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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Closed for enrollment

Contact information:

Smitha Mathew M.B.B.S.

(507)538-3560

Mathew.Smitha@mayo.edu

Minneapolis, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Closed for enrollment

Contact information:

Smitha Mathew M.B.B.S.

(507)538-3560

Mathew.Smitha@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Closed for enrollment

Contact information:

Smitha Mathew M.B.B.S.

(507) 538-3560

Mathew.Smitha@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Closed for enrollment

Contact information:

Smitha Mathew M.B.B.S.

(507) 538-3560

Mathew.Smitha@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20423642

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