What this study is
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.
What's being tested
- AVBT using Dynesys System Components
Intervention · DEVICE
Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.
- Spine fusion
Intervention · PROCEDURE
Children with scoliosis undergoing fusion surgery will form the control arm
Study details
- Official title
- Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
- Sponsor
- Mayo Clinic
- Conditions
- Scoliosis
- Enrolling
- 80 people
- Starts
- 2018-04-25
- Est. completion
- 2027-05
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 10 Years – 16 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male & female, age 10 years to 16 years.
- Scoliosis curve between 40-70 degrees.
- At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.
- Adolescent idiopathic scoliosis.
- Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).
- 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.
You can't join if
- Congenital, neuromuscular or syndromic scoliosis.
- Underlying neuromuscular disease.
- Pregnancy.
- Nonflexible curves (bending films show residual curve greater than 40 degrees).
- Prior surgery for scoliosis treatment.
- Patients with active systemic infection.
- Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMayo Clinic
Rochester, Minnesota, United States
Study team
Sponsor
Mayo Clinic
Study ID 17-007801
Principal investigator
A. Noelle Larson, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.