Status:
RECRUITING
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Lead Sponsor:
Pediatric Spine Foundation
Conditions:
Scoliosis Idiopathic
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04914507
Start Date
September 9 2021
End Date
September 1 2029
Last Update
November 15 2023
Active Locations (12)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
2
Shriners Children's Chicago
Chicago, Illinois, United States, 60707
3
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101
4
Washington University
St Louis, Missouri, United States, 63130