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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Scoliosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Tether group 40 patients and Fusion (control) group 40 patients

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pediatric Scoliosis Patients

Tether group

Group Type EXPERIMENTAL

AVBT using Dynesys System Components

Intervention Type DEVICE

Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.

Pediatric Scoliosis Control Patients

Fusion (control) group

Group Type ACTIVE_COMPARATOR

Spine fusion

Intervention Type PROCEDURE

Children with scoliosis undergoing fusion surgery will form the control arm

Interventions

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AVBT using Dynesys System Components

Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.

Intervention Type DEVICE

Spine fusion

Children with scoliosis undergoing fusion surgery will form the control arm

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No