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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT02200302
Eligibility Criteria:
Inclusion Criteria:
* 11≤ Adolescents \< 20 years old
* Patient undergoing treatment of AIS by the MID-C system in daily practice
* Minimum of 35 degrees Cobb angle, confirmed by X-ray. Lenke type 1 or 5
* Flexible major curve, correction to below 30° at lateral bending.
* Risser sign of 1 to 5
* Appropriate candidate for posterior surgical approach as determined by surgeon
* Subject has good general health as determined by physician.
* Subject has no known hypersensitivity and allergies to Titanium
* Subject's guardian willing to sign a written Informed Consent Form (ICF)
Exclusion Criteria:
* Cobb angle over 60 degrees
* Other non-idiopathic scoliosis.
* AIS which is not defined as Lenke type 1 or 5
* Previous spine surgery.
* Known allergy to any component of the device.
* Known active systemic disease, such as AIDS, HIV, or active infection
* Systemic disease that would affect the subject's welfare or overall outcome of the study as determined by the physician.
* Mentally compromised as determined by the physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
20 Years
Study:
NCT02200302
Study Brief:
Protocol Section:
NCT02200302