Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

January 30, 2018 updated by: Ellipse Technologies, Inc.
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Pokfulam
      • Hong Kong, Pokfulam, Hong Kong
        • University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Adolescent Idiopathic Diagnosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in major scoliotic curve magnitude
Time Frame: Change from baseline to 36 months postoperative
Measured in degrees
Change from baseline to 36 months postoperative
Number and Types of Adverse Events
Time Frame: Operative through 36 months postoperative
Operative through 36 months postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ellipse Technologies, Inc.

Investigators

  • Principal Investigator: Behrooz Akbarnia, MD, San Diego Center for Spinal Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR0038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent Idiopathic Scoliosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe