Multicentre, retrospective study finds SpineAssist to be clinically acceptable and accurate in 98% of spinal implant placements when compared to free-hand surgeries.
Mazor Robotics has announced that the journal Spine has published the results from a multicentre, retrospective study which found the company’s SpineAssist to be clinically accurate in 98% of implant placements in spinal surgery. By comparison, free-hand implant placements are documented in the literature to be misplaced in about 10% 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 USA, Germany, and Israel between June 2005 and June 2009. Accuracy of implant placement was assessed by intra-operative imaging and postoperative CT scans, which were performed in a subset of cases.
49% of the cases reported in the study used a minimally invasive approach, highlighting the contribution of SpineAssist to challenging procedures requiring highly developed surgical skills.
“SpineAssist is currently the only robotic system that provides surgical guidance for spine surgeries, redefining the standard of care that surgeons can provide for their patients,” said Ori Hadomi, CEO of Mazor Robotics. “Its higher accuracy means that more people are able to live with less pain and debilitation, a reality made possible through the combination of our unique technology and the skill of the surgeons who use the system.”
Overall, 3,271 pedicle screws (the most common type of spinal implants) and guide-wires were inserted in 635 patients. 98% of these were found to be clinically acceptable by fluoroscopic images. Accuracy of 646 implants placed in 139 patients was determined by postoperative CT scans, demonstrating that 98.3% 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 only four cases (0.5%), and following revisions were completely repaired. This is in sharp contrast to the 0.6% – 5% of neurological damage reported in the literature, 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.
The full study is available in the November 15, 2010 issue of Spine.