A Prospective Multicentric Trial on Accuracy, Efficiency, Safety, and Outcomes of Robot-Assisted Thoracic Pedicle Screw Fixation: Study Protocol

A Prospective Multicentric Trial on Accuracy, Efficiency, Safety, and Outcomes of Robot-Assisted Thoracic Pedicle Screw Fixation: Study Protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A Prospective Multicentric Trial on Accuracy, Efficiency, Safety, and Outcomes of Robot-Assisted Thoracic Pedicle Screw Fixation: Study Protocol Satish Kripalani, Jacob Oh, Srinivasa Vidyadhara, Bharat Dave, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9413910/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 10 You are reading this latest preprint version Abstract Introduction: Pedicle screw fixation is the gold standard for thoracic spine stabilization, but its accuracy is critical due to neurological and vascular complication risks. Robotic-assisted techniques show promise in improving accuracy and reducing radiation, but thoracic-specific evidence is limited. Methodology: This prospective multicentric observational cohort study involves 7 high-volume centers. 100 adult patients (18–65 years) undergoing robot-assisted thoracic pedicle screw fixation will be recruited. The standardized workflow includes positioning, robotic arm mounting, registration (CT-to-fluoroscopy or scan-and-plan), and screw insertion using powered instrumentation. Data collection will cover preoperative demographics, intraoperative parameters (operative time, radiation exposure, blood loss), and postoperative outcomes. Accuracy will be assessed via the Gertzbein-Robbins grading system on postoperative CT or O-arm scans. Efficiency metrics will cover registration, planning, and screw insertion times. Clinical outcomes (VAS, ODI, SRS-22, patient satisfaction) will be evaluated at 3, 6, and 12 months. Expected Outcomes: This multicentric trial will provide real-world evidence on robot-assisted thoracic pedicle screw fixation. The expectation is to develop a standardized workflow, yielding significantly higher screw placement accuracy than conventional techniques, while achieving comparable clinical outcomes. Discussion: Knowledge of Robotic pedicle screw fixation utility specific to the thoracic spine is limited. This study contributes by evaluating and comparing the two registration techniques (CT-to-Fluoroscopy and Scan-and-Plan), and assessing the accuracy, safety, efficiency, and clinical outcomes of robot-assisted thoracic pedicle screw placement. Robotic spine surgery thoracic pedicle screw accuracy multicentric trial workflow standardization Introduction Pedicle screw fixation is the gold standard for posterior stabilization in spine surgery. Because inaccurate screw placement carries a high risk of serious complications including neurological or vascular damage, instability, and implant failure, achieving precise placement is absolutely critical ( 1 , 2 ) . Studies examining pedicle screw placement in the thoracic and lumbar regions show that conventional techniques achieve a median accuracy of 83.6%, with a reported range of 27.6% to 100% (3) . By contrast, utilizing computer-based navigation notably raises the median accuracy to 95.1%, narrowing the overall range to 72% to 100% (3) . In recent years, the accuracy of pedicle screw placement has been further increased by the development of robot guided navigation. Literature consistently demonstrates that, as compared to the conventional free hand techniques, the accuracy of robot assisted pedicle screw placement has improved, with an added advantage of reduced radiation exposure ( 4 – 8 ) . Thoracic pedicle screw fixation is a critical component of surgical stabilization for thoracic spine pathologies. The thoracic vertebrae present a surgical challenge due to their complex anatomy and close proximity to vital structures like the spinal cord and aorta. These factors heighten the risk of screw misplacement, potentially leading to severe complications. Various studies show that the misplacement rate of thoracic pedicle screw can range from 7.15 to 30% (9–12) . Robotic-assisted spine surgery has shown promise in enhancing accuracy, reducing radiation exposure, and improving surgical outcomes in lumbar regions ( 4 – 7 ) . However, evidence specific to thoracic applications remains sparse, necessitating a multicentric trial to establish its utility. This study aims to address current knowledge gaps by evaluating the accuracy, safety, and efficiency of robot-assisted thoracic pedicle screw fixation in a real-world, multicenter setting. Study Objectives The primary objectives of the study will be as follows: To devise a uniform and defined workflow for robot assisted thoracic pedicle screw fixation. To determine the accuracy of robotic-assisted thoracic pedicle screw fixation using the Gertzbein-Robbins grading system on post procedure O-arm scan or postoperative CT scans. The secondary objectives of the study will be as follows: To evaluate intraoperative and postoperative complications. To analyze the impact of robotic assistance on operative parameters: surgical time, radiation exposure, and blood loss. To compare CT-Fluoroscopic and Scan-and-Plan Workflows To assess clinical outcomes, including pain relief, functional improvement, and patient satisfaction over a 12 month follow-up period. The findings are expected to provide high-quality evidence for clinical practice and potentially set new standards for thoracic spinal surgery. Methodology Study Design and Setting : This study will be a prospective, multicentric, observational cohort study. The study will have two arms: The first arm would cover all the primary and secondary objectives except the assessment of clinical outcomes with a duration of six months required for recruitment and no follow up period. The second arm will address the secondary objectives pertaining to the clinical assessment with a follow up period of 12 months. The total duration of the study will be 18 months. Participating Centers The study will involve 7 high-volume centers experienced in robotic spine surgery with experienced surgeons who have performed atleast 20 robot-assisted pedicle screw cases independently prior to participation using FDA/CE-approved robotic spine systems. The participating centres will be as follows: Sri Balaji Action Medical Institute, New Delhi. Stavya Spine Hospital and Research Institute, Ahmedabad. Manipal Hospital, Bangalore. Krishna Institute of Medical Sciences, Kondapur. Tan Tock Seng Hospital, Singapore. Sunway Medical Centre, Malaysia. Thailand, (TO BE DECIDED). Study Population and Recruitment: A total of 100 adult patients (aged 18–65 years) across participating centers undergoing robot-assisted thoracic pedicle screw placement will be recruited. This sample size is based on previously conducted studies ( 13 ) . Inclusion Criteria Adults aged 18–65 years, with indications for thoracic pedicle screw fixation (due to trauma, deformity, tumor, infection, or degenerative conditions), and the ability to provide written informed consent Exclusion Criteria Patients unable to undergo imaging, those with severe comorbidities precluding surgery, patients unable to complete follow-up, or those providing negative consent to participate. Intervention and Workflow Participating centers will use approved robotic systems for pedicle screw planning and placement and standardized neuro monitoring system. The standardized robotic workflow involves: 1. Bed frame attachment and patient positioning : A bed frame is attached to the radiolucent table. Bed frame helps to mount the robot to the operating table. Camera / navigation shall be placed at the cranial end of the table. The position of patient shall be prone with shoulders < 90 degrees abduction without excessive external rotation with elbows flexed to < 90 degrees. Proper padding must be ensured and abdomen should be free 2. Mounting of Robotic Arm : Robotic arm system is mounted on to the bed frame. It is typically mounted on right side of the patient when prone, but it can also be mounted as per surgeon’s preference 3. Mounting of patient to the robotic arm : Midline skin incision is taken and desired levels are exposed. One level, caudal to the last level to be fixed is also exposed unilaterally and a transpedicular Schanz screw is inserted at that level unilaterally. The patient is mounted to the robotic arm by connecting the Schanz screw and robotic arm using Schanz screw bridge. 