Overview

This trial is active, not recruiting.

Condition adolescent idiopathic scoliosis
Sponsor Ellipse Technologies, Inc.
Start date March 2012
End date April 2016
Trial size 20 participants
Trial identifier NCT01633931, PR0038

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Change in major scoliotic curve magnitude
time frame: Change from baseline to 36 months postoperative
Number and Types of Adverse Events
time frame: Operative through 36 months postoperative

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 10 years up to 15 years old.

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

Additional Information

Official title Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
Principal investigator Behrooz Akbarnia, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ellipse Technologies, Inc..