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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT05993195
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 or older with symptomatic degenerative lumbar spondylotic disease, either spondylosis, and/or spondylolisthesis
* who have failed conservative management of at least 6 weeks requiring 1 or 2 level lumbar interbody fusion (either PLIF or TLIF)
* All patients included will be index surgeries (no re-operations).
Exclusion Criteria:
* Patients who improve with consecutive management and do not undergo lumbar fusion surgery
* Surgery performed in the thoracic or cervical spine
* Surgery performed for tumor, infection, or trauma Patients who have an unstable fracture, tumor, and osteoporosis with T score exceeding -2.0
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05993195
Study Brief:
Protocol Section:
NCT05993195