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

Inclusion Criteria

• INCLUSION:
• Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy.
• Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression.
• Unresponsive to non-operative treatment for six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
• At least 18 years of age and skeletally mature at the time of surgery.
• A preoperative Neck Disability Index (NDI) score ≥30.
• A preoperative neck pain score (pain intensity + pain frequency) ≥8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
• If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery.
• Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria

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