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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT04296903
Eligibility Criteria:
Inclusion Criteria:
* Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;
* Cobb angle between 35-60 degrees (inclusive);
* Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;
* Kyphosis angles of ≤ 55 degrees measured from T5 to T12;
* Appropriate candidate for posterior surgical approach;
* Patient has good general health;
* Patient has no known hypersensitivity or allergies to titanium;
* Patient's guardian signs a written informed consent form (ICF).
Exclusion Criteria:
* Any type of non-idiopathic scoliosis;
* Any main thoracic deformity that includes vertebral levels and cranial including to T2;
* Known history of existing malignancy, or any systemic or local infection;
* Spinal cord abnormalities that require treatment;
* Known neurological deficit (defined as motor grade \< 5/5);
* Known poor bone quality defined as T score -1.5 or less;
* For female Patient, pregnancy;
* Previous spine surgery that would prevent the successful performance of the MID-C system ;
* Active systemic disease, such as AIDS, HIV, or active infection;
* Active infection or the skin is compromised at the surgical site;
* Systemic disease that would affect the Patient's welfare or overall outcome of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT04296903
Study Brief:
Protocol Section:
NCT04296903