DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUnity Health Toronto

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

140 Participants
are divided into 2 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