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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 : Recruiting
First Posted : April 24, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
A. Noelle Larson, Mayo Clinic

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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: Device Feasibility
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 : June 1, 2025
Estimated Study Completion Date : July 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

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




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



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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.

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


Contacts
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Contact: Smitha E Mathew, MD 507-538-3560 mathew.smitha@mayo.edu

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

Additional Information:
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Responsible Party: A. Noelle Larson, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03506334     History of Changes
Other Study ID Numbers: 17-007801
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors