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This study was withdrawn prior to enrollment due to challenges in initiating the project. No participants were enrolled, and no data were collected. The study will not proceed further and is being formally closed.
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The purpose of this device is to treat children and adolescents with scoliosis who have growth remaining. In patients with a curvature about the spine, Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity.
The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. This device received an HDE exemption from the FDA and requires MUSC IRB approval to be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Globus-tethering HUD patients | Experimental | The implantation of the REFLECT scoliosis tethering system in patients diagnosed with idiopathic scoliosis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REFLECT scoliosis correction system | Procedure | (i.e. purpose of research) The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity. |
| Measure | Description | Time Frame |
|---|---|---|
| Cobb angles | Decrease in cobb angles for patients who are actively still growing | Until patients reach the age of 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Murphy | Medical University of South Carolina | Principal Investigator |
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