Status:
RECRUITING
DIFFIR - Geriatric Distal Femur Fixation Versus Replacement
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Mount Sinai Hospital, Canada
NYU Langone Health
Conditions:
Distal Femur Fracture
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The current standard of care for most intra-articular distal femur fractures (above the knee joint) in geriatric patients is a surgical fixation using plates and screws to hold the fracture pieces in ...
Detailed Description
The proposed study is a prospective, randomized controlled trial, involving multiple centers across North America, to compare distal femur replacement (knee prosthesis) versus surgical fixation as a t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04076735
Start Date
October 1 2021
End Date
October 10 2028
Last Update
January 23 2025
Active Locations (1)
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1
St Michael's Hospital - Unity Health Toronto
Toronto, Ontario, Canada