Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected
 unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity
 above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The
 MID-C System is designed to act as an internal brace. Patients implanted with the device in
 the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum
 number of 200 patients will be enrolled in this study.
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.