Complications and Revision Rates in Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions: The MIS ReFRESH Prospective Comparative Study.

Study designProspective, multicenter, partially randomized.ObjectiveAssess rates of complications, revision surgery, and radiation between Mazor robotic-guidance (RG) and fluoro-guidance (FG).Summary of background dataMinimally invasive surgery MIS ReFRESH is the first study designed to compare RG and FG techniques in adult minimally invasive surgery (MIS) lumbar fusions.MethodsPrimary endpoints were analyzed at 1 year follow-up. Analysis of variables through Cox logistic regression and a Kaplan-Meier Survival Curve of surgical complications.ResultsNine sites enrolled 485 patients: 374 (RG arm) and 111 (FG arm). 93.2% of patients had more than 1 year f/u. There were no differences for sex, Charlson Comorbidity Index, diabetes, or tumor. Mean age of RG patients was 59.0 versus 62.5 for FG (P = 0.009) and body mass index (BMI) was 31.2 versus 28.1 (PConclusionMazor robotic-guidance was found to have a 5.8 times lower risk of a surgical complication and 11.0 times lower risk for revision surgery. Surgical time was similar between groups and robotic-guidance reduced fluoro time per screw by 80% (approximately 1 min/case).Level of Evidence: 2.