Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial

What this Trial Is About

Researchers are evaluating the use of the ADAPT system, a computer navigation tool that creates a 3D reconstruction of the femoral head during surgery, to improve the treatment of proximal femur fractures. This study compares intramedullary nailing procedures done with the ADAPT system to those done without it, aiming to improve screw placement, reduce surgery time, and lower radiation exposure. The trial is a randomized controlled study involving patients aged 50 to 85 years with specific types of femoral fractures. Participants will be randomly assigned to one of two groups: one group will receive intramedullary nailing assisted by the ADAPT system, which provides real-time tracking of screw placement, and the other group will undergo standard intramedullary nailing without this navigation aid. Both groups will have their surgeries assessed under blinded conditions, and the study will enroll a total of 96 patients. Data collected will include surgery duration, blood loss, radiation exposure, and surgeon satisfaction. During the one-year participation, patients will have follow-up visits to evaluate fracture healing, complications such as screw cut-out or cut-through, pain levels using a visual scale, and hip function through the Oxford Hip Score. The primary outcome is the tip to apex distance measured on X-rays immediately after surgery. Safety and adverse events related to treatment will be monitored throughout the follow-up period, which lasts up to 12 months after surgery.

A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System