None listed
Conditions
Brief summary
This is a study to collect data in a controlled manner on the use of the MAGEC Spinal Bracing and Distraction System in patients with Adolescent Idiopathic Scoliosis (AIS) who have failed external bracing therapy.
Interventions
The Ellipse MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that is surgically implanted using appropriate commercially available fixations components (i.e. pedicle screws, hooks, and/or connectors). The system includes a non-sterile hand held External Remote Controller that is used at various times after implant to non-invasively lengthen or shorten the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimi
The Ellipse MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that is surgically implanted using appropriate commercially available fixations components (i.e. pedicle screws, hooks, and/or connectors). The system includes a non-sterile hand held External Remote Controller that is used at various times after implant to non-invasively lengthen or shorten the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The rod includes a small internal magnet which allows the rod to be lengthened by use of the External Remote Controller. The MAGEC device is approved for commercial use in New Zealand and also is CE-marked. The duration of the implant procedure is approximately 1.5 - 2.5 hours, depending on the surgeon's preferred construct. The duration the device remains in place is prescribed by the physician and differs per patient. The device may remain in the patient for up to 5 years.
Sponsors
Ellipse Technologies, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
10 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of Adolescent Idiopathic Scoliosis; Failed external brace therapy; Skeletally immature; Age between 10 and 15; Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion.
Exclusion criteria
Patients with pacemaker, implanted cardiac defibrillator, or any other electronic implant; Patients who require an MRI following implantation, Patients who are pregnant or nursing.
Outcome results
None listed