A Study to Evaluate Anterior Vertebral Body Tethering (AVBT) Zimmer Biomet Tether System or Dynesys System to Treat Pediatric Scoliosis

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Minneapolis, Minnesota: 17-007801
    • Rochester, Minnesota: 17-007801
    NCT ID: NCT03506334
    Sponsor Protocol Number: 17-007801

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  1. Male & female, age 10 years to 16 years.
  2. Scoliosis curve between 40-70 degrees.
  3. At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.
  4. Adolescent idiopathic scoliosis.
  5. Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).
  6. Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate.
  7. 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:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Minneapolis, Minn.

Mayo Clinic principal investigator

A. Noelle Larson, M.D.

Contact us for the latest status

Contact information:

Smitha Mathew

(507)538-3560

Mathew.Smitha@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

A. Noelle Larson, M.D.

Open for enrollment

Contact information:

Smitha Mathew

(507)538-3560

Mathew.Smitha@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20423642

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