Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation

Status Completed

Clinical Trial Summary

This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults. There will be separate study arms for cases utilizing the three-dimensional (3D) MvIGS spine navigation system and cases that utilize conventional two-dimensional (2D) fluoroscopy.

Clinical Trial Description

This is a single center, randomized, prospective cohort study to comparatively evaluate the implementation of the MvIGS spine navigation system to conventional 2D fluoroscopy for pedicle screw fixation for the treatment of spinal stenosis with degenerative spondylolisthesis of the lumbar spine. Fluoroscopy and the MvIGS navigation system are both intraoperative imaging options available to aid spine surgeons. Fluoroscopy uses X-rays to obtain images of patient anatomy. The MvIGS spine navigation system provides patient specific, high quality intraoperative imaging with no radiation exposure. After the spine is exposed, intraoperative images are obtained using visible light then registered to the patient's preoperative computed tomography scan. Use of the proprietary integrated surgical light with embedded tracking technology and Instant Flash™ registration allows for continuous and direct visualization of the surgical field without disturbing surgeon workflow. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03968965
Study type	Interventional
Source	7D Surgical Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 9, 2018
Completion date	November 1, 2019

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