Novel MIS 3D NAV Single Step Pedicle Screw System (SSPSS): Workflow, Accuracy and Initial Clinical Experience

Abstract

Study Design: Prospective case series. Objective: SSPSS (single step pedicle screw system) was developed for minimally invasive spine surgery. We performed this study to report on safety, workflow, and our initial clinical experience with this novel technique. Methods: The prospective study was conducted on patients who underwent pedicle screw fixation between October 2017 and April 2018 using a novel single step 3D navigated pedicle screw system for MIS. Outcome measurements were obtained from intraoperative computerized tomography. The images were evaluated to determine pedicle wall penetration. We used a grading system to assess the severity of the pedicle wall penetration. Breaches were classified as grade 1 (<2 mm), grade 2 (2-4 mm), or grade 3 (<4 mm), 1 and as cranial, caudal, medial, and lateral. Results: Our study includes 135 screws in 24 patients. SSPSS eliminated K-wires and multiple steps traditionally necessary for MIS pedicle screw insertion. The median time per screw was 2.45 minutes. 3 screws were corrected intraoperatively. Pedicle wall penetration occurred in 14 screws (10%). Grade 1 breaches occurred in 4 screws (3%) and grade 2 breaches occurred in 10 screws (7%). Lateral breaches were observed more often than medial breaches. The accuracy rate in our study was 90% (Grade 0 breach). No revision surgeries were needed and no complications occurred. Conclusions: Our study suggests that SSPSS could be a safe, accurate, and efficient tool. Our accuracy rate is comparable to that found in the literature.