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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Device: MID-C System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MID-C treatment<br> | Device: MID-C System<br>* Minimal invasive deformity correction system for the treatment of AIS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of major Cobb angle ≤ 40° 5 years post-surgery | 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 | 5 years |