Clinical validation of a rapid, markerless, headset-contained augmented reality stereotactic neuronavigation system.

Objective: Digital enhancement and visualization technologies, such as augmented reality (AR), are increasingly used in surgery. Rapid and accurate patient registration with minimal device confinements enables AR systems to increase efficiency, safety, and effectiveness, especially in urgent/emergency and/or bedside scenarios. The aim of this study was to quantitatively compare an AR headset-based neuronavigation system with a standard-of-care reference array-based neurosurgical stereotactic navigation system in a real-world setting.

Methods: This clinical validation trial included adult patients undergoing cranial neurosurgery with stereotactic navigation at a single center from February 2024 to July 2024. Preoperative CT and MR images were acquired and used for construction of a 3D hologram model that included surface-based target fiducial markers for comparison. Preoperative images were stereotactically registered to the patient's head using standard techniques. The registration coordinates for the fiducial markers (control) and registration time were recorded. The AR system was then deployed to create a separate stereotactic registration to the same preoperative images. A second set of registration coordinates for the fiducial markers (experimental) were acquired using the AR system, and the time for this process was also recorded. The Wilcoxon signed-rank test was used to assess differences in registration time, and a linear mixed-effects model (LMM) was used to conduct equivalence testing of coordinates between the control and experimental data.

Results: Twenty patients (mean age ± SD 50.05 ± 14.38 years) were included in the trial. The mean baseline validation error of the control system was 0.73 ± 0.29 mm (range 0-1.0 mm). Using the control system as ground truth, the mean registration accuracy of the AR system was 2.16 ± 0.12 mm. LMM equivalence testing, conducted with margins of 3 mm and 2.5 mm, demonstrated statistical equivalence between the ground truth and AR system coordinates (p < 0.001 and p < 0.003, respectively). The time required for patient model registration using the AR system was a mean of 45.98 ± 15.00 seconds, which was significantly shorter compared with the control system (228.86 ± 100.06 seconds, p < 0.001).

Conclusions: The AR navigation system provided statistically similar registration accuracy and significantly faster patient model registration compared with the standard-of-care stereotactic neuronavigation system. AR navigation was accurate, fast, and had a minimal footprint, offering new opportunities to incorporate stereotaxis in low-resource, bedside, and urgent/emergency settings.