Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

Inclusion Criteria

• Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment & involving intractable radiculopathy, myelopathy, or both
• Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies
• Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
• Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)
• Must be ≥ 18 years; skeletally mature at time of surgery
• Preoperative NDI score ≥ 30
• Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire
• If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period
• Is willing to comply with the study plan and sign Patient Informed Consent Form

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 degrees.
• Has more than two cervical levels requiring surgical treatment
• Has a fused level 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
• 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 a DEXA Scan will be required to determine eligibility.)
• Postmenopausal non-Black female over age of 60 who weighs 70 years
• Male > 60 years who has sustained a non-traumatic hip or spine fracture
• If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower with vertebral crush fracture, 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
• Is a tobacco user who does not agree to suspend smoking prior to surgery
• Has chronic or acute renal failure or prior history of renal disease
• Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy
• Is mentally incompetent (If questionable, obtain psychiatric consult)
• Is a prisoner
• Is pregnant
• Is an alcohol and/or drug abuser as defined by 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