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Compares treatment options for Distal Femur Fracture
Official title DIFFIR - Geriatric Distal Femur Fixation Versus Replacement
ClinicalTrials.gov ID: NCT04076735
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.