An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine

Exclusion Criteria

• •A patient will be excluded from participating in this study for any of the following reasons:
• •1. Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels;
• •2. Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing:
• •1. Sagittal plane translation \> 3.5 mm, or
• •2. Sagittal plane angulation \> 20°
• •3. Has more than two cervical levels requiring surgical treatment;
• •4. Has severe pathology of the facet joints of the involved vertebral bodies;
• •5. Has had previous surgical intervention at either one or both of the involved levels;
• •6. Has been previously diagnosed with osteopenia or osteomalacia;
• •7. 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.):
• •1. . Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds.
• •2. Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture.
• •3. Male over the age of 70.
• •4. Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
• •If the level of BMD is a T score of -3.5 or lower (i.e., -3.6, -3.7, etc.) or a T score of -2.5 or lower (i.e., -2.6, -2.7 etc.) with vertebral crush fracture, then the patient is excluded from the study
• •8. Has presence of spinal metastases;
• •9. Has overt or active bacterial infection, either local or systemic;
• •10. Has chronic or acute renal failure or prior history of renal disease;
• •11. Has a documented allergy or intolerance to titanium, or a titanium alloy;
• •12. Is mentally incompetent. (If questionable, obtain psychiatric consult);
• •13. Is a prisoner;
• •14. Is pregnant;
• •15. 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;
• •16. Has history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
• •17. 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.);
• •18. 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.
• •19. Is currently taking or has had chronic usage of certain prescription medications (e.g., Cloxacillin, an antibiotic used for prophylaxis against surgical infections, and/or Clotrimazole).