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:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
NCT ID:
NCT01746212
Eligibility Criteria:
Inclusion Criteria: Patients are eligible for this study if the following criteria are all met.
* Patient will be surgically treated with an anterior lumbar interbody fusion, anterior only approach by one of the listed physician investigators
* Must have had a structural problem potentially amendable to primary fusion at one or two levels
* InQu Bone Graft Extender and Substitute will be used in the surgery
* Had failed conservative care for longer than three (3) months
* Had no psychological contraindications for surgery
* Aged 18 to 70 years of age at the time of surgery
Exclusion Criteria: Patients are ineligible for this study if any one of the following criteria apply.
* Patients that will not be surgically treated with an anterior lumbar interbody fusion, anterior only approach by one of the physician investigators
* InQu Bone Graft Extender and Substitute will not be used in the surgery
* Patient carries any one of the following diagnoses: spinal stenosis requiring decompression, isthmic spondylolisthesis, degenerative spondylolisthesis greater than three (3) millimeters, three or more degenerative levels, major deformity, have had a previous lumbar fusion, or if they have had a previous infection or tumor
* Individuals that can not provide consent for themselves
* Patients requiring revision surgery
* Aged younger than 18 or older than 70 at the time of surgery
* Patients will be excluded from participating in the study if, in the investigators' opinion, they will be unable to comply with study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01746212
Study Brief:
Protocol Section:
NCT01746212