Study of the eCential Robotics System for Improving Pedicle Screw Placement Accuracy in Spine Surgery at Amiens Picardie University Hospital

What this Trial Is About

Researchers are studying the use of the eCential Robotics surgical robot to improve the precision and safety of spinal surgery, especially for placing pedicle screws. This prospective study aims to confirm the safety, performance, and clinical benefits of this robotic system, which allows advanced preoperative planning using three-dimensional imaging to better understand each patients anatomy. The research supports the CE marking process for this innovative technology. The study evaluates the eCential Robotics solution, a unified platform combining 2D3D imaging, navigation, and robotics. The procedure involves patient reference setup on spinal processes, low-dose 2D and 3D imaging with a motorized X-ray C-arm, intraoperative implant planning, navigation using pre-calibrated instruments, and collaborative robot-surgeon handling to align pedicle aiming instruments. Real-time 3D visualization guides the procedure, and 3D imaging is used to verify screw placement. Participants will undergo spinal surgery using the robotic system and will be monitored for pedicle screw accuracy using the Gertzbein-Robbins Scale over 12 months. Additional outcomes include blood loss, operative time, X-ray exposure, hardware or software malfunctions, complications during and after surgery, discharge time, hospital stay length, and adverse events up to 12 months post-operation. The study begins with surgery and continues with follow-up assessments to evaluate safety and effectiveness over time.

Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery