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Active, Not Recruiting

NCT Number: NCT04296903

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rady Children's Hospital, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MID-C System

Device

Minimal invasive deformity correction system for the treatment of AIS

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Apifix

Industry

Registry information

Important dates

Study start
2020
Primary completion
2029
Study completion
2030
First posted
Mar 5, 2020
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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