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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Subject will receive anterior vertebral body tethering surgery.
Children's National Hospital
Washington D.C., District of Columbia, United States
RECRUITINGShriners Children's Chicago
Chicago, Illinois, United States
RECRUITINGGillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGMorgan Stanley Childrens Hospital of New York-Presbyterian
New York, New York, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGShriners Children's Portland
Portland, Oregon, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGThe Medical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGVanderbilt University
Nashville, Tennessee, United States
RECRUITING...and 2 more locations
The effect on three-dimensional spine growth as compared to normal controls
The three-dimensional spine growth of the subjects will be measured at each study timepoint and compared to known normal controls.
Time frame: 5 years
Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
Subjects who maintain a major Cobb angle less than or equal to 50 degrees at skeletal maturity will be considered a "success."
Time frame: 5 years
Complications associated with both the procedure and the device
Subjects will be monitored for complications associated with both the procedure and the device.
Time frame: 5 years
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