

Prior discectomy and/or laminectomy at the target or adjacent levels is allowed. fusion, arthroplasty, and/or other non-fusion procedures). E.1 Prior surgical procedure at the involved or adjacent spinal levels (e.g.Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.Ī subject will be excluded from participating in this study for any of the following reasons: Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months. Is at least 18 years of age and skeletally mature at the time of surgery. Has preoperative back and leg pain scores of (back pain ≥ 1 and leg pain ≥ 4) based on the Preoperative Back and Leg Pain Questionnaire. Has preoperative back and leg pain scores of (back pain ≥ 4 and leg pain ≥ 1) based on the Preoperative Back and Leg Pain Questionnaire. Has to meet either inclusion criteria 5 or 6 to qualify for the study: Has preoperative Oswestry Disability Index score ≥ 35. Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or.Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or.CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following: History of radiating leg or buttock pain, paresthesia, numbness or weakness, or.Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by: Why Should I Register and Submit Results?Ī subject must meet all of the following inclusion criteria to participate in this study:.
