Accuracy Assessment of Percutaneous Pedicle Screw Placement Using Cone Beam Computed Tomography with Metal Artifact Reduction.

Metal artifact reduction (MAR) algorithms are used with cone beam computed tomography (CBCT) during augmented reality surgical navigation for minimally invasive pedicle screw instrumentation. The aim of this study was to assess intra- and inter-observer reliability of pedicle screw placement and to compare the perception of baseline image quality (NoMAR) with optimized image quality (MAR). CBCT images of 24 patients operated on for degenerative spondylolisthesis using minimally invasive lumbar fusion were analyzed retrospectively. Images were treated using NoMAR and MAR by an engineer, thus creating 48 randomized files, which were then independently analyzed by 3 spine surgeons and 3 radiologists. The Gertzbein and Robins classification was used for screw accuracy rating, and an image quality scale rated the clarity of pedicle screw and bony landmark depiction. Intra-class correlation coefficients (ICC) were calculated. NoMAR and MAR led to similarly good intra-observer (ICC > 0.6) and excellent inter-observer (ICC > 0.8) assessment reliability of pedicle screw placement accuracy. The image quality scale showed more variability in individual image perception between spine surgeons and radiologists (ICC range 0.51−0.91). This study indicates that intraoperative screw positioning can be reliably assessed on CBCT for augmented reality surgical navigation when using optimized image quality. Subjective image quality was rated slightly superior for MAR compared to NoMAR.

Intraoperative cone beam computed tomography is as reliable as conventional computed tomography for identification of pedicle screw breach in thoracolumbar spine surgery.

OBJECTIVES: To test the hypothesis that intraoperative cone beam computed tomography (CBCT) using the Allura augmented reality surgical navigation (ARSN) system in a dedicated hybrid operating room (OR) matches computed tomography (CT) for identification of pedicle screw breach during spine surgery. METHODS: Twenty patients treated with spinal fixation surgery (260 screws) underwent intraoperative CBCT as well as conventional postoperative CT scans (median 12 months after surgery) to identify and grade the degree of pedicle screw breach on both scan types, according to the Gertzbein grading scale. Blinded assessments were performed by three independent spine surgeons and the CT served as the standard of reference. Screws graded as Gertzbein 0 or 1 were considered clinically accurate while grades 2 or 3 were considered inaccurate. Sensitivity, specificity, and negative predictive value were the primary metrics of diagnostic performance. RESULTS: For this patient group, the negative predictive value of an intraoperative CBCT to rule out pedicle screw breach was 99.6% (CI 97.75-99.99%). Among 10 screws graded as inaccurate on CT, 9 were graded as such on the CBCT, giving a sensitivity of 90.0% (CI 55.5-99.75%). Among the 250 screws graded as accurate on CT, 244 were graded as such on the CBCT, giving a specificity of 97.6% (CI 94.85-99.11%). CONCLUSIONS: CBCT, performed intraoperatively with the Allura ARSN system, is comparable and non-inferior to a conventional postoperative CT scan for ruling out misplaced pedicle screws in spinal deformity cases, eliminating the need for a postoperative CT. KEY POINTS: • Intraoperative cone beam computed tomography (CT) using the Allura ARSN is comparable with conventional CT for ruling out pedicle screw breaches after spinal fixation surgery. • Intraoperative cone beam computed tomography can be used to assess need for revisions of pedicle screws making routine postoperative CT scans unnecessary. • Using cone beam computed tomography, the specificity was 97.6% and the sensitivity was 90% for detecting pedicle screw breaches and the negative predictive value for ruling out a pedicle screw breach was 99.6%.

Radiation dose and image quality comparison during spine surgery with two different, intraoperative 3D imaging navigation systems.

