pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Study Overview
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Brief Summary
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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. The second method consists in replacing your knee joint with an artificial knee prosthesis (artificial knee joint). The primary objective is to determine if acute distal femur replacement improves knee pain and functional outcomes compared to surgical fixation. Secondary outcomes are mortality, reoperation, complications, post-operative pain and quality of life. A health economic analysis will be conducted to assess the cost-effectiveness of both treatments. A total of 148 patients (74/group) will be enrolled in the study.

Official Title
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pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femur Replacement (DFR)

Conditions
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Distal Femur Fracture, Periprosthetic Fracture Around Prosthetic Joint Implant Knee, Knee Fracture

Intervention / Treatment
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* Procedure: Distal Femur Replacement
* Procedure: Surgical fixation


Participation Criteria
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Eligibility Criteria
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Inclusion 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 Exclusion Criteria: • 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A - DFR<br> | Procedure: Distal Femur Replacement<br>* Knee surgery to remove the lower part of the femur and knee joint (where the broken bones are) and will replace them with an artificial knee joint (prosthesis).<br>|
| Active Comparator: Group B - ORIF<br> | Procedure: Surgical fixation<br>* Knee surgery to fix the fracture, that can use wires, nails, screws, pins or plates to health and fix the bones together.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee function | Compare knee pain between the two groups using the Oxford Knee Score - which is a patient reported outcome measure. It assess knee function and gives a rating from 0 to 48 - being 0 bad knee function and 48 - excellent knee function. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Track patient's death. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periprosthetic Distal Femur fracture, Knee replacement, Surgical fixation, Geriatric patients