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)

Running, not enrolling · Not applicable

Conditions studied: Adolescent Idiopathic Scoliosis

In brief

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.

Key facts

Study ID

NCT04296903

Run by

Apifix

People needed

201

Starts

2020-05-31

Expected to finish

2030-06-30

Last updated by the study team

2025-10-03

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Rady Children's Hospital — San Diego, California, United States
• Wolfson children's hospital — Jacksonville, Florida, United States
• Wellstar — Atlanta, Georgia, United States
• Riley Children's Health — Indianapolis, Indiana, United States
• Children's Mercy Hospital — Kansas City, Kansas, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Univ. of Mississippi Medical Center (UMMC) — Jackson, Mississippi, United States
• Women and Children's Hospital - University of Missouri Health Care — Columbia, Missouri, United States
• Shriners Hospitals for Children — St Louis, Missouri, United States
• Mount Sinai hospital — New York, New York, United States
• Rainbow babies and children — Cleveland, Ohio, United States
• Dayton Children's Hospital — Dayton, Ohio, United States
• Avera Health — Sioux Falls, South Dakota, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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