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

Description

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

Conditions

Scoliosis Idiopathic

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Scoliosis Idiopathic
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010

Chicago

Shriners Children's Chicago, Chicago, Illinois, United States, 60707

Saint Paul

Gillette Children's Specialty Healthcare, Saint Paul, Minnesota, United States, 55101

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63130

New York

Morgan Stanley Childrens Hospital of New York-Presbyterian, New York, New York, United States, 10032

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Portland

Shriners Children's Portland, Portland, Oregon, United States, 97239

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Charleston

The Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Nashville

Vanderbilt University, Nashville, Tennessee, United States, 37235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of idiopathic scoliosis
  • * Planned recipient of AVBT surgical treatment
  • * Skeletally immature
  • * Major Cobb angle ≥30° and ≤65°
  • * Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
  • * Failed or intolerant to bracing
  • * Presence of any systemic infection, local infection, or skin compromise at the anticipated surgical site
  • * Prior spinal surgery at the level(s) to be treated
  • * Evidence of documented poor bone quality
  • * Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions as determined by the treating physician
  • * Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
  • * Unwillingness to sign Informed Consent Form and participate in study procedures

Ages Eligible for Study

to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pediatric Spine Foundation,

Ron El-Hawary, MD, PRINCIPAL_INVESTIGATOR, Dalhousie University

Study Record Dates

2029-09