DIFFIR: Geriatric Distal Femur Fixation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femoral Replacement (DFR)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
St Michael's Hospital - Unity Health Toronto
RECRUITING
Toronto
Contact Information
Primary
Cassandra Tardif-Theriault, BKin
cassandra.tardif-theriault@unityhealth.to
+1416-864-6060
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2028-10-10
Participants
Target number of participants: 140
Treatments
Experimental: Distal femoral replacement (DFR)
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.
Active_comparator: Surgical Fixation (ORIF)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Ascension Health, Humber River Hospital, Stanford University, University of California, Brigham and Women's Hospital, University of Arkansas, Yale New Haven Health System Center for Healthcare Solutions, Thunder Bay Regional Health Sciences Centre, Oregon Health and Science University, Hamilton Health Sciences Corporation, University of Calgary, Gold Coast University Hospital, Australia, University of Otago, NYU Langone Health, Cedars-Sinai Medical Center, Hospital for Special Surgery, New York, Queen Elizabeth II Health Sciences Centre, Mount Sinai Hospital, Canada, OrthoCincy Orthopaedics & Sports Medicine, University of California, San Francisco
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov