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

Fluoro-registered Mazor X Stealth Edition Versus O-arm Navigation: a State of the Art Technology Comparison for Pedicle Screw Insertion

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04353895
Acronym
RGNV
Enrollment
36
Registered
2020-04-21
Start date
2021-04-01
Completion date
2023-12-31
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Spine

Keywords

Vertebral instability, Spondylolisthesis, Discopathy

Brief 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.

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.

Interventions

DEVICEGuidance for pedicle screw insertion (Mazor Stealth)

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

DEVICEGuidance for pedicle screw insertion (O-arm Navigation)

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

Sponsors

P. D. Dr. med. Duccio BOSCHERINI
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

single-blind, only for the patient, after randomization

Intervention model description

Medical device compared with gold standard

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pedicle screw accuracyIntraoperativeUsinge the Heary classification for thoracic screws and the Gertzbein classification for lumbar screws

Secondary

MeasureTime frameDescription
Radiation exposureIntraoperativeEffective dose calculated with the PCXMC software for 2D (from dose area product) and with the ICRP 103 recommandations for 3D (from dose length product)

Countries

Switzerland

Contacts

Primary ContactDuccio Boscherini, MD, PhD
d.boscherini@lasource.ch+41216470525
Backup ContactMarc Prod'homme, MD
marcprod86@gmail.com+41216470525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026