Careful protocol selection is required during intraoperative three-dimensional (3D) imaging for spine surgery to manage patient radiation dose and achieve clinical image quality. Radiation dose and image quality of a Medtronic O-arm commonly used during spine surgery, and a Philips hybrid operating room equipped with XperCT C-arm 3D cone-beam CT (hCBCT) are compared. The mobile O-arm (mCBCT) offers three different radiation dose settings (low, standard, and high), for four different patient sizes (small, medium, large, and extra large). The patient's radiation dose rate is constant during the entire 3D scan. In contrast, C-CBCT spine imaging uses three different field of views (27, 37, and 48 cm) using automatic exposure control (AEC) that modulates the patient's radiation dose rate during the 3D scan based on changing patient thickness. hCBCT uses additional x-ray beam filtration. Small, medium, and large trunk phantoms designed to mimic spine and soft tissue were imaged to assess radiation dose and image quality of the two systems. The estimated measured "patient" dose for the small, medium, and large phantoms imaged by the mCBCT considering all the dose settings ranged from 9.4-27.6 mGy, 8.9-33.3 mGy, and 13.8-40.6 mGy, respectively. The "patient" dose values for the same phantoms imaged with hCBCT were 2.8-4.6 mGy, 5.7-10.0 mGy, and 11.0-15.2 mGy. The CNR for the small, medium, and large phantoms was 2.9 to 3.7, 2.0 to 3.0, and 2.5 to 2.6 times higher with the hCBCT system, respectively. Hounsfield unit accuracy, noise, and uniformity of hCBCT exceeded the performance of the mCBCT; spatial resolution was comparable. Added x-ray beam filtration and AEC capability achieved clinical image quality for intraoperative spine surgery at reduced radiation dose to the patient in comparison to a reference O-arm system without these capabilities.

Augmented Reality on a C-Arm System: A Preclinical Assessment for Percutaneous Needle Localization.

Purpose To compare the navigational accuracy and radiation dose during needle localization of targets for augmented reality (AR) with and without motion compensation (MC) versus those for cone-beam computed tomography (CT) with real-time fluoroscopy navigation in a pig model. Materials and Methods This study was approved by the Institutional Animal Care and Use Committee. Three operators each localized 15 targets (bone fragments) approximately 7 cm deep in the paraspinal muscles of nine Yorkshire pigs by using each of the three modalities (AR with and without MC and cone-beam CT with fluoroscopy). Target depth, accuracy (distance between needle tip and target), and radiation dose (dose-area product [DAP]) were recorded for each procedure. Correlation between accuracy and depth of target was assessed by using the Pearson correlation coefficient. Two-way analysis of variance was used for differentiating accuracy and DAPs across navigation techniques and operator backgrounds. Results There was no correlation between depth of target and accuracy. There was no significant difference in accuracy between modalities (mean distance, 3.0 mm ± 1.9 [standard deviation] for cone-beam CT with fluoroscopy, 2.5 mm ± 2.0 for AR, and 3.2 mm ± 2.7 for AR with MC [P = .33]). There was, however, a significant difference in fluoroscopy radiation dose (10.4 Gy · cm(2) ± 10.6 for cone-beam CT fluoroscopy, 2.3 Gy · cm(2) ± 2.4 for AR, and 3.3 Gy · cm(2) ± 4.6 for AR with MC [P < .05]) and therefore in total procedural radiation dose (20.5 Gy · cm(2) ± 13.4 for cone-beam CT fluoroscopy, 12.6 Gy · cm(2) ± 5.3 for AR, 13.6 Gy · cm(2) ± 7.4 for AR with MC [P < .05]). Conclusion Use of an AR C-arm system reduces radiation dose while maintaining navigational accuracy compared with cone-beam CT fluoroscopy during image-guided percutaneous needle placement in a pig model. (©) RSNA, 2016 Online supplemental material is available for this article.

Estimates of diagnostic reference levels for pediatric peripheral and abdominal fluoroscopically guided procedures.

OBJECTIVE: The objective of our study was to survey radiation dose indexes of pediatric peripheral and abdominal fluoroscopically guided procedures from which estimates of diagnostic reference levels (DRLs) can be proposed for both a standard fluoroscope and a novel fluoroscope with advanced image processing and lower radiation dose rates. MATERIALS AND METHODS: Radiation dose structured reports were retrospectively collected for 408 clinical pediatric cases: Half of the procedures were performed with a standard imaging technology and half with a novel x-ray technology. Dose-area product (DAP), air Kerma (AK), fluoroscopy time, number of digital subtraction angiography images, and patient mass were collected to calculate and normalize radiation dose indexes for procedures completed with the standard and novel fluoroscopes. RESULTS: The study population was composed of 180 and 175 patients who underwent procedures with the standard and novel technology, respectively. The 21 different types of pediatric peripheral and abdominal interventional procedures produced 408 total studies. Median ages, mass and body mass index, fluoroscopy time per procedure, and total number of recorded images for the standard and novel technologies were not statistically different. The area of the x-ray beams was square at the level of the patient with a dimension of 10-13 cm. The dose reduction achieved with the novel fluoroscope ranged from 18% to 51% of the dose required with the standard fluoroscope. The median DAP and AK patient dose indexes were 0.38 Gy · cm(2) and 4.00 mGy, respectively, for the novel fluoroscope. CONCLUSION: Estimates of dose indexes of pediatric peripheral and abdominal fluoroscopically guided, clinical procedures should assist in the development of DRLs to foster management of radiation doses of pediatric patients.

