Treatment of Adolescent Idiopathic Scoliosis Using the Ellipse MAGEC System

Not Applicable

• Conditions: Adolescent Idiopathic Scoliosis; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12612000373875
• Lead Sponsor: Ellipse Technologies, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Diagnosis of Adolescent Idiopathic Scoliosis; Failed external brace therapy; Skeletally immature; Age between 10 and 15; Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion.

Exclusion Criteria

Patients with pacemaker, implanted cardiac defibrillator, or any other electronic implant; Patients who require an MRI following implantation, Patients who are pregnant or nursing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnitude of curve progression compared to baseline (through follow up period) until skeletal maturity. This outcome is assessed via x-ray analysis of the spinal Cobb Angle.[Baseline and 1-Week, 3-Month, 6-Month, 9-Month, 12-Month, 18-Month, 24-Month, 30-Month, and 36-Month Postoperative Visits]