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Significance: Oral cancer surgery requires accurate margin delineation to balance complete resection with post-operative functionality. Current in vivo fluorescence imaging systems provide two-dimensional margin assessment yet fail to quantify tumor depth prior to resection. Harnessing structured light in combination with deep learning (DL) may provide near real-time three-dimensional margin detection., Aim: A DL-enabled fluorescence spatial frequency domain imaging (SFDI) system trained with in silico tumor models was developed to quantify the depth of oral tumors., Approach: A convolutional neural network was designed to produce tumor depth and concentration maps from SFDI images. Three in silico representations of oral cancer lesions were developed to train the DL architecture: cylinders, spherical harmonics, and composite spherical harmonics (CSHs). Each model was validated with in silico SFDI images of patient-derived tongue tumors, and the CSH model was further validated with optical phantoms., Results: The performance of the CSH model was superior when presented with patient-derived tumors ( P -value < 0.05 ). The CSH model could predict depth and concentration within 0.4 mm and 0.4    μ g / mL , respectively, for in silico tumors with depths less than 10 mm., Conclusions: A DL-enabled SFDI system trained with in silico CSH demonstrates promise in defining the deep margins of oral tumors., (© 2024 The Authors.)

Background: Joint-sparing resection of periarticular bone tumors can be challenging because of complex geometry. Successful reconstruction of periarticular bone defects after tumor resection is often performed with structural allografts to allow for joint preservation. However, achieving a size-matched allograft to fill the defect can be challenging because allograft sizes vary, they do not always match a patient's anatomy, and cutting the allograft to perfectly fit the defect is demanding., Questions/purposes: (1) Is there a difference in mental workload among the freehand, patient-specific instrumentation, and surgical navigation approaches? (2) Is there a difference in conformance (quantitative measure of deviation from the ideal bone graft), elapsed time during reconstruction, and qualitative assessment of goodness-of-fit of the allograft reconstruction among the approaches?, Methods: Seven surgeons used three modalities in the same order (freehand, patient-specific instrumentation, and surgical navigation) to fashion synthetic bone to reconstruct a standardized bone defect. National Aeronautics and Space Administration (NASA) mental task load index questionnaires and procedure time were captured. Cone-beam CT images of the shaped allografts were used to measure conformance (quantitative measure of deviation from the ideal bone graft) to a computer-generated ideal bone graft model. Six additional (senior) surgeons blinded to modality scored the quality of fit of the allografts into the standardized tumor defect using a 10-point Likert scale. We measured conformance using the root-mean-square metric in mm and used ANOVA for multipaired comparisons (p < 0.05 was significant)., Results: There was no difference in mental NASA total task load scores among the freehand, patient-specific instrumentation, and surgical navigation techniques. We found no difference in conformance root-mean-square values (mean ± SD) between surgical navigation (2 ± 0 mm; mean values have been rounded to whole numbers) and patient-specific instrumentation (2 ± 1 mm), but both showed a small improvement compared with the freehand approach (3 ± 1 mm). For freehand versus surgical navigation, the mean difference was 1 mm (95% confidence interval [CI] 0.5 to 1.1; p = 0.01). For freehand versus patient-specific instrumentation, the mean difference was 1 mm (95% CI -0.1 to 0.9; p = 0.02). For patient-specific instrumentation versus surgical navigation, the mean difference was 0 mm (95% CI -0.5 to 0.2; p = 0.82). In evaluating the goodness of fit of the shaped grafts, we found no clinically important difference between surgical navigation (median [IQR] 7 [6 to 8]) and patient-specific instrumentation (median 6 [5 to 7.8]), although both techniques had higher scores than the freehand technique did (median 3 [2 to 4]). For freehand versus surgical navigation, the difference of medians was 4 (p < 0.001). For freehand versus patient-specific instrumentation, the difference of medians was 3 (p < 0.001). For patient-specific instrumentation versus surgical navigation, the difference of medians was 1 (p = 0.03). The mean ± procedural times for freehand was 16 ± 10 minutes, patient-specific instrumentation was 14 ± 9 minutes, and surgical navigation techniques was 24 ± 8 minutes. We found no differences in procedure times across three shaping modalities (freehand versus patient-specific instrumentation: mean difference 2 minutes [95% CI 0 to 7]; p = 0.92; freehand versus surgical navigation: mean difference 8 minutes [95% CI 0 to 20]; p = 0.23; patient-specific instrumentation versus surgical navigation: mean difference 10 minutes [95% CI 1 to 19]; p = 0.12)., Conclusion: Based on surgical simulation to reconstruct a standardized periarticular bone defect after tumor resection, we found a possible small advantage to surgical navigation over patient-specific instrumentation based on qualitative fit, but both techniques provided slightly better conformance of the shaped graft for fit into the standardized post-tumor resection bone defect than the freehand technique did. To determine whether these differences are clinically meaningful requires further study. The surgical navigation system presented here is a product of laboratory research development, and although not ready to be widely deployed for clinical practice, it is currently being used in a research operating room setting for patient care. This new technology is associated with a learning curve, capital costs, and potential risk. The reported preliminary results are based on a preclinical synthetic bone tumor study, which is not as realistic as actual surgical scenarios., Clinical Relevance: Surgical navigation systems are an emerging technology in orthopaedic and reconstruction surgery, and understanding their capabilities and limitations is paramount for clinical practice. Given our preliminary findings in a small cohort study with one scenario of standardized synthetic periarticular bone tumor defects, future investigations should include different surgical scenarios using allograft and cadaveric specimens in a more realistic surgical setting., Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Association of Bone and Joint Surgeons.)

Introduction: The adequacy of the surgical resection is the main controllable variable that is in the hands of the surgical team. There exists an unmet need to increase the rate of negative margins, particularly in cancers invading the craniofacial area. The study aimed 1) at developing a gross tumor model to be utilized for research, educational, and training purposes and 2) establishing the 3-dimensional relationship between the outer surface of the surgical specimen and tumor surface and test the effect of guiding ablations on cadavers with surgical navigation (SN)., Material and Methods: Seven cadaver heads were employed to create 24 craniofacial tumor models. Simulation of tumor resections was performed by 8 surgeons. Fourteen and 10 resections were performed with and without SN-guidance, respectively. Gross specimens underwent computed tomography and 3-dimensional analysis through dedicated software. Task load was assessed through a validated questionnaire. Tumor model reliability was studied based on visual analogue scale rate by surgeons and radiologists., Results: SN reduced the rate of margin involvement, particularly by decreasing the percentage of the gross specimen outer surface involvement in areas uncovered by normal bony structures. The workload of SN-aided ablations was found to be medium-to-somewhat-high. Tumor model reliability was deemed satisfactory except for the extension to bony structures., Conclusions: A gross tumor model for head and neck cancers involving the craniofacial area was developed and resulted satisfactorily reliable from both a surgical and radiologic standpoint. SN reduced the rate of margin involvement, particularly by improving delineation of bone-uncovered areas., (Copyright © 2021 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Background: Positive margins have been reported up to 80% in advanced maxillary cancers. Intraoperative navigation (IN) aims to improve margins, but provides a two-dimensional view of a registered instrument without anticipating any cutting directions, and the information is displayed in monitors outside surgical field. Augmented Reality (AR) can delineate margins while addressing the gaze-toggling drawback of IN. In a preclinical setting, we implemented preoperative-planned osteotomies needed for maxillectomies and projected this information on the surgical field using AR. We aimed to improve negative margin rates while retaining the benefits of AR., Methods: Five maxillary tumor models were built. Five fellowship-trained surgeons completed virtual unguided and AR-guided maxillectomies. Comparisons in terms of intratumoral cuts, close, adequate, and excessive distances from the tumor were performed. Differences between "ideal" cutting-plan and the AR-guided virtual osteotomies was obtained. Workload questionnaires to evaluate the technology were completed., Results: 115 virtual osteotomies were analyzed. Intra-tumoral and "close" margins were lower for the AR-assisted osteotomies (0.0% vs 1.9% p < 0.0001 and 0.8% vs 7.9% p < 0.0001). Proportion of "adequate" margins were higher in the AR simulations (25.3% vs 18.6%, p = 0.018). The AR osteotomies had high similarity with the pre-planned with interclass correlation index close to 1 in "adequate" margins 0.893 (95% CI: 0.804-0.949). Workload scores were better for AR-guided simulations for the domains of mental demand, performance, effort and frustration., Conclusion: The projector-based AR method improved margin delineation, and preoperative planning was accurately translated to the simulations. Clinical translation will aim to consolidate our preclinical findings to improve outcomes., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

An integrated augmented reality (AR) surgical navigation system that potentially improves intra-operative visualization of concealed anatomical structures. Integration of real-time tracking technology with a laser pico-projector allows the surgical surface to be augmented by projecting virtual images of lesions and critical structures created by multimodality imaging. We aim to quantitatively and qualitatively evaluate the performance of a prototype interactive AR surgical navigation system through a series of pre-clinical studies. Four pre-clinical animal studies using xenograft mouse models were conducted to investigate system performance. A combination of CT, PET, SPECT, and MRI images were used to augment the mouse body during image-guided procedures to assess feasibility. A phantom with machined features was employed to quantitatively estimate the system accuracy. All the image-guided procedures were successfully performed. The tracked pico-projector correctly and reliably depicted virtual images on the animal body, highlighting the location of tumour and anatomical structures. The phantom study demonstrates the system was accurate to 0.55 ± 0.33mm. This paper presents a prototype real-time tracking AR surgical navigation system that improves visualization of underlying critical structures by overlaying virtual images onto the surgical site. This proof-of-concept pre-clinical study demonstrated both the clinical applicability and high precision of the system which was noted to be accurate to <1mm., Competing Interests: The authors have declared that no competing interests exist.

