Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)

Inclusion Criteria

• The subject is scheduled to undergo a two or three level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using Cellentra™ VCBM, allograft spacers, and the MaxAn® Anterior Cervical Plate System.
• The subject is 18 years of age or older.
• The subject was unresponsive to conservative treatment for at least 6 weeks unless clinically indicated sooner.
• The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies.
• The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

Exclusion Criteria

• Subject has an active local or systemic infection.
• Subject is morbidly obese, defined as a BMI greater than 40.
• Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
• Subject has inadequate tissue coverage over the operative site.
• Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis.
• Any previous cervical spinal surgery.
• Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.) or immunocompromised.
• Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
• Subject who does not meet the specific indications for use of the Cellentra™ VCBM or MaxAn® Anterior Cervical Plate System.
• Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
• Subject is currently involved in another investigational drug or device study that could confound study data.
• Subject is a prisoner.
• Subject has a metal sensitivity/foreign body sensitivity.
• Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
• Subject has sensitivity or allergies to any of the processing agents. (See package insert for Cellentra™ VCBM).