4. Registration and workflow : Perform a 3D scan to establish the surgeon's working volume. Then perform a “snapshot” that tells the navigation system where the robotic arm is and merges the two together. Either of the two registration methods could be used depending on the practice at the centre: CT to fluoroscopy. Scan and plan. CT to Fluoroscopy Uses a preoperative 1mm slice CT scan data for screw trajectory planning, followed by intraoperative AP and lateral/oblique fluoroscopy images that are transferred to the software for registration. Scan and Plan Uses an intraoperative CT scan (O-arm spin) for image transfer and planning of screw trajectories 5.Pedicle screw insertion : The screw placement is from farthest to most proximal pedicle from the patient mounting pin in all cases except deformity and from the apex to periphery in spinal deformities. The robotic arm is sent to respective screw trajectory and a sleeve and a dilator is used to prepare a track through the fascia and the entry point and the trajectory is confirmed. Respective screw trajectories are drilled and tapped as per desired diameter. A navigated screw driver is used to place the screws in desired trajectories and the steps are repeated for all the screws. Powered instrumentation will be used for all steps. After placement of all the screws an AP and lateral shoot of C-Arm is taken to confirm the position of all the screws. Data collection and Outcome Measures: Preoperative Phase The following data will be collected during the preoperative phase Baseline demographic and clinical data collection. Preoperative CT/ XRAY, MRI of Thoracic spine. Preoperative DEXA scan wherever indicated. VAS, ODI scores of patient on admission. Intraoperative Data Collection The following intra-operative data will be collected Operative time, radiation exposure, blood loss, and any adverse events will be documented. Screw Placement Robot assisted Pedicle screws will be placed and any deviations from robotic guidance will be recorded. Postoperative Phase The following data will be collected post-operatively Immediate post procedure O-Arm scan or post operative CT scan for accuracy assessment Post op VAS, ODI scores Scheduled follow-ups at 3, 6, and 12 months and assessment of VAS, ODI scores along with functional improvement and patient satisfaction. Outcome Measures: ARM 1 OUTCOME MEASURES A) Primary Outcome Accuracy of Screw Placement : Evaluation will be done by two independent blinded assessors and by a third assessor in case of discrepancy using post procedure O-arm spin or postoperative CT scans uploaded in DICOM format by the participating centres and classified based on the Gertzbein-Robbins scale: Grade A: Fully within pedicle (< 2 mm breach) Grade B: 4 mm breach B) Secondary Outcomes 1. Safety: Incidence of intraoperative complications. Postoperative complications (e.g., neurological, vascular, or infection-related events etc.) 2. Operative Parameters: Estimated blood loss 3. Efficiency: Number of attempts per screw Efficiency of Robotic software and hardware. Registration time - from start to completion of registration Planning time - time required for planning of screws. Screw insertion time - from docking of the robotic arm to the screw placement completion. Total procedure time - from start of registration to screw placement completion 4. Radiation exposure ARM 2 SECONDARY OUTCOME MEASURES Clinical Outcomes : Pain relief: Visual Analog Scale (VAS) at baseline, 3, 6, and 12 months Functional improvement: Oswestry Disability Index (ODI) and Scoliosis Research Society-22 (SRS-22) scores at similar intervals Length of hospital stay Patient satisfaction Likert Scale ( 14 ) . Primary Endpoints: Accuracy of Pedicle Screw Placement: The primary endpoint is the proportion of screws classified as Grade A or B on the Gertzbein-Robbins scale, as assessed using post-procedure O-arm or postoperative CT imaging. Grade A (Screw fully within the pedicle) or Grade B (Cortical breach < 2 mm) pedicle screws will be considered as accurate. Screws with breaches ≥ 2 mm (Grades C and D) will be considered inaccurately placed. Secondary Endpoints: ARM 1 – Intraoperative and Procedural Outcomes 1. Safety: Incidence of intraoperative complications, including robotic system errors, hardware issues, and facet joint violations Incidence of postoperative complications, including neurological, vascular, or infection-related events 2. Operative Parameters: Estimated intraoperative blood loss (in mL) 3. Efficiency Metrics: Number of attempts per screw Registration time (from start to completion of registration; in minutes) Planning time (time required for planning of screws) Screw insertion time (from docking of the robotic arm to completion of screw insertion) Total procedure time (from start of registration to completion of screw placement; in minutes) 4. Radiation Exposure: Total intraoperative radiation exposure, measured in millisieverts (mSv) ARM 2 – Clinical Outcomes 1. Pain Relief: Change in Visual Analog Scale (VAS) scores from baseline to 3, 6, and 12 months postoperatively 2. Functional Improvement: Change in Oswestry Disability Index (ODI) and Scoliosis Research Society-22 (SRS-22) scores at 3, 6, and 12 months 3. Healthcare Utilization: Length of hospital stay (in days) 4. Patient Satisfaction: Patient-reported satisfaction at 12 months using Likert Scale ( 14 ) . Statistical Analysis The primary outcome (proportion of Grade A/B screws) will be compared using the Chi-square or Fisher’s exact test. Logistic regression will analyze risk factors for complication rates. Comparison of means for operative parameters will use t-tests or Mann-Whitney U tests. Clinical outcomes (longitudinal data) will be analyzed using repeated measures ANOVA. Subgroup analysis will be performed to assess the impact of pathology (trauma vs. deformity vs. tumor vs. degenerative) on outcomes Sample size calculations: The sample size (n) refers to the number of screws rather than the number of patients. This is based on comparison of pedicle screw placement accuracy between the Scan-&-Plan Group (p 1 = 0.991) and the CT-to-Fluoroscopy Group (p 2 = 0.981) [1], using the Gertzbein and Robbins classification system. (Enter Table 1 ) Table 1 Significance Level (α) Power (1 - β) Required Number of Screws per Group (n) 0.05 0.8 2,097 0.05 0.85 2,398 0.05 0.9 2,807 The required number of screws per group was calculated for different combinations of significance level (α) and power (1 - β) using the pwr.2p.test function in R. The effect size was derived from the accuracy proportions of the Scan-&-Plan Group (p 1 = 0.987) and the CT-to-Fluoroscopy Group (p 2 = 0.935) ( 13 ) , as measured by the Gertzbein and Robbins classification system. The results indicate the minimum number of screws needed per group to detect significant differences in accuracy under varying statistical parameters. Expected Outcomes This multicentric trial is designed to provide high-quality, real-world evidence on the utility of robot-assisted technology for thoracic pedicle screw fixation. The expectation is that the defined protocol and the use