First in man in-situ augmented reality pedicle screw navigation

Background Augmented reality (AR) is a rising technology gaining increasing utility in medicine. By superimposing the surgical site and the operator's visual field with computer-generated information, it has the potential to enhance the cognitive skills of surgeons. This is the report of the first in man case with "direct holographic navigation" as part of a randomized controlled trial. Case description A pointing instrument was equipped with a sterile fiducial marker, which was used to obtain a digital representation of the intraoperative bony anatomy of the lumbar spine. Subsequently, a previously validated registration method was applied to superimpose the surgery plan with the intraoperative anatomy. The registration result is shown in situ as a 3D AR hologram of the preoperative 3D vertebra model with the planned screw trajectory and entry point for validation and approval by the surgeon. After achieving alignment with the surgery plan, a borehole is drilled and the pedicle screw placed. Postoperativ computer tomography was used to measure accuracy of this novel method for surgical navigation. Outcome Correct screw positions entirely within bone were documented with a postoperative CT, with an accuracy similar to current standard of care methods for surgical navigation. The patient was mobilized uneventfully on the first postoperative day with little pain medication and dismissed on the fourth postoperative day. Conclusion This first in man report of direct AR navigation demonstrates feasibility in vivo. The continuation of this randomized controlled study will evaluate the value of this novel technology

Augmented reality navigation for spinal pedicle screw instrumentation using intraoperative 3D imaging

BACKGROUND CONTEXT Due to recent developments in augmented reality with head-mounted devices, holograms of a surgical plan can be displayed directly in the surgeon's field of view. To the best of our knowledge, three dimensional (3D) intraoperative fluoroscopy has not been explored for the use with holographic navigation by head-mounted devices in spine surgery. PURPOSE To evaluate the surgical accuracy of holographic pedicle screw navigation by head-mounted device using 3D intraoperative fluoroscopy. STUDY DESIGN In this experimental cadaver study, the accuracy of surgical navigation using a head-mounted device was compared with navigation with a state-of-the-art pose-tracking system. METHODS Three lumbar cadaver spines were embedded in nontransparent agar gel, leaving only commonly visible anatomy in sight. Intraoperative registration of preoperative planning was achieved by 3D fluoroscopy and fiducial markers attached to lumbar vertebrae. Trackable custom-made drill sleeve guides enabled real-time navigation. In total, 20 K-wires were navigated into lumbar pedicles using AR-navigation, 10 K-wires by the state-of-the-art pose-tracking system. 3D models obtained from postexperimental CT scans were used to measure surgical accuracy. MF is the founder and shareholder of Incremed AG, a Balgrist University Hospital start-up focusing on the development of innovative techniques for surgical executions. The other authors declare no conflict of interest concerning the contents of this study. No external funding was received for this study. RESULTS No significant difference in accuracy was measured between AR-navigated drillings and the gold standard with pose-tracking system with mean translational errors between entry points (3D vector distance; p=.85) of 3.4±1.6 mm compared with 3.2±2.0 mm, and mean angular errors between trajectories (3D angle; p=.30) of 4.3°±2.3° compared with 3.5°±1.4°. CONCLUSIONS In conclusion, holographic navigation by use of a head-mounted device achieve accuracy comparable to the gold standard of high-end pose-tracking systems. CLINICAL SIGNIFICANCE These promising results could result in a new way of surgical navigation with minimal infrastructural requirements but now have to be confirmed in clinical studies

Operator independent reliability of direct augmented reality navigated pedicle screw placement and rod bending

Background AR based navigation of spine surgeries may not only provide accurate surgical execution but also operator independency by compensating for potential skill deficits. “Direct” AR-navigation, namely superposing trajectories on anatomy directly, have not been investigated regarding their accuracy and operator's dependence. Purpose of this study was to prove operator independent reliability and accuracy of both AR assisted pedicle screw navigation and AR assisted rod bending in a cadaver setting. Methods Two experienced spine surgeons and two biomedical engineers (laymen) performed independently from each other pedicle screw instrumentations from L1-L5 in a total of eight lumbar cadaver specimens (20 screws/operator) using a fluoroscopy-free AR based navigation method. Screw fitting rods from L1 to S2-Ala-Ileum were bent bilaterally using an AR based rod bending navigation method (4 rods/operator). Outcome measures were pedicle perforations, accuracy compared to preoperative plan, registration time, navigation time, total rod bending time and operator's satisfaction for these procedures. Results 97.5% of all screws were safely placed (<2 mm perforation), overall mean deviation from planned trajectory was 6.8±3.9°, deviation from planned entry point was 4±2.7 mm, registration time per vertebra was 2:25 min (00:56 to 10:00 min), navigation time per screw was 1:07 min (00:15 to 12:43 min) rod bending time per rod was 4:22 min (02:07 to 10:39 min), operator's satisfaction with AR based screw and rod navigation was 5.38±0.67 (1 to 6, 6 being the best rate). Comparison of surgeons and laymen revealed significant difference in navigation time (1:01 min; 00:15 to 3:00 min vs. 01:37 min; 00:23 to 12:43 min; p = 0.004, respectively) but not in pedicle perforation rate. Conclusions Direct AR based screw and rod navigation using a surface digitization registration technique is reliable and independent of surgical experience. The accuracy of pedicle screw insertion in the lumbar spine is comparable with the current standard techniques

