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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ellipse Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01716936
First received: September 19, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition
Thoracic Insufficiency Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Further study details as provided by Ellipse Technologies, Inc.:

Primary Outcome Measures:
  • Change in Cobb Angle [ Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: No ]
    Measured in Degrees

  • Change in Thoracic Spine Height [ Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: No ]
    Measured in millimeters (mm)

  • Change in Space Available for Lung [ Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: No ]
    Measured as a percentage (%)

  • Ocurrence of Procedure-Related Complications [ Time Frame: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: Yes ]
  • Occurrence of Adverse Events [ Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Coronal Balance [ Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: No ]
    Measured in millimeters (mm)

  • Change in Sagittal Balance [ Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: No ]
    Measured in millimeters (mm)

  • Occurrence of Subsequent surgical interventions following initial implantation [ Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: No ]
  • Change in Weight [ Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively ] [ Designated as safety issue: No ]
    Measured in kilograms (kg)


Enrollment: 54
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
MAGEC Implant
All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study.

  Eligibility

Ages Eligible for Study:   up to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716936

Locations
Egypt
University of Cairo Public Hospital
Cairo, Egypt, 11559
Finland
University of Helsinki
Helsinki, Finland, 00029
Turku University Hospital
Turku, Finland
Hong Kong
University of Hong Kong
Hong Kong, Hong Kong
Italy
Instituto Rizzoli
Bologna, Italy
Bambin Gesu
Rome, Italy
New Zealand
Starship Children's Hospital
Auckland, New Zealand
Turkey
Ankara Gazi Universitesi Hastanesi
Ankara, Turkey
Hacettepe University Hospital
Ankara, Turkey
Florence Nightingale Hospital Ortopedi Bolumu
Istanbul, Turkey, 34403
Marmara Üniversitesi Eğt.ve Arş.Hastanesi
Istanbul, Turkey
Ege Sağlık Hastanesi
Izmir, Turkey
United Kingdom
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, United Kingdom, HA7 4LP
University Hospital of Wales
Cardiff, United Kingdom, CF 14 4XW
The Harley Street Clinic
London, United Kingdom
Sponsors and Collaborators
Ellipse Technologies, Inc.
Investigators
Principal Investigator: Behrooz A Akbarnia, MD San Diego Center for Spinal Disorders
  More Information

Additional Information:
No publications provided

Responsible Party: Ellipse Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01716936     History of Changes
Other Study ID Numbers: PR0056
Study First Received: September 19, 2012
Last Updated: August 13, 2013
Health Authority: Egypt: Institutional Review Board
Finland: Ethics Committee
Hong Kong: Ethics Committee
Italy: Ethics Committee
New Zealand: Ethics Committee
Turkey: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Ellipse Technologies, Inc.:
Thoracic Insufficiency Syndrome
Early Onset Spinal Deformity

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 14, 2014