clinical outcomes study evaluating the zero-p peek

Conditions: Cervical Disc Disease

Summary: this is a multi-center, prospective, outcomes study. in this study, the zero-p peek implant will be used in patients undergoing acdf for treatment of scdd at a single level between c3 and c7. the cohort will be followed over time to twenty-four (24) months after surgery. up to fifteen (15) sites will participate in this study. this is not a controlled study.

this was a post-market study

Eligibility criteria:
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.

Keywords: scdd