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

Scoliosis Clinical Trial

Official title:

Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03506334
• Other study ID #: 17-007801
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• AVBT using Dynesys System Components
Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.

Procedure:
• Spine fusion
Children with scoliosis undergoing fusion surgery will form the control arm

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision spine surgery within 2 years of index procedure	yes/no parameter, was revision surgery performed within 2 years of index procedure	2 years
Secondary	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)	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	1 year
Secondary	Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)	yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film	1 year
Secondary	Curve flexibility over instrumented vertebra > 5 degrees	Flexibility films will be obtained in patients postoperatively to assess flexibility	At least 1 year postoperatively
Secondary	Spinal disc health utilizing MRI	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).	At least 1 year postoperatively