Investigation of the Two Level Simplify® Cervical Artificial Disc

Exclusion Criteria

• •Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;
• •Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:
• •* Sagittal plane translation \> 3.5 mm, or
• •* Sagittal plane angulation \> 20°;
• •Has more than two cervical levels requiring surgical treatment;
• •Has a fused level (or artificial disc replacement) adjacent to the levels to be treated;
• •Has severe pathology of the facet joints of the involved vertebral bodies;
• •Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels;
• •Axial neck pain only (no radicular or myelopathy symptoms);
• •Has been previously diagnosed with osteopenia or osteomalacia;
• •Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility):
• •* Postmenopausal non-black female over 60 years of age who weighs less than 140 pounds;
• •* Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture;
• •* Male over the age of 70;
• •* Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
• •* If the level of bone mineral density is a T score of -1.5 or lower (i.e., -1.6, 1.7, etc.), then the patient is excluded from the study
• •Has presence of spinal metastases;
• •Has overt or active bacterial infection, either local or systemic;
• •Has insulin-dependent diabetes;
• •Has chronic or acute renal failure or prior history of renal disease;
• •Known PEEK, ceramic, titanium allergy;
• •Is mentally incompetent (if questionable, obtain psychiatric consult);
• •Is a prisoner;
• •Is pregnant;
• •Is currently an alcohol and/or drug abuser or currently undergoing treatment for alcohol and/or drug abuse;
• •Is involved with current or pending litigation regarding a spinal condition;
• •Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs;
• •Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
• •Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs);
• •Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation.