AVBT vs Spine Fusion for Scoliosis

Overseen By Orthopedic Study Office

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Congenital scoliosis, Neuromuscular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Noelle Larson, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for boys and girls aged 10-16 with moderate to severe scoliosis who still have at least a year of growth left. They must have specific types of scoliosis (Lenke 1, 2, 3C, or 5) with curves between 40-70 degrees. Participants need understanding parents who can consent and commit to follow-up visits. It's not for those pregnant, with certain allergies, substance abuse history, previous scoliosis surgery or other forms of scoliosis.

Inclusion Criteria

Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate

Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits

Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar)

Exclusion Criteria

I have had surgery for scoliosis.

Known, reported allergies to titanium, PET, or PCU

I currently have an active infection in my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Anterior Vertebral Body Tethering (AVBT) or fusion surgery

Surgical procedure

Postoperative Monitoring

Participants are monitored for spinal disc health and curve flexibility using MRI and flexibility films

At least 1 year

Follow-up

Participants are monitored for major Cobb angle progression and revision surgery

2 years

Treatment Details

Interventions

• AVBT using Dynesys System Components
• Spine Fusion

Trial Overview The study is testing the safety of AVBT using Zimmer Biomet Tether System or Dynesys components in young patients with scoliosis against traditional spine fusion methods. Researchers will compare outcomes from both treatments over short-term follow-ups.

Participant Groups

Group I: Pediatric Scoliosis Patients Experimental Treatment 1 Intervention

Tether group

Group II: Pediatric Scoliosis Control Patients Active Control 1 Intervention

Fusion (control) group

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+