AzTrials
AzTrials

Disorder of SpineRGNVNCT04353895

Mazor X Stealth Versus O-arm Navigation for Pedicle Screw Insertion

A study testing Guidance for pedicle screw insertion (Mazor Stealth) and Guidance for pedicle screw insertion (O-arm Navigation) in people with Disorder of Spine, run by P. D. Dr. med. Duccio BOSCHERINI at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Disorder of Spine
What is being tested?
Guidance for pedicle screw insertion (Mazor Stealth) and Guidance for pedicle screw insertion (O-arm Navigation)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSwitzerland
Study dates
1 Apr 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients
  • who require pedicle screw insertion for vertebral posterior stabilization

Who cannot join

  • children
  • participants incapable of judgment
  • participants under tutelage
  • vertebral fusion indication without pedicle screw implantation
  • refusal to participate
  • data missing for radiation exposure calculation
Show all 9Show fewer
  • unstable vertebral fracture requiring urgent fixation
  • pregnancy
  • refusal to participate

Trial locations and contacts

1 site in 1 country.

Duccio Boscherini, MD, PhD contact

+41216470525

d.boscherini@lasource.ch

Marc Prod'homme, MD contact

+41216470525

marcprod86@gmail.com

Switzerland1 site, 1 recruiting

  • Neuro Orthopedic Center

    Lausanne, Canton of Vaud, 1004

    Duccio Boscherini, MD, PhD, +41793679495, d.boscherini@lasource.ch

    Marc Prod'homme, MD, +41764112523, marcprod86@gmail.com

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
Guidance for pedicle screw insertion (Mazor Stealth), Guidance for pedicle screw insertion (O-arm Navigation)
Keywords
Vertebral instability, Spondylolisthesis, Discopathy
Medical subject headings
Spinal Diseases, Spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guidance for pedicle screw insertion (Mazor Stealth)Device

    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)Device

    Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion

Study groups in NCT04353895
Study groupRoleWhat they receive
Robotic group (RG)ExperimentalPatients in the RG group will be operated using the assistance of the Mazor X Stealth robot
Receives: Device: Guidance for pedicle screw insertion (Mazor Stealth)
O-arm navigation group (NV)Active comparatorPatients in the NV group will be operated using the guidance of the Stealth navigation
Receives: Device: Guidance for pedicle screw insertion (O-arm Navigation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pedicle screw accuracy

    Usinge the Heary classification for thoracic screws and the Gertzbein classification for lumbar screws

    Measured: Intraoperative

Secondary outcomes (1)

  1. Radiation exposure

    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)

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start1 Apr 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Medical device compared with gold standard
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353895
Sponsor's protocol ID
2020-00305
Acronym
RGNV
Status last verified
Feb 2022
First submitted
16 Apr 2020
Last updated
17 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All data will be available for the Investigators and for control from the ethical commission if asked

Publications

  • 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.

    PubMed 31501123

  • 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.

    PubMed 11415570

  • 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.

    PubMed 29859354

  • 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.

    PubMed 10905443

  • 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.

    PubMed 22469525

  • 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.

    PubMed 16955046

  • 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.

    PubMed 17297375

  • 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.

    PubMed 28463610

  • 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.

    PubMed 15070139

  • 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.

    PubMed 2326693

  • 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.

    PubMed 18082557

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Guidance for pedicle screw insertion (Mazor Stealth) and Guidance for pedicle screw insertion (O-arm Navigation) in people with Disorder of Spine, run by P. D. Dr. med. Duccio BOSCHERINI at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Duccio Boscherini, MD, PhD (+41216470525, d.boscherini@lasource.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pedicle screw accuracy (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353895, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in