Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion

This is an interventional treatment trial for Symptomatic Cervical Disc Disease focused on measuring Cervical Disc Disease, ACDF, Single-level Read More

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