Post-approval assessment of The Tether system for treating scoliosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to provide ongoing safety and efficacy data for The Tether HUD, a device used in Anterior Vertebral Body Tethering (AVBT) for treating progressive idiopathic scoliosis in skeletally immature patients. The study will collect long-term outcomes from patients who have undergone AVBT, which utilizes growth modulation techniques to correct spinal curvature while preserving flexibility. By monitoring these patients, the study seeks to ensure the continued safety and probable benefits of this innovative treatment approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Rady Children's Hospital
  San Diego, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• Ochsner Health
  New Orleans, Louisiana, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• University of Missouri - Columbia
  Columbia, Missouri, United States Recruiting

Study contacts

• Study coordinator: Monica Barascout, BS
• Email: Monica.Barascout@zimvie.com
• Phone: 1-303-465-8960

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.