Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

• Conditions: Adolescent Idiopathic Scoliosis

• Registration Number: NCT01633931
• Lead Sponsor: Ellipse Technologies, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-04
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in major scoliotic curve magnitude	Change from baseline to 36 months postoperative	Measured in degrees
Number and Types of Adverse Events	Operative through 36 months postoperative

Secondary Outcome Measures

Name	Time	Method
Radiographic evaluation coronal balance compared to baseline	Change from baseline to 36 months postoperative
Radiographic evaluation sagittal balance compared to baseline	Change from baseline to 36 months postoperative
Percent of patients indicated for surgical spine fusion	Change from baseline to 36 months postoperative
Comparison of Rib Hump prominence	Change from baseline to 36 months postoperative
Quality of life assessment via SRS-30 questionnaire	Change from baseline to 36 months postoperative
Expected vs. Actual Device Lengthening	All postoperative visits where lengthening is conducted

Trial Locations

Locations (1)

University of Hong Kong; 🇭🇰 Hong Kong, Pokfulam, Hong Kong