DIFFIR - Geriatric Distal Femur Fixation Versus Replacement
ConditionDistal Femur Fracture
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Distal femoral replacement
Procedure/SurgeryThe distal portion of the femur (up to two thirds) is excised and replaced by a endoprosthesis incorporating a hinged total knee replacement.
Surgical Fixation (ORIF)
Procedure/SurgeryA trained orthopaedic surgeon uses open or minimally invasive reduction techniques and achieves stable fixation with internal fixation devices (plates/screws or intramedullary nail) to restore structural integrity and alignment of the distal femur
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Distal femoral replacement (DFR)Experimental treatment 1 intervention
Group B: Surgical Fixation (ORIF)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oxford Knee Score (OKS)
A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after knee replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function.
Time frame
Our primary outcome is knee pain and function as measured by repeated measures of the Oxford Knee Score at 3, 6, 9 and 12 -months post-surgery to detect a 5 point improvement on the OKS with 0.5 correlation between assessments.Secondary outcomes
1
Daily morphine equivalent usage while in hospital
Assess patient's cumulative intake of any drugs in the opioid class (in Milligram Morphine Equivalent) over 24 hours while in hospital.
Time frame
The outcome will be assessed daily from the day of the surgery until the patient gets discharge from the hospital (24 hours up to 7 days)2
Visual Analog Pain Scale (VAS)
Assess pain from a visual scale that ranges from 0 to 10. Straight line with the endpoints defining extreme limits such as 'no pain at all' (zero) and 'pain as bad as it could be' (ten)
Time frame
Pain scale will be assessed immediately after surgery at 24 hours 48 hours, and then at each follow up visit at 3, 6, 9, 12, and 24 months post-surgery3
Health status and quality of life - EQ-5D questionnaire
The European Quality of Life 5 Dimensions (EQ5D) is a patient reported outcome where patients self rate their level of severity of health status and health related quality of life. Consists of 5 dimensions (mobility, selfcare, usual activities, pain/discomfort, anxiety/depression) and each one of them has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) where patients will indicate how they feel regarding their health status and quality of life.
Time frame
Questionnaire will be completed by patients at 3, 6, 9, 12, and 24 months post-surgery4
knee range of movement (ROM)
The therapist/assessor uses a goniometer (instrument that measures an angle of a joint) to measure the degree of knee flexion and extension of a patient. Knee Flexion - the measurable degree in which the leg (and knee joint) is bent. Knee Extension - The measurable degree in which the knee is extended (making the joint angle larger, or straightening the knee)
Time frame
Test will be completed at each follow up visit at 3, 6,12 and 24 months post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov