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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2027
  • participants needed
    80
  • sponsor
    Mayo Clinic
Updated on 2 July 2021

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.

Details
Condition Scoliosis
Treatment AVBT using Dynesys System Components, spine fusion
Clinical Study IdentifierNCT03506334
SponsorMayo Clinic
Last Modified on2 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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