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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02297256
Eligibility Criteria:
Inclusion Criteria:
* Must be 18 years old or older
* Scheduled for elective posterior spinal fusion of the thoracolumbar spine or lumbar spine with or without anterior interbody support
* Failed at least 6 weeks of conservative care
* ODI v2.1 score \> 30%
* No contraindication to BMAC (as per manufacturer)
* Signed consent form
Exclusion Criteria:
* Spondylolisthesis grade ≥ 3
* Pagets disease, osteomalacia, or any metabolic bone disease
* Use of medications that interfere with bone healing (chronic steroids)
* Patient unlikely to comply with post-op schedule with physician
* Recent history of chemical dependency
* Participation in other investigational device trial(s) within past 30 days
* Active malignancy
* Pregnancy or planning to become pregnant
* Direct involvement in execution of this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02297256
Study Brief:
Protocol Section:
NCT02297256