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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT01220505
Eligibility Criteria:
Inclusion Criteria:
* 200 subjects at 10 clinical centers.
* All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)
* All subjects are skeletally mature with spinal deformity.
* Risser score must be ≥ 3.
* Subjects or their representative must be willing and able to give informed consent and assent (if applicable).
* Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications
Exclusion Criteria:
* Any subject who does not meet the inclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01220505
Study Brief:
Protocol Section:
NCT01220505