Table 1

Key Inclusion/Exclusion Criteria

Key Inclusion Criteria:
  • Between 18 and 75 years of age

  • Treatment at one or two adjacent levels between L3 and S

  • Have not responded to at least 6 months of non-operative, conservative management

  • Have symptomatic degenerative disc disease (DDD) demonstrated by signs and/or symptoms of disc herniation, osteophyte formation, or loss of disc height

Key Exclusion Criteria:
  • Osteopenia or osteoporosis

  • Have a history of endocrine or metabolic disorders. Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV or active hepatitis.

  • Prior intra-abdominal or retroperitoneal surgery that would make the approach prohibitively dangerous, or prior anterior surgery at the same level

  • Have uncontrolled insulin dependent type 1 or type 2 diabetes

  • Require a treatment (e.g., posterior element decompression) that destabilizes the spine.

  • Isolated radicular compression syndromes, especially due to disc herniation

  • Bony lumbar stenosis, pars defect, increased segmental instability, spinal deformities, spondylolisthesis above 3mm at the involved level(s)

  • Radiological confirmation of severe facet joint disease or degeneration