An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

Exclusion Criteria

• •1. Posterior instrumentation necessary at same levels being treated
• •2. Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine
• •3. Instability associated with cervical spine trauma
• •4. Acute or chronic systemic or localized spinal infections
• •5. Previous deep anterior cervical surgeries such as thyroid, carotid, or high thoracic surgery (T5 and above)
• •6. History of previous cervical fusion surgery at greater than one level
• •7. Previous pseudoarthrosis at any level of the cervical spine
• •8. Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study
• •9. Severe osteoporosis (per the Investigator's diagnosis or per a T-score greater than or equal to 2.5 SD below the mean for a young, healthy adult) that may prevent adequate fixation of screws and thus preclude the use of a cervical plate system
• •10. Subjects who have a known or suspected allergy to any of the following antibiotics and/or reagents: Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin (HSA)
• •11. Immune compromised subjects
• •12. Pre-existing neurological abnormalities other than deficits produced by the spinal fusion (e.g. MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy)
• •13. Conditions that could preclude the possibility of fusion in the Investigator's opinion (e.g. cancer, kidney dialysis, smoking, uncontrolled diabetes, osteopenia)
• •14. History of pre-operative dysphagia
• •15. Symptomatic shoulder pathologies under active treatment
• •16. Known sensitivity to device materials
• •17. Subjects who, in the opinion of the Investigator, have any other existing condition that would compromise their participation and follow-up in this clinical study
• •18. Intraoperative decision by the surgeon to use implants not compatible or cleared for use with ViviGen
• •19. Intraoperative decision by the surgeon to use other bone grafts substitutes such as DBM or rhBMP