Mazor X Stealth Versus O-arm Navigation for Pedicle Screw Insertion
NCT ID: NCT04353895
Last Updated: 2022-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2021-04-01
2023-12-31
Brief Summary
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Detailed Description
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Medtronic (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.
The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Robotic group (RG)
Patients in the RG group will be operated using the assistance of the Mazor X Stealth robot
Guidance for pedicle screw insertion (Mazor Stealth)
Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion
O-arm navigation group (NV)
Patients in the NV group will be operated using the guidance of the Stealth navigation
Guidance for pedicle screw insertion (O-arm Navigation)
Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion
Interventions
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Guidance for pedicle screw insertion (Mazor Stealth)
Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion
Guidance for pedicle screw insertion (O-arm Navigation)
Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion
Eligibility Criteria
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Inclusion Criteria
* who require pedicle screw insertion for vertebral posterior stabilization
Exclusion Criteria
* participants incapable of judgment
* participants under tutelage
* vertebral fusion indication without pedicle screw implantation
* refusal to participate
* data missing for radiation exposure calculation
* unstable vertebral fracture requiring urgent fixation
* pregnancy
* refusal to participate
18 Years
ALL
No
Sponsors
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P. D. Dr. med. Duccio BOSCHERINI
OTHER
Responsible Party
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P. D. Dr. med. Duccio BOSCHERINI
Director of the Neuro Orthopedic Center
Principal Investigators
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Duccio Boscherini, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Neuro Orthopedic Center
Locations
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Neuro Orthopedic Center
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
Related Links
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\[Internet\]. Medtronic.com. 2019 \[cited 15 January 2020\].
Other Identifiers
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2020-00305
Identifier Type: -
Identifier Source: org_study_id
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