Anterior Vertebral Body Tethering
DeviceSubject will receive anterior vertebral body tethering surgery.
NCT Number: NCT04914507
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
Interested in participating?
Request InfoUp to 18 year
All sexes
Interventional
Not applicable
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Skeletally immature patients that receive AVBT surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Specifically:
Exclusion criteria
Subject will receive anterior vertebral body tethering surgery.
Time frame: 5 years
The three-dimensional spine growth of the subjects will be measured at each study timepoint and compared to known normal controls.
Time frame: 5 years
Subjects who maintain a major Cobb angle less than or equal to 50 degrees at skeletal maturity will be considered a "success."
Time frame: 5 years
Subjects will be monitored for complications associated with both the procedure and the device.
Contact information is provided by the study sponsor or research team.
Tricia St. Hilaire
CONTACT
Tyler Farber
CONTACT
Pediatric Spine Foundation
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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