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RECRUITING
NCT04914507
NA

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

Sponsor: Pediatric Spine Foundation

View on ClinicalTrials.gov

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

Interventions

DEVICE

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