Enrolling by invitation NCT03506334
Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AVBT using Dynesys System Components, Spine fusion.
- Who it may be relevant to
- Registry conditions: Scoliosis. Basic parameters: 10 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Overview
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.
Interventions
- 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
Primary outcome measures
- Revision spine surgery within 2 years of index procedure [Time frame: 2 years]
Secondary outcome measures (4)
- 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) [Time frame: 1 year]
- Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm) [Time frame: 1 year]
- Curve flexibility over instrumented vertebra > 5 degrees [Time frame: At least 1 year postoperatively]
- Spinal disc health utilizing MRI [Time frame: At least 1 year postoperatively]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Publications
- Mathew SE, Hargiss JB, Milbrandt TA, Stans AA, Shaughnessy WJ, Larson AN. Vertebral body tethering compared to posterior spinal fusion for skeletally immature adolescent idiopathic scoliosis patients: preliminary results from a matched case-control study. Spine Deform. 2022 Sep;10(5):1123-1131. doi: 10.1007/s43390-022-00519-3. Epub 2022 May 24. PMID 35610543
Identifiers
NCT: NCT03506334 · 17-007801