Purpose of Review: Image guided navigation has had significant impact in head and neck surgery, and has been most prolific in endonasal surgeries. Although conventional image guidance involves static computed tomography (CT) images attained in the preoperative setting, the continual evolution of surgical navigation technologies is fast expanding to incorporate both real-time data and bioinformation that allows for improved precision in surgical guidance. With the rapid advances in technologies, this article allows for a timely review of the current and developing techniques in surgical navigation for head and neck surgery., Recent Findings: Current advances for cross-sectional-based image-guided surgery include fusion of CT with other imaging modalities (e.g., magnetic resonance imaging and positron emission tomography) as well as the uptake in intraoperative real-time 'on the table' imaging (e.g., cone-beam CT). These advances, together with the integration of virtual/augmented reality, enable potential enhancements in surgical navigation. In addition to the advances in radiological imaging, the development of optical modalities such as fluorescence and spectroscopy techniques further allows the assimilation of biological data to improve navigation particularly for head and neck surgery., Summary: The steady development of radiological and optical imaging techniques shows great promise in changing the paradigm of head and neck surgery., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: Several technologies have been implemented in orthopedic surgery to improve surgical outcomes, usually focusing on more accurate execution of a surgical plan, but the development of the plan itself is also of great importance. The purpose of this study is to examine whether the use of preoperative computer planning platforms can improve the surgical plan?, Methods: Eight surgeons created a preoperative surgical plan to resect a distal femur parosteal osteosarcoma in two settings: (1) Using a 2-D and 3-D CT scan only (current standard); and (2) using a computer-assisted planning platform. The plans were thereafter virtually executed using a novel surgical navigation system and a Sawbones model. This simulated model was derived from, and identical to, an actual patient scenario. The outcomes of interest were the number of positive margin cuts, and the volume of the resected specimen., Results: Using the surgical plan developed with computer assistance, there were 4 positive margin cuts made by 2 surgeons. In comparison, using standard planning, there were 14 positive margin cuts made by all 8 surgeons (p = 0.02). The resection volume was larger in the computer-assisted plans (96 ± 10 mm 3 ) than in the standard plans (88 ± 7 mm 3 ) (p = 0.055)., Conclusions: Computer-assisted planning significantly decreased the risk of a positive margin resection in this Sawbones tumor model used to simulate resection of a primary bone sarcoma. This proof of concept study highlights the importance of advanced surgical planning and sets the ground for developing beneficial surgical planning systems.

This study evaluates a long-acting liposomal fluorescence / CT dual-modality contrast agent (CF800) in head and neck cancer to enhance intraoperative tumor demarcation with fluorescence imaging and cone-beam computed tomography (CBCT). CF800 was administered to 12 buccal cancer-bearing rabbits. Imaging was acquired at regular time points to quantify time-dependent contrast enhancement. Surgery was performed 5-7 days after, with intraoperative near-infrared fluorescence endoscopy and CBCT, followed by histological and ex-vivo fluorescence assessment. Tumor enhancement on CT was significant at 24, 96 and 120 hours. Volumetric analysis of tumor segmentation showed high correlation between CBCT and micro-CT. Fluorescence signal was apparent in both ex-vivo and in-vivo imaging. Histological correlation showed [100%] specificity for primary tumor. Sensitivity and specificity of CF800 in detecting nodal involvement require further investigation.CF800 is long acting and has dual function for CT and fluorescence contrast, making it an excellent candidate for image-guided surgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Surgical navigation systems based on preoperative imaging are now increasingly used for guidance of head and neck resection and reconstruction. The primary aim of this study was to quantify osteotomy cutting accuracy using an image-guidance system for intraoperative cone-beam computed tomography (CBCT) imaging and surgical saw navigation. To enable clinical translation of this CBCT-guided navigation system, a secondary aim of the study was to design and fabricate a patient reference tracker suitable for clinical use on a mobile mandible., Methods: First, a preclinical cadaveric study was performed to quantify navigation accuracy with the use of clinically suitable patient reference trackers. Second, a proof-of-principle patient study was conducted to evaluate this technique under clinical conditions., Results: In both preclinical (5 cadavers) and clinical (5 patients) experiments, the mean cutting accuracy was less than 2 mm. In all preclinical specimens, bilateral mandibulectomies and bilateral maxillectomies were performed, for a total of 20 cut planes for analysis. The mean (standard deviation [SD]) values for distance, pitch, and roll were 1.4 mm (1.1 mm), 4.2° (3.5°), and 2.9° (2.5°) mm, respectively. Five mandibulectomies were performed on five patients, for a total of 10 cut planes for analysis. The mean (SD) values for distance, pitch, and roll were 1.7 mm (0.8 mm), 5.4° (1.5°), and 6.7° (4.6°) mm, respectively., Conclusions: The overall performance in comparison to alternative approaches warrants further consideration. In terms of accuracy, the results presented here are comparable to recent systematic reviews assessing CAD-CAM cutting guides that cite accuracies of ~2 to 2.5 mm., Level of Evidence: 2 Laryngoscope, 130:1122-1127, 2020., (© 2019 The American Laryngological, Rhinological and Otological Society, Inc.)

