A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System

Brief Title

A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System

Official Title

A Retrospective Multicenter Review of Early Onset Spinal Deformity Patients That Underwent Either a Primary or Revision Spinal Bracing Procedure With the Ellipse Technologies MAGEC Spinal Bracing and Distraction System

Brief Summary

      The purpose of this study is to determine the safety profile and probable benefit of the
      Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity
      associated with thoracic insufficiency syndrome.
    



Study Type

Observational


Primary Outcome

Change in Cobb Angle

Secondary Outcome

 Change in Coronal Balance

Condition

Thoracic Insufficiency Syndrome


Study Arms / Comparison Groups

 MAGEC Implant
Description:  All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

54

Start Date

July 2012

Completion Date

January 2013

Primary Completion Date

January 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Early onset spinal deformity with any etiology

          -  Cobb angle measurement of 30 degrees or greater at the time of primary surgery

          -  Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery

          -  Age less than 11 years old at the time of MAGEC implant

          -  Implanted with the MAGEC system as either a primary or secondary revision spinal
             bracing procedure

          -  Patient has been implanted for a minimum of 6 months

          -  Patient signs informed consent for the use of their personal private data

        Exclusion Criteria:

          -  Patient declines to sign informed consent for the use of their personal private data.
      

Gender

All

Ages

N/A - 11 Years

Accepts Healthy Volunteers

No

Contacts

Behrooz A Akbarnia, MD, , 

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT01716936

Organization ID

PR0056


Responsible Party

Sponsor

Study Sponsor

Ellipse Technologies, Inc.


Study Sponsor

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


Verification Date

August 2013