INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate- Pilot Study

Inclusion criteria

• Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:

• herniated disc;
• osteophyte formation;
• decreased disc height;
• thickening of ligamentous tissue;
• disc degeneration; and/or
• facet joint degeneration.
• Has preoperative Neck Disability Index score >= 30;
• C2-C3 disc to C7-Tl disc level(s) of involvement.
• One or two adjacent levels requiring fusion;
• No previous surgical intervention at the involved fusion level(s);
• Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
• Age > 18 years at time of surgery;
• Is female of child-bearing potential, who is not pregnant or nursing, and who agrees to not get pregnant for 1 year following surgery;
• Willingness to comply with study plan and sign the consent form.

Exclusion criteria

• Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level(s).
• Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that anterior plating would be contraindicated.
• Has presence of spinal metastases.
• Has overt or active bacterial infection, either local or systemic.
• Has fever (temperature > 101°F oral) at the time of surgery.
• Has a documented titanium alloy allergy or intolerance.
• 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 usage.
• Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs.
• Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
• Has a history of exposure to injectable collagen implants.
• Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
• Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
• Has received any previous exposure to any/all BMP's of either human or animal extraction.
• Has a history of allergy to bovine products or a history of anaphylaxis.
• Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).
• Has a condition which requires postoperative medications that interfere with fusion, such as steroids, excluding routine perioperative anti-inflammatory drugs.