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

Mayo Clinic

Status: Invitation-only

Conditions: Scoliosis

Treatments: Procedure: Spine fusion; Device: AVBT using Dynesys System Components

Study type: Interventional

Funder types: Other

Identifiers

NCT03506334

17-007801

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Pediatric Scoliosis Patients

Experimental group

Description:

Tether group

Treatment:

Device: AVBT using Dynesys System Components

Pediatric Scoliosis Control Patients

Active Comparator group

Description:

Fusion (control) group

Treatment:

Procedure: Spine fusion