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Compares treatment options for Distal Femur Fracture
Official title pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement
ClinicalTrials.gov ID: NCT05805774
What this study is testing
- What it's testing
- Periprosthetic distal femur fractures are a significant source of morbidity and mortality for elderly patients. One treatment option involved a surgical fixation with plates or nails, screws and cables/wires along the side of your fractured bone.
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
- 65 years and older
- Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2)
- Fracture is acute (within 1 week from time of injury)
- Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury
- Independent or moderately frail with score of 3 to 6 on the validated Clinical Frailty Scale
You likely can't join if
- Active infection around the fracture (soft tissue or bone)
- Open fracture
- Bilateral femur fractures
- Major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries
- Pathological fracture excluding osteoporosis
- Ipsilateral total knee arthroplasty using revision components (varus/valgus constraint, stemmed femoral components)
See the full eligibility criteria
- 65 years and older
- Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2)
- Fracture is acute (within 1 week from time of injury)
- Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury
- Independent or moderately frail with score of 3 to 6 on the validated Clinical Frailty Scale
- Patient is able to read and understand the consent form document, or an interpreter is available to the patient at the time of consent and follow-up
- Patient or substitute decision maker is able to provide written informed consent to participate in the study
- Active infection around the fracture (soft tissue or bone)
- Open fracture
- Bilateral femur fractures
- Major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries
- Pathological fracture excluding osteoporosis
- Ipsilateral total knee arthroplasty using revision components (varus/valgus constraint, stemmed femoral components)
- Periprosthetic distal femur fracture around a loose or failing primary total knee arthroplasty (Lewis and Rorabeck Type III)
- Ipsilateral primary partial knee or patellofemoral arthroplasty
- Previous ORIF of the distal femur or proximal tibia or patella
- Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair
- Poly-trauma status (Injury Severity Score\>15) or any associated major injuries of the lower extremities that may hinder post-operative ambulation
- Medical contraindication 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.