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) (NCT04296903)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).
Location: Rady Children's Hospital — San Diego, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (14 Sites)
- Rady Children's Hospital — San Diego, California
- Wolfson children's hospital — Jacksonville, Florida
- Wellstar — Atlanta, Georgia
- Riley Children's Health — Indianapolis, Indiana
- Children's Mercy Hospital — Kansas City, Kansas
- Mayo Clinic — Rochester, Minnesota
- Univ. of Mississippi Medical Center (UMMC) — Jackson, Mississippi
- Women and Children's Hospital - University of Missouri Health Care — Columbia, Missouri
- Shriners Hospitals for Children — St Louis, Missouri
- Mount Sinai hospital — New York, New York
- Rainbow babies and children — Cleveland, Ohio
- Dayton Children's Hospital — Dayton, Ohio
- Avera Health — Sioux Falls, South Dakota
- University of Virginia — Charlottesville, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.