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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02104167
Eligibility Criteria:
Inclusion Criteria:
* Subject must have degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level between C2 and T1.
* The subject can have the ROI-C device at only one level.
* Autograft must have been used with the ROI-C device.
* Subject should have had a minimum of 6 (six) weeks of non-operative treatment prior to surgery.
* Subject must be at least 21 years of age at the time of surgery
Exclusion Criteria:
* No BMP was used in the interbody cage
* Subject was a prisoner at the time of surgery
* Subject was pregnant at the time of surgery
* Subject had an active infection or sepsis at the time of surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02104167
Study Brief:
Protocol Section:
NCT02104167