Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)

Exclusion Criteria

• •Any back or leg pain of unknown origin
• •Foot drop
• •Previous trauma to the study treatment level with compression or bursting
• •Previous retroperitoneal surgery
• •Other spinal surgery at affected level except IDET, laminotomy
• •Previous thoracic or lumbar fusion
• •Documented abnormal abdominal vessel or muscular/fascial pathology or morphology
• •Degenerative spondylolisthesis
• •Ischemic (spondylolytic) spondylolisthesis
• •Spondylitis
• •Documented significant spinal, foraminal or lateral stenosis
• •Severely reduced disc space height
• •Documented presence of free nuclear fragment
• •Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray
• •Scoliosis of the lumbar spine
• •Metabolic bone disease
• •Active systemic infection
• •Hepatitis
• •Active malignancy or history of metastatic malignancy
• •Any terminal or autoimmune disease
• •Any other disease, condition or surgery which might impair healing
• •Recent history of chemical or alcohol dependence
• •Current or extended use of any drug known to interfere with bone or soft tissue healing
• •Known metal allergy
• •Morbid obesity
• •Transitional vertebrae at level to be treated that has not clearly fused
• •Currently a prisoner
• •Currently involved in spinal litigation
• •Currently experiencing an episode of major mental illness
• •Pregnancy at time of enrollment, since this would contraindicate abdominal surgery
• •Participation in another drug, diologic or medical trial within 30 days of study surgery
• •Lives more than 300 miles from a study center or participation in any other investigational drug, biologic or medical device study.