Comprehensive Error Analysis for Robotic-assisted Placement of Pedicle Screws in Pediatric Spinal Deformity: The Initial Learning Curve.

BACKGROUND: Surgical navigation improves pedicle screw insertion accuracy and reliability. Robotic-assisted spinal surgery and screw placement has not been fully assessed in pediatric patients with spine deformity undergoing posterior spinal fusion. The purpose of this study was to describe the learning curve for robotically assisted pedicle screw placement in pediatric patients. METHODS: A retrospective review on a consecutive series of the first 19 pediatric patients who underwent posterior spinal fusion by a single surgeon using robotic navigation was performed. Demographics, curve parameters, pedicle diameter, vertebral rotation, and additional outcome measures were recorded. Screw position was assessed with calibrated intraoperative 3-dimensional fluoroscopic images. All complications of planned and placed robotically placed screws were recorded. RESULTS: A total of 194 left-sided screws were planned as robot-assisted. One hundred sixty-eight of the robotically planned screws (86.6%) were placed with robot assistance; 29 robotically planned screws (15.0%) were abandoned or converted to freehand. The mean time per robotically placed screw was 3.6±2.4 minutes. Fifteen breaches (8.9%) and 1 anterior perforation occurred with 2 critical (>2 to 4 mm) breaches, 1 was associated with a durotomy, and both occurred in the first case. There were no intraoperative/postoperative neuromonitoring changes and no sequela from the durotomy. Six breaches occurred in the first case. The odds ratio of obtaining a breach in screws with a matched trajectory was 0.275 (95% confidence interval: 0.089-0.848). CONCLUSIONS: Screw time and accuracy improved and the number of breaches decreased after 10 cases. This series had 2 critical breaches (between 2 and 4 mm) on the first case. Overall, excluding the 2 critical breaches, 98.8% of robotically executed screws were placed without a critical breach, which is comparable to previous pediatric deformity studies. Caution should be exercised during the initial training period to avoid complications as experience and training lead to an improved understanding of surgical planning, skive, and soft-tissue pressure on the end-effector all of which can impact accuracy of robotically assisted pedicle screw placement. LEVEL OF EVIDENCE: Case Series, IV.

Reasons for Revision Surgery after Cervical Disc Arthroplasty based on Medical Device Reports Maintained by the United States Food and Drug Administration.

STUDY DESIGN: Retrospective Database review. OBJECTIVE: Analyze revisions of CDAs reported to the MAUDE database. SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs. METHODS: The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared. RESULTS: A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify. CONCLUSION: The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification ,varying in their rerelvance depending on the CDA.

Anterior cervical osteotomy of diffuse idiopathic skeletal hyperostosis lesions with computer-assisted navigation surgery: A case report.

Key Clinical Message: Diffuse idiopathic skeletal hyperostosis (DISH) involves spine ligament ossification. Computer-assisted navigation (CAN) effectively aids complex surgeries, such as anterior cervical osteotomy, to alleviate progressive DISH-related dysphagia. Abstract: We describe a 68-year-old man with sudden onset dysphagia to both solids and liquids. Radiographic Imaging revealed DISH lesions from C2 down to the thoracic spine. The patient was successfully treated with CAN anterior osteotomy and resection of DISH lesions from C3-C6 and had complete symptom relief within 2 weeks post-operatively.

Assessing intraoperative pedicle screw placement accuracy using biplanar radiographs compared to three-dimensional imaging.

To date, biplanar imaging (2D) has been the method of choice for pedicle screw (PS) positioning and verified for the anteroposterior view and (spinal midline) M-line method. In recent years, the use of intraoperative three-dimensional (3D) imaging has become available with the Gertzbein-Robbins system (GRS) to assess PS breach and positioning confirmation. The aim is to determine if 2D imaging is sufficient to assess PS position in comparison to advanced 3D imaging.Retrospective review of prospectively collected data from 204 consecutive adult patients who underwent posterior thoracic and lumbar instrumented fusion for degenerative spinal surgery by a single surgeon (2019-2022).Of the 204 patients, 187 (91.6%) had intraoperative images available for analysis. A total of 1044 PS implants were used; 922 (88.3%) were robotically placed. Postoperative CT scans were verified with M-line/GRS findings. Among 103 patients (50.5%) with a total of 362 screws, (34.7%) had postoperative CT, intraoperative 3D scan, and intraoperative 2D scan for analysis. Postoperative CT findings were consistent with all GRS findings, validating that 3D imaging was accurate. Screws (1%) were falsely verified by the M-line as 3D imaging confirmed false negative or positive findings.In our series, intraoperative 3D scan was as accurate as postoperative CT scan in assessing PS breach. A significant number of PS may be falsely read as accurate on 2D imaging, that is in fact inaccurate when assessed on 3D imaging. An intraoperative post-instrumentation 3D scan may be preferable to prevent postoperative recognition of a falsely verified screw on biplanar imaging.

