Study: Robotic Surgery = 5-Fold Decline in Complications
Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, November 8th, 2017
A new, prospective, comparative, multi-center study sponsored by Israeli based Mazor Robotics Ltd provides quantitative evidence that robotic assist devices like the Mazor system, can reduce complications five-fold and revision surgeries seven-fold.
Mazor, which has a strategic distribution agreement with Medtronic Spine, announced the results of this significant new study on October 25.
According to Mazor, “The results demonstrate that spinal surgeries performed using Mazor Robotics’ proprietary Mazor Core technology have a five-fold reduction in surgical complications and a seven-fold reduction in revision surgeries, compared to freehand-based minimally invasive lumbar fusion surgeries.
“The study compared procedures using the Renaissance Guidance System, which is powered by Mazor Core technology, to fluoroscopic-guided, freehand procedures at one year post-surgery.”
“The study called MIS ReFRESH is a prospective, comparative, multi-center study in robotic-guided spine surgery. It is designed to assess the clinical impact of robotic-guidance, compared to fluoro-guidance on the incidence of clinical complications and revisions and use of intra-operative fluoroscopy.”
“The prospective study was initiated in 2014. There were 379 patients enrolled in the study, of which 287 were in the robotic-guided arm and 92 in the fluoro-guided control arm.”
“The results of this study completely eliminated any doubt I have had about the superiority of robotic-guided spine surgery,” commented Christopher Good, M.D. a nationally recognized orthopedic surgeon at the Virginia Spine Institute. “We see remarkable improvements in patient safety and value as well as cost savings when using Mazor Core technology-based systems.”
Ori Hadomi, chief executive officer of Mazor Robotics, told OTW, “This is the first time that robotic-guided spine surgery has been studied using the rigorous methodology of a prospective, controlled, multi-center study. It was designed to assess the clinical impact of robotic-guidance, compared to fluoro-guided procedures.”
“Studies of robotics often focus on accuracy, which does not always correlate to clinical outcomes. The major leap forward with MIS ReFRESH is that it goes beyond accuracy to assess the true impact of this technology on patient health and its translation to hospital economics by looking at clinical complications and revision surgeries.”
“The study revealed that spinal surgeries performed using Mazor Robotics’ proprietary Mazor Core technology have a five-fold reduction in surgical complications and a seven-fold reduction in revision surgeries, compared to freehand-based minimally invasive lumbar fusion surgeries: Relative Risk (RR) for an adverse event or complication was 5.3 times higher in the fluoro-guided control arm compared to the robotic guidance arm. Relative risk for revision surgery was 7.1 times higher for a fluoro-guided surgery compared to the robotic-guided cases.”
“Evidence-based medicine is fundamental to what we do, and we have consistently pursued clinical studies to evaluate the Mazor Core technology.”
“When looking at the results of our prospective, controlled study, we now have scientific evidence that demonstrates the impact of our product on patient outcomes when compared to fluoroscopic-guidance. In fact, Dr. Christopher Good, of the Virginia Spine Institute, was the only surgeon willing to randomize his cases between robotic-guided versus fluoro-guided, but after seeing the results, decided it was unethical for him to do so because of the clear superiority of robotic-guided spine surgery. While these results speak for themselves, Mazor Core technology is unique in [the] way it works, which is very different from navigation-based products, so I would caution against extrapolating results based on Mazor Core to all guidance technologies.”