Comparison of pediatric radiation dose and vessel visibility on angiographic systems using piglets as a surrogate: antiscatter grid removal vs. lower detector air kerma settings with a grid - a preclinical investigation.

The purpose of this study was to reduce pediatric doses while maintaining or improv-ing image quality scores without removing the grid from X-ray beam. This study was approved by the Institutional Animal Care and Use Committee. Three piglets (5, 14, and 20 kg) were imaged using six different selectable detector air kerma (Kair) per frame values (100%, 70%, 50%, 35%, 25%, 17.5%) with and without the grid. Number of distal branches visualized with diagnostic confidence relative to the injected vessel defined image quality score. Five pediatric interventional radiologists evaluated all images. Image quality score and piglet Kair were statistically compared using analysis of variance and receiver operating curve analysis to define the preferred dose setting and use of grid for a visibility of 2nd and 3rd order vessel branches. Grid removal reduced both dose to subject and imaging quality by 26%. Third order branches could only be visualized with the grid present; 100% detector Kair was required for smallest pig, while 70% detector Kair was adequate for the two larger pigs. Second order branches could be visualized with grid at 17.5% detector Kair for all three pig sizes. Without the grid, 50%, 35%, and 35% detector Kair were required for smallest to largest pig, respectively. Grid removal reduces both dose and image quality score. Image quality scores can be maintained with less dose to subject with the grid in the beam as opposed to removed. Smaller anatomy requires more dose to the detector to achieve the same image quality score.

Effect of real-time radiation dose feedback on pediatric interventional radiology staff radiation exposure.

PURPOSE: To measure and compare individual staff radiation dose levels during interventional radiologic (IR) procedures with and without real-time feedback to evaluate whether it has any impact on staff radiation dose. MATERIALS AND METHODS: A prospective trial was performed in which individuals filling five different staff roles wore radiation dosimeters during all IR procedures during two phases: a 12-week "closed" phase (measurements recorded but display was off, so no feedback was provided) and a 17-week "open" phase (display was on and provided real-time feedback). Radiation dose rates were recorded and compared by Mann-Whitney U test. RESULTS: There was no significant difference in median procedure time, fluoroscopy time, or patient dose (dose-area product normalized to fluoroscopy time) between the two phases. Overall, the median staff dose was lower in the open phase (0.56 µSv/min of fluoroscopy time) than in the closed phase (3.01 µSv/min; P < .05). The IR attending physician dose decreased significantly for procedures for which the physicians were close to the patient, but not for ones for which they were far away. CONCLUSIONS: A radiation dose monitoring system that provides real-time feedback to the interventional staff can significantly reduce radiation exposure to the primary operator, most likely by increasing staff compliance with use of radiation protection equipment and dose reduction techniques.

Significant dose reduction for pediatric digital subtraction angiography without impairing image quality: preclinical study in a piglet model.

OBJECTIVE: The purpose of this study was to validate the hypothesis that image quality of digital subtraction angiography (DSA) in pediatrics is not impaired when using a low-dose acquisition protocol. MATERIALS AND METHODS: Three piglets corresponding to common pediatric population sizes were used. DSA was performed in the aorta and renal, hepatic, and superior mesenteric arteries using both the commonly used reference standard and novel radiographic imaging noise reduction technologies to ensure pairwise radiation dose and image quality comparison. The air kerma per frame at the interventional reference point for each DSA acquisition was collected as a radiation dose measure, and image quality was evaluated by five interventional radiologists in a randomized blinded fashion using a 5-point scale. RESULTS: The mean air kerma (± SD) at the interventional reference point with the novel x-ray imaging noise reduction technology was significantly lower (1.1 ± 0.8 mGy/frame) than with the reference technology (4.2 ± 3.0 mGy/frame, p = 0.005). However, image quality was statistically similar, with average scores of 3.2 ± 0.4 and 3.1 ± 0.5 for the novel and reference technologies, respectively (p = 0.934); interrater absolute agreement was 0.77. CONCLUSION: The DSA radiation dose for pediatrics can be reduced by a factor of four with a novel x-ray imaging noise reduction technology without deterioration of image quality.

