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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Disorder of Spine

Intervention / Treatment
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* Device: Guidance for pedicle screw insertion (Mazor Stealth)
* Device: Guidance for pedicle screw insertion (O-arm Navigation)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Medical device compared with gold standard
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic group (RG)<br>Patients in the RG group will be operated using the assistance of the Mazor X Stealth robot | Device: Guidance for pedicle screw insertion (Mazor Stealth)<br>* Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion<br>|
| Active Comparator: O-arm navigation group (NV)<br>Patients in the NV group will be operated using the guidance of the Stealth navigation | Device: Guidance for pedicle screw insertion (O-arm Navigation)<br>* Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pedicle screw accuracy | Usinge the Heary classification for thoracic screws and the Gertzbein classification for lumbar screws | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation exposure | 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) | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebral instability, Spondylolisthesis, Discopathy