Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)

Launched by NUVASIVE · Jul 17, 2009

Keywords

ClinConnect Summary

A total of 175 subjects will be selected for enrollment in this study from multiple centers. The subjects will have degenerative conditions in the cervical spine and will be undergoing ACDF surgery as treatment at one or two levels. The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Persistent neck and/or arm pain unresponsive to conservative treatment for at least 6 weeks, unless clinically indicated sooner
• • 2. Indicated for anterior fusion at one or two contiguous cervical levels (C3 to T1)
• • 3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
• • 4. 18-70 years of age at the date of written informed consent
• • 5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
• • 6. Expected to survive at least 2 years beyond surgery
• • 7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
• • 8. Signed and dated Informed Consent Form
• Exclusion Criteria:
• • 1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
• • 2. Cervical spine abnormality requiring treatment at more than two levels
• • 3. Systemic or local infection; active or latent
• • 4. Previous failed fusion at the operative level
• • 5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
• • 6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
• • 7. Pregnant, or plans to become pregnant during the study
• • 8. Subject is a prisoner
• • 9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
• • 10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents that decrease the probability of survival to the two-year endpoint of the study
• • 11. Participating in another clinical study at any time during the study participation that would confound study data