Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-30 @ 11:59 PM
Study NCT ID:
NCT04353895
Status:
UNKNOWN
Last Update Posted:
2022-02-17
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mazor X Stealth Versus O-arm Navigation for Pedicle Screw Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single-blind, only for the patient, after randomization'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Medical device compared with gold standard'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pedicle screw accuracy', 'timeFrame': 'Intraoperative', 'description': 'Usinge the Heary classification for thoracic screws and the Gertzbein classification for lumbar screws'}], 'secondaryOutcomes': [{'measure': 'Radiation exposure', 'timeFrame': 'Intraoperative', 'description': 'Effective dose calculated with the PCXMC software for 2D (from dose area product) and with the ICRP 103 recommandations for 3D (from dose length product)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vertebral instability', 'Spondylolisthesis', 'Discopathy'], 'conditions': ['Disorder of Spine']}, 'referencesModule': {'references': [{'pmid': '31501123', 'type': 'BACKGROUND', 'citation': 'Staartjes VE, Molliqaj G, van Kampen PM, Eversdijk HAJ, Amelot A, Bettag C, Wolfs JFC, Urbanski S, Hedayat F, Schneekloth CG, Abu Saris M, Lefranc M, Peltier J, Boscherini D, Fiss I, Schatlo B, Rohde V, Ryang YM, Krieg SM, Meyer B, Kogl N, Girod PP, Thome C, Twisk JWR, Tessitore E, Schroder ML. The European Robotic Spinal Instrumentation (EUROSPIN) study: protocol for a multicentre prospective observational study of pedicle screw revision surgery after robot-guided, navigated and freehand thoracolumbar spinal fusion. BMJ Open. 2019 Sep 8;9(9):e030389. doi: 10.1136/bmjopen-2019-030389.'}, {'pmid': '11415570', 'type': 'BACKGROUND', 'citation': 'Nolte LP, Zamorano L, Visarius H, Berlemann U, Langlotz F, Arm E, Schwarzenbach O. Clinical evaluation of a system for precision enhancement in spine surgery. Clin Biomech (Bristol). 1995 Sep;10(6):293-303. doi: 10.1016/0268-0033(95)00004-5.'}, {'pmid': '29859354', 'type': 'BACKGROUND', 'citation': 'Staartjes VE, Klukowska AM, Schroder ML. Pedicle Screw Revision in Robot-Guided, Navigated, and Freehand Thoracolumbar Instrumentation: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Aug;116:433-443.e8. doi: 10.1016/j.wneu.2018.05.159. Epub 2018 May 31.'}, {'pmid': '10905443', 'type': 'BACKGROUND', 'citation': 'Laine T, Lund T, Ylikoski M, Lohikoski J, Schlenzka D. Accuracy of pedicle screw insertion with and without computer assistance: a randomised controlled clinical study in 100 consecutive patients. Eur Spine J. 2000 Jun;9(3):235-40. doi: 10.1007/s005860000146.'}, {'pmid': '22469525', 'type': 'BACKGROUND', 'citation': 'Hartl R, Lam KS, Wang J, Korge A, Kandziora F, Audige L. Worldwide survey on the use of navigation in spine surgery. World Neurosurg. 2013 Jan;79(1):162-72. doi: 10.1016/j.wneu.2012.03.011. Epub 2012 Mar 30.'}, {'pmid': '16955046', 'type': 'BACKGROUND', 'citation': 'Lieberman IH, Togawa D, Kayanja MM, Reinhardt MK, Friedlander A, Knoller N, Benzel EC. Bone-mounted miniature robotic guidance for pedicle screw and translaminar facet screw placement: Part I--Technical development and a test case result. Neurosurgery. 2006 Sep;59(3):641-50; discussion 641-50. doi: 10.1227/01.NEU.0000229055.00829.5B.'}, {'pmid': '17297375', 'type': 'BACKGROUND', 'citation': 'Togawa D, Kayanja MM, Reinhardt MK, Shoham M, Balter A, Friedlander A, Knoller N, Benzel EC, Lieberman IH. Bone-mounted miniature robotic guidance for pedicle screw and translaminar facet screw placement: part 2--Evaluation of system accuracy. Neurosurgery. 2007 Feb;60(2 Suppl 1):ONS129-39; discussion ONS139. doi: 10.1227/01.NEU.0000249257.16912.AA.'}, {'pmid': '28463610', 'type': 'BACKGROUND', 'citation': 'Schroder ML, Staartjes VE. Revisions for screw malposition and clinical outcomes after robot-guided lumbar fusion for spondylolisthesis. Neurosurg Focus. 2017 May;42(5):E12. doi: 10.3171/2017.3.FOCUS16534.'}, {'pmid': '15070139', 'type': 'BACKGROUND', 'citation': 'Heary RF, Bono CM, Black M. Thoracic pedicle screws: postoperative computerized tomography scanning assessment. J Neurosurg. 2004 Apr;100(4 Suppl Spine):325-31. doi: 10.3171/spi.2004.100.4.0325.'}, {'pmid': '2326693', 'type': 'BACKGROUND', 'citation': 'Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. doi: 10.1097/00007632-199001000-00004.'}, {'pmid': '18082557', 'type': 'BACKGROUND', 'citation': 'The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332. doi: 10.1016/j.icrp.2007.10.003.'}, {'type': 'BACKGROUND', 'citation': 'Servomaa A, Tapiovaara M. Organ dose calculation in medical x ray examinations by the program PCXMC. Radiation protection dosimetry. 1998 Nov 1;80(1-3):213-9'}, {'type': 'BACKGROUND', 'citation': "Nuclear Energy Agency Forum on Stakeholder ConfidenceChilton Seminar: Roger Cox -'Risks from low doses of low-LET radiation - the US National Academy of Sciences BEIR VII report'SRP Meeting on Source ManagementScientific Symposium to Mark the Past and Future Achievements of Richard Doll. Journal of Radiological Protection. 2006;26(1):119-123"}], 'seeAlsoLinks': [{'url': 'https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/spine-robotics/mazorx.html', 'label': '\\[Internet\\]. Medtronic.com. 2019 \\[cited 15 January 2020\\].'