Investigating Superion™ In Spinal Stenosis

Exclusion Criteria

• •Axial back pain only
• •Fixed motor deficit
• •Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
• •Unremitting pain in any spinal position
• •Significant peripheral neuropathy or acute denervation secondary to radiculopathy
• •Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
• •Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation
• •Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
• •Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
• •Spondylolysis (pars fracture)
• •Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2
• •Insulin-dependent diabetes mellitus
• •Prior surgery of the lumbar spine
• •Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
• •Infection in the disc or spine, past or present
• •Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
• •Tumor in the spine or a malignant tumor except for basal cell carcinoma
• •Involved in pending litigation of the spine or worker's compensation related to the back