PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in AIS
PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in 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. A total of 10 patients, who are planned
 to undrego the MID-C System implantation procedure will be enrolled for the study. A 5 years
 follow-up post surgery will be performed for these patients in order to evaluate the long
 term safety and efficacy of the MID-C System.
Inclusion Criteria:

 1. Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves; 2.

 -  Patients with Risser stage 0-1, primary Cobb angle between 35-50 degrees (inclusive),
 or

 -  Patients with Risser stage 0-1 and good brace compliant but curve progression above
 6°, or

 -  Patients with Risser stage 0-1 that are non-compliant with brace treatment and primary
 Cobb angle between 30-50 degrees or

 -  Patients with Risser stage 2, primary Cobb angle between 40-50 degrees (inclusive) 3.
 Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs
 or as evident by traction x-ray; 4. Kyphosis angles of ≤ 45 degrees measured from T5
 to T12; 5. Appropriate candidate for posterior surgical approach; 6. Patient has good
 general health; 7. Patient has no known hypersensitivity or allergies to titanium; 8.
 Patient's guardian signs a written informed consent form (ICF).

 Exclusion Criteria:

 1. Any type of non-idiopathic scoliosis;

 2. Any main thoracic deformity that includes vertebral levels and cranial including to
 T2;

 3. Cumulative vertebral wedging over the apex of the curve>15º

 4. Known history of existing malignancy, or any systemic or local infection;

 5. Spinal cord abnormalities that require treatment;

 6. Known neurological deficit (defined as motor grades < 5/5);

 7. Known poor bone quality defined as T score -1.5 or less;

 8. Previous spine surgery that would prevent the successful performance of the MID-C
 system;

 9. Active systemic disease, such as AIDS, HIV, or active infection;

 10. Active infection or the skin is compromised at the surgical site; and

 11. Systemic disease that would affect the patient's welfare or overall outcome of the
 study