140. Complications and revision rates in minimally invasive Mazor robotic-guided vs fluoroscopic-guided spinal fusions: the MIS ReFRESH prospective comparative study

BACKGROUND CONTEXT As robotic-guidance and minimally invasive approaches become more prevalent in spine surgery, there is a growing interest in high-level scientific evidence of their clinical value. MIS ReFRESH is the first prospective, multicenter study designed to compare robotic-guidance and fluoroscopic techniques for differences in surgical complications, revision surgery rates and exposure to intraoperative radiation. The MIS ReFRESH study assessed adults undergoing minimally invasive (MIS) lumbar fusions of 1-3 levels. PURPOSE To prospectively assess the impact of Mazor robotic-guidance compared to fluoro-guidance on the rates of surgical complications, revision surgery and intraoperative radiation exposure in MIS short lumbar fusions. STUDY DESIGN/SETTING Prospective, multicenter, controlled, partially randomized study. PATIENT SAMPLE Adult patients with degenerative lumbar conditions undergoing minimally invasive fusion of 1-3 levels. OUTCOME MEASURES Comparison of incidence of surgical complications, revision surgeries and intraoperative fluoroscopy time. Analysis of variables through Cox logistic regression model and a Kaplan Meyer Survival Curve of surgical complications. METHODS Data were prospectively collected from adult patients indicated for lumbar fusion surgery, including demographics, comorbidities, surgical complications, revision surgeries and use of intraoperative fluoroscopy (in seconds). A single site randomized patients between arms, while other sites enrolled exclusively to one arm. Primary endpoints were analyzed at 1-year follow-up. RESULTS A total of 9 sites enrolled 485 patients: 374 in the robot-guided arm (RG), and 111 in the fluoro-guided arm (FG). One site randomized patients, 16 to RG and 11 to FG. 93.2% of patients had \u003e1 year follow-up and were included in the analysis of primary endpoints. There were no differences between the groups with regards to gender, Charlson Comorbidity Index (CCI), Diabetes, Cancer or HIV status. RG patients were significantly heavier, younger and included more smokers. Mean age of RG patients was 59.0 years vs 62.5 for FG (p=0.009) and BMI was 31.2 vs 28.1, respectively (p CONCLUSIONS In a prospective, multicenter, comparative study of MIS lumbar fusions, surgeries performed with Mazor robotic guidance were found to have a 5.2 times lower risk of developing a surgical complication and 8.8 times lower risk for revision surgery compared to fluoro-guidance during the first year of follow-up. Normalized surgical times/instrumentation were similar between the two groups and RG reduced fluoro time per screw by 80%, or approximately a minute per case. FDA DEVICE/DRUG STATUS Mazor Renaissance Robotics (Approved for this indication).