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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT04058561
Eligibility Criteria:
Inclusion Criteria:
* All patients with diagnosis of Early Onset Scoliosis (scoliosis before age 10)
* Between 5 and 9 years of age (5.0 to 9.9 years)
* Major curve greater than 50 degrees at time of index surgery
* Dual-rod Magnetically Controlled Growing Rod implantation only
* Spine or rib-based constructs
* Pre-operative and intra-operative halo gravity traction is allowed
Exclusion Criteria:
* Patients with previous spine surgery, including other growth friendly techniques
* Patients who cannot abide by the study requirements due to geographical or other similar constraints
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
9 Years
Study:
NCT04058561
Study Brief:
Protocol Section:
NCT04058561