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

Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage

The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.

The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.

Inclusion Criteria Summary:

• Be between 18 and 60 years of age
• Have evidence of degenerative disc disease (DDD)
• History of back and/or radicular pain which is severe, ongoing and recurrent
• Minimum 6 month period of prior conservative care
• Moderate Oswestry Disability Index score
• Moderate pain score
• Be likely to return for all follow-up visits
• Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria Summary:

• 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.