What is the Purpose of this Study?
This study focuses on individuals who have a distal femur fracture. A distal femur fracture is a condition in which the bone breaks in several pieces above the knee joint, requiring surgery. The purpose of the study is to determine which of two types of treatment for distal femur fracture will result in less pain and best recovery (i.e., walk faster, return to daily activities). One treatment option is called surgical fixation. The surgeon fixes the bone with plates or nails, screws, and cables/wires along the side of the fractured bone to hold it together. The other treatment method is called distal femoral replacement, in which the surgeon replaces the knee joint with an artificial knee prosthesis. While both surgeries have been shown to treat fractures successfully, surgeons do not know which one is best. The goal of the study is to directly compare the two treatments to learn which is better (or if they have the same results). Participants will be randomly assigned to receive either distal femoral replacement or surgical fixation.
Eligibility
- * Male and female patients
- * 65 years and older
- * Isolated fracture of the distal femur (Classification 33)
- * Fracture is amendable to both treatments
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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
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
DIFFIR: Geriatric Distal Femur: Fixation versus Replacement
A Randomized Controlled Trial of Acute Open Reduction Internal Fixation versus Distal Femur Replacement