Scoliosis
Conditions
Brief 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.
Interventions
DEVICEAVBT using Dynesys System Components
Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.
PROCEDURESpine fusion
Children with scoliosis undergoing fusion surgery will form the control arm
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Tether group 40 patients and Fusion (control) group 40 patients
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision spine surgery within 2 years of index procedure | 2 years | yes/no parameter, was revision surgery performed within 2 years of index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 1 year | 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 |
| Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm) | 1 year | yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film |
| Curve flexibility over instrumented vertebra > 5 degrees | At least 1 year postoperatively | Flexibility films will be obtained in patients postoperatively to assess flexibility |
| Spinal disc health utilizing MRI | At least 1 year postoperatively | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORA. Noelle Larson, MD
Mayo Clinic
Outcome results
None listed