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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01338493
Eligibility Criteria:
Inclusion criteria:
* Degenerative Disc Disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
* Foraminal stenosis due to loss of disc height
* Back pain and/or leg pain.
Exclusion criteria:
* Spondylolisthesis at the affected or adjacent level
* Posterior facet joint damage and/or disease at the affected level, including facet osteoarthritis, pars fracture and prior laminectomy
* Obesity
* Osteoporosis
* Metallic allergy to cobalt-chromium-molybdenum alloys
* Psychosis
* Infection
* Spinal canal stenosis
* Overlying thoracolumbar kyphosis
* Systemic infection or infection at the site of surgery
* Osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
* Diseases of bone metabolism
* Pregnancy
* Signs of local inflammation
* Fever or Leukocytosis
* Grossly distorted anatomy caused by congenital abnormalities
* Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count (this also includes: spinal active oncology pathology; not healed fracture at treated or adjacent level)
* Any case where the implants or components selected would be too large or too small to achieve a successful result
* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
* Any patient unwilling to follow postoperative instructions.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01338493
Study Brief:
Protocol Section:
NCT01338493