A prospective clinical study for pedicle screw placement with augmented reality surgical navigation including intraoperative 3D imaging in a hybrid operating room was performed in 20 patients of whom 13 had scoliosis. The screw placement accuracy was 94.1% with an average navigation time of 5.4 minutes per screw placement.

Study Design. Cadaveric animal laboratory study. Objective. To evaluate the feasibility and accuracy of pedicle cannulation using an augmented reality surgical navigation (ARSN) system with automatic instrument tracking, yielding feedback of instrument position in relation to deep anatomy. Summary of Background Data. Minimally invasive spine surgery (MISS) has the possibility of reducing surgical exposure resulting in shorter hospital stays, lower blood loss and infection rates compared with open surgery but the drawback of limiting visual feedback to the surgeon regarding deep anatomy. MISS is mainly performed using image-guided 2D fluoroscopy, thus exposing the staff to ionizing radiation. Methods. A hybrid operating room (OR) equipped with a robotic C-arm with integrated optical cameras for augmented reality instrument navigation was used. In two pig cadavers, cone beam computed tomography (CBCT) scans were performed, a 3D model generated, and pedicle screw insertions were planned. Seventy-eight insertions were performed. Technical accuracy was assessed on post-insertion CBCTs by measuring the distance between the navigated device and the corresponding pre-planned path as well as the angular deviations. Drilling and hammering into the pedicle were also compared. Navigation time was measured. An independent reviewer assessed a simulated clinical accuracy according to Gertzbein. Results. The technical accuracy was 1.7 ± 1.0 mm at the bone entry point and 2.0 ± 1.3 mm at the device tip. The angular deviation was 1.7 ± 1.7° in the axial and 1.6 ± 1.2° in the sagittal plane. Navigation time per insertion was 195 ± 93 seconds. There was no difference in accuracy between hammering and drilling into the pedicle. The clinical accuracy was 97.4% to 100% depending on the screw size considered for placement. No ionizing radiation was used during navigation. Conclusion. ARSN with instrument tracking for MISS is feasible, accurate, and radiation-free during navigation. Level of Evidence: 3

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.Compared to conventional free-hand (FH) surgical technique, computer-assisted navigation using intraoperative 3D imaging has been shown to improve screw placement accuracy and reduce complications due to screw misplacements 1 . Moreover, improved accuracy has also been shown in more challenging conditions, such as scoliosis surgery, where it may be of even greater importance 2 . Consequently, navigation also reduces the frequency of postoperative revision surgery compared to FH surgery 3 .Although several studies have compared intraoperative image guidance to free-hand (FH) technique, the evidence in favor of navigation is still limited. In a recent systematic review, Chan et al., found only four studies comparing computed tomography (CT) guidance with free-hand methods head-to-head, including one small (10 patients in each group, 169 screws in total) randomized study 4 . Overall, the reviewers found only moderate level evidence showing that CT guidance has lower breach rates than FH, while screw-related complication rates were conflicting at 0% in CT navigation compared with 0%-1.7% in FH groups 5 . In a more recent retrospective study comparing O-arm navigation to FH, Wang et al. demonstrated higher pedicle screw accuracy and lower total

BACKGROUND Treatment of several spine disorders requires placement of pedicle screws. Detailed 3-dimensional (3D) anatomic information facilitates this process and improves accuracy. OBJECTIVE To present a workflow for a novel augmented-reality-based surgical navigation (ARSN) system installed in a hybrid operating room for anatomy visualization and instrument guidance during pedicle screw placement. METHODS The workflow includes surgical exposure, imaging, automatic creation of a 3D model, and pedicle screw path planning for instrument guidance during surgery as well as the actual screw placement, spinal fixation, and wound closure and intraoperative verification of the treatment results. Special focus was given to process integration and minimization of overhead time. Efforts were made to manage staff radiation exposure avoiding the need for lead aprons. Time was kept throughout the procedure and subdivided to reflect key steps. The navigation workflow was validated in a trial with 20 cases requiring pedicle screw placement (13/20 scoliosis). RESULTS Navigated interventions were performed with a median total time of 379 min per procedure (range 232-548 min for 4-24 implanted pedicle screws). The total procedure time was subdivided into surgical exposure (28%), cone beam computed tomography imaging and 3D segmentation (2%), software planning (6%), navigated surgery for screw placement (17%) and non-navigated instrumentation, wound closure, etc (47%). CONCLUSION Intraoperative imaging and preparation for surgical navigation totaled 8% of the surgical time. Consequently, ARSN can routinely be used to perform highly accurate surgery potentially decreasing the risk for complications and revision surgery while minimizing radiation exposure to the staff.

