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 spine surgery reduces tissue dissection and retraction, decreasing the morbidity associated with traditional open spine surgery by decreasing blood loss, blood transfusion, complications, and pain. One of the key challenges with a minimally invasive approach is achieving consistent posterior fusion. Although advantageous in all fusion surgeries, solid posterior fusion is particularly important in spinal deformity, revisions, and fusions without anterior column support. A minimally invasive surgical approach accomplished without sacrificing the quality of the posterior fusion has the potential to decrease both short- and long-term complications compared to the traditional open techniques. Innovations in navigated and robotic-assisted spine surgery continue to address this need. In this article, we will outline the feasibility of achieving posterior facet fusion using the Mazor X Stealth Edition Robotic Guidance System.

Study Design Prospective cohort study. Objectives In spine surgery, accurate screw guidance is critical to achieving satisfactory fixation. Augmented reality (AR) is a novel technology to assist in screw placement and has shown promising results in early studies. This study aims to provide our early experience evaluating safety and efficacy with an Food and Drug Administration-approved head-mounted (head-mounted device augmented reality (HMD-AR)) device. Methods Consecutive adult patients undergoing AR-assisted thoracolumbar fusion between October 2020 and August 2021 with 2 -week follow-up were included. Preoperative, intraoperative, and postoperative data were collected to include demographics, complications, revision surgeries, and AR performance. Intraoperative 3D imaging was used to assess screw accuracy using the Gertzbein-Robbins (G-R) grading scale. Results Thirty-two patients (40.6% male) were included with a total of 222 screws executed using HMD-AR. Intraoperatively, 4 (1.8%) were deemed misplaced and revised using AR or freehand. The remaining 218 (98.2%) screws were placed accurately. There were no intraoperative adverse events or complications, and AR was not abandoned in any case. Of the 208 AR-placed screws with 3D imaging confirmation, 97.1% were considered clinically accurate (91.8% Grade A, 5.3% Grade B). There were no early postoperative surgical complications or revision surgeries during the 2 -week follow-up. Conclusions This early experience study reports an overall G-R accuracy of 97.1% across 218 AR-guided screws with no intra or early postoperative complications. This shows that HMD-AR-assisted spine surgery is a safe and accurate tool for pedicle, cortical, and pelvic fixation. Larger studies are needed to continue to support this compelling evolution in spine surgery.

The study design is retrospective, multi-surgeon, single-center review. The objective is to evaluate complication rates, revision rates, and accuracy grading for robotic-guided S2 alar-iliac (S2AI) screws. Sixty-five consecutive patients underwent S2AI fixation (118 screws) as part of a posterior spine fusion using robotic-guidance. Screws were placed percutaneously in 14 cases and 51 were placed in an open fashion by three board-certified spine surgeons using the Mazor core technology robotic systems (Mazor X, n = 42; Mazor XSE, n = 23). Medical charts were retrospectively reviewed for revisions and complications. All patients were followed for 90 days or greater. Postoperative CT scans were obtained in 22 of the 51 patients, allowing for 46 screws to be reviewed by an independent neuroradiologist who graded the screws for accuracy. There were no intraoperative or postoperative complications associated with S2AI screw placement. There were no revisions found to be related to the S2AI screw placement. All 46 screws evaluated with postoperative CT scans were reported as being at the highest level of accuracy, grade A, with a breach distance of 0 mm (no breach). The robotic-guided technique for S2AI screw placement is a reliable method to achieving pelvic fixation with low complication and revision rates. In addition, a high degree of accuracy can be achieved without relying on visible and tactile landmarks needed for the freehand technique or the additional radiation associated with fluoroscopic-guidance.

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