| Eligibility |
Inclusion Criteria:
1. Male or female subject; at least 18 years of age
2. Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine,
with pain, paresthesias or paralysis in a specific nerve root distribution C2 through
T1, including at least one of the following:
1. Neck and/or arm pain of at least 30/100 mm on the visual analogue scale (VAS)
scale
2. Decreased muscle strength of at least one level on the clinical evaluation (0 to
5) scale
3. Abnormal sensation including hyperesthesia or hypoesthesia; and/or
4. Abnormal reflexes
3. Symptomatic cervical disc disease, facet arthropathy, or cervical spinal stenosis at 1
or 2 levels between C2 and T1, suitable for treatment with anterior discectomy,
decompression, and fusion
4. Radiographically determined pathology at the level to be treated correlating to
primary symptoms including at least one of the following:
1. Decreased disc height on radiography,) in comparison to a normal adjacent disc
2. Degenerative spondylosis
3. Disc herniation
5. NDI Score >30%.
6. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy,
physical therapy, chiropractic care and/or analgesics) for:
1. Approximately six weeks from radiculopathy or myelopathy with radiculopathy
symptom onset; or
2. Have the presence of symptoms or signs of nerve root/spinal cord compression
despite continued non-operative, conservative treatment; or
3. Sooner than 6 weeks for worsening symptoms of neurologic compromise.
7. Reported to be medically cleared for surgery.
8. Physically and mentally able and willing to comply with the Protocol, including the
ability to read and complete required forms and willing and able to adhere to the
scheduled follow-up visits and requirements of the Protocol.
9. Signed informed consent provided by subject.
Exclusion Criteria:
1. Have an active systemic infection or infection at the operative site.
2. Have a history of or anticipated treatment for active systemic infection, including
HIV or Hepatitis C.
3. Have previous trauma to the C2 to T1 levels resulting in significant bony or disco-
ligamentous cervical spine injury.
4. Have had any prior spine surgery at the operative level(s).
5. Have osteoporosis
6. Have Paget's disease of bone, osteomalacia or any other metabolic bone disease other
than osteoporosis (addressed above).
7. Have active malignancy that included a history of any invasive malignancy (except non-
melanoma skin cancer),unless the subject had been treated with curative intent and
there had been no clinical signs or symptoms of the malignancy for at least five
years.
8. Have symptomatic cervical disc disease or significant cervical spondylosis at more
than 2 levels.
9. Have a known allergy to titanium.
10. Are currently pregnant or breastfeeding at time of enrollment or have plans to become
pregnant within the next three years.
11. Have rheumatoid arthritis, lupus, or other autoimmune disease affecting the
musculoskeletal system
12. Have diseases or conditions that would preclude accurate clinical evaluation in the
opinion of the Investigator
13. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
High dose steroid use is defined as:
1. Daily, chronic use of oral steroids equivalent to 5 mg/day of prednisone or
greater.
2. Daily, chronic use of inhaled corticosteroids (at least twice per day).
3. Use of short-term (less than 10 days) oral steroids at a daily dose greater than
40mg prednisone equivalent within one month of the study procedure.
14. Have current or recent history (within 1 year prior to screening) of substance abuse
(alcoholism and/or narcotic addiction) requiring intervention.
15. Have a Body Mass Index (BMI) > 40 kg/m2.
16. Taking medications known to potentially interfere with bone/soft tissue healing (e.g.,
high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic
agents). High dose steroid use as defined in Exclusion Criterion 13.
17. Have pending personal litigation relating to spinal injury (worker's compensation is
not an exclusion).
18. Have a current history of heavy smoking (more than one pack of cigarettes per day).
19. Currently reside in a location, or anticipating a potential relocation, that may
interfere with completion of follow-up examinations.
20. Have mental illness or belonged to a vulnerable population, as determined by the
investigator (e.g., prisoner or developmentally disabled), that would compromise
ability to provide informed consent or compliance with follow-up requirements.
21. Have an uncontrolled seizure disorder.
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