Background: The image-guided operating room (OR) is an emerging standard for dealing with complex cases in many surgical disciplines including neurosurgery, thoracic surgery, maxillofacial trauma, and orthopedic surgery. Its use in head and neck oncological surgery is not well established. The primary aim of this study was to assess the image quality of cone-beam CT (CBCT) under real clinical conditions. The secondary aim was to assess the effect on surgical performance and decision making., Methods: Intraoperative 3D imaging was performed using a CBCT capable C-Arm mounted on a multi-axis robot (Siemens Zeego) in the image-guided OR. All patients had immediate preoperative imaging taken with further intraoperative imaging performed as required. Ten initial patients, comprising 28 intraoperative scans, were used for questionnaire-based image reviews conducted with experienced head and neck clinicians. Scans were assessed for aspects of both image quality and clinical utility, on separate 5-point Likert scales (1-5)., Results: The median rating for bony detail was 4 out of 5. Vascular detail was increased (P < 10 -8 ) from 1 to 3 with the use of IV contrast (region of interest CT# was 284 HU [SD, 47 HU]). Images were rated as 4 for freedom from artifact. Soft tissue definition was 2, with no significant improvement (P = .2) with the addition of IV iodinated contrast. Surgeons rated the greatest clinical utility (4) for the CBCT when assessing postreconstruction imaging of a complex case., Conclusions: The image quality of CBCT in the image-guided OR is good for bony detail and complex oncological reconstructions in the head and neck setting but probably has limited benefit for intraoperative soft tissue delineation. Future studies must also focus on clinical outcomes to help demonstrate the value of the image-guided OR., (© 2019 Wiley Periodicals, Inc.)

Background: The objective of this study was to assess the accuracy and reproducibility of a novel cone-beam computed tomography (CBCT)-guided navigation system designed for osteotomies with joint-sparing bone cuts., Methods: Eighteen surgeons participated in this study. First, 3 expert tumor surgeons resected bone tumors in 3 Sawbones tumor models identical to actual patient scenarios. They first performed these osteotomies without navigation and then performed them using a navigation system and 3-dimensional (3D) planning tools based on CBCT imaging. The 2 sets of measurements were compared using image-based measurements from post-resection CBCT. Next, 15 residents, fellows, and orthopaedic staff surgeons were instructed on the use of the system, and their navigated resections were compared with navigated resections performed by the 3 expert tumor surgeons., Results: One hundred and twenty-six navigated cuts done by the orthopaedic oncologists were compared with 126 non-navigated cuts by the same surgeons. The cuts violated the tumor in 22% (6) of the 27 non-navigated resections compared with none of the 27 navigated resections. The navigated cuts were significantly more accurate in terms of entry point, pitch, and roll (p < 0.001). The variation among the 3 surgeons when they used navigation was <0.6 mm for the entry cut and, on average, 1.5° for pitch and roll. All 18 surgeons then completed a total of 144 navigated cuts. The level of experience did not result in a significant difference among groups with regard to cut accuracy. Two cuts went into the tumor. The mean distance from the planned bone cuts to the actual entry points into bone was 1.5 mm (standard deviation [SD] = 1.4 mm) for all users. The mean difference in pitch and roll between the planned and actual cuts was 3.5° (SD = 2.8°) and 3.7° (SD = 3.2°) for all users., Conclusions: Even in expert hands, navigated cuts were significantly more accurate than non-navigated cuts. When the osteotomies were aided by navigation, their accuracy did not differ according to the level of professional experience. CBCT-based metrics enable intraoperative assessments of cut accuracy and reconstruction planning., Clinical Relevance: CBCT-guided navigated osteotomies can improve accuracy regardless of surgeon experience and decrease the variability among different surgeons.

Background: Intraoperative image guidance during transoral robotic surgery (TORS) is hampered by imaging-friendly instrumentation and intraoperative positioning. The purpose of this study was to develop and validate an accurate image-guidance system for TORS., Methods: A custom radiolucent mouth retractor was fabricated from biocompatible material (Med-610; Stratasys, Minneapolis, MN). Teflon beads were placed in the oropharynx and carotid arteries of 3 cadavers. CT scans were obtained in the preoperative and intraoperative positions. Displacement of targets between preoperative and intraoperative scans was measured. Surgical navigation was based on the open-source Image-Guided Surgery Toolkit. Target registration error (TRE) was determined by measuring the distance between the tracker and bead registered to preoperative versus intraoperative scans., Results: The inferior oropharyngeal targets demonstrated the greatest displacement between positions. A significant reduction in TRE was observed when registering the tracker to the intraoperative compared to the preoperative scan., Conclusion: This study describes an accurate intraoperative image-guidance system for TORS., (© 2017 Wiley Periodicals, Inc.)

