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:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT01661959
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥ 10 and ≤ 21 years at time of enrollment,
* male or female,
* diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement.
* Curve cobb of any magnitude - operative range
* Spina bifida Oculta is permitted
* Spondylolisthesis and Spondylolysis are permitted, as long as non-operative
* Non-operative idiopathic scoliosis patients:
* aged ≥ 10 and ≤ 21 years, male or female, curve cobb of ≥ 40º, for whom surgery has been offered and the patient has elected not to proceed with surgery.
OR
\- OPTIONAL BY SITE: aged ≥ 10 and ≤ 21 years, male or female, Curve cobb ≥ 30º and skeletally mature (with maturity defined as Age: girls \> 14 yrs; Boys \> 16 yrs and Risser of ≥ 4 Plus one of the following: Girls 2+ yrs post menarchal, boys shaving regularly, no height change in at least 6 months.
Exclusion Criteria:
* Prior spinal surgery
* MRI abnormalities (including \> 4mm of Syrinx and/or Chiari malformation)
* Neuromuscular or other serious co-morbidities
* Thoracogenic or cardiogenic scoliosis
* Associated syndrome or developmental delay
* Unable or unwilling to firmly commit to returning for required follow-up visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT01661959
Study Brief:
Protocol Section:
NCT01661959