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

Inclusion Criteria:

A patient must meet all of the following inclusion criteria to participate in this study:

1. Has cervical degenerative disc disease at two (2) contiguous cervical levels (from C3
to C7) requiring surgical treatment and involving intractable radiculopathy,
myelopathy or both;

2. 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 (e.g., neck and/or arm pain, functional deficit and /or
neurological deficit), and the requirement for surgical treatment is evidenced by
radiographic studies (e.g., CT, MRI, x-rays, etc.);

3. Has been unresponsive to non-operative treatment for at least six weeks or has the
presence of progressive symptoms or signs of nerve root/spinal cord compression in the
face of continued non-operative therapy;

4. Has no previous surgical intervention at the involved levels or any other
planned/staged surgical procedure at the involved levels or contiguous levels;

5. Has preoperative Neck Disability Index (NDI) score ≥ 30;

6. Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain
Questionnaire;

7. Must be at least 18 years of age and be skeletally mature at the time of surgery;

8. If a female of childbearing potential, patient is non-pregnant, non-nursing, and
agrees not to become pregnant during the study period;

9. Is willing to comply with the study plan and sign the Patient Informed Consent Form.

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 a fused level contiguous to the levels to be treated;

5. Has severe pathology of the facet joints of the involved vertebral bodies;

6. Has had previous surgical intervention at either one or both of the involved levels or
adjacent levels;

7. Has been previously diagnosed with osteopenia or osteomalacia;

8. 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

9. Has presence of spinal metastases;

10. Has overt or active bacterial infection, either local or systemic;

11. Has insulin dependent diabetes;

12. Is a tobacco user who does not agree to suspend smoking prior to surgery;

13. Has chronic or acute renal failure or prior history of renal disease;

14. Has a documented allergy or intolerance to titanium, or a titanium alloy;

15. Is mentally incompetent. (If questionable, obtain psychiatric consult);

16. Is a prisoner;

17. Is pregnant;

18. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for
alcohol and /or drug abuse;

19. Is involved with current or pending litigation regarding a spinal condition;

20. 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;

21. 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);

22. 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.);

23. 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.

24. Has had a procedure requiring the use of permanent metal implants [i.e., stents, joint
replacement, and/or dental implants (does not include fillings, crowns, or braces)];

25. 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).

26. Is currently working in a profession with increased exposure to metal particles (i.e.,
jewelry making, construction, iron working, metal grinding, welding, mining etc.).

27. Is currently receiving B12 injections and/or taking nutritional supplements and/or
vitamins containing titanium, vanadium, and aluminum based ingredients.