Clinical Accuracy, Technical Precision, and Workflow of the First in Human Use of an Augmented-Reality Head Mound Display Stereotactic Navigation System for Spine Surgery

2020 ◽  
Author(s):  
Camilo A Molina ◽  
Daniel M Sciubba ◽  
Jacob K Greenberg ◽  
Majid Khan ◽  
Timothy Witham

Abstract BACKGROUND Augmented reality mediated spine surgery is a novel technology for spine navigation. Benchmark cadaveric data have demonstrated high accuracy and precision leading to recent regulatory approval. Absence of respiratory motion in cadaveric studies may positively bias precision and accuracy results and analogous investigations are prudent in live clinical scenarios. OBJECTIVE To report a technical note, accuracy, precision analysis of the first in-human deployment of this technology. METHODS A 78-yr-old female underwent an L4-S1 decompression, pedicle screw, and rod fixation for degenerative spine disease. Six pedicle screws were inserted via AR-HMD (xvision; Augmedics, Chicago, Illinois) navigation. Intraoperative computed tomography was used for navigation registration as well as implant accuracy and precision assessment. Clinical accuracy was graded per the Gertzbein-Robbins (GS) scale by an independent neuroradiologist. Technical precision was analyzed by comparing 3-dimensional (3D) (x, y, z) virtual implant vs real implant position coordinates and reported as linear (mm) and angular (°) deviation. Present data were compared to benchmark cadaveric data. RESULTS Clinical accuracy (per the GS grading scale) was 100%. Technical precision analysis yielded a mean linear deviation of 2.07 mm (95% CI: 1.62-2.52 mm) and angular deviation of 2.41° (95% CI: 1.57-3.25°). In comparison to prior cadaveric data (99.1%, 2.03 ± 0.99 mm, 1.41 ± 0.61°; GS accuracy 3D linear and angular deviation, respectively), the present results were not significantly different (P > .05). CONCLUSION The first in human deployment of the single Food and Drug Administration approved AR-HMD stereotactic spine navigation platform demonstrated clinical accuracy and technical precision of inserted hardware comparable to previously acquired cadaveric studies.

Sensors ◽  
2022 ◽  
Vol 22 (2) ◽  
pp. 522
Author(s):  
Henrik Frisk ◽  
Eliza Lindqvist ◽  
Oscar Persson ◽  
Juliane Weinzierl ◽  
Linda K. Bruetzel ◽  
...  

Background: To investigate the accuracy of augmented reality (AR) navigation using the Magic Leap head mounted device (HMD), pedicle screws were minimally invasively placed in four spine phantoms. Methods: AR navigation provided by a combination of a conventional navigation system integrated with the Magic Leap head mounted device (AR-HMD) was used. Forty-eight screws were planned and inserted into Th11-L4 of the phantoms using the AR-HMD and navigated instruments. Postprocedural CT scans were used to grade the technical (deviation from the plan) and clinical (Gertzbein grade) accuracy of the screws. The time for each screw placement was recorded. Results: The mean deviation between navigation plan and screw position was 1.9 ± 0.7 mm (1.9 [0.3–4.1] mm) at the entry point and 1.4 ± 0.8 mm (1.2 [0.1–3.9] mm) at the screw tip. The angular deviation was 3.0 ± 1.4° (2.7 [0.4–6.2]°) and the mean time for screw placement was 130 ± 55 s (108 [58–437] s). The clinical accuracy was 94% according to the Gertzbein grading scale. Conclusion: The combination of an AR-HMD with a conventional navigation system for accurate minimally invasive screw placement is feasible and can exploit the benefits of AR in the perspective of the surgeon with the reliability of a conventional navigation system.


2020 ◽  
pp. 1-9 ◽  
Author(s):  
Camilo A. Molina ◽  
Frank M. Phillips ◽  
Matthew W. Colman ◽  
Wilson Z. Ray ◽  
Majid Khan ◽  
...  

