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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    36
  • sponsor
    P. D. Dr. med. Duccio BOSCHERINI
Updated on 21 March 2022

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.

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.

Details
Condition Disorder of Spine
Treatment Guidance for pedicle screw insertion (Mazor Stealth), Guidance for pedicle screw insertion (O-arm Navigation)
Clinical Study IdentifierNCT04353895
SponsorP. D. Dr. med. Duccio BOSCHERINI
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

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
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