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.