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

A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

This study is testing a new, less invasive scoliosis treatment called anterior vertebral body tethering to see how well it helps younger patients with spinal curve issues grow and avoid complications compared to traditional methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: Pediatric Spine Foundation (Academic / other)
• Locations: 12 sites (Washington D.C., District of Columbia and 11 other locations)
• Trial ID: NCT04914507 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are skeletally immature children diagnosed with idiopathic scoliosis who are planned recipients of AVBT and have a major Cobb angle between 30° and 65°.

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

Why it matters

Potential benefit: If successful, this study could offer a less invasive treatment option for children with scoliosis, potentially improving their long-term spinal health and quality of life.

How similar studies have performed: While AVBT is a novel approach, initial enthusiasm suggests potential, but long-term outcomes have yet to be thoroughly evaluated in similar studies.

Eligibility criteria

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 this trial is running

Washington D.C., District of Columbia and 11 other locations

• 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)
• Shriners Children's Portland — Portland, Oregon, United States (Recruiting)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
• The Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
• Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
• Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Ron El-Hawary, MD — Dalhousie University
• Study coordinator: Tyler Farber

Conditions Scoliosis Idiopathic; anterior vertebral body tethering