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The Tether™ - Vertebral Body Tethering System Post Approval Study

RecruitingObservational study

Who can join

All ages · All sexes

Full eligibility criteria
Inclusion Criteria:

* Diagnosis of progressive idiopathic scoliosis
* 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:

* Presence of any systemic infection, local infection, or skin compromise at the surgical site
* 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

About the study

This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.

What is being tested

Sponsor: ZimVie · Participants: 200 · Started: Oct 29, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04505579

Locations in the U.S.

CaliforniaRady Children's Hospital, San Diego
ColoradoChildren's Hospital Colorado, Aurora
GeorgiaChildren's Healthcare of Atlanta, Atlanta
LouisianaOchsner Health, New Orleans
MinnesotaMayo Clinic, Rochester
MissouriUniversity of Missouri - Columbia, Columbia
New YorkMount Sinai, New York
PennsylvaniaShriners Children's Hopital, Philadelphia
WashingtonSeattle Children's, Seattle

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.