Interim results from a world-first prospective study demonstrate that robotic-guided spine surgery results in a five-fold decrease in the rate of surgical complications, and in a seven-fold decrease in revision surgeries, compared to traditional minimally invasive surgery in the lumbar spine.
The multi-centre, prospective, partially randomised study—begun in 2014, and called MIS ReFRESH—analysed the surgical outcomes of 379 patients, of whom 287 received percutaneous/minimally invasive robotic-guided spinal fixation surgery, and 92 who received the surgery under fluoroscopy, either navigated or freehand. Both cohorts were comprised of adults aged 21 years or older who required thoracic, lumbar or lumbosacral surgery on four or fewer vertebrae levels.
The interim results from MIS ReFRESH show that the relative risk for a surgical adverse event (AE) or complication was 5.3 times higher in the fluoro-guided study cohort compared to the robotic-guided surgery cohort (p<0.001), and that the relative incidence of revision surgery was 7.1 times higher (p=0.012).
The robotic-guided surgery was conducted using a proprietary Mazor Core system from Mazor Robotics. Mazor are calling the results “groundbreaking”.
“The results of this study completely eliminated any doubt I have had about the superiority of robotic-guided spine surgery,” says orthopaedic surgeon Christopher Good (Virginia Spine Institute, USA). “We see remarkable improvements in patient safety and value as well as cost savings when using Mazor Core technology-based systems.”
The study compared traditional fluoroscopic-guided freehand procedures to the Renaissance guidance system, which uses the Mazor Core technology, at one year post-surgery. The data was prospectively collected by 10 surgeons from nine US centres.
“We believe that this is the first multi-centre, prospective, controlled study of robotic-guided spine surgery,” says Ori Hadomi, CEO of Mazor Robotics. “The study’s results … validate the clinical outcome superiority of Mazor Core technology”. He noted that the company finds it “rewarding” to deliver the study’s findings to the medical community.
The results of the study will be presented at the North American Spine Society (NASS) annual meeting in Orlando, USA by Good on Thursday, October 26 at 1:05pm local time.