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Clinical Trials/NCT04353895
NCT04353895UnknownNot Applicable

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

P. D. Dr. med. Duccio BOSCHERINI2 sites in 1 country36 target enrollmentStarted: April 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
36
Locations
2
Primary Endpoint
Pedicle screw accuracy

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

single-blind, only for the patient, after randomization

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Pedicle screw accuracy

Time Frame: Intraoperative

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

Secondary Outcomes

  • Radiation exposure(Intraoperative)

Investigators

Sponsor
P. D. Dr. med. Duccio BOSCHERINI
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

P. D. Dr. med. Duccio BOSCHERINI

Director of the Neuro Orthopedic Center

Neuro Orthopedic Center

Study Sites (2)

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