of robotic assistance will yield a significantly higher screw placement accuracy (Grade A/B screws) compared to historical rates for conventional techniques, thereby reducing the incidence of complications like neurological or vascular damage. Along with higher accuracy it is expected that robot assistance will give clinical outcomes comparable to conventional techniques. Discussion As per our knowledge there are limited studies on the utility of Robot assisted pedicle screw fixation specific to thoracic spine. In a multicentric study across 2 centres done by Garufi G et.al., a retrospective comparison was done between robotic surgery using the Excelsius GPS Robot and neuro-navigation with the O-arm for degenerative lumbo-sacral spine diseases in terms of accuracy of screw placement assessed by Gertzbein-Robbins scale using postoperative imaging, along with safety outcomes such as intraoperative and postoperative complications, operative parameters including blood loss, and efficiency metrics like registration time, planning time, screw insertion time, and radiation exposure; and found comparable outcomes in screw placement accuracy, operative time, blood loss, and functional recovery (ODI and VAS scores) between the two technologies, with robotic surgery showing a trend towards greater precision but no significant difference ( 15 ) . In another multicenter study across 4 centres done by Lee NJ et.al., it was shown that robot-assisted spine surgery resulted in steadily improving screw accuracy, efficiency, and radiation exposure, while maintaining low complication rates and decreasing hospital stay over 5 years. The findings validate the use of robotic platforms across various centers and highlight the trend toward improved value-based care in complex spine surgery ( 16 ) . In a sudy done by Orosz LD et.al., highlighting the reliability and safety of integrating robotic guidance with 3D navigation for spine fusion procedures, it was demonstrated that navigated robotic thoracolumbar surgery resulted in low rates of intraoperative (4.1%), postoperative surgical (6.6%), and revision (1.5%) complications within 90 days ( 17 ) . Thus there is a need for a multicentric study to address this gap in knowledge. A key contribution of this study is the formal evaluation and comparison of the CT-to-Fluoroscopy and Scan-and-Plan registration methods, which will help define best practices and potentially set new standards for robotic thoracic spinal surgery. Furthermore, by analyzing efficiency metrics (registration and setup time, total procedure time, screw planning time, screw insertion time, attempts per screw) and radiation exposure, the study will offer insights into the practical benefits and resource utilization associated with implementing the robotic workflow. Finally, the 12-month follow-up for Arm 2 will rigorously assess the clinical impact, correlating the procedural accuracy and efficiency metrics with meaningful patient-centered outcomes, including sustained pain relief (VAS), functional improvement (ODI, SRS-22), and patient satisfaction. The findings from this trial are expected to provide definitive evidence to guide clinical practice for robot-assisted thoracic pedicle screw fixation. Ethical Considerations It will be mandatory to get ethics committee approval from each participating centre along with written informed consent from each participant. To maintain confidentiality, data will be anonymized and stored securely. Declarations Conflict of interest: There is no conflict of interest among the authors related to this manuscript. Funding: It is an investigator-initiated trial with grant support from Medtronic. Author Contribution All authors were involved in the conceptualization, study design, critical review, and editing. SK (leading author) helped additionally in manuscript writing. HSC additionally helped in developing methodology and protocol along with manuscript writing References Li G, Lv G, Passias P et al (2010) Complications associated with thoracic pedicle screws in spinal deformity. Eur Spine J 19:1576–1584 Brasiliense LB, Theodore N, Lazaro BC et al (2010) Quantitative analysis of misplaced pedicle screws in the thoracic spine: how much pullout strength is lost? presented at the 2009 Joint Spine Section Meeting. J Neurosurg Spine 12:503–508 Kosmopoulos V, Schizas C (2007) Pedicle screw placement accuracy: a meta-analysis. Spine 32:E111–E120 Fan Y, Du JP, Liu JJ et al (2018) Accuracy of pedicle screw placement comparing robot-assisted technology and the free-hand with fluoroscopy-guided method in spine surgery: an updated meta-analysis. Med (Baltim) 97:e10970 Gao S, Lv Z, Fang H (2018) Robot-assisted and conventional freehand pedicle screw placement: a systematic review and meta-analysis of randomized controlled trials. Eur Spine J 27:921–930 Li H-M, Zhang R-J, Shen C-L (2020) Accuracy of pedicle screw placement and clinical outcomes of robot-assisted technique versus conventional freehand technique in spine surgery from nine randomized controlled trials: a meta-analysis. Spine 45:E111–E119 Liu H, Chen W, Wang Z et al (2016) Comparison of the accuracy between robot-assisted and conventional freehand pedicle screw placement: a systematic review and meta-analysis. Int J Comput Assist Radiol Surg 11:2273–2281 Macke JJ, Woo R, Varich L (2016) Accuracy of robot-assisted pedicle screw placement for adolescent idiopathic scoliosis in the pediatric population. J Robot Surg 10:145–150 Belmont PJ Jr, Klemme WR, Dhawan A, Polly DW Jr (2001) In vivo accuracy of thoracic pedicle screws. Spine 26:2340–2346 Di Silvestre M, Parisini P, Lolli F et al (2007) Complications of thoracic pedicle screws in scoliosis treatment. Spine 32:1655–1661 Gokcen HB, Erdogan S, Ozturk S et al (2018) Sagittal orientation and uniform entry for thoracic pedicle screw placement with free-hand technique: a retrospective study on 382 pedicle screws. Int J Surg 51:83–88 Perdomo-Pantoja A, Ishida W, Zygourakis C et al (2019) Accuracy of current techniques for placement of pedicle screws in the spine: a comprehensive systematic review and meta-analysis of 51,161 screws. World Neurosurg 126:664e3–678e3 Khan A, Soliman MAR, Lee NJ, Waqas M, Lombardi JM, Boddapati V, Levy LC, Mao JZ, Park PJ, Mathew J, Lehman RA, Mullin JP, Pollina J (2022) CT-to-fluoroscopy registration versus scan-and-plan registration for robot-assisted insertion of lumbar pedicle screws. Neurosurg Focus. ;52(1):E8. 10.3171/2021.10.FOCUS21506 . PMID: 34973678 Muniasamy K, Sivakumar A, Rameshbabu KN, Ganesan A, Rajkumar VA, Deshmukh GV, Sharma SVS (2024) Patient satisfaction and quality of life outcomes following robotic-assisted surgery: A survey-based study. Bioinformation 20(12):1964–1969 PMID: 40230909; PMCID: PMC11993418 Garufi G, Scalia G, Graziano F, Costanzo R, Porzio M, Ponzo G, Giuffrida M, Ricciardo G, Umana GE, Nicoletti GF, Cardali SM (2025) Robot-assisted versus navigated spinal fusion surgery: a comparative multicenter study on transpedicular screw placement accuracy and patient outcomes. Neurosurg Rev. ;48(1):524. 10.1007/s10143-025-03674-z . PMID: 40542927 Lee NJ, Leung E, Buchanan IA, Geiselmann M, Coury JR, Simhon ME, Zuckerman S, Buchholz AL, Pollina J, Jazini E, Haines C, Schuler TC, Good CR, Lombardi J, Lehman RA (2022) A multicenter study of the 5-year trends in robot-assisted spine surgery outcomes and complications. J Spine Surg 8(1):9–20. 10.21037/jss-21-102 PMID: 35441099; PMCID: PMC8990386 Orosz LD, Lee NJ, Gum JL, Lehman RA, Hage TR, Katz J, Amell-Angst T, Roy RT, Poulter GT, Haines CM, Jazini E, Good CR (2025) Ninety-Day Complication and Revision Surgery Rates Using Navigated Robotics in Thoracolumbar Spine Surgery: A PRoGRSS Interim Analysis. Int J Spine Surg. ;19(4):437–443. 