A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Recruiting now · Not applicable
Conditions studied: Scoliosis Idiopathic
In brief
Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device
Key facts
- Study ID
- NCT04914507
- Run by
- Pediatric Spine Foundation
- People needed
- 106
- Starts
- 2021-09-09
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2023-11-15
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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 is running
- Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
- Shriners Children's Chicago — Chicago, Illinois, United States (enrolling)
- Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- Morgan Stanley Childrens Hospital of New York-Presbyterian — New York, New York, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Shriners Children's Portland — Portland, Oregon, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- The Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- Vanderbilt University — Nashville, Tennessee, United States (enrolling)
- Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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