Diffuse reflectance spectroscopy: towards clinical application in breast cancer.

Diffuse reflectance spectroscopy (DRS) is a promising new technique for breast cancer diagnosis. However, inter-patient variation due to breast tissue heterogeneity may interfere with the accuracy of this technique. To tackle this issue, we aim to determine the diagnostic accuracy of DRS in individual patients. With this approach, DRS measurements of normal breast tissue in every individual patient are directly compared with measurements of the suspected malignant tissue. Breast tissue from 47 female patients was analysed ex vivo by DRS. A total of 1,073 optical spectra were collected. These spectra were analyzed for each patient individually as well as for all patients collectively and results were compared to the pathology analyses. Collective patient data analysis for discrimination between normal and malignant breast tissue resulted in a sensitivity of 90 %, a specificity of 88 %, and an overall accuracy of 89 %. In the individual analyses all measurements per patient were categorized as either benign or malignant. The discriminative accuracy of these individual analyses was nearly 100 %. The diagnosis was classified as uncertain in only one patient. Based on the results presented in this study, we conclude that the analysis of optical characteristics of different tissue classes within the breast of a single patient is superior to an analysis using the results of a cohort data analysis. When integrated into a biopsy device, our results demonstrate that DRS may have the potential to improve the diagnostic workflow in breast cancer.

Clinically useful dilution factors for iodine and gadolinium contrast material: an animal model of pediatric digital subtraction angiography using state-of-the-art flat-panel detectors.

BACKGROUND: Iodinated and gadolinium contrast agents pose some risk for certain pediatric patients, including allergic-like reactions, contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF). Digital flat-panel detectors enhance image quality during angiography and might allow use of more dilute contrast material to decrease risk of complications that might be dose-dependent, such as CIN and NSF. OBJECTIVE: To assess the maximum dilution factors for iodine- and gadolinium-based contrast agents suitable for vascular imaging with fluoroscopy and digital subtraction angiography (DSA) on digital flat-panel detectors in an animal model. MATERIALS AND METHODS: We performed selective catheterization of the abdominal aorta, renal artery and common carotid artery on a rabbit. In each vessel we performed fluoroscopy and DSA during contrast material injection using iodinated and gadolinium contrast material at 100%, 80%, 50%, 33% and 20% dilutions. An image quality score (0 to 3) was assigned by each of eight evaluators. Intracorrelation coefficient, paired t-test, one-way repeated analysis of variance, Spearman correlation and receiver operating characteristic curve analysis were applied to the data. RESULTS: Overall the image quality scores correlated linearly with dilution levels. For iodinated contrast material, the optimum cut-off level for DSA when a score of at least 2 is acceptable is above 33%; it is above 50% when a score of 3 is necessary. For gadolinium contrast material, the optimum cut-off for DSA images is above 50% when a score of at least 2 is acceptable and above 80% when a score of 3 is necessary. CONCLUSION: Knowledge of the relationship between image quality and contrast material dilution might allow a decrease in overall contrast load while maintaining appropriate image quality when using digital flat-panel detectors.

Minimally Invasive Transforaminal Lumbar Interbody Fusion Using Augmented Reality Surgical Navigation for Percutaneous Pedicle Screw Placement.

STUDY DESIGN: This was a retrospective observational study. OBJECTIVE: The aim of this study was to evaluate the accuracy of percutaneous pedicle screw placement using augmented reality surgical navigation during minimally invasive transforaminal lumbar interbody fusion (TLIF). SUMMARY OF BACKGROUND DATA: Augmented reality-based navigation is a new type of computer-assisted navigation where video cameras are used instead of infrared cameras to track the operated patients and surgical instruments. This technology has not so far been clinically evaluated for percutaneous pedicle screw placement. MATERIALS AND METHODS: The study assessed percutaneous pedicle screw placement in 20 consecutive patients who underwent single-level minimally invasive TLIF using augmented reality surgical navigation. Facet joint violation and depression by the inserted pedicle screws were evaluated. Secondary outcome such as radiation dose exposure, fluoroscopy time, and operative time were collected for 3 phases of surgery: preparation phase, pedicle screw placement, and decompression with cage placement. RESULTS: A clinical accuracy for screw placement within the pedicle (Gertzbein 0 or 1) of 94% was achieved. One screw violated the facet joint with a transarticular pathway. The screw head did not depress the facet in 54%. The use of fluoroscopy during navigation correlated with patient body-mass index (r=0.68, P<0.0001). The pedicle screw placement time corresponded to 36±5% of the total operative time of 117±11 minutes. A statistically significant decrease of 10 minutes in operative time was observed between the first and last 10 procedures which corresponded to the pedicle screw placement time decrease (48±9 vs. 38±7 min, P=0.0142). The learning curve model suggests an ultimate operative time decrease to 97 minutes. CONCLUSION: Augmented reality surgical navigation can be clinically used to place percutaneous screws during minimally invasive TLIF. However, the lack of tracking of the location of the device requires intraoperative fluoroscopy to monitor screw insertion depth especially in obese patients. LEVEL OF EVIDENCE: Level III.