Background: We set out to determine the accuracy of 3D-navigated mandibular and maxillary osteotomies with the ultimate aim to integrate virtual cutting guides and 3D-navigation into ablative and reconstructive head and neck surgery., Methods: Four surgeons (two attending, two clinical fellows) completed 224 unnavigated and 224 3D-navigated osteotomies on anatomical models according to preoperative 3D plans. The osteotomized bones were scanned and analyzed., Results: Median distance from the virtual plan was 2.1 mm unnavigated (IQR 2.6 mm, ≥3 mm in 33%) and 1.2 mm 3D-navigated (IQR 1.1 mm, ≥3 mm in 6%) (P<0.0001); median pitch was 4.5° unnavigated (IQR 7.1°) and 3.5° 3D-navigated (IQR 4.0°) (P<0.0001); median roll was 7.4° unnavigated (IQR 8.5°) and 2.6° 3D-navigated (IQR 3.8°) (P<0.0001)., Conclusion: 3D-rendering enables osteotomy navigation. 3 mm is an appropriate planning distance. The next steps are translating virtual cutting guides to free bone flap reconstruction and clinical use.

Objectives/hypothesis: Providing image guidance in a 3-dimensional (3D) format, visually more in keeping with the operative field, could potentially reduce workload and lead to faster and more accurate navigation. We wished to assess a 3D virtual-view surgical navigation prototype in comparison to a traditional 2D system., Methods: Thirty-seven otolaryngology surgeons and trainees completed a randomized crossover navigation exercise on a cadaver model. Each subject identified three sinonasal landmarks with 3D virtual (3DV) image guidance and three landmarks with conventional cross-sectional computed tomography (CT) image guidance. Subjects were randomized with regard to which side and display type was tested initially. Accuracy, task completion time, and task workload were recorded., Results: Display type did not influence accuracy (P > 0.2) or efficiency (P > 0.3) for any of the six landmarks investigated. Pooled landmark data revealed a trend of improved accuracy in the 3DV group by 0.44 millimeters (95% confidence interval [0.00-0.88]). High-volume surgeons were significantly faster (P < 0.01) and had reduced workload scores in all domains (P < 0.01), but they were no more accurate (P > 0.28)., Conclusion: Real-time 3D image guidance did not influence accuracy, efficiency, or task workload when compared to conventional triplanar image guidance. The subtle pooled accuracy advantage for the 3DV view is unlikely to be of clinical significance. Experience level was strongly correlated to task completion time and workload but did not influence accuracy., Level of Evidence: N/A. Laryngoscope, 126:1510-1515, 2016., (© 2016 The American Laryngological, Rhinological and Otological Society, Inc.)

The aim of this study was to demonstrate the role of advanced fabrication technology across a broad spectrum of head and neck surgical procedures, including applications in endoscopic sinus surgery, skull base surgery, and maxillofacial reconstruction. The initial case studies demonstrated three applications of rapid prototyping technology are in head and neck surgery: i) a mono-material paranasal sinus phantom for endoscopy training ii) a multi-material skull base simulator and iii) 3D patient-specific mandible templates. Digital processing of these phantoms is based on real patient or cadaveric 3D images such as CT or MRI data. Three endoscopic sinus surgeons examined the realism of the endoscopist training phantom. One experienced endoscopic skull base surgeon conducted advanced sinus procedures on the high-fidelity multi-material skull base simulator. Ten patients participated in a prospective clinical study examining patient-specific modeling for mandibular reconstructive surgery. Qualitative feedback to assess the realism of the endoscopy training phantom and high-fidelity multi-material phantom was acquired. Conformance comparisons using assessments from the blinded reconstructive surgeons measured the geometric performance between intra-operative and pre-operative reconstruction mandible plates. Both the endoscopy training phantom and the high-fidelity multi-material phantom received positive feedback on the realistic structure of the phantom models. Results suggested further improvement on the soft tissue structure of the phantom models is necessary. In the patient-specific mandible template study, the pre-operative plates were judged by two blinded surgeons as providing optimal conformance in 7 out of 10 cases. No statistical differences were found in plate fabrication time and conformance, with pre-operative plating providing the advantage of reducing time spent in the operation room. The applicability of common model design and fabrication techniques across a variety of otolaryngological sub-specialties suggests an emerging role for rapid prototyping technology in surgical education, procedure simulation, and clinical practice.

