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:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT02068768
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage)
* Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery
* Subject should have had a minimum of 6 months of non-operative treatment prior to surgery
* The placement of the Avenue L device must be a primary surgery
* Subject must be willing to sign the consent form and be able to return for all follow up visits.
Exclusion Criteria:
* Subject must not have had prior surgery at the operative level(s)
* Subject is known to have substance or alcohol addictions
* Subject has lateral curvature of the spine (scoliosis, all types)
* Subject is a prisoner
* Subject is pregnant
* Subject has an active infection or sepsis at the time of surgery
* Subject has any neuromuscular disorder that would preclude accurate neurologic evaluations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02068768
Study Brief:
Protocol Section:
NCT02068768