OBJECTIVEAugmented reality–mediated spine surgery (ARMSS) is a minimally invasive novel technology that has the potential to increase the efficiency, accuracy, and safety of conventional percutaneous pedicle screw insertion methods. Visual 3D spinal anatomical and 2D navigation images are directly projected onto the operator’s retina and superimposed over the surgical field, eliminating field of vision and attention shift to a remote display. The objective of this cadaveric study was to assess the accuracy and precision of percutaneous ARMSS pedicle implant insertion.METHODSInstrumentation was placed in 5 cadaveric torsos via ARMSS with the xvision augmented reality head-mounted display (AR-HMD) platform at levels ranging from T5 to S1 for a total of 113 total implants (93 pedicle screws and 20 Jamshidi needles). Postprocedural CT scans were graded by two independent neuroradiologists using the Gertzbein-Robbins scale (grades A–E) for clinical accuracy. Technical precision was calculated using superimposition analysis employing the Medical Image Interaction Toolkit to yield angular trajectory (°) and linear screw tip (mm) deviation from the virtual pedicle screw position compared with the actual pedicle screw position on postprocedural CT imaging.RESULTSThe overall implant insertion clinical accuracy achieved was 99.1%. Lumbosacral and thoracic clinical accuracies were 100% and 98.2%, respectively. Specifically, among all implants inserted, 112 were noted to be Gertzbein-Robbins grade A or B (99.12%), with only 1 medial Gertzbein-Robbins grade C breach (> 2-mm pedicle breach) in a thoracic pedicle at T9. Precision analysis of the inserted pedicle screws yielded a mean screw tip linear deviation of 1.98 mm (99% CI 1.74–2.22 mm) and a mean angular error of 1.29° (99% CI 1.11°–1.46°) from the projected trajectory. These data compare favorably with data from existing navigation platforms and regulatory precision requirements mandating that linear and angular deviation be less than 3 mm (p < 0.01) and 3° (p < 0.01), respectively.CONCLUSIONSPercutaneous ARMSS pedicle implant insertion is a technically feasible, accurate, and highly precise method.


2021 ◽  
Vol 51 (2) ◽  
pp. E10
Author(s):  
Alexander T. Yahanda ◽  
Emelia Moore ◽  
Wilson Z. Ray ◽  
Brenton Pennicooke ◽  
Jack W. Jennings ◽  
...  

OBJECTIVE Augmented reality (AR) is an emerging technology that has great potential for guiding the safe and accurate placement of spinal hardware, including percutaneous pedicle screws. The goal of this study was to assess the accuracy of 63 percutaneous pedicle screws placed at a single institution using an AR head-mounted display (ARHMD) system. METHODS Retrospective analyses were performed for 9 patients who underwent thoracic and/or lumbar percutaneous pedicle screw placement guided by ARHMD technology. Clinical accuracy was assessed via the Gertzbein-Robbins scale by the authors and by an independent musculoskeletal radiologist. Thoracic pedicle subanalysis was also performed to assess screw accuracy based on pedicle morphology. RESULTS Nine patients received thoracic or lumbar AR-guided percutaneous pedicle screws. The mean age at the time of surgery was 71.9 ± 11.5 years and the mean number of screws per patient was 7. Indications for surgery were spinal tumors (n = 4, 44.4%), degenerative disease (n = 3, 33.3%), spinal deformity (n = 1, 11.1%), and a combination of deformity and infection (n = 1, 11.1%). Presenting symptoms were most commonly low-back pain (n = 7, 77.8%) and lower-extremity weakness (n = 5, 55.6%), followed by radicular lower-extremity pain, loss of lower-extremity sensation, or incontinence/urinary retention (n = 3 each, 33.3%). In all, 63 screws were placed (32 thoracic, 31 lumbar). The accuracy for these screws was 100% overall; all screws were Gertzbein-Robbins grade A or B (96.8% grade A, 3.2% grade B). This accuracy was achieved in the thoracic spine regardless of pedicle cancellous bone morphology. CONCLUSIONS AR-guided surgery demonstrated a 100% accuracy rate for the insertion of 63 percutaneous pedicle screws in 9 patients (100% rate of Gertzbein-Robbins grade A or B screw placement). Using an ARHMS system for the placement of percutaneous pedicle screws showed promise, but further validation using a larger cohort of patients across multiple surgeons and institutions will help to determine the true accuracy enabled by this technology.


2021 ◽  
pp. 1-7
Author(s):  
Ann Liu ◽  
Yike Jin ◽  
Ethan Cottrill ◽  
Majid Khan ◽  
Erick Westbroek ◽  
...  

