Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ellipse Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01633931
First received: July 2, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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
Adolescent Idiopathic Scoliosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

Resource links provided by NLM:


Further study details as provided by Ellipse Technologies, Inc.:

Primary Outcome Measures:
  • Change in major scoliotic curve magnitude [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
    Measured in degrees

  • Number and Types of Adverse Events [ Time Frame: Operative through 36 months postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Radiographic evaluation coronal balance compared to baseline [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
  • Radiographic evaluation sagittal balance compared to baseline [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
  • Percent of patients indicated for surgical spine fusion [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
  • Quality of life assessment via SRS-30 questionnaire [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
  • Comparison of Rib Hump prominence [ Time Frame: Change from baseline to 36 months postoperative ] [ Designated as safety issue: No ]
  • Expected vs. Actual Device Lengthening [ Time Frame: All postoperative visits where lengthening is conducted ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Ellipse Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01633931     History of Changes
Other Study ID Numbers: PR0038
Study First Received: July 2, 2012
Last Updated: June 18, 2014
Health Authority: Hong Kong: Ethics Committee

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

ClinicalTrials.gov processed this record on October 29, 2014