Spinal meningiomas are the most common adult primary spinal tumor, constituting 24–45% of spinal intradural tumors and 2% of all meningiomas. The aim of this study was to assess postoperative complications, long-term outcomes, predictors of functional improvement and differences between elderly (≥70 years) and non-elderly (18–69 years) patients surgically treated for spinal meningiomas. Variables were retrospectively collected from patient charts and magnetic resonance images. Baseline comparisons, paired testing and regression analyses were used. In conclusion, 129 patients were included, with a median follow-up time of 8.2 years. Motor deficit was the most common presenting symptom (66%). The median time between diagnosis and surgery was 1.3 months. A postoperative complication occurred in 10 (7.8%) and tumor growth or recurrence in 6 (4.7%) patients. Surgery was associated with significant improvement of motor and sensory deficit, gait disturbance, bladder dysfunction and pain. Time to surgery, tumor area and the degree of spinal cord compression significantly predicted postoperative improvement in a modified McCormick scale (mMCs) in the univariable regression analysis, and spinal cord compression showed independent risk association in multivariable analysis. There was no difference in improvement, complications or tumor control between elderly and non-elderly patients. We concluded that surgery of spinal meningiomas was associated with significant long-term neurological improvement, which could be predicted by time to surgery, tumor size and spinal cord compression.

OBJECTIVEThe goal of this study was to develop and validate a system for automatic segmentation of the spine, pedicle identification, and screw path suggestion for use with an intraoperative 3D surgical navigation system.METHODSCone-beam CT (CBCT) images of the spines of 21 cadavers were obtained. An automated model-based approach was used for segmentation. Using machine learning methodology, the algorithm was trained and validated on the image data sets. For measuring accuracy, surface area errors of the automatic segmentation were compared to the manually outlined reference surface on CBCT. To further test both technical and clinical accuracy, the algorithm was applied to a set of 20 clinical cases. The authors evaluated the system’s accuracy in pedicle identification by measuring the distance between the user-defined midpoint of each pedicle and the automatically segmented midpoint. Finally, 2 independent surgeons performed a qualitative evaluation of the segmentation to judge whether it was adequate to guide surgical navigation and whether it would have resulted in a clinically acceptable pedicle screw placement.RESULTSThe clinically relevant pedicle identification and automatic pedicle screw planning accuracy was 86.1%. By excluding patients with severe spinal deformities (i.e., Cobb angle > 75° and severe spinal degeneration) and previous surgeries, a success rate of 95.4% was achieved. The mean time (± SD) for automatic segmentation and screw planning in 5 vertebrae was 11 ± 4 seconds.CONCLUSIONSThe technology investigated has the potential to aid surgeons in navigational planning and improve surgical navigation workflow while maintaining patient safety.

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.

Study Design. Prospective observational study. Objective. To assess staff and patient radiation exposure during augmented reality surgical navigation in spine surgery. Summary of Background Data. Surgical navigation in combination with intraoperative three-dimensional imaging has been shown to significantly increase the clinical accuracy of pedicle screw placement. Although this technique may increase the total radiation exposure compared with fluoroscopy, the occupational exposure can be minimized, as navigation is radiation free and staff can be positioned behind protective shielding during three-dimensional imaging. The patient radiation exposure during treatment and verification of pedicle screw positions can also be reduced. Methods. Twenty patients undergoing spine surgery with pedicle screw placement were included in the study. The staff radiation exposure was measured using real-time active personnel dosimeters and was further compared with measurements using a reference dosimeter attached to the C-arm (i.e., a worst-case staff exposure situation). The patient radiation exposures were recorded, and effective doses (ED) were determined. Results. The average staff exposure per procedure was 0.21 ± 0.06 μSv. The average staff-to-reference dose ratio per procedure was 0.05% and decreased to less than 0.01% after a few procedures had been performed. The average patient ED was 15.8 ± 1.8 mSv which mainly correlated with the number of vertebrae treated and the number of cone-beam computed tomography acquisitions performed. A low-dose protocol used for the final 10 procedures yielded a 32% ED reduction per spinal level treated. Conclusion. This study demonstrated significantly lower occupational doses compared with values reported in the literature. Real-time active personnel dosimeters contributed to a fast optimization and adoption of protective measures throughout the study. Even though our data include both cone-beam computed tomography for navigation planning and intraoperative screw placement verification, we find low patient radiation exposure levels compared with published data. Level of Evidence: 3