Post-approval assessment of The Tether system for treating scoliosis

The Tether™ - Vertebral Body Tethering System Post Approval Study

This study is looking at how well The Tether system works and its safety for kids with scoliosis who have had this treatment to help straighten their spines as they grow.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Sex: All
• Sponsor: ZimVie (Industry-sponsored)
• Locations: 10 sites (San Diego, California and 9 other locations)
• Trial ID: NCT04505579 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are skeletally immature individuals diagnosed with progressive idiopathic scoliosis and a major Cobb angle between 30° and 65°.

Not a fit: Patients with prior spinal surgery at the treatment levels or those with systemic infections or poor bone quality may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of AVBT, potentially improving treatment options for scoliosis patients.

How similar studies have performed: Other studies have explored growth-modulation techniques for scoliosis treatment, indicating a promising avenue for further investigation, although this specific approach is relatively novel.

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

Where this trial is running

San Diego, California and 9 other locations

• Rady Children's Hospital — San Diego, California, United States (Recruiting)
• Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
• Nemours Children's Health — Jacksonville, Florida, United States (Active_not_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)
• Mount Sinai — New York, New York, United States (Recruiting)
• Shriners Children's Hopital — Philadelphia, Pennsylvania, United States (Recruiting)
• Seattle Children's — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Monica Barascout, BS

Conditions Scoliosis Idiopathic