Identification of the epidural space with optical spectroscopy: an in vivo swine study.

BACKGROUND: Accurate identification of the epidural space is critical for safe and effective epidural anesthesia or treatment of acute lumbar radicular pain with epidural steroid injections. The loss-of-resistance technique is commonly used, but it is known to be unreliable. Even when it is performed in conjunction with two-dimensional fluoroscopic guidance, determining when the needle tip enters the epidural space can be challenging. In this swine study, we investigated whether the epidural space can be identified with optical spectroscopy, using a custom needle with optical fibers integrated into the cannula. METHODS: Insertion of the needle tip into the epidural space was performed with midline and paramedian approaches in a swine. In each insertion, optical spectra were acquired at different insertion depths, and anatomical localization of the needle was determined by three-dimensional imaging with rotational C-arm computed tomography. Optical spectra that included both visible and near-infrared wavelength ranges were processed to derive estimates of the blood and lipid volume fractions. RESULTS: In all insertions, the transition of the needle tip to the epidural space from an adjacent tissue structure (interspinous ligament or the ligamentum flavum) was found to be associated with an increase in the lipid volume fraction. These increases, which ranged from 1.6- to 3.0-fold, were statistically significant (P = 0.0020). Lipid fractions obtained from the epidural space were 1.9- to 20-fold higher than those obtained from muscle (P = 0.0013). Accidental penetration of an epidural vein during one insertion coincided with a high blood volume fraction. CONCLUSIONS: The spectroscopic information obtained with the optical spinal needle is complementary to fluoroscopic images, and it could potentially allow for reliable identification of the epidural space during needle placement.

A Novel Augmented-Reality-Based Surgical Navigation System for Spine Surgery in a Hybrid Operating Room: Design, Workflow, and Clinical Applications.

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.

Frameless Patient Tracking With Adhesive Optical Skin Markers for Augmented Reality Surgical Navigation in Spine Surgery.

STUDY DESIGN: Observational study. OBJECTIVE: The aim of this study was to evaluate the accuracy of a new frameless reference marker system for patient tracking by analyzing the effect of vertebral position within the surgical field. SUMMARY OF BACKGROUND DATA: Most modern navigation systems for spine surgery rely on a dynamic reference frame attached to a vertebra for tracking the patient. This solution has the drawback of being bulky and obstructing the surgical field, while requiring that the dynamic reference frame is moved between vertebras to maintain accuracy. METHODS: An augmented reality surgical navigation (ARSN) system with intraoperative cone beam computed tomography (CBCT) capability was installed in a hybrid operating room. The ARSN system used input from four video cameras for tracking adhesive skin markers placed around the surgical field. The frameless reference marker system was evaluated first in four human cadavers, and then in 20 patients undergoing navigated spine surgery. In each CBCT, the impact of vertebral position in the surgical field on technical accuracy was analyzed. The technical accuracy of the inserted pedicle devices was determined by measuring the distance between the planned position and the placed pedicle device, at the bone entry point. RESULTS: The overall mean technical accuracy was 1.65 ±â€Š1.24 mm at the bone entry point (n = 366). There was no statistically significant difference in technical accuracy between levels within CBCTs (P ≥ 0.12 for all comparisons). Linear regressions showed that null- to negligible parts of the effect on technical accuracy could be explained by the number of absolute levels away from the index vertebrae (r ≤ 0.007 for all, ß ≤ 0.071 for all). CONCLUSION: The frameless reference marker system based on adhesive skin markers is unobtrusive and affords the ARSN system a high accuracy throughout the navigated surgical field, independent of vertebral position. LEVEL OF EVIDENCE: 3.

Does Augmented Reality Navigation Increase Pedicle Screw Density Compared to Free-Hand Technique in Deformity Surgery? Single Surgeon Case Series of 44 Patients.

