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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT05023733
Eligibility Criteria:
Inclusion Criteria:
* Skeletally mature adults ages 35 - 80 years of age, inclusive
* Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis
* Subject undergoing one or two level transforaminal lumbar interbody fusion
* Able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires
Exclusion Criteria:
* Patients over 80 years of age
* Patients under 35 years of age
* Current smokers
* BMI\>42
* Subject has spondylolisthesis \> 2
* Subjects with multilevel \>2 levels of symptomatic disease
* Subjects with significant spinal deformity
* Subject is pregnant, plans to become pregnant or is breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT05023733
Study Brief:
Protocol Section:
NCT05023733