Comparing knee replacement to surgical fixation for elderly patients with distal femur fractures
DIFFIR: Geriatric Distal Femur Fixation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femoral Replacement (DFR)
NA · Unity Health Toronto · NCT04076735
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04076735 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older with closed, displaced, comminuted distal femur fractures who were ambulatory prior to their injury.
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.
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 performed: Other studies have explored similar surgical approaches, but this specific comparison of distal femoral replacement versus surgical fixation in geriatric patients is relatively novel.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Distal Femur Fracture, Geriatric fracture