10.14444/8777 . PMID: 40681341 Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9413910","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":626649327,"identity":"ad615388-a617-47f7-9888-19fbad3bdd00","order_by":0,"name":"Satish Kripalani","email":"","orcid":"","institution":"Sri Balaji Action Medical Institute","correspondingAuthor":false,"prefix":"","firstName":"Satish","middleName":"","lastName":"Kripalani","suffix":""},{"id":626649328,"identity":"7613b465-33f2-4ccb-8438-c1120ea10386","order_by":1,"name":"Jacob Oh","email":"","orcid":"","institution":"Tan Tock Seng Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jacob","middleName":"","lastName":"Oh","suffix":""},{"id":626649329,"identity":"974f3720-51bf-452f-905e-3cea76af12d9","order_by":2,"name":"Srinivasa Vidyadhara","email":"","orcid":"","institution":"Manipal Hospital","correspondingAuthor":false,"prefix":"","firstName":"Srinivasa","middleName":"","lastName":"Vidyadhara","suffix":""},{"id":626649330,"identity":"dcecd82a-3943-48ce-bef6-9d8de40951d5","order_by":3,"name":"Bharat Dave","email":"","orcid":"","institution":"Stavya Spine Universe","correspondingAuthor":false,"prefix":"","firstName":"Bharat","middleName":"","lastName":"Dave","suffix":""},{"id":626649331,"identity":"191fedf0-5581-4bfa-96c2-33a96da3f2c6","order_by":4,"name":"Wayne Yap","email":"","orcid":"","institution":"Tan Tock Seng Hospital","correspondingAuthor":false,"prefix":"","firstName":"Wayne","middleName":"","lastName":"Yap","suffix":""},{"id":626649332,"identity":"715fb53d-736d-442f-ad0b-670be9f1940c","order_by":5,"name":"Mirant Dave","email":"","orcid":"","institution":"Stavya Spine Universe","correspondingAuthor":false,"prefix":"","firstName":"Mirant","middleName":"","lastName":"Dave","suffix":""},{"id":626649333,"identity":"465efb4e-da74-4b3b-b532-a6dabeaaab61","order_by":6,"name":"Krishna Chaitnya","email":"","orcid":"","institution":"Krishna Institute of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Krishna","middleName":"","lastName":"Chaitnya","suffix":""},{"id":626649334,"identity":"7e24a8ae-92e9-4768-ae7c-61a4fb569617","order_by":7,"name":"Saw Lim Beng","email":"","orcid":"","institution":"Sunway Medical Centre","correspondingAuthor":false,"prefix":"","firstName":"Saw","middleName":"Lim","lastName":"Beng","suffix":""},{"id":626649335,"identity":"956a69f1-2cbf-402c-a79d-d2b3ceee7bf5","order_by":8,"name":"Harvinder Singh Chhabra","email":"data:image/png;base64,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","orcid":"","institution":"Sri Balaji Action Medical Institute","correspondingAuthor":true,"prefix":"","firstName":"Harvinder","middleName":"Singh","lastName":"Chhabra","suffix":""}],"badges":[],"createdAt":"2026-04-14 10:08:18","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9413910/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9413910/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":107722381,"identity":"bfad5d0e-3a00-4be7-ad16-e0ed2e4b1a60","added_by":"auto","created_at":"2026-04-24 11:21:50","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":225743,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9413910/v1/2a7146d1-9fb0-490d-89eb-27d77db0ac83.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"A Prospective Multicentric Trial on Accuracy, Efficiency, Safety, and Outcomes of Robot-Assisted Thoracic Pedicle Screw Fixation: Study Protocol","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePedicle screw fixation is the gold standard for posterior stabilization in spine surgery. Because inaccurate screw placement carries a high risk of serious complications including neurological or vascular damage, instability, and implant failure, achieving precise placement is absolutely critical\u003csup\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/sup\u003e. Studies examining pedicle screw placement in the thoracic and lumbar regions show that conventional techniques achieve a median accuracy of 83.6%, with a reported range of 27.6% to 100% \u003csup\u003e(3)\u003c/sup\u003e. By contrast, utilizing computer-based navigation notably raises the median accuracy to 95.1%, narrowing the overall range to 72% to 100%\u003csup\u003e(3)\u003c/sup\u003e. In recent years, the accuracy of pedicle screw placement has been further increased by the development of robot guided navigation. Literature consistently demonstrates that, as compared to the conventional free hand techniques, the accuracy of robot assisted pedicle screw placement has improved, with an added advantage of reduced radiation exposure\u003csup\u003e(\u003cspan additionalcitationids=\"CR5 CR6 CR7\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThoracic pedicle screw fixation is a critical component of surgical stabilization for thoracic spine pathologies. The thoracic vertebrae present a surgical challenge due to their complex anatomy and close proximity to vital structures like the spinal cord and aorta. These factors heighten the risk of screw misplacement, potentially leading to severe complications. Various studies show that the misplacement rate of thoracic pedicle screw can range from 7.15 to 30% \u003csup\u003e(9\u0026ndash;12)\u003c/sup\u003e. Robotic-assisted spine surgery has shown promise in enhancing accuracy, reducing radiation exposure, and improving surgical outcomes in lumbar regions \u003csup\u003e(\u003cspan additionalcitationids=\"CR5 CR6\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e. However, evidence specific to thoracic applications remains sparse, necessitating a multicentric trial to establish its utility.\u003c/p\u003e \u003cp\u003eThis study aims to address current knowledge gaps by evaluating the accuracy, safety, and efficiency of robot-assisted thoracic pedicle screw fixation in a real-world, multicenter setting.\u003c/p\u003e"},{"header":"Study Objectives","content":"\u003cp\u003eThe primary objectives of the study will be as follows:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eTo devise a uniform and defined workflow for robot assisted thoracic pedicle screw fixation.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTo determine the accuracy of robotic-assisted thoracic pedicle screw fixation using the Gertzbein-Robbins grading system on post procedure O-arm scan or postoperative CT scans.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eThe secondary objectives of the study will be as follows:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eTo evaluate intraoperative and postoperative complications.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTo analyze the impact of robotic assistance on operative parameters: surgical time, radiation exposure, and blood loss.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTo compare CT-Fluoroscopic and Scan-and-Plan Workflows\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTo assess clinical outcomes, including pain relief, functional improvement, and patient satisfaction over a 12 month follow-up period.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eThe findings are expected to provide high-quality evidence for clinical practice and potentially set new standards for thoracic spinal surgery.\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u0026nbsp;\u003c/div\u003e"},{"header":"Methodology","content":"\u003cp\u003e\u003cspan class=\"BoldUnderline\"\u003eStudy Design and Setting\u003c/span\u003e: This study will be a prospective, multicentric, observational cohort study. The study will have two arms: The first arm would cover all the primary and secondary objectives except the assessment of clinical outcomes with a duration of six months required for recruitment and no follow up period.