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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