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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04914507
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pediatric Spine Foundation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ron El-Hawary, MD
Principal Investigator Affiliation Dalhousie University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scoliosis Idiopathic
Arms & Interventions

Arms

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.

Interventions

Device: - Anterior Vertebral Body Tethering

Subject will receive anterior vertebral body tethering surgery.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's National Hospital, Washington, District of Columbia

Status

Recruiting

Address

Children's National Hospital

Washington, District of Columbia, 20010

Gillette Children's Specialty Healthcare, Saint Paul, Minnesota

Status

Recruiting

Address

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101

Site Contact

Michaela Reardon

[email protected]

651-229-1710

Washington University, Saint Louis, Missouri

Status

Recruiting

Address

Washington University

Saint Louis, Missouri, 63130

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Shriners Children's Portland, Portland, Oregon

Status

Recruiting

Address

Shriners Children's Portland

Portland, Oregon, 97239

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

The Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

The Medical University of South Carolina

Charleston, South Carolina, 29425

Primary Children's Hospital, Salt Lake City, Utah

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City, Utah, 84113

International Sites

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Status

Recruiting

Address

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8LI