leads to fewer non-unions than the standard plate-plus-nail repair in adults having surgery for a distal femur fracture.
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Comparing knee joint replacement to surgical fixation for elderly patients with distal femur fractures
This study is testing whether total knee joint replacement or surgical fixation works better for older patients with broken thigh bones near their knee to help them feel less pain and improve their daily activities.
-
Comparing two surgical methods for treating distal femur fractures
This study is testing which of two surgical methods works better for helping older patients recover from specific knee fractures after they've had knee replacement surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.