Identifying Non-Union Rates Using Carbo-fix Lateral Plate Devices and Standard Plate-Nail Construct in Distal Femur Fractures

What this Trial Is About

Researchers are evaluating ways to reduce the rates of non-union, or failure to heal, in patients with distal femur fractures. Distal femur fractures can result from high-energy trauma in younger adults or low-energy trauma in elderly individuals with osteoporosis. This trial compares two surgical approaches: the Carbo-fix carbon fiber lateral locking plate and the standard metal lateral plate combined with an intramedullary nail. Both methods are currently used as standard care, and the goal is to see which one results in fewer non-unions and better patient outcomes. Participants will be randomly assigned to receive either the Carbo-fix carbon fiber lateral plate or the standard metal plate and nail combination during surgery. Both treatments involve fixing the broken femur with implants to support healing. The Carbo-fix plate is made of carbon fiber with unique properties such as high strength and improved imaging visibility during surgery. Surgery details like length, blood loss, and complications will be recorded. Patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. During each follow-up visit, patients will have X-rays to check bone healing and will complete patient-reported outcome surveys about pain and physical function. Researchers will track the time it takes for the bone to heal, pain levels, any infections, reoperations, and alignment of the femur. Safety is monitored through standard care procedures, and patients’ medical information is kept confidential. The study aims to enroll around 100 patients over two years, with equal numbers in each treatment group.

Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures