Mazor Robotics, a developer of surgical robots and complementing products, announced today that Spine, a leading journal in its field, has published the results from a multi-center, retrospective study that found the company's SpineAssist® to be clinically accurate in 98 percent of implant placements in spinal surgery. By comparison, free-hand implant placements are documented in the literature to be misplaced in about 10 percent of cases. Additionally, the study demonstrated that SpineAssist contributes to significantly lower rates of misplaced screws and neurological deficits than free-hand procedures.
The study, designed to clarify the clinical acceptance of robotically-guided spinal implants, was based on clinical experience obtained from more than 840 cases performed in 14 hospitals in the U.S., Germany and Israel between June 2005 and June 2009. Accuracy of implant placement was assessed by intraoperative imaging and postoperative CT scans, which were performed in a subset of cases.
Overall, 3,271 pedicle screws and guide-wires were inserted in 635 patients. It was found that 98 percent of these were clinically acceptable by fluoroscopic images. Accuracy of 646 implants placed in 139 patients was determined by postoperative CT scans, demonstrating that 98.3 percent of the implants were within the safe zone.
In the study, none of the patients operated on with SpineAssist experienced any long term neurological deficits. Moreover, neurological deficits were observed in four cases, and, following revisions, were completely repaired. This is in contrast to the 0.6 to five percent of neurological damage reported when performed free-hand.
The SpineAssist system consists of a robotic device that mounts above the patient’s spine and a workstation running advanced surgical planning software. The system is both FDA cleared and CE marked.