NCT04682418

Pedicle Screw Placement With XVS

Feasibility Study of Pedicle Screw Placement in the Spine With the XVISION SPINE System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Augmedics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Spine Fusion

Interventions

Type	Name	Description
DEVICE	xvision Spine sytem	pedicle screw placement will be performed using the XVS navigation system

Timeline

• Start date: 2018-05-20
• Primary completion: 2021-03-16
• Completion: 2021-07-07
• First posted: 2020-12-23
• Last updated: 2021-08-24

Locations

3 sites across 1 country: Israel