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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MID-C treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MID-C System | Device | Minimal invasive deformity correction system for the treatment of AIS |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | United States | ||
| Wolfson children's hospital |
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Prospective Registry, multi center, single arm, non-randomized, new enrollment cohort study
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| Jacksonville |
| Florida |
| 32207 |
| United States |
| Wellstar | Atlanta | Georgia | 30060 | United States |
| Riley Children's Health | Indianapolis | Indiana | 46202 | United States |
| Children's Mercy Hospital | Kansas City | Kansas | 64108 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Univ. of Mississippi Medical Center (UMMC) | Jackson | Mississippi | 39216 | United States |
| Women and Children's Hospital - University of Missouri Health Care | Columbia | Missouri | 65201 | United States |
| Shriners Hospitals for Children | St Louis | Missouri | 63110 | United States |
| Mount Sinai hospital | New York | New York | 10029 | United States |
| Rainbow babies and children | Cleveland | Ohio | 44106 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| Avera Health | Sioux Falls | South Dakota | 57105 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |