Phase
Condition
N/ATreatment
Anterior Vertebral Body Tethering
Clinical Study ID
Ages < 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Skeletally immature patients that receive AVBT surgical treatment toobtain 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 determinedby radiographic imaging
- Failed or intolerant to bracing
Exclusion
Exclusion Criteria:
- Presence of any systemic infection, local infection, or skin compromise at theanticipated 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 ofspinal surgery, such as coagulation disorders, allergies to the implant materials, andpatient's unwillingness or inability to cooperate with post-operative careinstructions 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 forfollow-up visits as described in protocol and Informed Consent
- Unwillingness to sign Informed Consent Form and participate in study procedures
Study Design
Connect with a study center
Children's Hospital of Eastern Ontario
Ottawa, Ontario K1H 8LI
CanadaActive - Recruiting
Children's National Hospital
Washington, District of Columbia 20010
United StatesActive - Recruiting
Shriners Children's Chicago
Chicago, Illinois 60707
United StatesActive - Recruiting
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota 55101
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63130
United StatesActive - Recruiting
Morgan Stanley Childrens Hospital of New York-Presbyterian
New York, New York 10032
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Shriners Children's Portland
Portland, Oregon 97239
United StatesActive - Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
The Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Vanderbilt University
Nashville, Tennessee 37235
United StatesActive - Recruiting
Primary Children's Hospital
Salt Lake City, Utah 84113
United StatesActive - Recruiting
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