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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
- Anterior Vertebral Body Tethering (device)
Sponsor: ZimVie · Participants: 200 · Started: Oct 29, 2020
Contact the study team
- Monica Barascout, BS · Phone: 1-303-465-8960
- Kim Martinez · Phone: 1-303-465-8960
Official record on ClinicalTrials.gov — NCT04505579
Locations in the U.S.
| California | Rady Children's Hospital, San Diego |
| Colorado | Children's Hospital Colorado, Aurora |
| Georgia | Children's Healthcare of Atlanta, Atlanta |
| Louisiana | Ochsner Health, New Orleans |
| Minnesota | Mayo Clinic, Rochester |
| Missouri | University of Missouri - Columbia, Columbia |
| New York | Mount Sinai, New York |
| Pennsylvania | Shriners Children's Hopital, Philadelphia |
| Washington | Seattle Children's, Seattle |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.