Trial Summary
What is the purpose of this trial?
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.
Research Team
AN
Noelle Larson, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for boys and girls aged 10-16 with moderate to severe scoliosis who still have at least a year of growth left. They must have specific types of scoliosis (Lenke 1, 2, 3C, or 5) with curves between 40-70 degrees. Participants need understanding parents who can consent and commit to follow-up visits. It's not for those pregnant, with certain allergies, substance abuse history, previous scoliosis surgery or other forms of scoliosis.Inclusion Criteria
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
Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar)
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Exclusion Criteria
I have had surgery for scoliosis.
Known, reported allergies to titanium, PET, or PCU
I currently have an active infection in my body.
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Treatment Details
Interventions
- AVBT using Dynesys System Components (Spinal Tethering)
- Spine Fusion (Spinal Fusion)
Trial OverviewThe study is testing the safety of AVBT using Zimmer Biomet Tether System or Dynesys components in young patients with scoliosis against traditional spine fusion methods. Researchers will compare outcomes from both treatments over short-term follow-ups.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Pediatric Scoliosis PatientsExperimental Treatment1 Intervention
Tether group
Group II: Pediatric Scoliosis Control PatientsActive Control1 Intervention
Fusion (control) group
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Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+
Dr. Gianrico Farrugia
Mayo Clinic
Chief Executive Officer since 2019
MD from University of Malta Medical School
Dr. Richard Afable
Mayo Clinic
Chief Medical Officer
MD from Loyola Stritch School of Medicine