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

NCT03506334 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 17-007801
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Revision spine surgery within 2 years of index procedure

  yes/no parameter, was revision surgery performed within 2 years of index procedure

  2 years

Secondary Outcomes (4)

• Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm)

  1 year

• Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)

  1 year

• Curve flexibility over instrumented vertebra > 5 degrees

  At least 1 year postoperatively

• Spinal disc health utilizing MRI

  At least 1 year postoperatively

Study Arms (2)

Pediatric Scoliosis Patients

EXPERIMENTAL

Tether group

Device: AVBT using Dynesys System Components

Pediatric Scoliosis Control Patients

ACTIVE COMPARATOR

Fusion (control) group

Procedure: Spine fusion

Interventions

AVBT using Dynesys System Components DEVICE

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

Pediatric Scoliosis Patients

Spine fusion PROCEDURE

Children with scoliosis undergoing fusion surgery will form the control arm

Pediatric Scoliosis Control Patients

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male \& female, age 10 years to 16 years.
• Scoliosis curve between 40-70 degrees.
• At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.
• Adolescent idiopathic scoliosis.
• Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).
• Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate.
• Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits.

You may not qualify if:

• Congenital, neuromuscular or syndromic scoliosis.
• Underlying neuromuscular disease.
• Pregnancy.
• Nonflexible curves (bending films show residual curve greater than 40 degrees).
• Prior surgery for scoliosis treatment.
• Patients with active systemic infection.
• Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Mathew SE, Hargiss JB, Milbrandt TA, Stans AA, Shaughnessy WJ, Larson AN. Vertebral body tethering compared to posterior spinal fusion for skeletally immature adolescent idiopathic scoliosis patients: preliminary results from a matched case-control study. Spine Deform. 2022 Sep;10(5):1123-1131. doi: 10.1007/s43390-022-00519-3. Epub 2022 May 24.

  PMID: 35610543 DERIVED

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• A. Noelle Larson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Tether group 40 patients and Fusion (control) group 40 patients

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 24, 2018
• Study Start: April 25, 2018
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)