Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease

Inclusion Criteria:

• Age 18 - 60, skeletally mature

• Symptomatic DDD with objective evidence of lumbar DDD, with any of the following characteristics by MRI scan:

  • instability as defined by ≥ 3mm translation or ≥ 5° angulation.
  • osteophyte formation of facet joints or vertebral endplates.
  • decreased disc height of >2mm as compared to the adjacent level.
  • scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule.
  • herniated nucleus pulposus.
  • facet joint degeneration/changes.
  • vacuum phenomenon.

• Single level symptomatic disease at L4/L5 or L5/S1.

  • six months of unsuccessful conservative treatment
• ODI score ≥ 40/100.
• Surgical candidate for an anterior approach to the lumbar spine.
• Back pain at the operative level only, with or without leg pain.
• Back pain VAS score greater than the higher of the two VAS leg pain scores.
• VAS back pain score ≥ 40/100 mm.
• Willing to return for follow-up visits and sign an Informed Consent and HIPAA Authorization.

Exclusion Criteria:

• Previous surgery at any lumbar level, except IDET (Intradiscal Electrothermal Annuloplasty), percutaneous nucleoplasty, or microdiscectomy.
• Chronic radiculopathy, i.e., subject complaint of unremitting pain with a predominance of leg pain symptoms greater than back pain symptoms extending over a period of at least 1 year.
• endplate dimensions smaller than 34.5 mm in medial-lateral and/or 27 mm in the anterior-posterior direction
• Evidence of significant, symptomatic disc degeneration at another lumbar level.
• Preoperative remaining disc height < 3mm
• Myelopathy.
• Previous compression or burst fracture at the affected level.
• Sequestered herniated nucleus pulposus with migration.
• Mid-sagittal stenosis of <8mm (by MRI).
• Degenerative or lytic spondylolisthesis > 3mm.
• Spondylolysis.
• Isthmic spondylolisthesis.
• Lumbar scoliosis (> 11 degrees of sagittal plane deformity).
• Spinal tumor.
• Active systemic infection or infection at the site of surgery.
• Facet ankylosis or severe facet degeneration.
• Continuing steroid use or prior use for more than 2 months.
• History of allergies to any of the device components.
• Pregnancy or planning to become pregnant within the next 2 years.
• Morbid obesity (BMI >35).
• Investigational drug or device use within 30 days.
• Osteoporosis or osteopenia
• Metabolic bone disease.
• Leg pain with migrated sequestrum fragment.
• History of rheumatoid arthritis, lupus, or other autoimmune disorder.
• Ankylosing spondylitis.
• History of HIV/AIDS or hepatitis that precludes surgery.
• History of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolytic disease.
• Current or recent history of illicit drug or alcohol abuse, or dependence as defined as the continued use of alcohol despite the development of social, legal, or health problems.
• Life expectancy <5 years.
• Chemotherapy within past 5 years or any cancer other than non-melanoma skin cancer treated with curative intent within the past 5 years.
• Prior nephrectomy.
• Abdominal adhesions, endometriosis, inflammatory bowel disease, Crohn's disease, diverticulitis, ulcerative colitis or other abdominal pathology that would preclude abdominal surgical approach.
• Insulin-dependent diabetes.
• Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, ALS (amyotrophic lateral sclerosis), or multiple sclerosis.
• History of Pelvic Inflammatory Disease.
• Peritonitis.
• Currently in active spinal litigation as a result of medical negligence.
• Prisoner.
• Psychiatric or cognitive impairment that would interfere with the subject's ability to comply with the study requirements, e.g., Alzheimer's disease.