CompletedNCT01716936Updated Aug 15, 2013

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

An observational study in Thoracic Insufficiency Syndrome, sponsored by Ellipse Technologies, Inc.. Completed at 15 sites in 7 countries. Open to participants aged Up to 11 Years. Per ClinicalTrials.gov, last updated 2013-08-15.

Sponsored by Ellipse Technologies, Inc. · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 54
Ages: Up to 11 Years
Sex: All

Study 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.

Conditions studied

Thoracic Insufficiency Syndrome

Browse trials for

Congenital Abnormalities 980

Keywords

Thoracic Insufficiency Syndrome
Early Onset Spinal Deformity

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 54 is below the median of 153 across 446 observational studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

Ellipse Technologies, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 11 Years
Sexes eligible: All
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).

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

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 54 participants (actual)

Groups and cohorts

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

15 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01716936
Lead sponsor: Ellipse Technologies, Inc.
Responsible party: Sponsor
First posted: Oct 30, 2012
Start date: Jul 2012
Primary completion: Jan 2013
Completion: Jan 2013
Last update: Aug 15, 2013

Study contacts

Behrooz A Akbarnia, MD

principal investigator · San Diego Center for Spinal Disorders

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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