Importance: Previous preclinical studies of localized intraoperative virtual endoscopy-image-guided surgery (LIVE-IGS) for skull base surgery suggest a potential clinical benefit., Objective: The first aim was to evaluate the registration accuracy of virtual endoscopy based on high-resolution magnetic resonance imaging under clinical conditions. The second aim was to implement and assess real-time proximity alerts for critical structures during skull base drilling., Design and Setting: Patients consecutively referred for sinus and skull base surgery were enrolled in this prospective case series., Participants: Five patients were used to check registration accuracy and feasibility with the subsequent 11 patients being treated under LIVE-IGS conditions with presentation to the operating surgeon (phase 2)., Intervention: Sixteen skull base patients were endoscopically operated on by using image-based navigation while LIVE-IGS was tested in a clinical setting., Main Outcome and Measures: Workload was quantitatively assessed using the validated National Aeronautics and Space Administration Task Load Index (NASA-TLX) questionnaire., Results: Real-time localization of the surgical drill was accurate to ~1 to 2 mm in all cases. The use of 3-mm proximity alert zones around the carotid arteries and optic nerve found regular clinical use, as the median minimum distance between the tracked drill and these structures was 1 mm (0.2-3.1 mm) and 0.6 mm (0.2-2.5 mm), respectively. No statistical differences were found in the NASA-TLX indicators for this experienced surgical cohort., Conclusions and Relevance: Real-time proximity alerts with virtual endoscopic guidance was sufficiently accurate under clinical conditions. Further clinical evaluation is required to evaluate the potential surgical benefits, particularly for less experienced surgeons or for teaching purposes., (© American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.)

Background: Augmented reality (AR) surgical navigation systems, designed to increase accuracy and efficiency, have been shown to negatively impact on attention. We wished to assess the effect "head-up" AR displays have on attention, efficiency, and accuracy, while performing a surgical task, compared with the same information being presented on a submonitor (SM)., Methods: Fifty experienced otolaryngology surgeons (n = 42) and senior otolaryngology trainees (n = 8) performed an endoscopic surgical navigation exercise on a predissected cadaveric model. Computed tomography-generated anatomic contours were fused with the endoscopic image to provide an AR view. Subjects were randomized to perform the task with a standard endoscopic monitor with the AR navigation displayed on an SM or with AR as a single display. Accuracy, task completion time, and the recognition of unexpected findings (a foreign body and a critical complication) were recorded., Results: Recognition of the foreign body was significantly better in the SM group (15/25 [60%]) compared with the AR alone group (8/25 [32%]; p = 0.02). There was no significant difference in task completion time (p = 0.83) or accuracy (p = 0.78) between the two groups., Conclusion: Providing identical surgical navigation on a SM, rather than on a single head-up display, reduced the level of inattentional blindness as measured by detection of unexpected findings. These gains were achieved without any measurable impact on efficiency or accuracy. AR displays may distract the user and we caution injudicious adoption of this technology for medical procedures.

Objectives/hypothesis: Image-guided surgery (IGS) systems are frequently utilized during cranial base surgery to aid in orientation and facilitate targeted surgery. We wished to assess the performance of our recently developed localized intraoperative virtual endoscopy (LIVE)-IGS prototype in a preclinical setting prior to deployment in the operating room. This system combines real-time ablative instrument tracking, critical structure proximity alerts, three-dimensional virtual endoscopic views, and intraoperative cone-beam computed tomographic image updates., Study Design: Randomized-controlled trial plus qualitative analysis., Methods: Skull base procedures were performed on 14 cadaver specimens by seven fellowship-trained skull base surgeons. Each subject performed two endoscopic transclival approaches; one with LIVE-IGS and one using a conventional IGS system in random order. National Aeronautics and Space Administration Task Load Index (NASA-TLX) scores were documented for each dissection, and a semistructured interview was recorded for qualitative assessment., Results: The NASA-TLX scores for mental demand, effort, and frustration were significantly reduced with the LIVE-IGS system in comparison to conventional navigation (P < .05). The system interface was judged to be intuitive and most useful when there was a combination of high spatial demand, reduced or absent surface landmarks, and proximity to critical structures. The development of auditory icons for proximity alerts during the trial better informed the surgeon while limiting distraction., Conclusions: The LIVE-IGS system provided accurate, intuitive, and dynamic feedback to the operating surgeon. Further refinements to proximity alerts and visualization settings will enhance orientation while limiting distraction. The system is currently being deployed in a prospective clinical trial in skull base surgery., (© 2013 The American Laryngological, Rhinological and Otological Society, Inc.)

Objectives/hypothesis: Skull base surgery (SBS) involves operative tasks in close proximity to critical structures in a complex three-dimensional (3D) anatomy. The aim was to investigate the value of virtual planning (VP) based on preoperative magnetic resonance imaging (MRI) for surgical planning in SBS and to compare the effects of virtual planning with 3D contours between the expert and the surgeon in training., Study Design: Retrospective analysis., Methods: Twelve patients with manually segmented anatomical structures based on preoperative MRI were evaluated by eight surgeons in a randomized order using a validated National Aeronautics and Space Administration Task Load Index (NASA-TLX) questionnaire., Results: Multivariate analysis revealed significant reduction of workload when using VP (P<.0001) compared to standard planning. Further, it showed that the experience level of the surgeon had a significant effect on the NASA-TLX differences (P<.05). Additional subanalysis did not reveal any significant findings regarding which type of surgeon benefits the most (P>.05)., Conclusions: Preoperative anatomical segmentation with virtual surgical planning using contours in endoscopic SBS significantly reduces the workload for the expert and the surgeon in training., (Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.)

