Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

Ellipse Technologies

Status: Unknown

Conditions: Adolescent Idiopathic Scoliosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01633931

PR0038

Details and patient eligibility

About

The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.

Enrollment: 20 estimated patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• History of previous surgical treatment for AIS