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Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

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ClinicalTrials.gov Identifier: NCT01633931
Recruitment Status : Active, not recruiting
First Posted : July 6, 2012
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ellipse Technologies, Inc.

Brief Summary:
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.

Condition or disease
Adolescent Idiopathic Scoliosis

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
Actual Study Start Date : March 2012
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis
U.S. FDA Resources




Primary Outcome Measures :
  1. Change in major scoliotic curve magnitude [ Time Frame: Change from baseline to 36 months postoperative ]
    Measured in degrees

  2. Number and Types of Adverse Events [ Time Frame: Operative through 36 months postoperative ]

Secondary Outcome Measures :
  1. Radiographic evaluation coronal balance compared to baseline [ Time Frame: Change from baseline to 36 months postoperative ]
  2. Radiographic evaluation sagittal balance compared to baseline [ Time Frame: Change from baseline to 36 months postoperative ]
  3. Percent of patients indicated for surgical spine fusion [ Time Frame: Change from baseline to 36 months postoperative ]
  4. Quality of life assessment via SRS-30 questionnaire [ Time Frame: Change from baseline to 36 months postoperative ]
  5. Comparison of Rib Hump prominence [ Time Frame: Change from baseline to 36 months postoperative ]
  6. Expected vs. Actual Device Lengthening [ Time Frame: All postoperative visits where lengthening is conducted ]


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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Adolescent Idiopathic Diagnosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633931


Locations
Hong Kong
University of Hong Kong
Hong Kong, Pokfulam, Hong Kong
Sponsors and Collaborators
Ellipse Technologies, Inc.
Investigators
Principal Investigator: Behrooz Akbarnia, MD San Diego Center for Spinal Disorders

Additional Information:
Responsible Party: Ellipse Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01633931     History of Changes
Other Study ID Numbers: PR0038
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases