Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

Exclusion Criteria

• •symptomatic DDD at more than one level
• •previous fusion at any lumbar level or laminectomy at the target level (discectomy, Intradiscal Electrothermal Annuloplasty, laminotomy, or nucleolysis performed \> 6 months ago are permitted)
• •clinically compromised vertebral bodies, at the affected level due to previous trauma, i.e., compression or burst fracture
• •pars defect
• •involved vertebral endplate dimensionally smaller than 34.5 mm in the medial-lateral direction and/or 27 mm in the anterior-posterior direction
• •disc height less than 5 mm at the target level
• •bony stenosis
• •lytic spondylolisthesis, spondylolisthesis greater than 3mm
• •lumbar scoliosis greater than 11 degrees.
• •osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease
• •Schmorl's nodes, an incomplete annulus, or endplates that are not intact
• •spinal tumors
• •symptomatic facet joint disease
• •free fragment herniation confirmed radiographically
• •isolated radicular compression syndrome, especially due to a disc herniation
• •arachnoiditis
• •active infection or surgical site infection
• •is using any medication known to interfere with bone/soft tissue healing
• •rheumatoid arthritis or other autoimmune disease
• •systemic disease such as AIDS, HIV, hepatitis
• •morbid obesity defined as body mass index (BMI) \>40 or a weight more than 100 lbs over ideal body weight
• •psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse
• •active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years
• •documented allergies to metal or plastic; i.e., cobalt, chromium, molybdenum, polyethylene, titanium or polyetheretherketone
• •pregnancy, or interested in becoming pregnant within the next two years
• •prisoner
• •involvement in an investigational drug or device study within 30 days