Clinical trial NCT01633931: Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
Official title: Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Ellipse Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Adolescent Idiopathic Diagnosis

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.


Eligibility 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

Primary outcomes:
measure: Change in major scoliotic curve magnitude
timeFrame: Change from baseline to 36 months postoperative
measure: Number and Types of Adverse Events
timeFrame: Operative through 36 months postoperative
Secondary outcomes:
measure: Radiographic evaluation coronal balance compared to baseline
timeFrame: Change from baseline to 36 months postoperative
measure: Radiographic evaluation sagittal balance compared to baseline
timeFrame: Change from baseline to 36 months postoperative
measure: Percent of patients indicated for surgical spine fusion
timeFrame: Change from baseline to 36 months postoperative
measure: Quality of life assessment via SRS-30 questionnaire
timeFrame: Change from baseline to 36 months postoperative
measure: Comparison of Rib Hump prominence
timeFrame: Change from baseline to 36 months postoperative
measure: Expected vs. Actual Device Lengthening
timeFrame: All postoperative visits where lengthening is conducted
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
state: Pokfulam
Study officials:
affiliation: San Diego Center for Spinal Disorders
name: Behrooz Akbarnia, MD
role: PRINCIPAL_INVESTIGATOR
References: