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

Last updated: November 14, 2023
Sponsor: Pediatric Spine Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Anterior Vertebral Body Tethering

Clinical Study ID

NCT04914507
PSSG0121
  • Ages < 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria: Skeletally immature patients that receive AVBT surgical treatment toobtain and maintain correction of progressive idiopathic scoliosis. Specifically:

  • 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 determinedby radiographic imaging
  • Failed or intolerant to bracing

Exclusion

Exclusion Criteria:

  • Presence of any systemic infection, local infection, or skin compromise at theanticipated 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 ofspinal surgery, such as coagulation disorders, allergies to the implant materials, andpatient's unwillingness or inability to cooperate with post-operative careinstructions 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 forfollow-up visits as described in protocol and Informed Consent
  • Unwillingness to sign Informed Consent Form and participate in study procedures

Study Design

Total Participants: 106
Treatment Group(s): 1
Primary Treatment: Anterior Vertebral Body Tethering
Phase:
Study Start date:
September 09, 2021
Estimated Completion Date:
September 30, 2029

Connect with a study center

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8LI
    Canada

    Active - Recruiting

  • Children's National Hospital

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Shriners Children's Chicago

    Chicago, Illinois 60707
    United States

    Active - Recruiting

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • Morgan Stanley Childrens Hospital of New York-Presbyterian

    New York, New York 10032
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Shriners Children's Portland

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • The Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Vanderbilt University

    Nashville, Tennessee 37235
    United States

    Active - Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.