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A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

Scoliosis Idiopathic Clinical Trial

Official title:
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

Clinical Trial Summary

Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04914507
Study type Interventional
Source Pediatric Spine Foundation
Contact Tyler Farber
Phone 3197501029
Email tfarber@pediatricspine.org
Status Recruiting
Phase N/A
Start date September 9, 2021
Completion date September 2029
View Details
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