Wearable Technology for Assessment and Surgical Assistance in Minimally Invasive Surgery

Wearable technology is an emerging field that has the potential to revolutionize healthcare. Advances in sensors, augmented reality devices, the internet of things, and artificial intelligence offer clinically relevant and promising functionalities in the field of surgery. Apart from its well-known benefits for the patient, minimally invasive surgery (MIS) is a technically demanding surgical discipline for the surgeon. In this regard, wearable technology has been used in various fields of application in MIS such as the assessment of the surgeon’s ergonomic conditions, interaction with the patient or the quality of surgical performance, as well as in providing tools for surgical planning and assistance during surgery. The aim of this chapter is to provide an overview based on the scientific literature and our experience regarding the use of wearable technology in MIS, both in experimental and clinical settings

Review on Augmented Reality in Oral and Cranio-Maxillofacial Surgery: Toward 'Surgery-Specific' Head-Up Displays

In recent years, there has been an increasing interest towards the augmented reality as applied to the surgical field. We conducted a systematic review of literature classifying the augmented reality applications in oral and cranio-maxillofacial surgery (OCMS) in order to pave the way to future solutions that may ease the adoption of AR guidance in surgical practice. Publications containing the terms 'augmented reality' AND 'maxillofacial surgery', and the terms 'augmented reality' AND 'oral surgery' were searched in the PubMed database. Through the selected studies, we performed a preliminary breakdown according to general aspects, such as surgical subspecialty, year of publication and country of research; then, a more specific breakdown was provided according to technical features of AR-based devices, such as virtual data source, visualization processing mode, tracking mode, registration technique and AR display type. The systematic search identified 30 eligible publications. Most studies (14) were in orthognatic surgery, the minority (2) concerned traumatology, while 6 studies were in oncology and 8 in general OCMS. In 8 of 30 studies the AR systems were based on a head-mounted approach using smart glasses or headsets. In most of these cases (7), a video-see-through mode was implemented, while only 1 study described an optical-see-through mode. In the remaining 22 studies, the AR content was displayed on 2D displays (10), full-parallax 3D displays (6) and projectors (5). In 1 case the AR display type is not specified. AR applications are of increasing interest and adoption in oral and cranio-maxillofacial surgery, however, the quality of the AR experience represents the key requisite for a successful result. Widespread use of AR systems in the operating room may be encouraged by the availability of 'surgery-specific' head-mounted devices that should guarantee the accuracy required for surgical tasks and the optimal ergonomics

Sonification as a reliable alternative to conventional visual surgical navigation

Despite the undeniable advantages of image-guided surgical assistance systems in terms of accuracy, such systems have not yet fully met surgeons' needs or expectations regarding usability, time efficiency, and their integration into the surgical workflow. On the other hand, perceptual studies have shown that presenting independent but causally correlated information via multimodal feedback involving different sensory modalities can improve task performance. This article investigates an alternative method for computer-assisted surgical navigation, introduces a novel four-DOF sonification methodology for navigated pedicle screw placement, and discusses advanced solutions based on multisensory feedback. The proposed method comprises a novel four-DOF sonification solution for alignment tasks in four degrees of freedom based on frequency modulation synthesis. We compared the resulting accuracy and execution time of the proposed sonification method with visual navigation, which is currently considered the state of the art. We conducted a phantom study in which 17 surgeons executed the pedicle screw placement task in the lumbar spine, guided by either the proposed sonification-based or the traditional visual navigation method. The results demonstrated that the proposed method is as accurate as the state of the art while decreasing the surgeon's need to focus on visual navigation displays instead of the natural focus on surgical tools and targeted anatomy during task execution

Marker-free surgical navigation of rod bending using a stereo neural network and augmented reality in spinal fusion

The instrumentation of spinal fusion surgeries includes pedicle screw placement and rod implantation. While several surgical navigation approaches have been proposed for pedicle screw placement, less attention has been devoted towards the guidance of patient-specific adaptation of the rod implant. We propose a marker-free and intuitive Augmented Reality (AR) approach to navigate the bending process required for rod implantation. A stereo neural network is trained from the stereo video streams of the Microsoft HoloLens in an end-to-end fashion to determine the location of corresponding pedicle screw heads. From the digitized screw head positions, the optimal rod shape is calculated, translated into a set of bending parameters, and used for guiding the surgeon with a novel navigation approach. In the AR-based navigation, the surgeon is guided step-by-step in the use of the surgical tools to achieve an optimal result. We have evaluated the performance of our method on human cadavers against two benchmark methods, namely conventional freehand bending and marker-based bending navigation in terms of bending time and rebending maneuvers. We achieved an average bending time of 231s with 0.6 rebending maneuvers per rod compared to 476s (3.5 rebendings) and 348s (1.1 rebendings) obtained by our freehand and marker-based benchmarks, respectively

