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The Sponsor decided to focus their resources on the clinical data collection for the second generation of the investigational device.
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The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Vertebral Body Tethering surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Vertebral Body Tethering | Device | The SCOLI-TETHER (MIScoli) System is intended for anterolateral vertebral body fixation and internal fastening of the convex side of the thoracic curvatures thereby reducing the deformity and preventing the progression of idiopathic scoliosis in growing children/adolescents at high risk for curve progression while preserving motion. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of device- &/or procedure-related SAEs | Rate of positively adjudicated device or procedure related serious adverse events including subsequent secondary surgical intervention and neurological events from baseline (preoperative) through 12 months | 12 months |
| Change in Cobb angle measurement | The change in Cobb angle measurement from baseline (preoperative) to 12 months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Firoz Miyanji | BC Children's | Principal Investigator |
| Kevin Smit | CHEO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHEO | Ottawa | Canada |
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