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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT07279051
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 and 80 years.
* Presence of unilateral neurogenic claudication or radicular pain in the lower limbs, with failure to respond to at least 3 months of conservative treatment.
* Presence of bilateral neurogenic claudication or radicular pain in the lower limbs, but with complete resolution of neurological symptoms in at least one lower limb during recumbency and an unremarkable physical examination, alongside failure to respond to at least 3 months of conservative treatment.
* Radiologically confirmed single- or two-level lumbar spinal stenosis on MRI, with evidence of instability specifically at the stenotic level(s) on standing lateral radiographs.
* The mMO-TLIF or TLIF surgical procedure is performed by the same lead surgeon at each participating investigational site.
* Subjects voluntarily participate and provide written informed consent.
Exclusion Criteria:
* Presence of bilateral radicular pain in the lower limbs that does not completely resolve at rest.
* History of previous lumbar spine trauma or surgery.
* Presence of spinal infection, tuberculosis, or tumor.
* Contraindications to surgery, such as severe systemic medical diseases, coagulation disorders, severe active infectious diseases, or osteoporosis.
* Significant intervertebral space collapse, presence of bony ankylosis, etc.
* Incomplete data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07279051
Study Brief:
Protocol Section:
NCT07279051