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)
Public ClinicalTrials.gov record NCT04296903. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04296903
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 201 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 30, 2020
- Primary completion
- Jun 29, 2029
- Completion
- Jun 29, 2030
- Last update posted
- Oct 2, 2025
2020 – 2030
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | — |
| Wolfson children's hospital | Jacksonville | Florida | 32207 | — |
| Wellstar | Atlanta | Georgia | 30060 | — |
| Riley Children's Health | Indianapolis | Indiana | 46202 | — |
| Children's Mercy Hospital | Kansas City | Kansas | 64108 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| Univ. of Mississippi Medical Center (UMMC) | Jackson | Mississippi | 39216 | — |
| Women and Children's Hospital - University of Missouri Health Care | Columbia | Missouri | 65201 | — |
| Shriners Hospitals for Children | St Louis | Missouri | 63110 | — |
| Mount Sinai hospital | New York | New York | 10029 | — |
| Rainbow babies and children | Cleveland | Ohio | 44106 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| Avera Health | Sioux Falls | South Dakota | 57105 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04296903, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2025 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04296903 live on ClinicalTrials.gov.