Adolescent Idiopathic Scoliosis
Conditions
Brief summary
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.
Interventions
DEVICEMID-C System
Minimal invasive deformity correction system for the treatment of AIS
Sponsors
Apifix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of major Cobb angle ≤ 40° 5 years post-surgery | 5 years | Spinal Cobb angle will be measured at 5 years post op. the percent of patients with Cobb angle ≤ 40° 5 years post-surgery will be calculated |
Countries
United States
Outcome results
None listed