A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Start Date
9/9/2021
Completion Date
9/1/2029
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
Eligibility Criteria
Age Range: No minimum to 18 years
Interventions
Anterior Vertebral Body Tethering
Conditions
Locations
Children's National Hospital
Washington D.C., District of Columbia 20010
United States
Shriners Children's Chicago
Chicago, Illinois 60707
United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota 55101
United States
Washington University
St Louis, Missouri 63130
United States
Morgan Stanley Childrens Hospital of New York-Presbyterian
New York, New York 10032
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Shriners Children's Portland
Portland, Oregon 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
The Medical University of South Carolina
Charleston, South Carolina 29425
United States
Vanderbilt University
Nashville, Tennessee 37235
United States
Primary Children's Hospital
Salt Lake City, Utah 84113
United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario K1H 8LI
Canada