}]}, 'descriptionModule': {'briefSummary': 'The investigators would like to investigate the fluoro-registered Mazor X Stealth in terms of pedicle screw accuracy and radiation exposure in comparison with the O-arm and navigation as the institutional gold standard.', 'detailedDescription': 'Pedicle screw insertion for spinal fusion is a surgical procedure regularly performed around the world. Surgeons use free-hand, navigation or robotic techniques. The navigation began in 1995 in spine surgery. Surgical navigation systems provide pedicle screw insertion by projecting screw trajectories on a three-dimensional (3D) image acquisition, preoperatively or during the surgical procedure. Laine et al reported better accuracy and safety in pedicle screw insertion using the navigation system. Other authors reported less irradiation with the use of computer-assisted navigation. Robotic guidance was introduced in 2006 and assists the surgeon through a mechanical guidance according to a planning of screw trajectories on 3D imaging. This technique allows stable guidance for pedicle drilling and screw insertion, leading to greater screw positioning in lumbar fusion.\n\nMedtronic (Medtronic, Minneapolis, MN, USA) introduced the Mazor X Stealth in Europa in 2019, including the Mazor robotic device with the navigation technology within the same system. The hypothesis would be a combination of the stability of the robot during screw insertion and the accuracy of the navigation with cumulative benefit from the two techniques.\n\nThe goal of this study is to compare radiological and clinical results of the use of the new Mazor Stealth with the surgical O-arm navigation during pedicle screw insertion for posterior lumbar fusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* who require pedicle screw insertion for vertebral posterior stabilization\n\nExclusion Criteria:\n\n* children\n* participants incapable of judgment\n* participants under tutelage\n* vertebral fusion indication without pedicle screw implantation\n* refusal to participate\n* data missing for radiation exposure calculation\n* unstable vertebral fracture requiring urgent fixation\n* pregnancy\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT04353895', 'acronym': 'RGNV', 'briefTitle': 'Mazor X Stealth Versus O-arm Navigation for Pedicle Screw Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Neuro Orthopedic Center'}, 'officialTitle': 'Fluoro-registered Mazor X Stealth Edition Versus O-arm Navigation: a State of the Art Technology Comparison for Pedicle Screw Insertion', 'orgStudyIdInfo': {'id': '2020-00305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic group (RG)', 'description': 'Patients in the RG group will be operated using the assistance of the Mazor X Stealth robot', 'interventionNames': ['Device: Guidance for pedicle screw insertion (Mazor Stealth)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'O-arm navigation group (NV)', 'description': 'Patients in the NV group will be operated using the guidance of the Stealth navigation', 'interventionNames': ['Device: Guidance for pedicle screw insertion (O-arm Navigation)']}], 'interventions': [{'name': 'Guidance for pedicle screw insertion (Mazor Stealth)', 'type': 'DEVICE', 'description': 'Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion', 'armGroupLabels': ['Robotic group (RG)']}, {'name': 'Guidance for pedicle screw insertion (O-arm Navigation)', 'type': 'DEVICE', 'description': 'Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion', 'armGroupLabels': ['O-arm navigation group (NV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1004', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Duccio Boscherini, MD, PhD', 'role': 'CONTACT', 'email': 'd.boscherini@lasource.ch', 'phone': '+41793679495'}, {'name': "Marc Prod'homme, MD", 'role': 'CONTACT', 'email': 'marcprod86@gmail.com', 'phone': '+41764112523'}, {'name': 'Duccio Boscherini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': "Marc Prod'homme, MD", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Didier Grasset, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Neuro Orthopedic Center', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Duccio Boscherini, MD, PhD', 'role': 'CONTACT', 'email': 'd.boscherini@lasource.ch', 'phone': '+41216470525'}, {'name': "Marc Prod'homme, MD", 'role': 'CONTACT', 'email': 'marcprod86@gmail.com', 'phone': '+41216470525'}], 'overallOfficials': [{'name': 'Duccio Boscherini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neuro Orthopedic Center'}]}, 'ipdSharingStatementModule': {'url': 'https://www.cno.ch', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available from the beginning of the study, and until 10 years according to cantonal rules', 'ipdSharing': 'YES', 'description': 'All data will be available for the Investigators and for control from the ethical commission if asked', 'accessCriteria': 'Local professional computer'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'P. D. Dr. med. Duccio BOSCHERINI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of the Neuro Orthopedic Center', 'investigatorFullName': 'P. D. Dr. med. Duccio BOSCHERINI', 'investigatorAffiliation': 'Neuro Orthopedic Center'}}}}