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A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Sponsor: Pediatric Spine Foundation
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
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2021-09-09
Completion Date
2029-09
Last Updated
2023-11-15
Healthy Volunteers
No
Conditions
Interventions
Anterior Vertebral Body Tethering
Subject will receive anterior vertebral body tethering surgery.
Locations (12)
Children's National Hospital
Washington D.C., District of Columbia, United States
Shriners Children's Chicago
Chicago, Illinois, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
Washington University
St Louis, Missouri, United States
Morgan Stanley Childrens Hospital of New York-Presbyterian
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Shriners Children's Portland
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada