Clinical Outcomes Study Evaluating the Zero-P PEEK

Launched by SYNTHES USA HQ, INC. · Jul 23, 2009

Keywords

ClinConnect Summary

This was a post-market study

Gender

ALL

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.