Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
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Layout table for eligibility information
Ages Eligible for Study:
10 Years to 15 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients diagnosed with Adolescent Idiopathic Diagnosis
Diagnosis of Adolescent Idiopathic Scoliosis
Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
Skeletally immature (Risser Sign 0, 1, 2, or 3)
In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
Age between 10 and 15
Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion
Candidate for surgical implantation of spinal instrumentation
Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol
Must sign informed consent to permit the use of personal health data
Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
Patients who require an MRI following implantation
Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature