Study Design.: Prospective observational study. Objective.: The aim of this study was to evaluate the accuracy of pedicle screw placement using augmented reality surgical navigation (ARSN) in a clinical trial. Summary of Background Data.: Recent cadaveric studies have shown improved accuracy for pedicle screw placement in the thoracic spine using ARSN with intraoperative 3D imaging, without the need for periprocedural x-ray. In this clinical study, we used the same system to place pedicle screws in the thoracic and lumbosacral spine of 20 patients. Methods.: The study was performed in a hybrid operating room with an integrated ARSN system encompassing a surgical table, a motorized flat detector C-arm with intraoperative 2D/3D capabilities, integrated optical cameras for augmented reality navigation, and noninvasive patient motion tracking. Three independent reviewers assessed screw placement accuracy using the Gertzbein grading on 3D scans obtained before wound closure. In addition, the navigation time per screw placement was measured. Results.: One orthopedic spinal surgeon placed 253 lumbosacral and thoracic pedicle screws on 20 consenting patients scheduled for spinal fixation surgery. An overall accuracy of 94.1% of primarily thoracic pedicle screws was achieved. No screws were deemed severely misplaced (Gertzbein grade 3). Fifteen (5.9%) screws had 2 to 4 mm breach (Gertzbein grade 2), occurring in scoliosis patients only. Thirteen of those 15 screws were larger than the pedicle in which they were placed. Two medial breaches were observed and 13 were lateral. Thirteen of the grade 2 breaches were in the thoracic spine. The average screw placement time was 5.2 ± 4.1 minutes. During the study, no device-related adverse event occurred. Conclusion.: ARSN can be clinically used to place thoracic and lumbosacral pedicle screws with high accuracy and with acceptable navigation time. Consequently, the risk for revision surgery and complications could be minimized. Level of Evidence: 3

A cadaveric laboratory study. The aim of this study was to assess the feasibility and accuracy of thoracic pedicle screw placement using augmented reality surgical navigation (ARSN). Recent advances in spinal navigation have shown improved accuracy in lumbosacral pedicle screw placement but limited benefits in the thoracic spine. 3D intraoperative imaging and instrument navigation may allow improved accuracy in pedicle screw placement, without the use of x-ray fluoroscopy, and thus opens the route to image-guided minimally invasive therapy in the thoracic spine. ARSN encompasses a surgical table, a motorized flat detector C-arm with intraoperative 2D/3D capabilities, integrated optical cameras for augmented reality navigation, and noninvasive patient motion tracking. Two neurosurgeons placed 94 pedicle screws in the thoracic spine of four cadavers using ARSN on one side of the spine (47 screws) and free-hand technique on the contralateral side. X-ray fluoroscopy was not used for either technique. Four independent reviewers assessed the postoperative scans, using the Gertzbein grading. Morphometric measurements of the pedicles axial and sagittal widths and angles, as well as the vertebrae axial and sagittal rotations were performed to identify risk factors for breaches. ARSN was feasible and superior to free-hand technique with respect to overall accuracy (85% vs. 64%, P < 0.05), specifically significant increases of perfectly placed screws (51% vs. 30%, P < 0.05) and reductions in breaches beyond 4 mm (2% vs. 25%, P < 0.05). All morphometric dimensions, except for vertebral body axial rotation, were risk factors for larger breaches when performed with the free-hand method. ARSN without fluoroscopy was feasible and demonstrated higher accuracy than free-hand technique for thoracic pedicle screw placement. N/A.

Study Design.: Cadaveric laboratory study. Objective.: To assess the feasibility and accuracy of minimally invasive thoracolumbar pedicle screw placement using augmented reality (AR) surgical navigation. Summary of Background Data.: Minimally invasive spine (MIS) surgery has increasingly become the method of choice for a wide variety of spine pathologies. Navigation technology based on AR has been shown to be feasible, accurate, and safe in open procedures. AR technology may also be used for MIS surgery. Methods.: The AR surgical navigation was installed in a hybrid operating room (OR). The hybrid OR includes a surgical table, a motorized flat detector C-arm with intraoperative 2D/3D imaging capabilities, integrated optical cameras for AR navigation, and patient motion tracking using optical markers on the skin. Navigation and screw placement was without any x-ray guidance. Two neurosurgeons placed 66 Jamshidi needles (two cadavers) and 18 cannulated pedicle screws (one cadaver) in the thoracolumbar spine. Technical accuracy was evaluated by measuring the distance between the tip of the actual needle position and the corresponding planned path as well as the angles between the needle and the desired path. Time needed for navigation along the virtual planned path was measured. An independent reviewer assessed the postoperative scans for the pedicle screws’ clinical accuracy. Results.: Navigation time per insertion was 90 ± 53 seconds with an accuracy of 2.2 ± 1.3 mm. Accuracy was not dependent on operator. There was no correlation between navigation time and accuracy. The mean error angle between the Jamshidi needles and planned paths was 0.9° ± 0.8°. No screw was misplaced outside the pedicle. Two screws breached 2 to 4 mm yielding an overall accuracy of 89% (16/18). Conclusion.: MIS screw placement directed by AR with intraoperative 3D imaging in a hybrid OR is accurate and efficient, without any fluoroscopy or x-ray imaging during the procedure. Level of Evidence: N/A

Background: Conventional spinal navigation solutions have been criticized for having a negative impact on time in the operating room and workflow. AR navigation could potentially alleviate some of these concerns while retaining the benefits of navigated spine surgery. The objective of this study is to summarize the current evidence for using augmented reality (AR) navigation in spine surgery.Methods: We performed a systematic review to explore the current evidence for using AR navigation in spine surgery. PubMed and Web of Science were searched from database inception to November 27, 2020, for data on the AR navigation solutions; the reported efficacy of the systems; and their impact on workflow, radiation, and cost-benefit relationships.Results: In this systematic review, 28 studies were included in the final analysis. The main findings were superior workflow and non-inferior accuracy when comparing AR to free-hand (FH) or conventional surgical navigation techniques. A limited number of studies indicated decreased use of radiation. There were no studies reporting mortality, morbidity, or cost-benefit relationships.Conclusions: AR provides a meaningful addition to FH surgery and traditional navigation methods for spine surgery. However, the current evidence base is limited and prospective studies on clinical outcomes and cost-benefit relationships are needed.

This study aimed to compare screw placement accuracy and clinical aspects between Augmented Reality Surgical Navigation (ARSN) and free-hand (FH) technique. Twenty patients underwent spine surgery with screw placement using ARSN and were matched retrospectively to a cohort of 20 FH technique cases for comparison. All ARSN and FH cases were performed by the same surgeon. Matching was based on clinical diagnosis and similar proportions of screws placed in the thoracic and lumbosacral vertebrae in both groups. Accuracy of screw placement was assessed on postoperative scans according to the Gertzbein scale and grades 0 and 1 were considered accurate. Procedure time, blood loss and length of hospital stay, were collected as secondary endpoints. A total of 262 and 288 screws were assessed in the ARSN and FH groups, respectively. The share of clinically accurate screws was significantly higher in the ARSN vs FH group (93.9% vs 89.6%, p < 0.05). The proportion of screws placed without a cortical breach was twice as high in the ARSN group compared to the FH group (63.4% vs 30.6%, p < 0.0001). No statistical difference was observed for the secondary endpoints between both groups. This matched-control study demonstrated that ARSN provided higher screw placement accuracy compared to free-hand.

To evaluate the efficacy of early intracranial pressure (ICP)-targeted treatment, compared to standard intensive care, in adults with community acquired acute bacterial meningitis (ABM) and severely impaired consciousness. A prospectively designed intervention-control comparison study of adult cases from September 2004 to January 2012. Included patients were confirmed ABM-cases, aged 16–75 years, with severely impaired mental status on admission. Fifty-two patients, given ICP-targeted treatment at the neuro-intensive care unit, and 53 control cases, treated with conventional intensive care, were included. All the patients received intensive care with mechanical ventilation, sedation, antibiotics and corticosteroids according to current guidelines. Additional ICP-treatment in the intervention group included cerebrospinal fluid drainage using external ventricular catheters (n = 48), osmotherapy (n = 21), hyperventilation (n = 13), external cooling (n = 9), gram-doses of methylprednisolone (n = 3) and deep barbiturate sedation (n = 2) aiming at ICP 50 mmHg. The primary endpoint was mortality at two months and secondary endpoint was Glasgow outcome score and hearing ability at follow-up at 2–6 months. The mortality was significantly lower in the intervention group compared to controls, 5/52 (10%) versus 16/53 (30%; relative risk reduction 68%; p<0.05). Furthermore, only 17 patients (32%) in the control group fully recovered compared to 28 (54%) in the intervention group (relative risk reduction 40%; p<0.05). Early neuro-intensive care using ICP-targeted therapy, mainly cerebrospinal fluid drainage, reduces mortality and improves the overall outcome in adult patients with ABM and severely impaired mental status on admission.