Mazor X Stealth Versus O-arm Navigation for Pedicle Screw Insertion (RGNV)
February 1, 2022 updated by: P. D. Dr. med. Duccio BOSCHERINI
Fluoro-registered Mazor X Stealth Edition Versus O-arm Navigation: a State of the Art Technology Comparison for Pedicle Screw Insertion
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
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.
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.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Duccio Boscherini, MD, PhD
- Phone Number: +41216470525
- Email: d.boscherini@lasource.ch
Study Contact Backup
- Name: Marc Prod'homme, MD
- Phone Number: +41216470525
- Email: marcprod86@gmail.com
Study Locations
-
-
VD
-
Lausanne, VD, Switzerland, 1004
- Recruiting
- Neuro Orthopedic Center
-
Contact:
- Duccio Boscherini, MD, PhD
- Phone Number: +41793679495
- Email: d.boscherini@lasource.ch
-
Contact:
- Marc Prod'homme, MD
- Phone Number: +41764112523
- Email: marcprod86@gmail.com
-
Principal Investigator:
- Duccio Boscherini, MD, PhD
-
Sub-Investigator:
- Marc Prod'homme, MD
-
Sub-Investigator:
- Didier Grasset, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients
- who require pedicle screw insertion for vertebral posterior stabilization
Exclusion Criteria:
- children
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Robotic group (RG)
Patients in the RG group will be operated using the assistance of the Mazor X Stealth robot
|
Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion
|
|
Active Comparator: O-arm navigation group (NV)
Patients in the NV group will be operated using the guidance of the Stealth navigation
|
Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pedicle screw accuracy
Time Frame: Intraoperative
|
Usinge the Heary classification for thoracic screws and the Gertzbein classification for lumbar screws
|
Intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiation exposure
Time Frame: Intraoperative
|
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)
|
Intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Duccio Boscherini, MD, PhD, Neuro Orthopedic Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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, Avon). 1995 Sep;10(6):293-303. doi: 10.1016/0268-0033(95)00004-5.
- 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.
- 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.
- 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
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
April 16, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 21, 2020
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 1, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-00305
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data will be available for the Investigators and for control from the ethical commission if asked
IPD Sharing Time Frame
Data will be available from the beginning of the study, and until 10 years according to cantonal rules
IPD Sharing Access Criteria
Local professional computer
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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