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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01716936




Registration number
NCT01716936
Ethics application status
Date submitted
19/09/2012
Date registered
30/10/2012
Date last updated
15/08/2013

Titles & IDs
Public title
A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System
Scientific 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
Secondary ID [1] 0 0
PR0056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracic Insufficiency Syndrome 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
MAGEC Implant - All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Cobb Angle
Timepoint [1] 0 0
Baseline and 6, 12, 18 and 24 Months Postoperatively
Primary outcome [2] 0 0
Change in Thoracic Spine Height
Timepoint [2] 0 0
Baseline and 6, 12, 18 and 24 Months Postoperatively
Primary outcome [3] 0 0
Change in Space Available for Lung
Timepoint [3] 0 0
Baseline and 6, 12, 18 and 24 Months Postoperatively
Primary outcome [4] 0 0
Ocurrence of Procedure-Related Complications
Timepoint [4] 0 0
Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
Primary outcome [5] 0 0
Occurrence of Adverse Events
Timepoint [5] 0 0
Baseline and 6, 12, 18 and 24 Months Postoperatively
Secondary outcome [1] 0 0
Change in Coronal Balance
Timepoint [1] 0 0
Baseline and 6, 12, 18 and 24 Months Postoperatively
Secondary outcome [2] 0 0
Change in Sagittal Balance
Timepoint [2] 0 0
Baseline and 6, 12, 18 and 24 Months Postoperatively
Secondary outcome [3] 0 0
Occurrence of Subsequent surgical interventions following initial implantation
Timepoint [3] 0 0
Baseline and 6, 12, 18 and 24 Months Postoperatively
Secondary outcome [4] 0 0
Change in Weight
Timepoint [4] 0 0
Baseline and 6, 12, 18 and 24 Months Postoperatively

Eligibility
Key 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
Minimum age
No limit
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient declines to sign informed consent for the use of their personal private data.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Egypt
State/province [1] 0 0
Cairo
Country [2] 0 0
Finland
State/province [2] 0 0
Helsinki
Country [3] 0 0
Finland
State/province [3] 0 0
Turku
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Hong Kong
Country [5] 0 0
Italy
State/province [5] 0 0
Bologna
Country [6] 0 0
Italy
State/province [6] 0 0
Rome
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
Turkey
State/province [8] 0 0
Ankara
Country [9] 0 0
Turkey
State/province [9] 0 0
Istanbul
Country [10] 0 0
Turkey
State/province [10] 0 0
Izmir
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Middlesex
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Cardiff
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ellipse Technologies, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01716936
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Behrooz A Akbarnia, MD
Address 0 0
San Diego Center for Spinal Disorders
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01716936