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

Intervention / Treatment

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

Study Contact Backup

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, 1004
        • Recruiting
        • Neuro Orthopedic Center
        • Contact:
        • Contact:
        • 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
Device: Guidance for pedicle screw insertion (Mazor Stealth)
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
Device: 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

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

P. D. Dr. med. Duccio BOSCHERINI

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

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

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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