Pedicle Screw Placement With XVS

Status Completed

Clinical Trial Summary

Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system. Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score. Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration. Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score. Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Spine Fusion

Clinical Trial Details

NCT number	NCT04682418
Study type	Interventional
Source	Augmedics
Contact
Status	Completed
Phase	N/A
Start date	May 20, 2018
Completion date	July 7, 2021

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