• Ran Harel, Yoram Anekstein, Michael Raichel, Camilo A Molina, Miguel A Ruiz-Cardozo, Emanuele Orrú, Majid Khan, Yigal Mirovsky, and Yossi Smorgick.
• Department of Neurosurgery and the Spine Unit, Sheba Medical Center, Tel Hashomer, Israel, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
• World Neurosurg. 2022 Aug 1; 164: e1226-e1232.

ObjectiveThis 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.MethodsThe 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.ResultsThe 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%.ConclusionsThe 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.Copyright © 2022 Elsevier Inc. All rights reserved.

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