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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT04318795
Eligibility Criteria:
Inclusion Criteria:
* Intermittent claudication with pain or numbness or weakness of lower limb(s) with or without low back pain
* An imaging study (MRI or CT) showing single level lumbar spinal stenosis
Exclusion Criteria:
* Insufficient conservative treatment (6 weeks)
* Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
* Previous spinal surgery
* Other comorbid conditions that contraindicating surgery
* Possible pregnancy that contraindicating radiological examination
* Age less than 18 years old
* Combination with 2°spondylolisthesis or segmental instability (slip distance \>4mm or angle change \>10° in dynamic plain film)
* Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
* Equal to or more than two responsible level
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04318795
Study Brief:
Protocol Section:
NCT04318795