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

Thoracic Insufficiency Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716936
• Other study ID #: PR0056
• Status: Completed
• Phase: N/A
• First received: September 19, 2012
• Last updated: August 13, 2013
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: August 2013
• Source: Ellipse Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review BoardFinland: Ethics CommitteeHong Kong: Ethics CommitteeItaly: Ethics CommitteeNew Zealand: Ethics CommitteeTurkey: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 11 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thoracic Insufficiency Syndrome

Locations

Country	Name	City	State
Egypt	University of Cairo Public Hospital	Cairo
Finland	University of Helsinki	Helsinki
Finland	Turku University Hospital	Turku
Hong Kong	University of Hong Kong	Hong Kong
Italy	Instituto Rizzoli	Bologna
Italy	Bambin Gesu	Rome
New Zealand	Starship Children's Hospital	Auckland
Turkey	Ankara Gazi Universitesi Hastanesi	Ankara
Turkey	Hacettepe University Hospital	Ankara
Turkey	Florence Nightingale Hospital Ortopedi Bolumu	Istanbul
Turkey	Marmara Üniversitesi Egt.ve Ars.Hastanesi	Istanbul
Turkey	Ege Saglik Hastanesi	Izmir
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	The Harley Street Clinic	London
United Kingdom	Royal National Orthopaedic Hospital NHS Trust	Stanmore	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Ellipse Technologies, Inc.

Countries where clinical trial is conducted

Egypt,  Finland,  Hong Kong,  Italy,  New Zealand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cobb Angle	Measured in Degrees	Baseline and 6, 12, 18 and 24 Months Postoperatively	No
Primary	Change in Thoracic Spine Height	Measured in millimeters (mm)	Baseline and 6, 12, 18 and 24 Months Postoperatively	No
Primary	Change in Space Available for Lung	Measured as a percentage (%)	Baseline and 6, 12, 18 and 24 Months Postoperatively	No
Primary	Ocurrence of Procedure-Related Complications		Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively	Yes
Primary	Occurrence of Adverse Events		Baseline and 6, 12, 18 and 24 Months Postoperatively	Yes
Secondary	Change in Coronal Balance	Measured in millimeters (mm)	Baseline and 6, 12, 18 and 24 Months Postoperatively	No
Secondary	Change in Sagittal Balance	Measured in millimeters (mm)	Baseline and 6, 12, 18 and 24 Months Postoperatively	No
Secondary	Occurrence of Subsequent surgical interventions following initial implantation		Baseline and 6, 12, 18 and 24 Months Postoperatively	No
Secondary	Change in Weight	Measured in kilograms (kg)	Baseline and 6, 12, 18 and 24 Months Postoperatively	No

External Links

•   Ellipse Technologies, Inc. Website