PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in 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. 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.

Official Title
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Post-approval Study to Evaluate the Continued Safety and Efficacy of the MID-C System 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 -Minimal invasive deformity correction system for the treatment of AIS


Participation Criteria
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Eligibility Criteria
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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: Any type of non-idiopathic scoliosis; Any main thoracic deformity that includes vertebral levels and cranial including to T2; Cumulative vertebral wedging over the apex of the curve>15º Known history of existing malignancy, or any systemic or local infection; Spinal cord abnormalities that require treatment; Known neurological deficit (defined as motor grades < 5/5); Known poor bone quality defined as T score -1.5 or less; 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; and 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
Maximum Age: 18 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: The study is a prospective, 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>Follow-up measurements during 5 years post MIC-C system implantationin order to evaluate safety and efficacy parameters. | Device: MID-C System -Minimal invasive deformity correction system for the treatment of AIS<br>* A 5 years follow-up will be performed for all patients who underwent AIS repair surgery using the MID-C System. The follow-up in order to assess safety and efficacy measurments. Eligible Patients will be followed and assessed at the following time points: Immediate Post-op up to 6 weeks, 6 months, 12 months, and then annually out to 5 years post-implantation. During the study, the following rating scales and assessments will be conducted to assess the probable benefit and safety of the treatment: Physical exam,X-rays,Cobb angle measurements,Adverse Events (AEs) and Scoliosis research society (SRS-22) questionnaire: The questionnaire is commonly used to assess health related quality of life in children with AIS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy endpoint | Maintenance of major Cobb angle ≤ 30° 5 years post-surgery | 5 years post MID-C system implantation | 
| Safety endpoint | Serious adverse events, and device or procedure-related adverse events | 5 years post MID-C system implantation |