NCT03506334Enrolling By InvitationNot Applicable
Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Mayo Clinic
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Revision spine surgery within 2 years of index procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
Pediatric Scoliosis Patients
Experimental
Tether group
Intervention: AVBT using Dynesys System Components (Device)
Pediatric Scoliosis Control Patients
Active Comparator
Fusion (control) group
Intervention: Spine fusion (Procedure)
Outcomes
Primary Outcomes
Revision spine surgery within 2 years of index procedure
Time Frame: 2 years
yes/no parameter, was revision surgery performed within 2 years of index procedure
Secondary Outcomes
- Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)(1 year)
- Spinal disc health utilizing MRI(At least 1 year postoperatively)
- 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)
- Curve flexibility over instrumented vertebra > 5 degrees(At least 1 year postoperatively)
Investigators
A. Noelle Larson, MD
Principal Investigator
Mayo Clinic
Study Sites (1)
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