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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Thoracic Insufficiency Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MAGEC Implant<br>All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic Insufficiency Syndrome, Early Onset Spinal Deformity