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 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT03908203
Eligibility Criteria:
Inclusion Criteria:
* Given written Informed Consent;
* Single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine L4-L5 or L5-S1;
* Mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain;
* Symptoms persisting for at least three months prior to surgery;
* Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Exclusion Criteria:
* Lumbar deformation of non-degenerative etiology;
* Spondylolisthesis grade II or higher (25% slip or greater) of any etiology;
* Patient that has already undergone a lumbar fusion surgery;
* Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study
* Concurrent participation in another clinical study that may confound study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03908203
Study Brief:
Protocol Section:
NCT03908203