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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Device: MID-C System

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Wolfson Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30060
      • Wellstar
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Health
  • Kansas
    • Kansas City, Kansas, United States, 64108
      • Children's Mercy Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Univ. of Mississippi Medical Center (UMMC)
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Women and Children's Hospital - University of Missouri Health Care
    • St Louis, Missouri, United States, 63110
      • Shriners Hospitals for Children
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Rainbow babies and children
    • Dayton, Ohio, United States, 45404
      • Dayton Children's Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Health
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MID-C treatment	Device: MID-C System; Minimal invasive deformity correction system for the treatment of AIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Apifix

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2020
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: MID-C-AIS-03-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No