Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation (NCT03968965) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
United States64 participantsStarted 2018-05-09
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Diagnosis of spinal stenosis of the lumbar spine with ≤ grade 2 degenerative spondylolisthesis
* Skeletally mature adults between the ages of 18-85 years at the time of surgery
* Has completed at least 6 months of conservative therapy
* Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study
Exclusion Criteria:
* Gross instability, defined as \> 3 mm translational motion on flexion/extension studies
* Degenerative spondylolisthesis \> grade 2
* Degenerative scoliosis \> 10° at any level in lumbar spine
* Congenital lumbar spinal stenosis
* Endplate changes
* Visible change in disc height
* Radiographic confirmation of facet joint disease or degeneration
* Prior surgery at any lumbar level including the level being treated except for: Lamino/Foraminotomy, Microdiscectomy, IDET, and Percutaneous Discectomy
* Any evidence of a prior/current fracture, compromised vertebra, current or past trauma, or tumor at affected level or the spinous processes at the adjacent levels
* Requires destabilizing surgical decompression that adversely affects the functioning of the facets
* Cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)
* Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other t…
What they're measuring
1
Mean Total Length of Operative Time
Timeframe: Data captured up to four hours after end of surgery