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

Not Applicable

• Conditions: Scoliosis
• Interventions: Device: AVBT using Dynesys System Components; Procedure: Spine fusion

• Registration Number: NCT03506334
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-24
• Study Start: 2018-04-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pediatric Scoliosis Patients	AVBT using Dynesys System Components	Tether group
Pediatric Scoliosis Control Patients	Spine fusion	Fusion (control) group

Primary Outcome Measures

Name	Time	Method
Revision spine surgery within 2 years of index procedure	2 years	yes/no parameter, was revision surgery performed within 2 years of index procedure

Secondary Outcome Measures

Name	Time	Method
Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)	1 year	yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film
Spinal disc health utilizing MRI	At least 1 year postoperatively	Spinal disc health will be assessed in Tether patients post-operatively using an MRI in conjunction with the Pfirrmann classification (scored I to V, where I indicated normal and V indicated the worst degeneration).
Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm)	1 year	yes/no parameter, did major Cobb angle worsen by 10 degrees and curve magnitude \< 50 degrees at latest f/u after 1st erect postop film
Curve flexibility over instrumented vertebra > 5 degrees	At least 1 year postoperatively	Flexibility films will be obtained in patients postoperatively to assess flexibility

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States