Background: Advanced image-guidance systems allowing presentation of three-dimensional navigational data in real time are being developed enthusiastically for many medical procedures. Other industries, including aviation and the military, have noted that shifting attention toward such compelling assistance has detrimental effects. Using the detection rate of unexpected findings, we assess whether inattentional blindness is significant in a surgical context and evaluate the impact of on-screen navigational cuing with augmented reality., Methods: Surgeons and trainees performed an endoscopic navigation exercise on a cadaveric specimen. The subjects were randomized to either a standard endoscopic view (control) or an AR view consisting of an endoscopic video fused with anatomic contours. Two unexpected findings were presented in close proximity to the target point: one critical complication and one foreign body (screw). Task completion time, accuracy, and recognition of findings were recorded., Results: Detection of the complication was 0/15 in the AR group versus 7/17 in the control group (p = 0.008). Detection of the screw was 1/15 (AR) and 7/17 (control) (p = 0.041). Recognition of either finding was 12/17 for the control group and 1/15 for the AR group (p < 0.001). Accuracy was greater for the AR group than for the control group, with the median distance from the target point measuring respectively 2.10 mm (interquartile range [IQR], 1.29-2.37) and 4.13 (IQR, 3.11-7.39) (p < 0.001)., Conclusion: Inattentional blindness was evident in both groups. Although more accurate, the AR group was less likely to identify significant unexpected findings clearly within view. Advanced navigational displays may increase precision, but strategies to mitigate attentional costs need further investigation to allow safe implementation.

Background: Due to proximity to critical structures, the need for spatial awareness during endoscopic sinus surgery (ESS) is essential. We have developed an augmented, real-time image-guided surgery (ART-IGS) system that provides live navigational data and proximity alerts to the operating surgeon during ablation. We wished to test the hypothesis that task workload would be reduced when using this technology., Methods: A trial involved 8 otolaryngology residents and fellows performing ESS on cadaveric specimens; 1 side in a conventional method (control) and 1 side with ART-IGS. After computed tomography scanning, anatomical contouring, and registration of the head, a three-dimensional (3D) virtual endoscopic view, ablative tool tracking, and proximity alerts were enabled. Each subject completed ESS tasks and rated their workload during and after the exercise using the National Aeronautics and Space Administration (NASA) Task Load Index (TLX). A questionnaire and open feedback interview were completed after the procedure., Results: There was a significant reduction in mental demand, temporal demand, effort, and frustration when using the ART-IGS system in comparison to the control (p < 0.02). Perceived performance was increased (p = 0.02). Most subjects agreed that the system was sufficiently accurate, caused minimal interruption, and increased confidence. Optical tracking line-of-sight issues were frequently cited as the main limitation early in the study; however, this was largely resolved., Conclusion: ART-IGS reduces task workload for trainees performing ESS. Live navigation and alert zones may be a valuable intraoperative teaching aid., (Copyright © 2012 American Rhinologic Society-American Academy of Otolaryngic Allergy, LLC.)

Objectives/hypothesis: Our group has developed an augmented image guidance system that incorporates intraoperative cone-beam computed tomography (CBCT), virtual or augmented displays, and image registration. We assessed the potential benefits of augmented endoscopy derived from this system for use during skull base navigation. Specifically, we wished to evaluate target localization accuracy and the effect on task workload and confidence., Study Design: Prospective, sequential, paired preclinical trial., Methods: A single cadaver head underwent computed tomography, and critical structures were contoured. The specimen was reimaged after endoscopic dissection and deformable registration allowed contours to be displayed on postablation CBCT imaging. A real-time virtual view including anatomical contours was provided parallel to the real endoscopic image. Twelve subjects were asked to endoscopically localize seven skull base landmarks in a conventional manner. The same exercise was then performed with augmented endoscopy. Precise three-dimensional (3D) localization was recorded with a tracked probe. The NASA task load index was completed after each exercise. A short questionnaire was also administered., Results: The real-time augmented image guidance system aided localization in 85% of responses and increased confidence in 97%. There was a significant reduction in mental demand, effort, and frustration when the technology was employed, with an increase in perceived performance (P < .05). Three dimensional navigational precision was improved for all landmarks., Conclusions: Real-time augmented image-guided surgery increases accuracy and confidence in trainee surgeons and decreases task workload during skull base navigation. This technology shows great promise in assisting in skull base surgery even for experienced surgeons., (Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.)

