Long-Term Study of Anterior Vertebral Body Tethering Surgery for Children with Idiopathic Scoliosis Assessing Spine Growth, Curve Control, and Surgery Outcomes

What this Trial Is About

Researchers are evaluating the long-term clinical outcomes of anterior vertebral body tethering AVBT, a minimally invasive growth modulation technique recently approved by the FDA for treating scoliosis in skeletally immature children. The study focuses on how AVBT affects three-dimensional spine growth compared to normal controls, whether it maintains the major Cobb angle at or below 50 degrees at skeletal maturity, and the complications related to the procedure and device. Participants will undergo AVBT surgery as clinically indicated after completing all pre-operative assessments. This procedure aims to control curve progression by applying compression on the convex side of the spinal deformity. The study follows patients for up to five years to monitor spine growth, curve maintenance, and any complications associated with the surgery and the device. During the study, participants will have regular assessments to evaluate three-dimensional spine growth and spinal curve measurements. Researchers will compare these outcomes to those of normal controls and track any surgery or device-related complications over a five-year period. The study involves follow-up visits to ensure ongoing monitoring of participant health and treatment effects.

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