Treatments and/or Procedures

Study Criteria

Inclusion Criteria:

  1. Symptomatic cervical disc disease (SCDD) in the one vertebral level between C3/C4 to
     C7/T1, defined as neck or arm (radicular) pain, or functional or neurological deficit
     and correlated with radiculopathy or myelopathy or radiographic confirmation (by CT,
     MRI, x-ray, etc.) of any of the following:

       -  Herniated nucleus pulposus;

       -  Spondylosis (defined by the presence of osteophytes); or

       -  Loss of disc height.

  2. Requires only one cervical vertebral level to be surgically treated, confirmed
     radiologically by Xray, CT, or MRI and correlated with neurologic examination prior to
     enrollment;

  3. Age between 22 and 70 years (inclusive);

  4. Skeletally mature patients;

  5. Failed at least 6 weeks of conservative treatment (e.g. medication, physical therapy),
     or exhibit progressive symptoms or signs of spinal cord/nerve root compression with
     continued non-operative care;

  6. Neck Disability Index (NDI) Questionnaire score of at least 30 (on a scale from 0 to
     100);

  7. Able to read and Understand all documents used in this study, including the Informed
     Consent and patient-reported outcome questionnaires;

  8. Understand and read English at elementary level;

  9. Patient must understand and sign the Informed Consent document that has been approved
     by the Ethics committee, Institutional review Board and the FDA.

Exclusion Criteria:

  1. More than one vertebral level requiring treatment, confirmed radiologically by X-ray,
     CT, or MRI

  2. Cervical instability;

  3. Prior fusion surgery at any cervical vertebral level;

  4. Prior surgery at the level to be treated with the exception of surgery that does not
     require the use of hardware and/or the treatment of facet disease;

  5. Severe facet disease;

  6. Clinically compromised vertebral bodies at the affected level(s) due to current or
     past trauma

  7. Neck or arm pain of unknown etiology;

  8. Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone
     disease;

     a. Osteoporosis is defined as history of fragility fracture and Dexa (DXA) T-score <
     -2.5 or QCT T-score < 80mg/cubic cm. History of a fragility fracture requires that a
     DXA scan or QCT scan is completed

  9. Pregnant or interested in becoming pregnant in the next 2 years;

 10. Active systemic or local infection;

 11. History of severe allergy or anaphylaxis especially to titanium, polyethylene, cobalt,
     chromium or molybdenum;

 12. Taking medications or any drug known to potentially interfere with bone/soft tissue
     healing (e.g., steroids, bisphosphonates);

 13. Rheumatoid arthritis or another autoimmune disease that affects musculoskeletal
     system;

 14. Acquired immune deficiency syndrome (AIDS) or an AIDS-related complex;

 15. Active malignancy or history of invasive malignancy within the last five years, except
     for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has
     been definitely treated; patients with carcinoma in situ of the uterine cervix treated
     definitely more than 1 year prior to enrollment may enter the study;

 16. Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, and
     amyotrophic lateral sclerosis;

 17. Pre-existent neurologic or mental disorder which would preclude accurate evaluation
     and followup (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric
     disorder with hallucinations and/or delusions or schizophrenia);

 18. Substance use disorder categorized as moderate to severe as defined in DSM-V;

 19. Mental/Psychiatric disorder as defined in DSM-V;

 20. Alcohol abuse disorder categorized as moderate to severe as defined in DSM-V;

 21. Current Smokers;

 22. Use of bone growth stimulator in the region of the cervical spine within the past 30
     days;

 23. Participation in other investigational device or drug clinical trials within 30 days
     of surgery;

 24. Prisoners;

 25. Morbid obesity, defined as body mass index ("BMI") > 40;

 26. Type 1 diabetes mellitus requiring daily insulin therapy unless there is documentation
     of a recent A1c (within 6 months) of less than 7.1 or Type 2 diabetes where the
     clinical presentation precludes the patient from having surgery;

 27. Involved in litigation related to the spine;

 28. On workers compensation