Comparing Polymer OrthoLoop Cerclage to Standard Cerclage for Healing Femoral and Humeral Fractures A 36-Month Study on Prosthetic and Primary Fracture Treatments

What this Trial Is About

Researchers are investigating the use of a new polymer cerclage system called OrthoLoop in managing fractures of the femur and humerus bones, including those around prosthetic hips and shoulders. This study compares OrthoLoop to standard cerclage systems, mainly metallic ones, to see if it improves bone healing and reduces complications. The study focuses on adults aged 18 and older who require cerclage wiring as part of their fracture treatment. Participants receive either the OrthoLoop polymer cerclage device or a standard cerclage system after surgical repair of their fracture. The study is designed with two groups and follows patients for 36 months after surgery. Follow-up visits are scheduled at 6-8 weeks, 3 months, 6 months, and 36 months to monitor healing, pain, device performance, and any complications. During the study, researchers evaluate bone healing success six months after surgery, track the rate and timing of bone union, and observe any rupture or movement of the cerclage devices. Pain levels and surgical details are recorded at multiple intervals. The study also collects data on complications and surgeon satisfaction with the devices. This thorough follow-up aims to provide a detailed assessment of the OrthoLoop system compared to standard care over three years.

Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )