Complication Rate in Robotic-Guided vs Fluoro-Guided Minimally Invasive Spinal Fusion Surgery: Report from MIS Refresh Prospective Comparative Study

Abstract

BACKGROUND CONTEXT: As robotic-guidance is becoming more common in spine surgery, there has been a growing body of literature on the technology's accuracy, reduction of intraoperative radiation and surgical efficiency. Yet little has been reported in the literature on its impact on surgical complication rates. The authors present a time-sensitive analysis of complications from the MIS ReFFRESH prospective comparative study. PURPOSE: To prospectively assess the impact of robotic-guidance, compared to fluoro-guidance, on the complication rate in minimally invasive short lumbar fusions. STUDY DESIGN/SETTING: Prospective, multicenter, controlled, partially randomized study. PATIENT SAMPLE: Adults suffering from degenerative disease of the lumbar spine indicated for fusion surgery of 1–3 levels. OUTCOME MEASURES: Clinically significant complications (ie, unresolved new neurological deficits, infections requiring irrigation and debridement, complaints requiring a revision or readmission for treatment) were assessed in a Cox regression and plotted on a Kaplan-Meier Survival Curve, to assess the event rate at 90, 180 and 365 days postsurgery. METHODS: Data were prospectively collected from adult patients indicated for fusion surgery, including multiple data-points such as demographics, indication for surgery and complications. A single site randomized patients between robotic-guided (RG) and fluoro-guided (FG) arms, while other sites enrolled exclusively to one arm. A multivariate logistic regression analysis was performed to assess the odds ratio for a complication between the 2 study arms. RESULTS: Altogether, 7 sites enrolled 329 cases, 250 in RG and 79 in FG. One site randomized patients, 15 to RG and 11 to FG. RG patients were slightly older than in FG (58.9 vs 62.1 years respectively, p=.065) and had a higher BMI (31.3 vs 28.0, p