MID-C System for Adolescent Idiopathic Scoliosis

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Apifix

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adolescents with a specific type of scoliosis called Adolescent Idiopathic Scoliosis. They should have certain curvature angles in their spine, be in good health, and not allergic to titanium. It's not for those who are pregnant, had previous spine surgery that affects the MID-C system use, have poor bone quality or active infections.

Inclusion Criteria

I am in good overall health.

Patient's guardian signs a written informed consent form (ICF)

You do not have any known allergies or sensitivities to titanium.

+7 more

Exclusion Criteria

Known poor bone quality defined as T score -1.5 or less

I need treatment for my spinal cord abnormalities.

I have a type of scoliosis that is not idiopathic.

+8 more

Participant Groups

The study tests the safety and benefit of the MID-C System as an internal brace for scoliosis over five years post-implantation. This device connects to the spine at two points and is meant for patients recently implanted following FDA approval.

1Treatment groups

Experimental Treatment

Group I: MID-C treatmentExperimental Treatment1 Intervention