About this trial
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 the correct position, until the fracture as healed.
However, surgical fixation of these complex fractures in geriatric patients, is associated with significant complications, such as non-union (when the broken bone does not heal properly), infection and the need for revision surgery. Additionally, surgical fixation requires prolonged immobilization of of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Geriatric patients, especially those frail and with cognition impairment, are unable to adhere to the immobilization restrictions, which leads to an increased risk of fixation failure (broken bone does not heal).
Another treatment option for those patients is an acute distal femoral replacement (artificial knee), where damaged parts of the knee joint are replaced with artificial prosthesis. This procedure allows patients to walk immediately after the surgery and faster return to previous level of function, therefore avoiding the complications for immobilization.
There is a lack of guideline and evidence to suggest which surgical technique is best to provide superior function outcomes, lower complications and reduced costs. The proposed study seeks to answer this question by performing a large clinical trial comparing knee replacement versus surgical fixation in geriatric patients with distal femur fracture.
Eligibility criteria
Qualifiers
Male and female patients
65 years and older
Isolated fracture of the distal femur (Classification 33)
Fracture is amendable to both treatments
Disqualifiers
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
Trial design
Treatments tested in this trial
- Distal femoral replacement
- Surgical Fixation (ORIF)
Treatment groups
Sponsors and collaborators
Unity Health Toronto
Lead sponsor
Mount Sinai Hospital, Canada
Collaborator
NYU Langone Health
Collaborator
Brigham and Women's Hospital
Collaborator
Queen Elizabeth II Health Sciences Centre
Collaborator
Hamilton Health Sciences Corporation
Collaborator
Yale New Haven Health System Center for Healthcare Solutions
Collaborator
Oregon Health and Science University
Collaborator
OrthoCincy Orthopaedics & Sports Medicine
Collaborator
University of California
Collaborator
Hospital for Special Surgery, New York
Collaborator
Stanford University
Collaborator
Cedars-Sinai Medical Center
Collaborator
Thunder Bay Regional Health Sciences Centre
Collaborator
University of California, San Francisco
Collaborator
University of Arkansas
Collaborator
University of Calgary
Collaborator
Ascension Health
Collaborator
University of Otago
Collaborator
Gold Coast University Hospital, Australia
Collaborator
Humber River Hospital
Collaborator
Ottawa Hospital Research Institute
Collaborator