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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT03506334
Status
Enrolling By Invitation

Conditions

  • Scoliosis

Eligibility Criteria

Sex
ALL
Age
10 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • AVBT using Dynesys System Components — DEVICE
    Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.
  • Spine fusion — PROCEDURE
    Children with scoliosis undergoing fusion surgery will form the control arm

Study Details

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.

Key Dates

Start date
Apr 25, 2018
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Pediatric Scoliosis Patients
    Tether group
  • Active Comparator: Pediatric Scoliosis Control Patients
    Fusion (control) group

Primary Outcome Measure

Revision spine surgery within 2 years of index procedure [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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By research site
Mayo Clinic· Rochester, MN

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