Robot-Assisted Lumbar Pedicle Screw Placement Based on 3D Magnetic Resonance Imaging.

STUDY DESIGN: Human Cadaveric Study. OBJECTIVE: This study aims to explore the feasibility of using preoperative magnetic resonance imaging (MRI), zero-time-echo (ZTE) and spoiled gradient echo (SPGR), as source data for robotic-assisted spine surgery and assess the accuracy of pedicle screws. METHODS: Zero-time-echo and SPGR MRI scans were conducted on a human cadaver. These images were manually post-processed, producing a computed tomography (CT)-like contrast. The Mazor X robot was used for lumbar pedicle screw-place navigating of MRI. The cadaver underwent a postoperative CT scan to determine the actual position of the navigated screws. RESULTS: Ten lumbar pedicle screws were robotically navigated of MRI (4 ZTE; 6 SPGR). All MR-navigated screws were graded A on the Gertzbein-Robbins scale. Comparing preoperative robotic planning to postoperative CT scan trajectories: The screws showed a median deviation of overall 0.25 mm (0.0; 1.3), in the axial plane 0.27 mm (0.0; 1.3), and in the sagittal plane 0.24 mm (0.0; 0.7). CONCLUSION: This study demonstrates the first successful registration of MRI sequences, ZTE and SPGR, in robotic spine surgery here used for intraoperative navigation of lumbar pedicle screws achieving sufficient accuracy, showcasing potential progress toward radiation-free spine surgery.

Background, techniques, applications, current trends, and future directions of minimally invasive endoscopic spine surgery: A review of literature.

Across many of the surgical specialties, the use of minimally invasive techniques that utilize indirect visualization has been increasingly replacing traditional techniques which utilize direct visualization. Arthroscopic surgery of the appendicular skeleton has evolved dramatically and become an integral part of musculoskeletal surgery over the last several decades, allowing surgeons to achieve similar or better outcomes, while reducing cost and recovery time. However, to date, the axial skeleton, with its close proximity to critical neural and vascular structures, has not adopted endoscopic techniques at as rapid of a rate. Over the past decade, increased patient demand for less invasive spine surgery combined with surgeon desire to meet these demands has driven significant evolution and innovation in endoscopic spine surgery. In addition, there has been an enormous advancement in technologies that assist in navigation and automation that help surgeons circumvent limitations of direct visualization inherent to less invasive techniques. There are currently a multitude of endoscopic techniques and approaches that can be utilized in the treatment of spine disorders, many of which are evolving rapidly. Here we present a review of the field of endoscopic spine surgery, including the background, techniques, applications, current trends, and future directions, to help providers gain a better understanding of this growing modality in spine surgery.

Robotic-navigated assistance in spine surgery.

The aim of this study was to assess the accuracy of pedicle screw placement, as well as intraoperative factors, radiation exposure, and complication rates in adult patients with degenerative disorders of the thoracic and lumbar spines who have undergone robotic-navigated spinal surgery using a contemporary system. The authors reviewed the prospectively collected data on 196 adult patients who had pedicle screws implanted with robot-navigated assistance (RNA) using the Mazor X Stealth system between June 2019 and March 2022. Pedicle screws were implanted by one experienced spinal surgeon after completion of a learning period. The accuracy of pedicle screw placement was determined using intraoperative 3D fluoroscopy. A total of 1,123 pedicle screws were implanted: 1,001 screws (89%) were placed robotically, 63 (6%) were converted from robotic placement to a freehand technique, and 59 (5%) were planned to be implanted freehand. Of the robotically placed screws, 942 screws (94%) were determined to be Gertzbein and Robbins grade A with median deviation of 0.8 mm (interquartile range 0.4 to 1.6). Skive events were noted with 20 pedicle screws (1.8%). No adverse clinical sequelae were noted in the 90-day follow-up. The mean fluoroscopic exposure per screw was 4.9 seconds (SD 3.8). RNA is highly accurate and reliable, with a low rate of abandonment once mastered. No adverse clinical sequelae occurred after implanting a large series of pedicle screws using the latest generation of RNA. Understanding of patient-specific anatomical features and the real-time intraoperative identification of risk factors for suboptimal screw placement have the potential to improve accuracy further.

Prospective Comparison of Two Robotically Navigated Pedicle Screw Instrumentation Techniques.

