NCT01716936

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
7 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

6 months

First QC Date

September 19, 2012

Last Update Submit

August 13, 2013

Conditions

Thoracic Insufficiency Syndrome

Keywords

Thoracic Insufficiency SyndromeEarly Onset Spinal Deformity

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Change in Coronal Balance

    Baseline and 6, 12, 18 and 24 Months Postoperatively

  • Change in Sagittal Balance

    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

    Baseline and 6, 12, 18 and 24 Months Postoperatively

Study Arms (1)

MAGEC Implant

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

Eligibility Criteria

AgeUp to 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Cairo Public Hospital

Cairo, 11559, Egypt

Location

University of Helsinki

Helsinki, 00029, Finland

Location

Turku University Hospital

Turku, Finland

Location

University of Hong Kong

Hong Kong, Hong Kong

Location

Instituto Rizzoli

Bologna, Italy

Location

Bambin Gesu

Rome, Italy

Location

Starship Children's Hospital

Auckland, New Zealand

Location

Ankara Gazi Universitesi Hastanesi

Ankara, Turkey (Türkiye)

Location

Hacettepe University Hospital

Ankara, Turkey (Türkiye)

Location

Florence Nightingale Hospital Ortopedi Bolumu

Istanbul, 34403, Turkey (Türkiye)

Location

Marmara Üniversitesi Eğt.ve Arş.Hastanesi

Istanbul, Turkey (Türkiye)

Location

Ege Sağlık Hastanesi

Izmir, Turkey (Türkiye)

Location

Royal National Orthopaedic Hospital NHS Trust

Stanmore, Middlesex, HA7 4LP, United Kingdom

Location

University Hospital of Wales

Cardiff, CF 14 4XW, United Kingdom

Location

The Harley Street Clinic

London, United Kingdom

Location

Study Officials

  • Behrooz A Akbarnia, MD

    San Diego Center for Spinal Disorders

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2012

First Posted

October 30, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 15, 2013

Record last verified: 2013-08

Locations

EG(1)IT(2)NZ(1)GB(3)HK(1)FI(2)TU(5)