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)
MID-C System: Minimal invasive deformity correction system for the treatment of AIS
Study 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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
—
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.
Primary outcome measure(s)
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
Trial sites (14)
Facility
City
Region
Status
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
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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