Kineflex/C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)

Inclusion Criteria:

• have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI;
• have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms;
• have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression;
• have moderate disability neck disability index (NDI) score; AND
• be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation

Exclusion Criteria:

• marked cervical instability;
• non discogenic neck pain or non discogenic source of symptoms;
• radiographic confirmation of severe facet disease or facet degeneration;
• bridging osteophytes;
• prior surgery at the level to be treated;
• prior fusion at any cervical level;
• more than one neck surgery via anterior approach;
• previous trauma to the C3-C7 levels resulting in compression or bursting;
• documented presence of free nuclear fragment at any cervical level;
• severe myelopathy;
• any paralysis;
• history of chemical or alcohol dependence;
• active systemic infection;
• infection at the site of surgery;
• prior disc space infection or osteomyelitis in the cervical spine;
• any terminal, systemic or autoimmune disease;
• metabolic bone disease (e.g., osteoporosis, gout, osteomalacia, Paget's disease);
• any disease, condition or surgery which might impair healing;
• known metal allergy;
• arachnoiditis;
• currently experiencing an episode of major mental illness;
• pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery;
• morbid obesity; use of spinal stimulator at any cervical level prior to surgery;
• currently a prisoner;
• currently involved in spinal litigation which may influence the subjects reporting of symptoms; OR
• lives more than 300 miles from study center or participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery