Clinical Outcomes Study Evaluating the Zero-P PEEK

This was a post-market study

Inclusion Criteria:

1. Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7
requiring:

1. Neck or arm (radicular) pain and/or

2. Functional/neurological deficit confirmed by imaging (CT, MRI, X-Ray) of at least
one of the following:

i. herniated nucleus pulposus

ii. spondylosis (defined by presence of osteophytes)

iii. loss of disc height

2. NDI score greater than or equal to 15/50 (30%) (considered moderate disability);

3. Skeletally mature adult between the ages of 18-70 years at the time of surgery;

4. Has completed at least six (6) weeks of conservative therapy;

5. Psychosocially, mentally and physically able to fully comply with this protocol
including adhering to scheduled visits, treatment plan, completing forms, and other
study procedures;

6. Personally signed and dated informed consent document prior to any study-related
procedures indicating that the patient has been informed of all pertinent aspects of
the study.

Exclusion Criteria:

1. More than one vertebral level to be fused;

2. Posterior instrumentation necessary at same level;

3. Has had previous surgery at the index level;

4. Has a fused level adjacent to the index level;

5. Active systemic or local infection;

6. Known or documented history of communicable disease, including AIDS or HIV;

7. Active hepatitis (receiving medical treatment within two years);

8. Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical
condition(s) that would represent a significant increase in surgical risk or interfere
with normal healing;

9. Immunologically suppressed, or has received systemic steroids, excluding nasal
steroids, at any dose daily for > 1 month within last 12 months;

10. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;

11. Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple
Calculated Osteoporosis Risk Estimation), will be used to screen patients who require
a DEXA bone mineral density measurement. If DEXA is required, exclusion will be
defined as a DEXA bone density measured T score ≤ -1.0.

12. Previous known allergy to the materials contained in the device, such as
polyetheretherketone (PEEK) or titanium alloy (TAN);

13. Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds
over ideal body weight;

14. Active malignancy. A patient with a history of any invasive malignancy (except
non-melanoma skin cancer), unless treated with curative intent and there has been no
clinical signs or symptoms of the malignancy for more than 5 years;

15. Current or recent history (within last 2 years) of substance abuse (e.g., recreational
drugs, narcotics, or alcohol);

16. Pregnant or planning to become pregnant during study period;

17. Involved in study of another investigational product that may affect outcome;

18. History of psychosocial disorders that could prevent accurate completion of self
reporting assessment scales;

19. Patients who are incarcerated.