A degradation fragment of type X collagen is a real-time marker for bone growth velocity.
Ryan F Coghlan, Jon A Oberdorf, Susan Sienko...
https://pubmed.ncbi.nlm.nih.gov/29212713Actively Recruiting
Phase Not Applicable
Age: 0 - 18Years
All Genders
ID04914507
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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term clinical outcomes of anterior vertebral body tethering (AVBT), a minimally invasive growth modulation technique recently approved by the FDA for treating scoliosis in skeletally immature children. The study focuses on how AVBT affects three-dimensional spine growth compared to normal controls, whether it maintains the major Cobb angle at or below 50 degrees at skeletal maturity, and the complications related to the procedure and device. Participants will undergo AVBT surgery as clinically indicated after completing all pre-operative assessments. This procedure aims to control curve progression by applying compression on the convex side of the spinal deformity. The study follows patients for up to five years to monitor spine growth, curve maintenance, and any complications associated with the surgery and the device. During the study, participants will have regular assessments to evaluate three-dimensional spine growth and spinal curve measurements. Researchers will compare these outcomes to those of normal controls and track any surgery or device-related complications over a five-year period. The study involves follow-up visits to ensure ongoing monitoring of participant health and treatment effects.
CONDITIONS
Brief Title
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic scoliosis
- Planned recipient of anterior vertebral body tethering surgical treatment
- Skeletally immature
- Major Cobb angle greater than or equal to 30 degrees and less than or equal to 65 degrees
- Osseous structure adequate for screw fixation as confirmed by imaging
- Failed or intolerant to bracing
You will not qualify if you...
- Presence of any systemic or local infection, or skin issues at the surgical site
- Prior spinal surgery at the levels to be treated
- Documented poor bone quality
- Medical or surgical conditions preventing spinal surgery benefit, including coagulation disorders and allergies to implant materials
- Unwillingness or inability to cooperate with post-operative care
- Living situations preventing 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - As clinically indicated
Participants will undergo anterior vertebral body tethering surgery followed by immediate post-operative care.
Post-operative Follow-up
Duration - Up to 5 years
Participants will be monitored for long-term clinical outcomes and spine growth after surgery.
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
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Research Team
T
Tyler Farber
T
Tricia St. Hilaire
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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Published Research Related To This Trial
Idiopathic scoliosis.
Per Trobisch, Olaf Suess, Frank Schwab
https://pubmed.ncbi.nlm.nih.gov/21191550Pulmonary function following early thoracic fusion in non-neuromuscular scoliosis.
Lori A Karol, Charles Johnston, Kiril Mladenov...
https://pubmed.ncbi.nlm.nih.gov/18519321Anterior vertebral body tethering for immature adolescent idiopathic scoliosis: one-year results on the first 32 patients.
Amer F Samdani, Robert J Ames, Jeff S Kimball...
https://pubmed.ncbi.nlm.nih.gov/25510515Growth modulation by means of anterior tethering resulting in progressive correction of juvenile idiopathic scoliosis: a case report.
Charles H Crawford, Lawrence G Lenke
https://pubmed.ncbi.nlm.nih.gov/20048114Anterior vertebral body tethering for idiopathic scoliosis: two-year results.
Amer F Samdani, Robert J Ames, Jeff S Kimball...
https://pubmed.ncbi.nlm.nih.gov/24921854Safety and efficacy of anterior vertebral body tethering in the treatment of idiopathic scoliosis.
Firoz Miyanji, Jeff Pawelek, Luigi A Nasto...
https://pubmed.ncbi.nlm.nih.gov/33249889Three-dimensional True Spine Length: A Novel Technique for Assessing the Outcomes of Scoliosis Surgery.
Alan J Spurway, Jennifer K Hurry, Luke Gauthier...
https://pubmed.ncbi.nlm.nih.gov/28614286When Do Patients Return to Physical Activities and Athletics After Scoliosis Surgery?: A Validated Patient Questionnaire Based Study.
Vishal Sarwahi, Stephen Wendolowski, Rachel Gecelter...
https://pubmed.ncbi.nlm.nih.gov/28604495