The Tether™ - Vertebral Body Tethering System Post Approval Study

Recruiting now

Conditions studied: Scoliosis Idiopathic

In brief

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.

Key facts

Study ID

NCT04505579

Run by

ZimVie

People needed

200

Starts

2020-10-29

Expected to finish

2027-12-31

Last updated by the study team

2024-02-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Seattle Children's — Seattle, Washington, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Rady Children's Hospital — San Diego, California, United States (enrolling)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Ochsner Health — New Orleans, Louisiana, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• University of Missouri - Columbia — Columbia, Missouri, United States (enrolling)
• Mount Sinai — New York, New York, United States (enrolling)
• Shriners Children's Hopital — Philadelphia, Pennsylvania, United States (enrolling)
• Nemours Children's Health — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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