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ACTIVE NOT RECRUITING
NCT04296903
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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