Adolescent Idiopathic Scoliosis
Conditions
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.
Interventions
None listed
Sponsors
Ellipse Technologies, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in major scoliotic curve magnitude | Change from baseline to 36 months postoperative | Measured in degrees |
| Number and Types of Adverse Events | Operative through 36 months postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic evaluation coronal balance compared to baseline | Change from baseline to 36 months postoperative |
| Radiographic evaluation sagittal balance compared to baseline | Change from baseline to 36 months postoperative |
| Comparison of Rib Hump prominence | Change from baseline to 36 months postoperative |
| Quality of life assessment via SRS-30 questionnaire | Change from baseline to 36 months postoperative |
| Percent of patients indicated for surgical spine fusion | Change from baseline to 36 months postoperative |
| Expected vs. Actual Device Lengthening | All postoperative visits where lengthening is conducted |
Countries
Hong Kong
Outcome results
None listed