Augmented navigation

Spinal fixation procedures have the inherent risk of causing damage to vulnerable anatomical structures such as the spinal cord, nerve roots, and blood vessels. To prevent complications, several technological aids have been introduced. Surgical navigation is the most widely used, and guides the surgeon by providing the position of the surgical instruments and implants in relation to the patient anatomy based on radiographic images. Navigation can be extended by the addition of a robotic arm to replace the surgeon’s hand to increase accuracy. Another line of surgical aids is tissue sensing equipment, that recognizes different tissue types and provides a warning system built into surgical instruments. All these technologies are under continuous development and the optimal solution is yet to be found. The aim of this thesis was to study the use of Augmented Reality (AR), Virtual Reality (VR), Artificial Intelligence (AI), and tissue sensing technology in spinal navigation to improve precision and prevent surgical errors. The aim of Paper I was to develop and validate an algorithm for automatizing the intraoperative planning of pedicle screws. An AI algorithm for automatic segmentation of the spine, and screw path suggestion was developed and evaluated. In a clinical study of advanced deformity cases, the algorithm could provide correct suggestions for 86% of all pedicles—or 95%, when cases with extremely altered anatomy were excluded. Paper II evaluated the accuracy of pedicle screw placement using a novel augmented reality surgical navigation (ARSN) system, harboring the above-developed algorithm. Twenty consecutively enrolled patients, eligible for deformity correction surgery in the thoracolumbar region, were operated on using the ARSN system. In this cohort, we found a pedicle screw placement accuracy of 94%, as measured according to the Gertzbein grading scale. The primary goal of Paper III was to validate an extension of the ARSN system for placing pedicle screws using instrument tracking and VR. In a porcine cadaver model, it was demonstrated that VR instrument tracking could successfully be integrated with the ARSN system, resulting in pedicle devices placed within 1.7 ± 1.0 mm of the planed path. Paper IV examined the feasibility of a robot-guided system for semi-automated, minimally invasive, pedicle screw placement in a cadaveric model. Using the robotic arm, pedicle devices were placed within 0.94 ± 0.59 mm of the planned path. The use of a semi-automated surgical robot was feasible, providing a higher technical accuracy compared to non-robotic solutions. Paper V investigated the use of a tissue sensing technology, diffuse reflectance spectroscopy (DRS), for detecting the cortical bone boundary in vertebrae during pedicle screw insertions. The technology could accurately differentiate between cancellous and cortical bone and warn the surgeon before a cortical breach. Using machine learning models, the technology demonstrated a sensitivity of 98% [range: 94-100%] and a specificity of 98% [range: 91-100%]. In conclusion, several technological aids can be used to improve accuracy during spinal fixation procedures. In this thesis, the advantages of adding AR, VR, AI and tissue sensing technology to conventional navigation solutions were studied

Pedicle screw navigation using surface digitization on the Microsoft HoloLens

Purpose In spinal fusion surgery, imprecise placement of pedicle screws can result in poor surgical outcome or may seriously harm a patient. Patient-specific instruments and optical systems have been proposed for improving precision through surgical navigation compared to freehand insertion. However, existing solutions are expensive and cannot provide in situ visualizations. Recent technological advancement enabled the production of more powerful and precise optical see-through head-mounted displays for the mass market. The purpose of this laboratory study was to evaluate whether such a device is sufficiently precise for the navigation of lumbar pedicle screw placement. Methods A novel navigation method, tailored to run on the Microsoft HoloLens, was developed. It comprises capturing of the intraoperatively reachable surface of vertebrae to achieve registration and tool tracking with real-time visualizations without the need of intraoperative imaging. For both surface sampling and navigation, 3D printable parts, equipped with fiducial markers, were employed. Accuracy was evaluated within a self-built setup based on two phantoms of the lumbar spine. Computed tomography (CT) scans of the phantoms were acquired to carry out preoperative planning of screw trajectories in 3D. A surgeon placed the guiding wire for the pedicle screw bilaterally on ten vertebrae guided by the navigation method. Postoperative CT scans were acquired to compare trajectory orientation (3D angle) and screw insertion points (3D distance) with respect to the planning. Results The mean errors between planned and executed screw insertion were 3.38∘±1.73∘ for the screw trajectory orientation and 2.77±1.46 mm for the insertion points. The mean time required for surface digitization was 125±27s. Conclusions First promising results under laboratory conditions indicate that precise lumbar pedicle screw insertion can be achieved by combining HoloLens with our proposed navigation method. As a next step, cadaver experiments need to be performed to confirm the precision on real patient anatomy