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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 : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
A. Noelle Larson, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE April 3, 2018
First Posted Date  ICMJE April 24, 2018
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE April 25, 2018
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
Major cobb angle curve progression greater than 10 degrees from 1st erect x-ray to follow-up [ Time Frame: 1 year ]
yes/no parameter, did major Cobb angle worsen by 10 degrees from immediately after surgery until 1 year postoperatively
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Official Title  ICMJE Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Scoliosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Pediatric Scoliosis Patients
    Tether group
    Intervention: Device: AVBT using Dynesys System Components
  • Active Comparator: Pediatric Scoliosis Control Patients
    Fusion (control) group
    Intervention: Procedure: Spine fusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019)
80
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2018)
25
Estimated Study Completion Date  ICMJE July 1, 2027
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Smitha E Mathew, MD 507-538-3560 mathew.smitha@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03506334
Other Study ID Numbers  ICMJE 17-007801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A. Noelle Larson, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: A. Noelle Larson, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP