The Tether™ - Vertebral Body Tethering System Post Approval Study

Recruiting Observational Study
Scoliosis Idiopathic
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
ZimVie · Industry
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About This Trial

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.

Trial Locations
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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 * Fail…
Contacts

Monica Barascout, BS

1-303-465-8960

Monica.Barascout@zimvie.com

CONTACT

Kim Martinez

1-303-465-8960

Kim.Martinez@zimvie.com

CONTACT