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

November 14, 2023 updated by: Pediatric Spine Foundation

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8LI
        • Recruiting
        • Children's Hospital of Eastern Ontario
        • Principal Investigator:
          • Kevin Smit, MD
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Hospital
        • Principal Investigator:
          • Laurel Blakemore, MD
    • Illinois
      • Chicago, Illinois, United States, 60707
        • Recruiting
        • Shriners Children's Chicago
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Gillette Children's Specialty Healthcare
        • Principal Investigator:
          • Tenner Guillaume, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Morgan Stanley Childrens Hospital of New York-Presbyterian
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Shriners Children's Portland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • The Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Recruiting
        • Vanderbilt University
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • Primary Children's Hospital

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.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anterior Vertebral Body Tethering
The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete.
Device: Anterior Vertebral Body Tethering
Subject will receive anterior vertebral body tethering surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect on three-dimensional spine growth as compared to normal controls
Time Frame: 5 years
The three-dimensional spine growth of the subjects will be measured at each study timepoint and compared to known normal controls.
5 years
Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
Time Frame: 5 years
Subjects who maintain a major Cobb angle less than or equal to 50 degrees at skeletal maturity will be considered a "success."
5 years
Complications associated with both the procedure and the device
Time Frame: 5 years
Subjects will be monitored for complications associated with both the procedure and the device.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatric Spine Foundation

Investigators

  • Principal Investigator: Ron El-Hawary, MD, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSSG0121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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