Complications and Revision Rates in Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions

Abstract

Study Design. Prospective, multicenter, partially randomized. Objective. Assess rates of complications, revision surgery, and radiation between Mazor robotic-guidance (RG) and fluoroguidance (FG). Summary of Background Data. Minimally invasive surgery MIS ReFRESH is the first study designed to compare RG and FG techniques in adult minimally invasive surgery (MIS) lumbar fusions. Methods. Primary endpoints were analyzed at 1 year follow-up. Analysis of variables through Cox logistic regression and a Kaplan-Meier Survival Curve of surgical complications. Results. Nine 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 ¼ 0.009) and body mass index (BMI) was 31.2 versus 28.1 (P< 0.001). Percentage of smokers was almost double in the RG (15.2% vs. 7.2%, P ¼ 0.029). Surgical time was similar (skin-toskin time/no. of screws) at 24.9 minutes RG and 22.9 FG (P ¼ 0.550). Fluoroscopy during surgery/no. of screws was 15.5 seconds RG versus 35.4 seconds FG, (15 seconds average reduction). Fluoroscopy time during instrumentation/no. of screws was 3.6 seconds RG versus 17.8 seconds FG showing an 80% average reduction of fluoro time/screw in RG (P < 0.001). Within 1 year follow-up, there were 39 (10.4%) surgical complications RG versus 39 (35.1%) FG, and 8 (2.1%) revisions RG versus 7 (6.3%) FG. Cox regression analysis including age, sex, BMI, CCI, and no. of screws, demonstrated that the hazard ratio (HR) for complication was 5.8 times higher FG versus RG (95% CI: 3.5-9.6, P < 0.001). HR for revision surgery was 11.0 times higher FG versus RG cases (95% CI 2.9-41.2, P < 0.001). Conclusion. Mazor 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).

Minimally Invasive Posterior Facet Decortication and Fusion Using Navigated Robotic Guidance: Feasibility and Workflow Optimization

“…In the prospective comparative MIS ReFRESH study, Good et al [ 1 ] showed that MIS robotic-guided surgery had 5.8 times fewer surgical complications related to screw placement and 11.0 times fewer revision surgeries compared to MIS fluoroscopic-guided surgery. The study also showed a reduction of intraoperative radiation exposure by 80% with robotic guidance.…”

“…A growing body of literature demonstrates that robotic-guided spine surgery leads to decreased implant-related complications, revision surgeries, and intraoperative radiation exposure while achieving a high a degree of implant accuracy [ 1 - 4 ]. Given the potential advantages to minimally invasive robotic-guided spine surgery combined with navigation and the latest robotic software advancements, utilization of these invaluable intraoperative tools is expected to increase.…”

Index Surgery Cost of Fluoroscopic Freehand Versus Robotic-Assisted Pedicle Screw Placement in Lumbar Instrumentation: An Age, Sex, and Approach-Matched Cohort Comparison

“…The current literature indicates that the accuracy and precision with the use of robotics is highly effective, both in cadaver studies and patient cases. 29 The complication rate was reduced in two studies reviewing robot-assisted MISs in comparison with fluoroscopy-guided surgeries, 3 , 30 and there were few studies that indicated lower revision surgery and revision rates with the use of robotics. 3 , 31 , 32 Kantelhardt et al 3 reported a reduction in average length of hospital stay by 27%.…”

Development and Clinical Trial of a New Orthopedic Surgical Robot for Positioning and Navigation

“…Furthermore, few complications happened in the Tuoshou group, which is consistent with the high safety of robotic surgery. Additionally, similar to other spinal surgical robots, the Tuoshou robot only needs one time of three-dimensional scan during the operation, which greatly reduces radiation exposure [ 27 , 28 ].…”