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

NCT04353895 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-02-17

No results posted yet for this study

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.

Conditions

  • Disorder of Spine

Interventions

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

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

Sponsors & Collaborators

  • P. D. Dr. med. Duccio BOSCHERINI

    lead OTHER

Principal Investigators

  • Duccio Boscherini, MD, PhD · Neuro Orthopedic Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04353895 on ClinicalTrials.gov