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

Completed

• Conditions: Thoracic Insufficiency Syndrome

• Registration Number: NCT01716936
• Lead Sponsor: Ellipse Technologies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-13
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Occurrence of Adverse Events	Baseline and 6, 12, 18 and 24 Months Postoperatively

Secondary Outcome Measures

Name	Time	Method
Change in Coronal Balance	Baseline and 6, 12, 18 and 24 Months Postoperatively	Measured in millimeters (mm)
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)

Trial Locations

Locations (15)

University of Cairo Public Hospital; 🇪🇬 Cairo, Egypt

University of Helsinki; 🇫🇮 Helsinki, 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, Turkey

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