Novel Pedicle Navigator Based on Micro Inertial Navigation System (MINS) and Bioelectric Impedance Analysis (BIA) to Facilitate Pedicle Screw Placement in Spine Surgery: Study in a Porcine Model.

<bold>Study Design: </bold>A porcine model.<bold>Objective: </bold>The study aims to design a novel pedicle navigator based on micro-inertial navigation system (MINS) and bioelectrical impedance analysis (BIA) to assist place pedicle screw placement and validate the utility of the system in enhancing pedicle screw placement.<bold>Summary Of Background Data: </bold>The incidence of pedicle screw malpositioning in complicated spinal surgery is still high.Procedures such as computed tomography image-guided navigation, and robot-assisted surgery have been used to improve the precision of pedicle screw placement, but it remains an unmet clinical need.<bold>Methods: </bold>The miniaturized integrated framework containing MINS was mounted inside the hollow handle of the pedicle finder. The inner core was complemented by a high-intensity electrode for measuring bioelectric impedance. Twelve healthy male Wuzhishan minipigs of similar age and weight were used in this experiment and randomized to the MINS-BIA or freehand (FH) group. Pedicle screw placement was determined according to the modified Gertzbein-Robbins grading system on computed tomography images. An impedance detected by probe equal to the baseline value for soft tissue was defined as cortical bone perforation.<bold>Results: </bold>A total of 216 screws were placed in 12 minipigs. There were 15 pedicle breaches in the navigator group and 31 in the FH group; the detection rates of these breaches were 14 of 15 (93.3%) and 25 of 31 (80.6%), respectively, with a statistically significant difference between groups. The mean offsets between the planned and postoperatively measured tilt angles of the screw trajectory were 4.5° ± 5.5° in the axial plane and 4.8° ± 3.3° in the sagittal plane with the navigator system and 7.0° ± 5.1° and 7.7° ± 4.7°, respectively, with the FH technique; the differences were statistically significant.<bold>Conclusion: </bold>A novel and portable navigator based on MINS and BIA could be beneficial for improving or maintaining accuracy while reducing overall radiation exposure. [ABSTRACT FROM AUTHOR]