\u003c/p\u003e\n\u003cp\u003eThe second arm will address the secondary objectives pertaining to the clinical assessment with a follow up period of 12 months. The total duration of the study will be 18 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipating Centers\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study will involve 7 high-volume centers experienced in robotic spine surgery with experienced surgeons who have performed atleast 20 robot-assisted pedicle screw cases independently prior to participation using FDA/CE-approved robotic spine systems.\u003c/p\u003e\n\u003cp\u003eThe participating centres will be as follows:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eSri Balaji Action Medical Institute, New Delhi.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eStavya Spine Hospital and Research Institute, Ahmedabad.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eManipal Hospital, Bangalore.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eKrishna Institute of Medical Sciences, Kondapur.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTan Tock Seng Hospital, Singapore.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eSunway Medical Centre, Malaysia.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThailand, (TO BE DECIDED).\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003ch3\u003eStudy Population and Recruitment:\u003c/h3\u003e\n\u003cp\u003eA total of 100 adult patients (aged 18\u0026ndash;65 years) across participating centers undergoing robot-assisted thoracic pedicle screw placement will be recruited. This sample size is based on previously conducted studies\u003csup\u003e(\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAdults aged 18\u0026ndash;65 years, with indications for thoracic pedicle screw fixation (due to trauma, deformity, tumor, infection, or degenerative conditions), and the ability to provide written informed consent\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients unable to undergo imaging, those with severe comorbidities precluding surgery, patients unable to complete follow-up, or those providing negative consent to participate.\u003c/p\u003e\n\u003ch3\u003eIntervention and Workflow\u003c/h3\u003e\n\u003cp\u003eParticipating centers will use approved robotic systems for pedicle screw planning and placement and standardized neuro monitoring system.\u003c/p\u003e\n\u003cp\u003eThe standardized robotic workflow involves:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1. Bed frame attachment and patient positioning\u003c/strong\u003e: A bed frame is attached to the radiolucent table. Bed frame helps to mount the robot to the operating table.\u003c/p\u003e\n\u003cp\u003eCamera / navigation shall be placed at the cranial end of the table.\u003c/p\u003e\n\u003cp\u003eThe position of patient shall be prone with shoulders\u0026thinsp;\u0026lt;\u0026thinsp;90 degrees abduction without excessive external rotation with elbows flexed to \u0026lt;\u0026thinsp;90 degrees. Proper padding must be ensured and abdomen should be free\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2. Mounting of Robotic Arm\u003c/strong\u003e: Robotic arm system is mounted on to the bed frame. It is typically mounted on right side of the patient when prone, but it can also be mounted as per surgeon\u0026rsquo;s preference\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3. Mounting of patient to the robotic arm\u003c/strong\u003e: Midline skin incision is taken and desired levels are exposed. One level, caudal to the last level to be fixed is also exposed unilaterally and a transpedicular Schanz screw is inserted at that level unilaterally. The patient is mounted to the robotic arm by connecting the Schanz screw and robotic arm using Schanz screw bridge.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e4. Registration and workflow\u003c/strong\u003e: Perform a 3D scan to establish the surgeon's working volume. Then perform a \u0026ldquo;snapshot\u0026rdquo; that tells the navigation system where the robotic arm is and merges the two together.\u003c/p\u003e\n\u003cp\u003eEither of the two registration methods could be used depending on the practice at the centre:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eCT to fluoroscopy.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eScan and plan.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eCT to Fluoroscopy\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUses a preoperative 1mm slice CT scan data for screw trajectory planning, followed by intraoperative AP and lateral/oblique fluoroscopy images that are transferred to the software for registration.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eScan and Plan\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUses an intraoperative CT scan (O-arm spin) for image transfer and planning of screw trajectories\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e5.Pedicle screw insertion\u003c/strong\u003e: The screw placement is from farthest to most proximal pedicle from the patient mounting pin in all cases except deformity and from the apex to periphery in spinal deformities. The robotic arm is sent to respective screw trajectory and a sleeve and a dilator is used to prepare a track through the fascia and the entry point and the trajectory is confirmed. Respective screw trajectories are drilled and tapped as per desired diameter. A navigated screw driver is used to place the screws in desired trajectories and the steps are repeated for all the screws. Powered instrumentation will be used for all steps. After placement of all the screws an AP and lateral shoot of C-Arm is taken to confirm the position of all the screws.\u003c/p\u003e\n\u003ch3\u003eData collection and Outcome Measures:\u003c/h3\u003e\n\u003cp\u003e\u003cstrong\u003ePreoperative Phase\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe following data will be collected during the preoperative phase\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eBaseline demographic and clinical data collection.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePreoperative CT/ XRAY, MRI of Thoracic spine.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePreoperative DEXA scan wherever indicated.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eVAS, ODI scores of patient on admission.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eIntraoperative Data Collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe following intra-operative data will be collected\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eOperative time, radiation exposure, blood loss, and any adverse events will be documented.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eScrew Placement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRobot assisted Pedicle screws will be placed and any deviations from robotic guidance will be recorded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePostoperative Phase\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe following data will be collected post-operatively\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eImmediate post procedure O-Arm scan or post operative CT scan for accuracy assessment\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePost op VAS, ODI scores\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eScheduled follow-ups at 3, 6, and 12 months and assessment of VAS, ODI scores along with functional improvement and patient satisfaction.