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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT03302520
Eligibility Criteria:
Inclusion Criteria:
* patients aged between 30 and 80
* patients who required one-level PLIF between L1 and S1 among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal stenosis or those who required PLIF due to grade I or II spondylolisthesis
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form.
Exclusion Criteria:
* osteoporosis patients with average T-scores of L1-L4 at \<-3.0 in DEXA bone density tests
* women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
* patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
* patients with abnormal blood potassium and phosphorus levels;
* patients with liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease;
* patients deemed to have less than 1-year life expectancy;
* patients with mental retardation or whose parents or legal guardians were older or had mental disabilities;
* other patients viewed as inappropriate by the staff
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT03302520
Study Brief:
Protocol Section:
NCT03302520