INDEPENDENCE Spacer for Lumbar Fusion

Inclusion Criteria:

• • Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 with degeneration confirmed by patient history and radiographic examination

  • Experience pain, functional deficit and/or neurological deficit for a minimum of six months
  • Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months and/or presentation with progressive symptoms of nerve root or spinal cord compression prior to enrollment
  • At least 18 years of age and maximum 65 years of age
  • Ability to provide Informed Consent for study participation and to return for all follow-up visits

Exclusion Criteria:

• • Presence of systemic or localized infection at the site of surgery

  • More than 2 levels to be instrumented
  • Previous fusion attempt at the involved level(s)
  • More than three previous open, posterior, lumbar spinal surgical procedures at the involved level(s)
  • Trauma at the level(s) to be fused
  • More than grade 1 spondylolisthesis
  • Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
  • Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
  • Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
  • Immunosuppressive disorder
  • Pregnant or interested in becoming pregnant during the duration of the study
  • History of substance abuse (drugs or alcohol)
  • Any known allergy to a metal alloy
  • Mentally incompetent or prisoner
  • Currently a participant in another study