RecruitingNot ApplicableNCT04914507

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


Sponsor

Pediatric Spine Foundation

Enrollment

106 participants

Start Date

Sep 9, 2021

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Anterior Vertebral Body Tethering for people with scoliosis idiopathic. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAnterior 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

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NCT04914507


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