Recruiting

Observational Study

Sponsor:

Pediatric Spine Foundation

Code:

NCT04914507

Conditions

Scoliosis Idiopathic

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Anterior Vertebral Body Tethering

Study Details

Brief 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

Conditions

Scoliosis Idiopathic

Study ID

NCT04914507

Start date

Sep 9, 2021

Status verified date

Nov, 2023

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

106 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Anterior Vertebral Body Tethering

Subject will receive anterior vertebral body tethering surgery.

Primary outcome measure

  • The effect on three-dimensional spine growth as compared to normal controls [ Time Frame: 5 years ]
  • Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity [ Time Frame: 5 years ]
  • Complications associated with both the procedure and the device [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Tyler Farber

3197501029tfarber@pediatricspine.org

Tricia St. Hilaire

4844106413tsthilaire@pediatricspine.org

Locations

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010

Principal Investigator:

Laurel Blakemore, MD

Shriners Children's Chicago

Recruiting

Chicago, Illinois, United States, 60707

Gillette Children's Specialty Healthcare

Recruiting

Saint Paul, Minnesota, United States, 55101

Principal Investigator:

Tenner Guillaume, MD

Washington University

Recruiting

Saint Louis, Missouri, United States, 63130

Morgan Stanley Childrens Hospital of New York-Presbyterian

Recruiting

New York, New York, United States, 10032

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Shriners Children's Portland

Recruiting

Portland, Oregon, United States, 97239

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

The Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37235

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8LI

Principal Investigator:

Kevin Smit, MD

More Information

Sponsor

Pediatric Spine Foundation

Last update posted

Nov 15, 2023

Last verified

Nov, 2023

Keywords

  • anterior vertebral body tethering

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pediatric Spine Foundation on 2023-11-15.