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

NCT04914507 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-11-15

No results posted yet for this study

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

Interventions

DEVICE

Anterior Vertebral Body Tethering

Subject will receive anterior vertebral body tethering surgery.

Sponsors & Collaborators

  • Pediatric Spine Foundation

    lead OTHER

Principal Investigators

  • Ron El-Hawary, MD · Dalhousie University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2028-09-30
Completion
2029-09-30
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04914507 on ClinicalTrials.gov