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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT03247166
Eligibility Criteria:
Inclusion Criteria:
* Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis
* Patients with degenerative spondylolisthesis
* Patients with at least 3 months failed conservative treatment
* Narrowing of the lumbar spinal canal
* Patients with lower back pain or sciatica
Exclusion Criteria:
* Discogenic back pain at TOPS System level
* Back or non-radicular leg pain of unknown etiology at TOPS System level
* Lytic spondylolisthesis at TOPS System level
* More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure
* Known allergy to titanium and/or polyurethane
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT03247166
Study Brief:
Protocol Section:
NCT03247166