Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT01291134
Eligibility Criteria:
Inclusion Criteria:
* Persistent neck and/or arm pain consistent to symptomatic cervical degenerative disc disease
* Moderate Neck Disability Index
* Unresponsive to conservative treatment for at least 6 weeks
Exclusion Criteria:
* More than 4 levels requiring surgical treatment
* Prior failed fusion surgery at the index level(s)
* Systemic or local infection in the disc or cervical spine, past or present
* Active systemic disease
* Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
* Known or suspected history of alcohol and/or drug abuse
* Involved in pending litigation or worker's compensation relating to the spine
* Pregnant or plans to become pregnant during the duration of the study
* Insulin-dependent diabetes mellitus
* Life expectancy less than study duration
* Any significant psychological disturbance that in the opinion of the Investigator could impair consent process or ability to complete self-assessment questionnaires
* BMI greater than 40
* Undergoing chemotherapy or radiation treatment, or chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
* Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01291134
Study Brief:
Protocol Section:
NCT01291134