RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2021-09-09
Study Completion:2029-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04914507

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.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of idiopathic scoliosis
  2. * Planned recipient of AVBT surgical treatment
  3. * Skeletally immature
  4. * Major Cobb angle ≥30° and ≤65°
  5. * Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
  6. * Failed or intolerant to bracing
  1. * Presence of any systemic infection, local infection, or skin compromise at the anticipated surgical site
  2. * Prior spinal surgery at the level(s) to be treated
  3. * Evidence of documented poor bone quality
  4. * 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
  5. * 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
  6. * Unwillingness to sign Informed Consent Form and participate in study procedures

Contacts and Locations

Study Contact

Tyler Farber
CONTACT
3197501029
tfarber@pediatricspine.org
Tricia St. Hilaire
CONTACT
4844106413
tsthilaire@pediatricspine.org

Principal Investigator

Ron El-Hawary, MD
PRINCIPAL_INVESTIGATOR
Dalhousie University

Study Locations (Sites)

Children's National Hospital
Washington, 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
Saint 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

Collaborators and Investigators

Sponsor: Pediatric Spine Foundation

  • Ron El-Hawary, MD, PRINCIPAL_INVESTIGATOR, Dalhousie University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-09
Study Completion Date2029-09

Study Record Updates

Study Start Date2021-09-09
Study Completion Date2029-09

Terms related to this study

Keywords Provided by Researchers

  • anterior vertebral body tethering

Additional Relevant MeSH Terms

  • Scoliosis Idiopathic