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NCT04914507From ClinicalTrials.govRecruiting

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

  • Scoliosis Idiopathic

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Pediatric Spine Foundation
Enrolment target
106
Started
9 September 2021
Main results due
September 2028
Study sites
12
Registry updated
28 September 2026

Can you take part?

  • Up to 18 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria: Skeletally immature patients that receive AVBT surgical treatment to obtain 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 determined by radiographic imaging
* Failed or intolerant to bracing

Exclusion Criteria:

* 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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(12)

  • Children's National Hospital

    Washington D.C., District of Columbia, United States

    Recruiting

  • Shriners Children's Chicago

    Chicago, Illinois, United States

    Recruiting

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota, United States

    Recruiting

  • Washington University

    St Louis, Missouri, United States

    Recruiting

  • Morgan Stanley Childrens Hospital of New York-Presbyterian

    New York, New York, United States

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, United States

    Recruiting

  • Shriners Children's Portland

    Portland, Oregon, United States

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Recruiting

  • The Medical University of South Carolina

    Charleston, South Carolina, United States

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, United States

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, United States

    Recruiting

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, Canada

    Recruiting

Showing 12 of 12 sites. 12 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04914507. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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