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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00549627
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing primary spinal fusion with pedicle screw fixation of the spine anywhere from T1to S1
* Subjects must be skeletally mature as defined by closed growth plates on wrist via radiographs
* Written informed consent and assent (assent for adolescents)
Exclusion Criteria:
* Pedicle screw insertion by image guided techniques, including Fluoronav
* Tumor
* Diagnoses associated with diminished bone mineral density such as osteogenesis imperfecta, severe osteopenia, neurofibromatosis
* Severe senile osteoporosis (\> 2 standard deviations below the norm)
* Women who are pregnant
* Children with open growth plates
* Previously fused spinal levels
* Unwillingness to sign written informed consent and assent.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00549627
Study Brief:
Protocol Section:
NCT00549627