INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial

Exclusion Criteria

• •EXCLUSION:
• •1. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.
• •2. Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs.
• •3. Previous surgical intervention at the involved level.
• •4. Any subsequent planned/staged surgical procedure at the involved or adjacent level(s).
• •5. Fused level adjacent to the level to be treated.
• •6. Severe pathology of the facet joints of the involved vertebral bodies.
• •7. Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan.
• •8. Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
• •9. Overt or active bacterial infection, either local or systemic.
• •10. Insulin dependent diabetes.
• •11. Chronic or acute renal failure or prior history of renal disease.
• •12. Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.
• •13. Is mentally incompetent. (if questionable, obtain psychiatric consult.)
• •14. Is a prisoner.
• •15. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
• •16. On oral or injectable steroids for 6 weeks or more at the time of enrollment.
• •17. A history of autoimmune disease.
• •18. History of exposure to injectable collagen or silicone implants.
• •19. History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
• •20. Received any previous exposure to any/all BMPs either human or animal extraction.
• •21. History of allergy to bovine products.
• •22. History of any allergy resulting in anaphylaxis.
• •23. History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta).
• •24. Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids.
• •25. Received treatment with an investigational therapy (drug, device, or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.