STUDY DESIGN: Retrospective comparison between an interventional and a control cohort. OBJECTIVE: The aim of this study was to investigate whether the use of an augmented reality surgical navigation (ARSN) system for pedicle screw (PS) placement in deformity cases could alter the total implant density and PS to hook ratio compared to free-hand (FH) technique. SUMMARY OF BACKGROUND DATA: Surgical navigation in deformity surgery provides the possibility to place PS in small and deformed pedicles were hooks would otherwise have been placed, and thereby achieve a higher screw density in the constructs that may result in better long-term patient outcomes. METHODS: Fifteen deformity cases treated with ARSN were compared to 29 cases treated by FH. All surgeries were performed by the same orthopedic spine surgeon. PS, hook, and combined implant density were primary outcomes. Procedure time, deformity correction, length of hospital stay, and blood loss were secondary outcomes. The surgeries in the ARSN group were performed in a hybrid operating room (OR) with a ceiling-mounted robotic C-arm with integrated video cameras for AR navigation. The FH group was operated with or without fluoroscopy as deemed necessary by the surgeon. RESULTS: Both groups had an overall high-density construct (>80% total implant density). The ARSN group, had a significantly higher PS density, 86.3% ±â€Š14.6% versus 74.7% ±â€Š13.9% in the FH group (P < 0.05), whereas the hook density was 2.2% ±â€Š3.0% versus 9.7% ±â€Š9.6% (P < 0.001). Neither the total procedure time (min) 431 ±â€Š98 versus 417 ±â€Š145 nor the deformity correction 59.3% ±â€Š16.6% versus 60.1% ±â€Š17.8% between the groups were significantly affected. CONCLUSION: This study indicates that ARSN enables the surgeon to increase the PS density and thereby minimize the use of hooks in deformity surgery without prolonging the OR time. This may result in better constructs with possible long-term advantage and less need for revision surgery. LEVEL OF EVIDENCE: 3.

Augmented reality navigation with intraoperative 3D imaging vs fluoroscopy-assisted free-hand surgery for spine fixation surgery: a matched-control study comparing accuracy.

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.

Augmented Reality Surgical Navigation in Spine Surgery to Minimize Staff Radiation Exposure.

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 ±â€Š0.06 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 ±â€Š1.8 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.

Diffuse optical tomography of the breast: preliminary findings of a new prototype and comparison with magnetic resonance imaging.

This paper presents an evaluation of a prototype diffuse optical tomography (DOT) system. Seventeen women with 18 breast lesions (10 invasive carcinomas, 2 fibroadenomas, and 6 benign cysts; diameters 13-54 mm) were evaluated with DOT and magnetic resonance imaging (MRI). A substantial fraction of the original 36 recruited patients could not be examined using this prototype due to technical problems. A region of interest (ROI) was drawn at the lesion position as derived from MRI and at the mirror image site in the contralateral healthy breast. ROIs were assessed quantitatively and qualitatively by two observers independently in two separate readings. Intra- and interobserver agreements were calculated using kappa statistics (k) and intraclass correlation coefficients (ICCs). Discriminatory values for presence of malignancy were determined by receiver operating characteristic (ROC) analyses. Intraobserver agreements were excellent (k 0.88 and 0.88; ICC 0.978 and 0.987), interobserver agreements were good to excellent (k 0.77-0.95; ICC 0.96-0.98). Discriminatory values for presence of malignancy were 0.92-0.93 and 0.97-0.99 for quantitative and qualitative ROC analysis, respectively. This DOT system has the potential to discriminate malignant from benign breast tissue in a reproducible qualitative and quantitative manner. Important technical improvements are required before this technique is ready for clinical application.

Augmented and Virtual Reality Instrument Tracking for Minimally Invasive Spine Surgery: A Feasibility and Accuracy Study.

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 ±â€Š1.0 mm at the bone entry point and 2.0 ±â€Š1.3 mm at the device tip. The angular deviation was 1.7 ±â€Š1.7° in the axial and 1.6 ±â€Š1.2° in the sagittal plane. Navigation time per insertion was 195 ±â€Š93 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.

Machine learning for automated 3-dimensional segmentation of the spine and suggested placement of pedicle screws based on intraoperative cone-beam computer tomography.

OBJECTIVE: The 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. METHODS: Cone-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. RESULTS: The 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. CONCLUSIONS: The technology investigated has the potential to aid surgeons in navigational planning and improve surgical navigation workflow while maintaining patient safety.