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

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.

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.

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

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

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

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)

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

All data will be available for the Investigators and for control from the ethical commission if asked

Data will be available from the beginning of the study, and until 10 years according to cantonal rules

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