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 | Active Not Recruiting FDA Device

• 1 other identifier: MID-C-AIS-03-18
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• Maintenance of major Cobb angle ≤ 40° 5 years post-surgery

  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

  5 years

Study Arms (1)

MID-C treatment

EXPERIMENTAL

Device: MID-C System

Interventions

MID-C System DEVICE

Minimal invasive deformity correction system for the treatment of AIS

MID-C treatment

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Apifix: lead

Study Sites (14)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Wolfson children's hospital

Jacksonville, Florida, 32207, United States

Location

Wellstar

Atlanta, Georgia, 30060, United States

Location

Riley Children's Health

Indianapolis, Indiana, 46202, United States

Location

Children's Mercy Hospital

Kansas City, Kansas, 64108, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Univ. of Mississippi Medical Center (UMMC)

Jackson, Mississippi, 39216, United States

Location

Women and Children's Hospital - University of Missouri Health Care

Columbia, Missouri, 65201, United States

Location

Shriners Hospitals for Children

St Louis, Missouri, 63110, United States

Location

Mount Sinai hospital

New York, New York, 10029, United States

Location

Rainbow babies and children

Cleveland, Ohio, 44106, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

Avera Health

Sioux Falls, South Dakota, 57105, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 5, 2020
• Study Start: May 31, 2020
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)