Back to resultsAnterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Primary Purpose
Scoliosis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AVBT using Dynesys System Components
Spine fusion
Sponsored by
About this trial
This is an interventional other trial for Scoliosis
Eligibility Criteria
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.
- Pregnancy.
- 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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pediatric Scoliosis Patients
Pediatric Scoliosis Control Patients
Arm Description
Tether group
Fusion (control) group
Outcomes
Primary Outcome Measures
Revision spine surgery within 2 years of index procedure
yes/no parameter, was revision surgery performed within 2 years of index procedure
Secondary Outcome Measures
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)
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)
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
Flexibility films will be obtained in patients postoperatively to assess flexibility
Spinal disc health utilizing MRI
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03506334
Brief Title
Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Official Title
Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Tether group 40 patients and Fusion (control) group 40 patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pediatric Scoliosis Patients
Arm Type
Experimental
Arm Description
Tether group
Arm Title
Pediatric Scoliosis Control Patients
Arm Type
Active Comparator
Arm Description
Fusion (control) group
Intervention Type
Device
Intervention Name(s)
AVBT using Dynesys System Components
Intervention Description
Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.
Intervention Type
Procedure
Intervention Name(s)
Spine fusion
Intervention Description
Children with scoliosis undergoing fusion surgery will form the control arm
Primary Outcome Measure Information:
Title
Revision spine surgery within 2 years of index procedure
Description
yes/no parameter, was revision surgery performed within 2 years of index procedure
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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)
Description
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
Time Frame
1 year
Title
Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)
Description
yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film
Time Frame
1 year
Title
Curve flexibility over instrumented vertebra > 5 degrees
Description
Flexibility films will be obtained in patients postoperatively to assess flexibility
Time Frame
At least 1 year postoperatively
Title
Spinal disc health utilizing MRI
Description
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).
Time Frame
At least 1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Pregnancy.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Noelle Larson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35610543
Citation
Mathew SE, Hargiss JB, Milbrandt TA, Stans AA, Shaughnessy WJ, Larson AN. Vertebral body tethering compared to posterior spinal fusion for skeletally immature adolescent idiopathic scoliosis patients: preliminary results from a matched case-control study. Spine Deform. 2022 Sep;10(5):1123-1131. doi: 10.1007/s43390-022-00519-3. Epub 2022 May 24.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
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