Evaluation of a New Unified Robotic Platform: a Cadaver Study

Abstract

The Spine Cobot System (eCential Robotics, France) is a new platform which unifies 2D/3D imaging, navigation and a robotic arm. The intent is to increase patient and surgeon safety without adding time or complexity to the surgical workflow. The primary endpoint of this cadaveric trial is to assess the precision and safety of pedicular screw positioning. The secondary endpoint is to confirm the system’s usability by the operative team. The Spine Cobot System is composed of a C-arm, a station which includes the software, an infrared camera and a collaborative robotic arm (cobot). Screw placement and neural safety were assessed. Precision of screw placement was determined by comparing the final 3D acquisition to the surgeon’s planned trajectory. Safety was quantified by 3 blinded surgeons using the Gertzbein-Robbins classification. Additionally, the usability of the integrated system for spine surgery was assessed. A system evaluation was performed in compliance with international standards (IEC, FDA). Three experienced surgeons placed 90 pedicular screws in 3 prone cadavers. 100% (90/90) of the screws were accurately placed according to the Gertzbein-Robbins classification. 97% (87/90) were classified as Grade 0 and 3% (3/90) as Grade 1. The average pilot hole middle point distance deviation is 1.3mm±0.88 mm. The average pilot hole angular deviation is 0.6°±0.6°. Only 2 usability errors were observed during the workflow assessment, and none was critical for patient safety. This preliminary study shows the efficiency of the system for pedicular screw placement, with precision and safety results. This confirms the functionality of a unified system for usability and effectiveness.