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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAGEC Implant | All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients worldwide implanted with the Ellipse Technologies Spinal Bracing and Distraction System (Invitation to Volunteer Non-Probability Sample).
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| Name | Affiliation | Role |
|---|---|---|
| Behrooz A Akbarnia, MD | San Diego Center for Spinal Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cairo Public Hospital | Cairo | 11559 | Egypt | |||
| University of Helsinki |
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| 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 |
| 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 (Türkiye) |
| Hacettepe University Hospital | Ankara | Turkey (Türkiye) |
| Florence Nightingale Hospital Ortopedi Bolumu | Istanbul | 34403 | Turkey (Türkiye) |
| Marmara Üniversitesi Eğt.ve Arş.Hastanesi | Istanbul | Turkey (Türkiye) |
| Ege Sağlık Hastanesi | Izmir | Turkey (Türkiye) |
| 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 |