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Pedicle Screw Placement With XVS

NCT04682418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-08-24

No results posted yet for this study

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

DEVICE

xvision Spine sytem

pedicle screw placement will be performed using the XVS navigation system

Sponsors & Collaborators

  • Augmedics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-20
Primary Completion
2021-03-16
Completion
2021-07-07

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04682418 on ClinicalTrials.gov