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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT04682418
Eligibility Criteria:
Inclusion Criteria:
1. Subjects aged 18 - 80 yrs.
2. Subjects with Spondylosis scheduled to undergo an elective short (6 or less consecutive vertebrae) S1-L1 open spinal fixation surgery using pedicle screws.
3. Subjects requiring a posterior approach surgical procedure.
4. Subjects with normal global spinal alignment (coronal, sagittal view) and/ or patients with degenerative spine disorders.
Exclusion Criteria:
1. Subjects with severe Osteoporosis (T score \<-3.5)
2. Subjects with kyphosis at the operated area (≥ stage 3)
3. Subjects with Spondylolisthesis Grade III and above.
4. Subjects scheduled for revision fusion surgery (prior laminectomy or discectomy is not excluded).
5. Subjects with significant abnormalities of bones (e.g. osteogenesis imperfecta, tumors, infection or malignancy, etc.)
6. Subjects with neurologic diseases or damage (e.g. due to trauma, tumor, Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
7. Subjects with spinal cord abnormalities with any neurologic symptoms or signs
8. Paraplegia.
9. Pedicle fracture documented before or during surgery.
10. Women pregnant or lactating
11. Subjects requiring anterior release or instrumentation.
12. Subjects who are unwilling to sign written informed consent and assent to participate in the study.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04682418
Study Brief:
Protocol Section:
NCT04682418