Long-term outcomes of a new scoliosis treatment using anterior vertebral body tethering

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 study evaluates the long-term clinical outcomes of skeletally immature patients with idiopathic scoliosis who undergo anterior vertebral body tethering (AVBT), a minimally invasive technique aimed at controlling spinal curve progression. The research focuses on assessing three-dimensional spine growth compared to normal controls, maintaining a major Cobb angle of 50 degrees or less at skeletal maturity, and identifying any complications associated with the procedure and device. By analyzing these outcomes, the study aims to provide valuable insights into the effectiveness and safety of AVBT as an alternative to traditional spinal fusion.

Why it matters

Who can join: the full rules

Inclusion Criteria: Skeletally immature patients that receive AVBT surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Specifically:

* Diagnosis of idiopathic scoliosis
* Planned recipient of AVBT surgical treatment
* Skeletally immature
* 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 anticipated surgical site
* Prior spinal surgery at the level(s) to be treated
* Evidence of documented poor bone quality
* 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 as determined by the treating physician
* 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

• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Shriners Children's Chicago
  Chicago, Illinois, United States Recruiting
• Gillette Children's Specialty Healthcare
  Saint Paul, Minnesota, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• Morgan Stanley Childrens Hospital of New York-Presbyterian
  New York, New York, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Ron El-Hawary, MD — Dalhousie University
• Study coordinator: Tyler Farber
• Email: tfarber@pediatricspine.org
• Phone: 3197501029

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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.