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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01367860
Eligibility Criteria:
Inclusion Criteria:
* single disc herniation, posterolateral, at any lumbar level, with a size of up to 1 / 3 of the spinal canal sagittal diameter, with radicular pain correlated with findings at MRI
* Failure of nonoperative treatment with at least one anti-inflammatory medication and at least two weeks of physical therapy within a period of 6 months
* acceptance of completion of informed consent
Exclusion Criteria:
* Force \<4 / 5 in a muscle group in the lower limb
* Herniated Disc extrusa large (\> 1 / 3 of the sagittal canal diameter) or sequestered herniation
* moderate to grade stenosis of the central canal, lateral recess or foramen
* Surgery in the previous level involved
* Herniated disc at another level in the affected side
* Loss of disc height significantly (\> 60%) compared with the adjacent higher level
* Infection at the insertion of the device
* Pregnancy
* Any illness or medications that contraindicate surgical treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
76 Years
Study:
NCT01367860
Study Brief:
Protocol Section:
NCT01367860