Comparing Knee Replacement and Surgical Fixation for Older Adults with Periprosthetic Distal Femur Fractures A Randomized Trial to Improve Knee Pain and Function

What this Trial Is About

Periprosthetic distal femur fractures are serious injuries that affect elderly patients and can lead to significant health problems and risk of death. Researchers are studying whether replacing the distal femur and knee joint with an artificial knee prosthesis provides better knee pain relief and function compared to traditional surgical fixation using plates, nails, screws, or wires. This randomized controlled trial aims to compare these two surgical treatments in patients aged 65 and older who have sustained a recent fracture around a stable knee replacement. Participants will be randomly assigned to one of two groups one receiving a distal femur replacement surgery where the broken bone and knee joint are removed and replaced with an artificial joint, and the other undergoing surgical fixation to stabilize the fracture using hardware such as wires, screws, or plates. The study will enroll a total of 148 patients, with 74 in each treatment group. The trial will monitor outcomes including knee function, mortality, reoperation rates, complications, pain after surgery, and quality of life. During the study, participants will be followed for at least 12 months to assess knee function and up to 24 months to evaluate survival and other secondary outcomes. Researchers will collect data on health economics to understand the cost-effectiveness of each treatment. Patients will undergo regular assessments to monitor their recovery and any complications. The total participation time includes these follow-up periods to provide a comprehensive evaluation of both surgical approaches.

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement