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

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

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 Overview

• Status: Completed
• Conditions: Thoracic Insufficiency Syndrome

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11559
    • University of Cairo Public Hospital
• Finland
  • Helsinki, Finland, 00029
    • University of Helsinki
  • Turku, Finland
    • Turku University Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong
• Italy
  • Bologna, Italy
    • Instituto Rizzoli
  • Rome, Italy
    • Bambin Gesù
• New Zealand
  • Auckland, New Zealand
    • Starship Children's Hospital
• Turkey
  • Ankara, Turkey
    • Hacettepe University Hospital
  • Ankara, Turkey
    • Ankara Gazi Universitesi Hastanesi
  • Istanbul, Turkey, 34403
    • Florence Nightingale Hospital Ortopedi Bolumu
  • Istanbul, Turkey
    • Marmara Üniversitesi Eğt.ve Arş.Hastanesi
  • Izmir, Turkey
    • Ege Sağlık Hastanesi
• United Kingdom
  • Cardiff, United Kingdom, CF 14 4XW
    • University Hospital of Wales
  • London, United Kingdom
    • The Harley Street Clinic
  • Middlesex
    • Stanmore, Middlesex, United Kingdom, HA7 4LP
      • Royal National Orthopaedic Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients worldwide implanted with the Ellipse Technologies Spinal Bracing and Distraction System (Invitation to Volunteer Non-Probability Sample).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MAGEC Implant; All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cobb Angle	Measured in Degrees	Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Thoracic Spine Height	Measured in millimeters (mm)	Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Space Available for Lung	Measured as a percentage (%)	Baseline and 6, 12, 18 and 24 Months Postoperatively
Ocurrence of Procedure-Related Complications		Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Adverse Events		Baseline and 6, 12, 18 and 24 Months Postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Coronal Balance	Measured in millimeters (mm)	Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Sagittal Balance	Measured in millimeters (mm)	Baseline and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Subsequent surgical interventions following initial implantation		Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Weight	Measured in kilograms (kg)	Baseline and 6, 12, 18 and 24 Months Postoperatively

Collaborators and Investigators

• Sponsor: Ellipse Technologies, Inc.
• Investigators: Principal Investigator: Behrooz A Akbarnia, MD, San Diego Center for Spinal Disorders

Publications and helpful links

Helpful Links

• Ellipse Technologies, Inc. Website

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): August 15, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Thoracic Insufficiency Syndrome; Early Onset Spinal Deformity
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: PR0056