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

Area of Science:

• Neurosurgery
• Medical Imaging
• Augmented Reality

Background:

• Augmented reality (AR) and digital visualization technologies are increasingly integrated into surgical procedures.
• AR systems offer potential for enhanced efficiency, safety, and effectiveness, particularly in urgent or bedside scenarios.
• Accurate patient registration is crucial for AR system performance in real-world surgical applications.

Purpose of the Study:

• To quantitatively compare the performance of an AR headset-based neuronavigation system against a standard-of-care reference array-based neurosurgical stereotactic navigation system.
• To evaluate registration accuracy and time efficiency in a real-world clinical setting.

Main Methods:

• A clinical validation trial involving adult patients undergoing cranial neurosurgery.
• Preoperative CT and MR images were used to create 3D hologram models with fiducial markers for registration.
• Comparison of registration coordinates and time between the AR system and a standard stereotactic navigation system using Wilcoxon signed-rank test and linear mixed-effects models (LMM).

Main Results:

• The AR system achieved a mean registration accuracy of 2.16 ± 0.12 mm, demonstrating statistical equivalence to the control system (p < 0.001 and p < 0.003).
• Patient model registration using the AR system was significantly faster (mean 45.98 ± 15.00 seconds) compared to the control system (228.86 ± 100.06 seconds, p < 0.001).
• The mean baseline validation error of the control system was 0.73 ± 0.29 mm.

Conclusions:

• The AR neuronavigation system demonstrated statistically similar registration accuracy and significantly improved speed compared to conventional stereotactic navigation.
• AR navigation is accurate, fast, and minimally invasive, presenting opportunities for stereotaxis in resource-limited, bedside, and emergency neurosurgical settings.