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

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 than spinal stenosis
• Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses)
• Morbid obesity, defined as BMI > 40 kg/m2
• Active systemic or local infection
• Active Hepatitis (receiving medical treatment within two years)
• Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia
• Insulin dependent diabetes mellitus or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing
• Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months
• History of Paget's disease, osteomalacia, or any other metabolic bone disease
• Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy >5 years
• Involved in study of another investigational product that may affect outcome
• Women who are pregnant, lactating or anticipate becoming pregnant within 24 months post-surgery
• Patients who are incarcerated
• Worker's compensation cases
• Patients involved in active litigation relating to his/her spinal condition