This study aimed to compare screw accuracy and incidence of skive between two robotically navigated instrumented techniques in posterior spine fusion surgery: manual anti-skive instrumentation with an anti-skive cannula (ASC) and the use of a navigated, high-speed drill (HSD). Over a 3-year period, consecutive patients are undergoing RNA posterior fusion surgery with either ASC (n = 53) or HSD (n = 63). Both groups met a value of approximately 292 screws in our analysis (296 ASC, 294 HSD), which was determined by a biostatistician at an academic institution. Screw accuracy and skive was analyzed using preoperative CT and intraoperative three-dimensional (3D) fluoroscopy. Among 590 planned robotically inserted pedicle screws (296 ASC, 294 HSD), 245 ASC screws (82.8%) and 283 HSD screws (96.3%) were successfully inserted (p < 0.05). Skive events occurred in 4/283 (1.4%) HSD screws and 15/245 (6.2%) ASC screws (p < 0.05). HSD screws showed better accuracy in the axial and sagittal planes, being closer to planned trajectories in all directions except cranial deviation (p < 0.05). Additionally, HSD had a significantly lower time per screw (1.9 ± 1.0 min) compared to ASC (3.2 ± 2.0 min, p < 0.001). No adverse clinical effects were observed. The HSD technique showed significant improvements in time and screw accuracy compared to ASC. Biplanar fluoroscopy and 3D imaging resulted in significantly lower radiation exposure and time compared to ASC. These significant findings in the HSD group may be attributed to the lower occurrence of malpositioned screws, leading to a decrease in the need for second authentication. This represents a notable iterative improvement of the RNA platform.

Augmented reality for minimally invasive spinal surgery.

Background: Augmented reality (AR) is an emerging technology that can overlay computer graphics onto the real world and enhance visual feedback from information systems. Within the past several decades, innovations related to AR have been integrated into our daily lives; however, its application in medicine, specifically in minimally invasive spine surgery (MISS), may be most important to understand. AR navigation provides auditory and haptic feedback, which can further enhance surgeons' capabilities and improve safety. Purpose: The purpose of this article is to address previous and current applications of AR, AR in MISS, limitations of today's technology, and future areas of innovation. Methods: A literature review related to applications of AR technology in previous and current generations was conducted. Results: AR systems have been implemented for treatments related to spinal surgeries in recent years, and AR may be an alternative to current approaches such as traditional navigation, robotically assisted navigation, fluoroscopic guidance, and free hand. As AR is capable of projecting patient anatomy directly on the surgical field, it can eliminate concern for surgeon attention shift from the surgical field to navigated remote screens, line-of-sight interruption, and cumulative radiation exposure as the demand for MISS increases. Conclusion: AR is a novel technology that can improve spinal surgery, and limitations will likely have a great impact on future technology.

Cervical Spine Navigation and Enabled Robotics: A New Frontier in Minimally Invasive Surgery.

Background: Robotic-assisted and computer-assisted navigation (CAN) systems utilization has been rapidly increasing in recent years. Most existing data using these systems are performed in the thoracic, lumbar, and sacral spine. The unique anatomy of the cervical spine maybe where these technologies have the greatest potential. To date, the role of navigation-enabled robotics in the cervical spine remains in its early stages of development and study. Purpose: This review article describes the early experience, case descriptions and technical considerations with cervical spine screw fixation and decompression using CAN and robotic-assisted surgery. Methods: Representative cervical cases with early surgical experience with cervical and robotic assisted surgery with CAN. Surgical set up, technique considerations, instrumentation, screw accuracy and screw placement were elevated and recorded for each representative cervical case. Results: Existing robotic assisted spine surgical systems are reviewed as they pertain to the cervical spine. Method for cervical reference and positioning on radiolucent Mayfield tongs are presented. C1 lateral mass, odontoid fracture fixation, C2 pedicle, translaminar, subaxial lateral mass, mid cervical pedicle, navigated decompression and ACDF cases and techniques are presented. Conclusion: In conclusion, within the last several years, the use of CANs in spinal surgery has grown and the cervical spine shows the greatest potential. Several robotic systems have had FDA clearance for use in the spine, but such use requires simultaneous intraoperative fluoroscopic confirmation. In the coming years, this recommendation will likely be dropped as accuracy improves.

Evaluation of K-wireless robotic and navigation assisted pedicle screw placement in adult degenerative spinal surgery: learning curve and technical notes.

