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

Launched by MAYO CLINIC · Apr 16, 2018

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.