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch3\u003eOutcome Measures:\u003c/h3\u003e\n\u003cp\u003e\u003cspan class=\"BoldUnderline\"\u003eARM 1 OUTCOME MEASURES\u003c/span\u003e\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003ch2\u003eA) Primary Outcome\u003c/h2\u003e\n\u003cdiv id=\"Sec9\" class=\"Section3\"\u003e\n\u003ch2\u003e\u003cstrong\u003eAccuracy of Screw Placement\u003c/strong\u003e:\u003c/h2\u003e\n\u003cp\u003eEvaluation will be done by two independent blinded assessors and by a third assessor in case of discrepancy using post procedure O-arm spin or postoperative CT scans uploaded in DICOM format by the participating centres and classified based on the Gertzbein-Robbins scale:\u003c/p\u003e\n\u003cp\u003eGrade A: Fully within pedicle (\u0026lt;\u0026thinsp;2 mm breach)\u003c/p\u003e\n\u003cp\u003eGrade B: \u0026lt;2 mm breach\u003c/p\u003e\n\u003cp\u003eGrade C: 2\u0026ndash;4 mm breach\u003c/p\u003e\n\u003cp\u003eGrade D: \u0026gt;4 mm breach\u003c/p\u003e\n\u003cp\u003eB) Secondary Outcomes\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cp\u003e1. Safety:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eIncidence of intraoperative complications.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePostoperative complications (e.g., neurological, vascular, or infection-related events etc.)\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n\u003cp\u003e2. Operative Parameters:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eEstimated blood loss\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n3. Efficiency:\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of attempts per screw\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eEfficiency of Robotic software and hardware.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eRegistration time - from start to completion of registration\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePlanning time - time required for planning of screws.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eScrew insertion time - from docking of the robotic arm to the screw placement completion.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTotal procedure time - from start of registration to screw placement completion\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e4. Radiation exposure\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n\u003ch2\u003eARM 2 SECONDARY OUTCOME MEASURES\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eClinical Outcomes\u003c/strong\u003e :\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003ePain relief: Visual Analog Scale (VAS) at baseline, 3, 6, and 12 months\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eFunctional improvement: Oswestry Disability Index (ODI) and Scoliosis Research Society-22 (SRS-22) scores at similar intervals\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eLength of hospital stay\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatient satisfaction Likert Scale\u003csup\u003e(\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n\u003ch2\u003ePrimary Endpoints:\u003c/h2\u003e\n\u003cdiv id=\"Sec14\" class=\"Section3\"\u003e\n\u003ch2\u003eAccuracy of Pedicle Screw Placement:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eThe primary endpoint is the proportion of screws classified as Grade A or B on the Gertzbein-Robbins scale, as assessed using post-procedure O-arm or postoperative CT imaging.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eGrade A (Screw fully within the pedicle) or Grade B (Cortical breach\u0026thinsp;\u0026lt;\u0026thinsp;2 mm) pedicle screws will be considered as accurate.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eScrews with breaches\u0026thinsp;\u0026ge;\u0026thinsp;2 mm (Grades C and D) will be considered inaccurately placed.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n\u003ch2\u003eSecondary Endpoints:\u003c/h2\u003e\n\u003cp\u003e\u003cspan class=\"Underline\"\u003eARM 1 \u0026ndash; Intraoperative and Procedural Outcomes\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e1. Safety:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eIncidence of intraoperative complications, including robotic system errors, hardware issues, and facet joint violations\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eIncidence of postoperative complications, including neurological, vascular, or infection-related events\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e2. Operative Parameters:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eEstimated intraoperative blood loss (in mL)\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e3. Efficiency Metrics:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of attempts per screw\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eRegistration time (from start to completion of registration; in minutes)\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePlanning time (time required for planning of screws)\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eScrew insertion time (from docking of the robotic arm to completion of screw insertion)\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTotal procedure time (from start of registration to completion of screw placement; in minutes)\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e4. Radiation Exposure:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eTotal intraoperative radiation exposure, measured in millisieverts (mSv)\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cspan class=\"Underline\"\u003eARM 2 \u0026ndash; Clinical Outcomes\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e1. Pain Relief:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eChange in Visual Analog Scale (VAS) scores from baseline to 3, 6, and 12 months postoperatively\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e2. Functional Improvement:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eChange in Oswestry Disability Index (ODI) and Scoliosis Research Society-22 (SRS-22) scores at 3, 6, and 12 months\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e3. Healthcare Utilization:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eLength of hospital stay (in days)\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e4. Patient Satisfaction:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003ePatient-reported satisfaction at 12 months using Likert Scale\u003csup\u003e(\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n\u003ch2\u003eStatistical Analysis\u003c/h2\u003e\n\u003cp\u003eThe primary outcome (proportion of Grade A/B screws) will be compared using the Chi-square or Fisher\u0026rsquo;s exact test. Logistic regression will analyze risk factors for complication rates. Comparison of means for operative parameters will use t-tests or Mann-Whitney U tests. Clinical outcomes (longitudinal data) will be analyzed using repeated measures ANOVA. Subgroup analysis will be performed to assess the impact of pathology (trauma vs. deformity vs. tumor vs. degenerative) on outcomes\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\n\u003ch2\u003eSample size calculations:\u003c/h2\u003e\n\u003cp\u003eThe sample size (n) refers to the number of screws rather than the number of patients. This is based on comparison of pedicle screw placement accuracy between the Scan-\u0026amp;-Plan Group (p\u003csub\u003e1\u003c/sub\u003e\u0026thinsp;=\u0026thinsp;0.991) and the CT-to-Fluoroscopy Group (p\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;=\u0026thinsp;0.981) [1], using the Gertzbein and Robbins classification system.\u003c/p\u003e\n\u003cp\u003e(Enter Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eSignificance Level (\u0026alpha;)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003ePower (1 - \u0026beta;)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eRequired Number of Screws per Group (n)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e0.05\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e0.8\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e2,097\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0.85\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2,398\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e0.