OBJECTIVE Augmented reality (AR) is a novel technology which, when applied to spine surgery, offers the potential for efficient, safe, and accurate placement of spinal instrumentation. The authors report the accuracy of the first 205 pedicle screws consecutively placed at their institution by using AR assistance with a unique head-mounted display (HMD) navigation system. METHODS A retrospective review was performed of the first 28 consecutive patients who underwent AR-assisted pedicle screw placement in the thoracic, lumbar, and/or sacral spine at the authors’ institution. Clinical accuracy for each pedicle screw was graded using the Gertzbein-Robbins scale by an independent neuroradiologist working in a blinded fashion. RESULTS Twenty-eight consecutive patients underwent thoracic, lumbar, or sacral pedicle screw placement with AR assistance. The median age at the time of surgery was 62.5 (IQR 13.8) years and the median body mass index was 31 (IQR 8.6) kg/m2. Indications for surgery included degenerative disease (n = 12, 43%); deformity correction (n = 12, 43%); tumor (n = 3, 11%); and trauma (n = 1, 4%). The majority of patients (n = 26, 93%) presented with low-back pain, 19 (68%) patients presented with radicular leg pain, and 10 (36%) patients had documented lower extremity weakness. A total of 205 screws were consecutively placed, with 112 (55%) placed in the lumbar spine, 67 (33%) in the thoracic spine, and 26 (13%) at S1. Screw placement accuracy was 98.5% for thoracic screws, 97.8% for lumbar/S1 screws, and 98.0% overall. CONCLUSIONS AR depicted through a unique HMD is a novel and clinically accurate technology for the navigated insertion of pedicle screws. The authors describe the first 205 AR-assisted thoracic, lumbar, and sacral pedicle screws consecutively placed at their institution with an accuracy of 98.0% as determined by a Gertzbein-Robbins grade of A or B.


2017 ◽  
Vol 08 (01) ◽  
pp. 014-019
Author(s):  
Arun Srivastava ◽  
Jayesh Sardhara ◽  
Sanjay Behari ◽  
Sindgikar Pavaman ◽  
Jeena Joseph ◽  
...  

ABSTRACT Context: Existence of complex variable bony and vertebral artery (VA) anomalies at craniovertebral junction (CVJ) in subset of complex CVJ anomalies demands individualized instrumentation policy and placing screws in each bone requires strategic preoperative planning and intraoperative skills. Aim: To evaluate the clinical accuracy of knock and drill (K and D) technique for the screw placement in complex CVJ anomalies. Settings and Design: Prospective study and operative technical note. Materials and Methods: Totally 36 consecutive patients (16 - pediatrics, 20 - adult patients) of complex CVJ: Complete/partial occipitalized C1 vertebra; at least one hypoplastic (C1/C2) articular mass, rotational component, and variations in the third part of VA were included in this study. Preoperative detail computed tomography (CT) CT CVJ with three-dimensional reconstruction was done for the assessment of CVJ anatomy and facet joint orientation. The accuracy of novel technique was assessed with postoperative CT to evaluate cortical breach in between 5th and 7th postoperative day in all the patients. All patients were underwent clinico-radiological evaluation at 6-month follow-up. Results: Totally 144 screws were placed using K and D technique (pediatric group - 64 screws, adult patients - 80 screws). Total of 12 screws were placed in C1 lateral mass in both age group without any bony cortical breach and complication. Sixteen C2 pedicle screws and 12 C2 pars screw in pediatrics and 18 C2 pedicle screws in adult patients were placed without any bony breach or VA injury. Out of thirty subaxial lateral mass screws in pediatric group, the bony breach was encountered with one screw (3.3%). Total of 38 C2 pars screws was placed in adult group in which bony breach along with VA injury was encounter with 1screw (2.6%). Conclusion: A simple technique of K and D for placing a screw increases the accuracy and spectrum of bony purchase and has the potential to reduce the complication in patients with complex CVJ anomalies.


2019 ◽  
Vol 31 (1) ◽  
pp. 139-146 ◽  
Author(s):  
Camilo A. Molina ◽  
Nicholas Theodore ◽  
A. Karim Ahmed ◽  
Erick M. Westbroek ◽  
Yigal Mirovsky ◽  
...  

OBJECTIVEAugmented reality (AR) is a novel technology that has the potential to increase the technical feasibility, accuracy, and safety of conventional manual and robotic computer-navigated pedicle insertion methods. Visual data are directly projected to the operator’s retina and overlaid onto the surgical field, thereby removing the requirement to shift attention to a remote display. The objective of this study was to assess the comparative accuracy of AR-assisted pedicle screw insertion in comparison to conventional pedicle screw insertion methods.METHODSFive cadaveric male torsos were instrumented bilaterally from T6 to L5 for a total of 120 inserted pedicle screws. Postprocedural CT scans were obtained, and screw insertion accuracy was graded by 2 independent neuroradiologists using both the Gertzbein scale (GS) and a combination of that scale and the Heary classification, referred to in this paper as the Heary-Gertzbein scale (HGS). Non-inferiority analysis was performed, comparing the accuracy to freehand, manual computer-navigated, and robotics-assisted computer-navigated insertion accuracy rates reported in the literature. User experience analysis was conducted via a user experience questionnaire filled out by operators after the procedures.RESULTSThe overall screw placement accuracy achieved with the AR system was 96.7% based on the HGS and 94.6% based on the GS. Insertion accuracy was non-inferior to accuracy reported for manual computer-navigated pedicle insertion based on both the GS and the HGS scores. When compared to accuracy reported for robotics-assisted computer-navigated insertion, accuracy achieved with the AR system was found to be non-inferior when assessed with the GS, but superior when assessed with the HGS. Last, accuracy results achieved with the AR system were found to be superior to results obtained with freehand insertion based on both the HGS and the GS scores. Accuracy results were not found to be inferior in any comparison. User experience analysis yielded “excellent” usability classification.CONCLUSIONSAR-assisted pedicle screw insertion is a technically feasible and accurate insertion method.


2021 ◽  
Vol 151 ◽  
pp. 290
Author(s):  
Alexander J. Schupper ◽  
Jeremy Steinberger ◽  
Yakov Gologorsky

2021 ◽  
Author(s):  
Yingda Li ◽  
Michael Y Wang

Abstract Endoscopy and robotics represent two emerging technologies within the field of spine surgery, the former an ultra-MIS approach minimizing the perioperative footprint and the latter leveraging accuracy and precision. Herein, we present the novel incorporation of robotic assistance into endoscopic laminotomy, applied to a 27-yr-old female with a large caudally migrated L4-5 disc herniation. Patient consent was obtained. Robotic guidance was deployed in (1) planning of a focussed laminotomy map, pivoting on a single skin entry point; (2) percutaneous targeting of the interlaminar window; and (3) execution of precision drilling, controlled for depth. Through this case, we illustrated the potential synergy between these 2 technologies in achieving precise bony removal tailored to the patient's unique pathoanatomy while simultaneously introducing safety mechanisms against human error and improving surgical ergonomics.1,2 The physicians consented to the publication of their images.


Sensors ◽  
2021 ◽  
Vol 21 (6) ◽  
pp. 2234
Author(s):  
Sebastian Kapp ◽  
Michael Barz ◽  
Sergey Mukhametov ◽  
Daniel Sonntag ◽  
Jochen Kuhn

Currently an increasing number of head mounted displays (HMD) for virtual and augmented reality (VR/AR) are equipped with integrated eye trackers. Use cases of these integrated eye trackers include rendering optimization and gaze-based user interaction. In addition, visual attention in VR and AR is interesting for applied research based on eye tracking in cognitive or educational sciences for example. While some research toolkits for VR already exist, only a few target AR scenarios. In this work, we present an open-source eye tracking toolkit for reliable gaze data acquisition in AR based on Unity 3D and the Microsoft HoloLens 2, as well as an R package for seamless data analysis. Furthermore, we evaluate the spatial accuracy and precision of the integrated eye tracker for fixation targets with different distances and angles to the user (n=21). On average, we found that gaze estimates are reported with an angular accuracy of 0.83 degrees and a precision of 0.27 degrees while the user is resting, which is on par with state-of-the-art mobile eye trackers.


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