Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04914507

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anterior Vertebral Body Tethering

Device

Subject will receive anterior vertebral body tethering surgery.

Primary outcomes

  1. 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.

  2. 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."

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tricia St. Hilaire

CONTACT

[email protected]

4844106413

Tyler Farber

CONTACT

[email protected]

3197501029

Sponsors and collaborators

Lead sponsor

Pediatric Spine Foundation

Other

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Jun 4, 2021
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.