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Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis

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ClinicalTrials.gov Identifier: NCT03506334
Recruitment Status : Active, not recruiting
First Posted : April 24, 2018
Last Update Posted : February 6, 2023
Sponsor:
Information provided by (Responsible Party):
A. Noelle Larson, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Scoliosis Device: AVBT using Dynesys System Components Procedure: Spine fusion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Tether group 40 patients and Fusion (control) group 40 patients
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pediatric Scoliosis Patients
Tether group
 Device: AVBT using Dynesys System Components
Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.
Active Comparator: Pediatric Scoliosis Control Patients
Fusion (control) group
 Procedure: Spine fusion
Children with scoliosis undergoing fusion surgery will form the control arm


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
    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

  2. Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm) [ Time Frame: 1 year ]
    yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film

  3. Curve flexibility over instrumented vertebra > 5 degrees [ Time Frame: At least 1 year postoperatively ]
    Flexibility films will be obtained in patients postoperatively to assess flexibility

  4. Spinal disc health utilizing MRI [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506334


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: A. Noelle Larson, MD Mayo Clinic
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: A. Noelle Larson, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03506334    
Other Study ID Numbers: 17-007801
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases