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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01716936

Enrollment

Registered

2012-10-30

Start date

2012-07-31

Completion date

2013-01-31

Last updated

2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Insufficiency Syndrome

Keywords

Thoracic Insufficiency Syndrome, Early Onset Spinal Deformity

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 11 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in Sagittal Balance	Baseline and 6, 12, 18 and 24 Months Postoperatively	Measured in millimeters (mm)
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	Measured in kilograms (kg)
Change in Coronal Balance	Baseline and 6, 12, 18 and 24 Months Postoperatively	Measured in millimeters (mm)

Countries

Egypt, Finland, Hong Kong, Italy, New Zealand, Turkey (Türkiye), United Kingdom

Outcome results