The Tether™ - Vertebral Body Tethering System Post Approval Study
NCT ID: NCT04505579
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2020-10-29
2027-12-31
Brief Summary
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Detailed Description
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The objective of the study is to assess the ongoing safety and probable benefit of The Tether HUD which was approved by the FDA under an HDE. Subject enrollment and data collection will be managed by the Harms Study Group (HSG) and Setting Scoliosis Straight Foundation (SSSF) Registry. Institutions that are HSG members or affiliates, with Investigators/surgeons that are trained and approved to perform surgeries with The Tether, will participate in the registry. Ten sites from this group will be identified as study sites specific to this Tether post-approval study (PAS). Consecutive subjects from these sites, that meet the eligibility criteria of this study, will be flagged in the registry as the PAS cohort and the study endpoints will be assessed across this population.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tether
Patients who have received The Tether HUD for treatment of idiopathic scoliosis.
Anterior Vertebral Body Tethering
Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).
Interventions
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Anterior Vertebral Body Tethering
Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments
* Major Cobb angle ≥30° and ≤65°
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
* Failed or intolerant to bracing
Exclusion Criteria
* Prior spinal surgery at the level(s) to be treated
* Documented poor bone quality, defined as a T-score -1.5 or less
* Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
* Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
* Unwillingness to sign Informed Consent Form and participate in study procedures
ALL
No
Sponsors
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Setting Scoliosis Straight Foundation
OTHER
Exponent, Inc.
UNKNOWN
ZimVie
INDUSTRY
Responsible Party
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Locations
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Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Children's Health
Jacksonville, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ochsner Health
New Orleans, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri - Columbia
Columbia, Missouri, United States
Mount Sinai
New York, New York, United States
Shriners Children's Hopital
Philadelphia, Pennsylvania, United States
Seattle Children's
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Peter O Newton, MD
Role: primary
Mark Erickson, MD
Role: primary
Joshua Murphy, MD
Role: primary
Lawrence Haber, MD
Role: primary
Daniel Hoernschemeyer, MD
Role: primary
Baron Lonner, MD
Role: primary
Amer F Samdani
Role: primary
Burt Yaszay, MD
Role: primary
Other Identifiers
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RAU2019-40S
Identifier Type: -
Identifier Source: org_study_id
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