Introduction: Intraoperative imaging reveals morphologic changes and resolves anatomic uncertainties during surgery. The automatic registration (AR) approach provides registered intraoperative images for real-time tracking within seconds of acquisition., Purpose: (1) To design an AR device for clinical use integrated with cone-beam computed tomography, (2) to compare the accuracy and reproducibility of manual and automatic registration, and (3) to evaluate the robustness of the AR system., Methods: An AR device consisting of an acrylic face shield with fiducials mounted on an adjustable arm was designed. Eight surface and five internal divot markers were placed with bony fixation to a cadaveric head. Internal markers were localized on the image representing the "true" location. This was compared to the positions localized using a navigational system when both manual registration and AR were applied. A series of surgical tasks and variation of the AR device height above the surgical field was performed, and target registration error (TRE) was measured., Results: The mean fiducial registration error (FRE) for manual and automatic registration was 0.72 mm ± 0.03 and 0.41 mm ± 0.01, respectively. The mean TRE for manual and automatic registration was 0.89 mm ± 0.26 and 0.91 mm ± 0.25, respectively., Conclusions: AR offers a more accurate and reproducible FRE and a TRE equally comparable to that of manual registration. This system also demonstrates robustness with comparable accuracy and reproducibility throughout different surgical tasks and variation of AR device height up to 9 cm above the surgical field. This system is currently being translated into clinical trials.

Advances in image-guided surgery have led to minimally-invasive, high-precision procedures that increase the efficacy of treatment, minimize surgical complications, and reduce patient recovery time. A recent advance in intraoperative 3D imaging includes cone-beam CT (CBCT) implemented on a mobile C-arm. This paper investigates the effect of the number and configuration of fiducials on target registration error (TRE) and identifies fiducial configurations that minimize TRE for rigid point-based registration in CBCT-guided head and neck surgery. Best configurations were those that minimized the distance between the centroid of fiducials and the surgical target while maximizing fiducial separation (distance from principal axes). Configurations with as few as 4 fiducials could be identified that minimized TRE (e.g., TRE < 0.3 mm for the pituitary, cochlea, and nasion), with more fiducials (6 or more) providing improved TRE uniformity throughout the volume of clinical interest. If possible, fiducials affixed to the skin or cranium (e.g., 4-6 markers) should include a majority about the target (to minimize centroid-to-target distance) with others at a distance (to maximize separation). A greater number of fiducials distributed evenly can provide low, uniform TRE for all targets--e.g., 8 markers, TRE approximately 0.2-0.6 mm throughout the volume of interest. Such work helps guide the implementation of C-arm CBCT in head and neck surgery in a manner that maximizes surgical precision and exploits intraoperative image guidance to its full potential.

The procedure required for registering a surgical navigation system prior to use in a surgical procedure is conventionally a time-consuming manual process that is prone to human errors and must be repeated as necessary through the course of a procedure. The conventional procedure becomes even more time consuming when intra-operative 3D imaging such as the C-arm cone-beam CT (CBCT) is introduced, as each updated volume set requires a new registration. To improve the speed and accuracy of registering image and world reference frames in image-guided surgery, a novel automatic registration algorithm was developed and investigated. The surgical navigation system consists of either Polaris (Northern Digital Inc., Waterloo, ON) or MicronTracker (Claron Technology Inc., Toronto, ON) tracking camera(s), custom software (Cogito running on a PC), and a prototype CBCT imaging system based on a mobile isocentric C-arm (Siemens, Erlangen, Germany). Experiments were conducted to test the accuracy of automatic registration methods for both the MicronTracker and Polaris tracking cameras. Results indicate the automated registration performs as well as the manual registration procedure using either the Claron or Polaris camera. The average root-mean-squared (rms) observed target registration error (TRE) for the manual procedure was 2.58 +/- 0.42 mm and 1.76 +/- 0.49 mm for the Polaris and MicronTracker, respectively. The mean observed TRE for the automatic algorithm was 2.11 +/- 0.13 and 2.03 +/- 0.3 mm for the Polaris and MicronTracker, respectively. Implementation and optimization of the automatic registration technique in Carm CBCT guidance of surgical procedures is underway.

Limb length, alignment and rotation can be difficult to determine in femoral shaft fractures. Shaft axis rotation is particularly difficult to assess intraoperatively. Femoral malpositioning can cause deformity, pain and secondary degenerative joint damage. The aim of this study is to develop an intraoperative method based on cone-beam computed tomography (CBCT) to guide alignment of femoral shaft fractures. We hypothesize that bone surface matching can predict malrotation even with severe comminution. A cadaveric femur was imaged at 16 femoral periaxial malrotations (-51.2 degrees to 60.1 degrees). The images were processed resulting in an unwrapped bone surface plot consisting of a pattern of ridges and valleys. Fracture gaps were simulated by removing midline CT slices. The gaps were reconstituted by extrapolating the existing proximal and distal fragments to the midline of the fracture. The two bone surfaces were then shifted to align bony features. Periaxial malrotation was accurately assessed using surface matching (r2 = 0.99, slope 1.0). The largest mean error was 2.20 degrees and the average difference between repeated measurements was 0.49 degrees. CBCT can provide intraoperative high-resolution images with a large field of view. This quality of imaging enables surface matching algorithms to be utilized even with large areas of comminution.