A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Recruiting
N/A
Interventional Study
Scoliosis Idiopathic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 18
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 106 (estimated)
- Sponsor
- Pediatric Spine Foundation · Other
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About This Trial
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 t…
Trial Locations
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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°…
Contacts