The XVS System During Open Spinal Fixation Procedures in Patients Requiring Pedicle Screw Placement in the Lumbosacral Spine

Objective: This pilot study was undertaken to evaluate the safety, performance, and usability of the Xvision-Spine (XVS) System (Augmedics, Arlington Heights, IL) during open spinal fixation procedures in patients requiring pedicle screw placement in the lumbosacral spine. Methods: The XVS System is an augmented reality head-mounted display (HMD) based on a computer navigation system designed to assist surgeons in accurately placing pedicle screws. It uses an HMD-mounted tracking camera to provide optical tracking technology, and provides the surgeon a translucent direct near-eye display of the navigated surgical instrument's location relative to the computed tomographic image. We report the preliminary results of a prospective series of all consecutive patients who underwent augmented reality-assisted pedicle screw placement in the lumbosacral vertebrae at 3 institutions. Clinical accuracy for each pedicle screw was graded with Gertzbein-Robbins scores by 2 independent and blinded neuroradiologists. Results: The 19 study participants included 8 men and 11 women with a mean age of 59.13 ± 12.09 and 59.91 ± 12.89 years, respectively. Seventeen procedures were successfully completed via the XVS System. Two procedures were not completed due to technical issues with the system's intraoperative scanner. A total of 86 screws were inserted. The accuracy of the XVS System was 97.7%. Conclusions: The XVS System's performance in accurate placement of pedicle screws in the lumbosacral vertebrae had an overall accuracy of 97.7%. These preliminary results were comparable to the accuracy of other manual computer-assisted navigation systems reported in the literature.