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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00493558
Eligibility Criteria:
Inclusion Criteria:
* Patients must be at least 20 years of age
* Clinical and radiologic history of spondylolisthesis (no greater than grade 1)
* Spinal stenosis for which conservative treatment has failed
* Degenerative disc disease, characterized by one or more of the following:
* instability (defined as angular motion \> 5° and/or translation \> 4mm, based on Flex/Ext radiographs)
* osteophyte formation
* decreased disc height
* thickening of ligamentous tissue
* disc degeneration or herniation
* facet joint degeneration
Exclusion Criteria:
* Fusion at more than one level
* Non-fusion surgery at the involved level
* Previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
* Patients with a highly-communicable disease, inflammatory or auto-immune based joint disease
* Those with a history of endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
* Patients with a documented titanium or tantalum alloy allergy or intolerance
* Patients currently receiving active treatment for cancer or treatment with steroids such as cortisone
* Patients with significant medical history that, in the Investigator's opinion, would not make them a good study candidate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00493558
Study Brief:
Protocol Section:
NCT00493558