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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03802656
Eligibility Criteria:
Inclusion Criteria:
1. Males or females age 8 to 16 years old at time of enrollment (inclusive)
2. Diagnosis of idiopathic scoliosis
3. Sanders bone age of less than or equal to 4
4. Thoracic or thoracolumbar/lumbar curves of greater than or equal to 35 degrees and less than or equal to 60 degrees from levels T4 through L3
5. Lenke classification of 1, 2, 3, 5, or 6
6. Patient has already been identified for and recommended to have surgical intervention
7. Spina bifida occulta is permitted
8. Spondylolysis or Spondylolisthesis is permitted, as long as it is non-operative, the patient has not had any previous surgery for this, and no surgery is planned in the future
9. Completed standard-of-care procedures as outlined in Section 5
Exclusion Criteria:
1. Pregnancy (current)
2. Prior spinal or chest surgery
3. MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
4. Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
5. Associated syndrome, including Marfan Disease or Neurofibromatosis
6. Sanders bone age greater than 4
7. Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60 degrees
8. Compensatory curve greater than 35 degrees without intent to treat surgically
9. Unable or unwilling to firmly commit to returning for required follow-up visits
10. Investigator judgement that the subject/family may not be a candidate for the intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
16 Years
Study:
NCT03802656
Study Brief:
Protocol Section:
NCT03802656