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

Exclusion Criteria

• •Any other cervical spinal condition requiring surgical treatment at the involved level
• •Documented or diagnosed cervical instability defined by radiographs showing
• •1. Sagittal plane translation \> 3.5mm or
• •2. 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)
• •1. Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
• •2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
• •3. Male over the age of 70
• •4. 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.