Actively Recruiting
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Led by Pediatric Spine Foundation · Updated on 2023-11-15
106
Participants Needed
12
Research Sites
416 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic scoliosis
- Planned recipient of anterior vertebral body tethering surgical treatment
- Skeletally immature patients
- Major Cobb angle between 30 and 65 degrees
- Osseous structure adequate for screw fixation based on imaging
- Failed or intolerant to bracing
You will not qualify if you...
- Presence of any systemic or local infection or skin issues at the surgery site
- Prior spinal surgery at the levels planned for treatment
- Documented poor bone quality
- Medical or surgical conditions preventing benefit from spinal surgery, including coagulation disorders or allergies to implant materials
- Unwillingness or inability to follow post-operative care instructions
- Living situation or personal circumstances preventing return for follow-up visits
- Unwillingness to sign informed consent and participate in study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Shriners Children's Chicago
Chicago, Illinois, United States, 60707
Actively Recruiting
3
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
4
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
5
Morgan Stanley Childrens Hospital of New York-Presbyterian
New York, New York, United States, 10032
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Shriners Children's Portland
Portland, Oregon, United States, 97239
Actively Recruiting
8
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
The Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
10
Vanderbilt University
Nashville, Tennessee, United States, 37235
Actively Recruiting
11
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
12
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8LI
Actively Recruiting
Research Team
T
Tyler Farber
CONTACT
T
Tricia St. Hilaire
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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