NCT04076735 DIFFIR - Geriatric Distal Femur Fixation Versus Replacement
| NCT ID | NCT04076735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Unity Health Toronto |
| Condition | Distal Femur Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2021-10-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Amir Khoshbin, MD
PRINCIPAL INVESTIGATOR
St Michael's Hospital - Unity Health Toronto
Frequently Asked Questions
Who can join the NCT04076735 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Distal Femur Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04076735 currently recruiting?
Yes, NCT04076735 is actively recruiting participants. Contact the research team at cassandra.tardif-theriault@unityhealth.to for enrollment information.
Where is the NCT04076735 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04076735 clinical trial?
NCT04076735 is sponsored by Unity Health Toronto. The principal investigator is Amir Khoshbin, MD at St Michael's Hospital - Unity Health Toronto. The trial plans to enroll 140 participants.