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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT03105167
Eligibility Criteria:
Inclusion Criteria:
1. Age of at least 18 years;
2. All of participants will be informed consent;
3. Chronic low back pain (visual analogue scale at least 3 out of 10 at rest and at least 5 out of 10 under physical strain) after having failed conservative treatment for 6 months;
4. Single-segment lower lumbar vertebral disease (Including lumbar spinal cannal stenosis, foraminal stenosis, segmental instability, lumbar disc herniation, and painful disc degeneration (back disc);
Exclusion Criteria:
1. Serious deformity of lumbar vertebrae;
2. Dysplasia of lumbar pedicle or vertebral laminar;
3. Obvious osteoporosis of lumbar vertebrae;
4. Metabolic bone diseases such as osteomalacia or Paget's disease;
5. Spondylolisthesis \> grade 2 (Meyerding);
6. Caudaequina injury or severe radiculopathy;
7. Post inflammatory instability of the vertebral spine;
8. Body mass index \> 30;
9. Immunologic diseases or Metabolic syndrome;
10. Therapy with systemic corticosteroids or immunosuppressants;
11. Current using Coumadin (or Warfarin) or Heparin therapy for more than 6 months at the time of operation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03105167
Study Brief:
Protocol Section:
NCT03105167