Treatment of One and/or Two Level Cervical Degenerative Disc Disease

Exclusion Criteria

• •1. Have an active systemic infection or infection at the operative site.
• •2. Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
• •3. Have previous trauma to the C2 to T1 levels resulting in significant bony or disco- ligamentous cervical spine injury.
• •4. Have had any prior spine surgery at the operative level(s).
• •5. Have osteoporosis
• •6. Have Paget's disease of bone, osteomalacia or any other metabolic bone disease other than osteoporosis (addressed above).
• •7. Have active malignancy that included a history of any invasive malignancy (except non- melanoma skin cancer),unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years.
• •8. Have symptomatic cervical disc disease or significant cervical spondylosis at more than 2 levels.
• •9. Have a known allergy to titanium.
• •10. Are currently pregnant or breastfeeding at time of enrollment or have plans to become pregnant within the next three years.
• •11. Have rheumatoid arthritis, lupus, or other autoimmune disease affecting the musculoskeletal system
• •12. Have diseases or conditions that would preclude accurate clinical evaluation in the opinion of the Investigator
• •13. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
• •High dose steroid use is defined as:
• •1. Daily, chronic use of oral steroids equivalent to 5 mg/day of prednisone or greater.
• •2. Daily, chronic use of inhaled corticosteroids (at least twice per day).
• •3. Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40mg prednisone equivalent within one month of the study procedure.
• •14. Have current or recent history (within 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
• •15. Have a Body Mass Index (BMI) \> 40 kg/m2.
• •16. Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents). High dose steroid use as defined in Exclusion Criterion 13.
• •17. Have pending personal litigation relating to spinal injury (worker's compensation is not an exclusion).
• •18. Have a current history of heavy smoking (more than one pack of cigarettes per day).
• •19. Currently reside in a location, or anticipating a potential relocation, that may interfere with completion of follow-up examinations.
• •20. Have mental illness or belonged to a vulnerable population, as determined by the investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements.
• •21. Have an uncontrolled seizure disorder.