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2,807\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eThe required number of screws per group was calculated for different combinations of significance level (\u0026alpha;) and power (1 - \u0026beta;) using the pwr.2p.test function in R. The effect size was derived from the accuracy proportions of the Scan-\u0026amp;-Plan Group (p\u003csub\u003e1\u003c/sub\u003e\u0026thinsp;=\u0026thinsp;0.987) and the CT-to-Fluoroscopy Group (p\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;=\u0026thinsp;0.935) \u003csup\u003e(\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/sup\u003e, as measured by the Gertzbein and Robbins classification system. The results indicate the minimum number of screws needed per group to detect significant differences in accuracy under varying statistical parameters.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\n\u003ch2\u003eExpected Outcomes\u003c/h2\u003e\n\u003cp\u003eThis multicentric trial is designed to provide high-quality, real-world evidence on the utility of robot-assisted technology for thoracic pedicle screw fixation. The expectation is that the defined protocol and the use of robotic assistance will yield a significantly higher screw placement accuracy (Grade A/B screws) compared to historical rates for conventional techniques, thereby reducing the incidence of complications like neurological or vascular damage. Along with higher accuracy it is expected that robot assistance will give clinical outcomes comparable to conventional techniques.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eAs per our knowledge there are limited studies on the utility of Robot assisted pedicle screw fixation specific to thoracic spine. In a multicentric study across 2 centres done by Garufi G et.al., a retrospective comparison was done between robotic surgery using the Excelsius GPS Robot and neuro-navigation with the O-arm for degenerative lumbo-sacral spine diseases in terms of accuracy of screw placement assessed by Gertzbein-Robbins scale using postoperative imaging, along with safety outcomes such as intraoperative and postoperative complications, operative parameters including blood loss, and efficiency metrics like registration time, planning time, screw insertion time, and radiation exposure; and found comparable outcomes in screw placement accuracy, operative time, blood loss, and functional recovery (ODI and VAS scores) between the two technologies, with robotic surgery showing a trend towards greater precision but no significant difference\u003csup\u003e(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn another multicenter study across 4 centres done by Lee NJ et.al., it was shown that robot-assisted spine surgery resulted in steadily improving screw accuracy, efficiency, and radiation exposure, while maintaining low complication rates and decreasing hospital stay over 5 years. The findings validate the use of robotic platforms across various centers and highlight the trend toward improved value-based care in complex spine surgery\u003csup\u003e(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn a sudy done by Orosz LD et.al., highlighting the reliability and safety of integrating robotic guidance with 3D navigation for spine fusion procedures, it was demonstrated that navigated robotic thoracolumbar surgery resulted in low rates of intraoperative (4.1%), postoperative surgical (6.6%), and revision (1.5%) complications within 90 days\u003csup\u003e(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThus there is a need for a multicentric study to address this gap in knowledge. A key contribution of this study is the formal evaluation and comparison of the CT-to-Fluoroscopy and Scan-and-Plan registration methods, which will help define best practices and potentially set new standards for robotic thoracic spinal surgery. Furthermore, by analyzing efficiency metrics (registration and setup time, total procedure time, screw planning time, screw insertion time, attempts per screw) and radiation exposure, the study will offer insights into the practical benefits and resource utilization associated with implementing the robotic workflow.\u003c/p\u003e \u003cp\u003eFinally, the 12-month follow-up for Arm 2 will rigorously assess the clinical impact, correlating the procedural accuracy and efficiency metrics with meaningful patient-centered outcomes, including sustained pain relief (VAS), functional improvement (ODI, SRS-22), and patient satisfaction. The findings from this trial are expected to provide definitive evidence to guide clinical practice for robot-assisted thoracic pedicle screw fixation.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eEthical Considerations\u003c/strong\u003e \u003cp\u003eIt will be mandatory to get ethics committee approval from each participating centre along with written informed consent from each participant. To maintain confidentiality, data will be anonymized and stored securely.\u003c/p\u003e \u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eConflict of interest:\u003c/h2\u003e \u003cp\u003eThere is no conflict of interest among the authors related to this manuscript.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003eIt is an investigator-initiated trial with grant support from Medtronic.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAll authors were involved in the conceptualization, study design, critical review, and editing. SK (leading author) helped additionally in manuscript writing. HSC additionally helped in developing methodology and protocol along with manuscript writing\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLi G, Lv G, Passias P et al (2010) Complications associated with thoracic pedicle screws in spinal deformity. Eur Spine J 19:1576\u0026ndash;1584\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrasiliense LB, Theodore N, Lazaro BC et al (2010) Quantitative analysis of misplaced pedicle screws in the thoracic spine: how much pullout strength is lost? presented at the 2009 Joint Spine Section Meeting. J Neurosurg Spine 12:503\u0026ndash;508\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKosmopoulos V, Schizas C (2007) Pedicle screw placement accuracy: a meta-analysis. Spine 32:E111\u0026ndash;E120\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFan Y, Du JP, Liu JJ et al (2018) Accuracy of pedicle screw placement comparing robot-assisted technology and the free-hand with fluoroscopy-guided method in spine surgery: an updated meta-analysis. Med (Baltim) 97:e10970\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGao S, Lv Z, Fang H (2018) Robot-assisted and conventional freehand pedicle screw placement: a systematic review and meta-analysis of randomized controlled trials. Eur Spine J 27:921\u0026ndash;930\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi H-M, Zhang R-J, Shen C-L (2020) Accuracy of pedicle screw placement and clinical outcomes of robot-assisted technique versus conventional freehand technique in spine surgery from nine randomized controlled trials: a meta-analysis. Spine 45:E111\u0026ndash;E119\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu H, Chen W, Wang Z et al (2016) Comparison of the accuracy between robot-assisted and conventional freehand pedicle screw placement: a systematic review and meta-analysis. Int J Comput Assist Radiol Surg 11:2273\u0026ndash;2281\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMacke JJ, Woo R, Varich L (2016) Accuracy of robot-assisted pedicle screw placement for adolescent idiopathic scoliosis in the pediatric population. J Robot Surg 10:145\u0026ndash;150\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBelmont PJ Jr, Klemme WR, Dhawan A, Polly DW Jr (2001) In vivo accuracy of thoracic pedicle screws. Spine 26:2340\u0026ndash;2346\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDi Silvestre M, Parisini P, Lolli F et al (2007) Complications of thoracic pedicle screws in scoliosis treatment. Spine 32:1655\u0026ndash;1661\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGokcen HB, Erdogan S, Ozturk S et al (2018) Sagittal orientation and uniform entry for thoracic pedicle screw placement with free-hand technique: a retrospective study on 382 pedicle screws. Int J Surg 51:83\u0026ndash;88\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePerdomo-Pantoja A, Ishida W, Zygourakis C et al (2019) Accuracy of current techniques for placement of pedicle screws in the spine: a comprehensive systematic review and meta-analysis of 51,161 screws. World Neurosurg 126:664e3\u0026ndash;678e3\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKhan A, Soliman MAR, Lee NJ, Waqas M, Lombardi JM, Boddapati V, Levy LC, Mao JZ, Park PJ, Mathew J, Lehman RA, Mullin JP, Pollina J (2022) CT-to-fluoroscopy registration versus scan-and-plan registration for robot-assisted insertion of lumbar pedicle screws. Neurosurg Focus. ;52(1):E8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3171/2021.10.FOCUS21506\u003c/span\u003e\u003cspan address=\"10.3171/2021.10.FOCUS21506\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 34973678\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMuniasamy K, Sivakumar A, Rameshbabu KN, Ganesan A, Rajkumar VA, Deshmukh GV, Sharma SVS (2024) Patient satisfaction and quality of life outcomes following robotic-assisted surgery: A survey-based study. Bioinformation 20(12):1964\u0026ndash;1969 PMID: 40230909; PMCID: PMC11993418\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGarufi G, Scalia G, Graziano F, Costanzo R, Porzio M, Ponzo G, Giuffrida M, Ricciardo G, Umana GE, Nicoletti GF, Cardali SM (2025) Robot-assisted versus navigated spinal fusion surgery: a comparative multicenter study on transpedicular screw placement accuracy and patient outcomes. Neurosurg Rev. ;48(1):524. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s10143-025-03674-z\u003c/span\u003e\u003cspan address=\"10.1007/s10143-025-03674-z\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 40542927\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee NJ, Leung E, Buchanan IA, Geiselmann M, Coury JR, Simhon ME, Zuckerman S, Buchholz AL, Pollina J, Jazini E, Haines C, Schuler TC, Good CR, Lombardi J, Lehman RA (2022) A multicenter study of the 5-year trends in robot-assisted spine surgery outcomes and complications. J Spine Surg 8(1):9\u0026ndash;20. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.21037/jss-21-102\u003c/span\u003e\u003cspan address=\"10.21037/jss-21-102\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003ePMID: 35441099; PMCID: PMC8990386\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOrosz LD, Lee NJ, Gum JL, Lehman RA, Hage TR, Katz J, Amell-Angst T, Roy RT, Poulter GT, Haines CM, Jazini E, Good CR (2025) Ninety-Day Complication and Revision Surgery Rates Using Navigated Robotics in Thoracolumbar Spine Surgery: A PRoGRSS Interim Analysis. Int J Spine Surg. ;19(4):437\u0026ndash;443. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.14444/8777\u003c/span\u003e\u003cspan address=\"10.14444/8777\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 40681341\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-robotic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jors","sideBox":"Learn more about [Journal of Robotic Surgery](http://link.springer.com/journal/11701)","snPcode":"11701","submissionUrl":"https://submission.nature.com/new-submission/11701/3","title":"Journal of Robotic Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Robotic spine surgery, thoracic pedicle screw, accuracy, multicentric trial, workflow standardization","lastPublishedDoi":"10.21203/rs.3.rs-9413910/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9413910/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction:\u003c/strong\u003e Pedicle screw fixation is the gold standard for thoracic spine stabilization, but its accuracy is critical due to neurological and vascular complication risks. Robotic-assisted techniques show promise in improving accuracy and reducing radiation, but thoracic-specific evidence is limited.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethodology:\u003c/strong\u003e This prospective multicentric observational cohort study involves 7 high-volume centers. 100 adult patients (18–65 years) undergoing robot-assisted thoracic pedicle screw fixation will be recruited. The standardized workflow includes positioning, robotic arm mounting, registration (CT-to-fluoroscopy or scan-and-plan), and screw insertion using powered instrumentation. Data collection will cover preoperative demographics, intraoperative parameters (operative time, radiation exposure, blood loss), and postoperative outcomes. Accuracy will be assessed via the Gertzbein-Robbins grading system on postoperative CT or O-arm scans. Efficiency metrics will cover registration, planning, and screw insertion times. Clinical outcomes (VAS, ODI, SRS-22, patient satisfaction) will be evaluated at 3, 6, and 12 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExpected Outcomes:\u003c/strong\u003e This multicentric trial will provide real-world evidence on robot-assisted thoracic pedicle screw fixation. The expectation is to develop a standardized workflow, yielding significantly higher screw placement accuracy than conventional techniques, while achieving comparable clinical outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e Knowledge of Robotic pedicle screw fixation utility specific to the thoracic spine is limited. This study contributes by evaluating and comparing the two registration techniques (CT-to-Fluoroscopy and Scan-and-Plan), and assessing the accuracy, safety, efficiency, and clinical outcomes of robot-assisted thoracic pedicle screw placement.\u003c/p\u003e","manuscriptTitle":"A Prospective Multicentric Trial on Accuracy, Efficiency, Safety, and Outcomes of Robot-Assisted Thoracic Pedicle Screw Fixation: Study Protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-24 11:21:30","doi":"10.21203/rs.3.rs-9413910/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-04-21T01:17:17+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-19T23:40:37+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"317707668192556070148316162869797682190","date":"2026-04-19T23:16:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"68686841231261374684717423525284664501","date":"2026-04-16T16:56:33+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-16T16:44:27+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"82241332431359651596951962807290527596","date":"2026-04-16T16:35:03+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-16T16:31:52+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-16T11:08:24+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-04-16T08:49:47+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Robotic Surgery","date":"2026-04-14T09:51:10+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-robotic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jors","sideBox":"Learn more about [Journal of Robotic Surgery](http://link.springer.com/journal/11701)","snPcode":"11701","submissionUrl":"https://submission.nature.com/new-submission/11701/3","title":"Journal of Robotic Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"4c6bc3a9-a975-45d7-9d45-1e8d3a36eae8","owner":[],"postedDate":"April 24th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-08T11:23:10+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-24 11:21:30","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9413910","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9413910","identity":"rs-9413910","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}