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Enrolling by Invitation

NCT Number: NCT03506334

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

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

AVBT using Dynesys System Components

Device

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

Spine Fusion

Procedure

Children with scoliosis undergoing fusion surgery will form the control arm

Primary outcomes

  1. Revision spine surgery within 2 years of index procedure

    Time frame: 2 years

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

Secondary outcomes

  1. 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)

    Time frame: 1 year

    yes/no parameter, did major Cobb angle worsen by 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film

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

    Time frame: 1 year

    yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film

  3. Curve flexibility over instrumented vertebra > 5 degrees

    Time frame: At least 1 year postoperatively

    Flexibility films will be obtained in patients postoperatively to assess flexibility

  4. Spinal disc health utilizing MRI

    Time frame: At least 1 year postoperatively

    Spinal disc health will be assessed in Tether patients post-operatively using an MRI in conjunction with the Pfirrmann classification (scored I to V, where I indicated normal and V indicated the worst degeneration).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2018
Registry last updated
Jul 7, 2026

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.

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