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
Diagnosis of idiopathic scoliosis
Planned recipient of AVBT surgical treatment
Skeletally immature
Major Cobb angle ≥30° and ≤65°
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
Single group
Anterior Vertebral Body Tethering
DeviceSubject will receive anterior vertebral body tethering surgery.
The effect on three-dimensional spine growth as compared to normal controls
The three-dimensional spine growth of the subjects will be measured at each study timepoint and compared to known normal controls.
Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
Subjects who maintain a major Cobb angle less than or equal to 50 degrees at skeletal maturity will be considered a "success."
Complications associated with both the procedure and the device
Subjects will be monitored for complications associated with both the procedure and the device.
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