Ensayos clínicos

Inclusion Criteria:

• Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves.
• Cobb angle between 40-60 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.
• 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.