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Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01633931
Recruitment Status : Active, not recruiting
First Posted : July 6, 2012
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):

July 2, 2012
July 6, 2012
September 1, 2017
March 2012
April 2012   (Final data collection date for primary outcome measure)
  • Change in major scoliotic curve magnitude [ Time Frame: Change from baseline to 36 months postoperative ]
    Measured in degrees
  • Number and Types of Adverse Events [ Time Frame: Operative through 36 months postoperative ]
Not Provided
Complete list of historical versions of study NCT01633931 on ClinicalTrials.gov Archive Site
  • Radiographic evaluation coronal balance compared to baseline [ Time Frame: Change from baseline to 36 months postoperative ]
  • Radiographic evaluation sagittal balance compared to baseline [ Time Frame: Change from baseline to 36 months postoperative ]
  • Percent of patients indicated for surgical spine fusion [ Time Frame: Change from baseline to 36 months postoperative ]
  • Quality of life assessment via SRS-30 questionnaire [ Time Frame: Change from baseline to 36 months postoperative ]
  • Comparison of Rib Hump prominence [ Time Frame: Change from baseline to 36 months postoperative ]
  • Expected vs. Actual Device Lengthening [ Time Frame: All postoperative visits where lengthening is conducted ]
Not Provided
Not Provided
Not Provided
 
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients diagnosed with Adolescent Idiopathic Diagnosis
Adolescent Idiopathic Scoliosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
October 2017
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Adolescent Idiopathic Scoliosis
  • 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 with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
  • 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
Sexes Eligible for Study: All
10 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
Finland,   Italy,   New Zealand
 
NCT01633931
PR0038
No
Not Provided
Not Provided
Ellipse Technologies, Inc.
Ellipse Technologies, Inc.
Not Provided
Principal Investigator: Behrooz Akbarnia, MD San Diego Center for Spinal Disorders
Ellipse Technologies, Inc.
June 2017