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

Launched by PEDIATRIC SPINE FOUNDATION · May 31, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Anterior Vertebral Body Tethering (AVBT) for children with idiopathic scoliosis, a condition where the spine curves abnormally. The study aims to understand how well AVBT works in the long term by examining how it affects spine growth, whether it helps keep the curve of the spine under control as the child grows, and any complications that may arise from the procedure. AVBT is a less invasive option compared to traditional spinal fusion surgery, which has excited many families seeking alternatives for their children.

To participate in this trial, patients need to be children who are still growing and have been diagnosed with idiopathic scoliosis. They should have a significant curve in their spine (between 30° and 65°) and must not have had previous spinal surgery. The trial is currently recruiting participants of all genders aged from infancy to 17 years. Families can expect to work closely with medical professionals throughout the study, including follow-up visits to monitor the child’s progress after the AVBT procedure. It's important for families to understand that participation involves commitment and adherence to post-surgery care instructions to get the most benefit from this new treatment.

Gender

ALL

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