Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
Sponsor: Apifix
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.
Key Details
Gender
All
Age Range
10 Years - Any
Study Type
INTERVENTIONAL
Enrollment
201
Start Date
2020-05-31
Completion Date
2030-06-30
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
MID-C System
Minimal invasive deformity correction system for the treatment of AIS
Locations (14)
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