Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

Inclusion Criteria

• Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation
• One level requiring surgical treatment
• C3-C4 disc to C6-C7 disc level involvement
• Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression
• No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level.
• Preop Neck Disability index score ≥ 30
• Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire
• Not pregnant at time of surgery
• Willing and able to comply with study plan and able to understand and sign patient informed consent

Exclusion Criteria

• Any other cervical spinal condition requiring surgical treatment at the involved level
• Documented or diagnosed cervical instability defined by radiographs showing
• Sagittal plane translation > 3.5mm or
• Sagittal plane angulation > 20 degrees.
• More than one cervical level requiring surgery
• A fused level adjacent to the level to be treated
• Severe pathology of the facet joint of involved bodies
• Previous surgery at the involved level
• Previously diagnosed osteopenia or osteomalacia
• Any of the following that may be associated with an osteoporosis diagnosis (if "Yes" to any of these, a DEXA Scan will be required to determine eligibility)
• Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
• Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
• Male over the age of 70
• Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.

If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded.

• Presence of spinal metastases
• Overt or active bacterial infection, either local or systemic
• Severe insulin dependent diabetes
• Chronic or acute renal failure or history of renal disease
• Temperature > 101º F oral at surgery
• Documented allergy to stainless steel, titanium or a titanium alloy
• Mentally incompetent
• Is a prisoner
• Is pregnant
• Is an alcohol and/or drug abuser
• Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories)
• A history of endocrine or metabolic disorder known to affect osteogenesis
• A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy.
• Received treatment with an investigational therapy within 28 days prior to surgery or planned for 16 weeks following implantation.