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)

ApiFix

Status

Active, not recruiting

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Device: MID-C System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04296903

MID-C-AIS-03-18

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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.