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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT00444405
Eligibility Criteria:
Inclusion Criteria:
* Recurrent lumbar disc herniation by MRI or CT with history of decompression at the same level in the past
* Recurrent symptomatic history (with or without back pain) with radicular leg pain that improved following the first surgery
* Male or female 18-75 years old
* Flexion and extension x-rays that demonstrate an absence of sponylolisthesis or spondylolisthesis with less than 3 mm of movement
Exclusion Criteria:
* Recurrence of disc herniation within 3 months of first decompression
* Multiple level herniated discs
* No history of lumbar back surgery except as in Inclusion criteria above
* Documented severe osteoporosis or osteopenia
* Symptoms of low back pain only
* Diabetes mellitus
* Patients with suspected or diagnosed psychological/psychiatric problems that could compromise the reliability of their results
* Lumbar spondylolisthesis on flexion/extension x-rays \> 3 mm
* History of lumbar spine fractures (new or old)
* Any concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
* Autoimmune diseases
* Age less than 18 or greater than 75 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00444405
Study Brief:
Protocol Section:
NCT00444405