80 Participants Needed

AVBT vs Spine Fusion for Scoliosis

NP
DP
OS
Overseen ByOrthopedic Study Office
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

AN

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)
See 4 more

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.
See 5 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Pediatric Scoliosis PatientsExperimental Treatment1 Intervention
Tether group
Group II: Pediatric Scoliosis Control PatientsActive Control1 Intervention
Fusion (control) group

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+
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