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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT05566704
Eligibility Criteria:
Inclusion Criteria:
1. Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
2. Male or female patients who are ≥18 years of age at the time of surgery
3. Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome
4. Treated with ALIF procedure with the Modulus ALIF System at:
* One or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (DDD), degenerative spondylolisthesis, or spinal stenosis, or
* Any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as \>10º coronal curve) or sagittal deformity
5. Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:
* 1-2 levels treated for DDD, and
* 3 or 4 interfixated screws placed, and
* Implant lordosis is ≤20°
Exclusion Criteria:
1. Patient was a prisoner at the time of Modulus ALIF treatment
2. Patient was participating in another clinical study during treatment that would confound study data
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05566704
Study Brief:
Protocol Section:
NCT05566704