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Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis

NCT03506334 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-11

No results posted yet for this study

Summary

The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.

Conditions

  • Scoliosis

Interventions

DEVICE

AVBT using Dynesys System Components

Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.

PROCEDURE

Spine fusion

Children with scoliosis undergoing fusion surgery will form the control arm

Sponsors & Collaborators

Principal Investigators

  • A. Noelle Larson, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03506334 on ClinicalTrials.gov