Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
NCT ID: NCT01633931
Last Updated: 2018-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2012-03-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
* Skeletally immature (Risser Sign 0, 1, 2, or 3)
* In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
* Age between 10 and 15
* Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion
* Candidate for surgical implantation of spinal instrumentation
* Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol
* Must sign informed consent to permit the use of personal health data
Exclusion Criteria
* Patients who require an MRI following implantation
* Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
* History of previous surgical treatment for AIS
10 Years
15 Years
ALL
No
Sponsors
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Ellipse Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Behrooz Akbarnia, MD
Role: PRINCIPAL_INVESTIGATOR
San Diego Center for Spinal Disorders
Locations
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University of Hong Kong
Hong Kong, Pokfulam, Hong Kong
Countries
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Other Identifiers
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PR0038
Identifier Type: -
Identifier Source: org_study_id
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