BACKGROUND: K-wireless robotic pedicle screw instrumentation with navigation is a new technology with large potential. Barriers to adoption are added registration time with robotic-navigated system and reliable screw positioning. Understanding the learning curve and limitations is crucial for successful implementation. The purpose of this study was to describe a learning curve of k-wireless robotic assisted pedicle screw placement with navigation and compare to conventional techniques. METHODS: A retrospective review of prospectively collected data of 65 consecutive adult patients underwent robotic-navigated posterior spinal fusion by a single spine surgeon. Registration, screw placement, and positioning times were recorded. All patients underwent intra-operative 3D fluoroscopy and screw trajectory was compared to pre-operative CT. RESULTS: A total of 364 instrumented pedicles were planned robotically, 311 (85.4%) were placed robotically; 17 screws (4.7%) converted to k-wire, 21 (5.8%) converted to freehand, and 15 (4.1%) planned freehand. Of the 311 robotically placed pedicle screws, three dimensional fluoroscopic imaging showed 291 (93.5%) to be GRS Grade A in the axial plane (fully contained within the pedicle) and 281 (90.4%) were GRS Grade A in the sagittal plane. All breached screw deviations from plan were identified on 3D fluoroscopy during surgery and repositioned and confirmed by additional 3d fluoroscopy scan. Reasons for conversion included morphology of starting point (n=18), soft tissue pressure (n=9), hypoplastic pedicles (n=6), obstructive reference pin placement (n=2), and robotic arm issues (n=1). Seventeen (5.5%) critical breaches (≥2-4 mm) were recorded in 11 patients, 9 (2.9%) critical breaches were due to soft tissue pressure causing skive. Two patients experienced 6 (1.9%) critical breaches from hypoplastic pedicles, and 3 (0.9%) unplanned lateral breaches were found in another patient. One patient (0.3%) experienced skive due to morphology and spinal instability from isthmic spondylolisthesis. Imaging showed 143 screws placed medially to plan (1.2±0.9 mm), 170 lateral (1.2±1.1 mm), 193 screws caudal (1.0±0.6 mm) and 117 cranial (0.6±0.5 mm). No adverse clinical sequelae occurred from implantation of any screw. CONCLUSIONS: The learning curve showed improvement in screw times for the first several cases. Understanding the learning curve and situations where the robotic technique may be suboptimal can help guide the surgeon safe and effectively for adoption, as well as further refine these technologies.

Overview of Robotic Technology in Spine Surgery.

As robotics in spine surgery has progressed over the past 2 decades, studies have shown mixed results on its clinical outcomes and economic impact. In this review, we highlight the evolution of robotic technology over the past 30 years, discussing early limitations and failures. We provide an overview of the history and evolution of currently available spinal robotic platforms and compare and contrast the available features of each. We conclude by summarizing the literature on robotic instrumentation accuracy in pedicle screw placement and clinical outcomes such as complication rates and briefly discuss the future of robotic spine surgery.

Comparing the Efficacy of Radiation Free Machine-Vision Image-Guided Surgery With Traditional 2-Dimensional Fluoroscopy: A Randomized, Single-Center Study.

Background: Three-dimensional (3D) computer-assisted navigation (CAN) has emerged as a potential alternative to 2-dimensional (2D) fluoroscopy in the surgical placement of spinal instrumentation. Recently, 3D-CAN systems have improved significantly in their ability to provide real-time anatomical referencing while shortening the registration and set-up time. A novel system in navigation, Machine-Vision Image-Guided Surgery (MvIGS; 7D Surgical, Toronto, Canada) was cleared by the US Food and Drug Administration, but its potential benefits in reducing intra-operative radiation exposure to patients and enhancing surgical accuracy of pedicle screw placement are not fully known. Purpose: We sought to conduct a prospective, randomized, clinical study comparing the 3D-MvIGS spinal navigation system and 2D-fluoroscopy for pedicle screw insertion up to 3 levels (T10-S1) and for various measures of surgical efficacy. Methods: Sixty-two eligible patients were randomized to receive spine surgery using either the 3D-MvIGS group or the conventional 2D-fluoroscopy for pedicle screw fixation for the treatment of spinal stenosis and degenerative spondylolisthesis. Intra-operative parameters and procedure-related unintended protocol violations were recorded. Results: Operative time and estimated blood loss were not significantly different between groups. Radiation time and exposure to patients were significantly reduced in the 3D-MvIGS group. There was no difference between groups in pedicle screw placement accuracy (2D-fluoroscopy group, 96.6%; 3D-MvIGS group, 94.2%). There were no major complications or cases that required revision surgery. Conclusion: The 3D-MvIGS navigation system performed comparably with 2D-fluoroscopy in terms of pedicle screw placement accuracy and operative time. The 3D-MvIGS showed a significant reduction in radiation exposure to patients. In more complex cases or larger cohorts, the true value of greater anatomical visualization can be elucidated.