Green Sun Medical Dynamic Scoliosis Brace (GSM)

Children's Healthcare of Atlanta, Children's Hospital Los Angeles, Shriners Children's Southern California

This is a pilot study to collect preliminary short-term data concerning the safety and performance of the Green Sun Dynamic brace in a sample of subjects with adolescent idiopathic scoliosis who are currently being treated with a TLSO.

The Green Sun Medical Dynamic Brace (GSM) brace was developed as an alternative to rigid thoracolumbosacral orthoses (TLSOs, braces) commonly used to prevent continued curve progression in patients with adolescent idiopathic scoliosis (AIS). The brace applies corrective forces to the muscular and bony structures of the spine while preserving range of motion (ROM). The orthosis is prefabricated and adjusted for each patient. A series of semi-rigid segments encircle the patient's torso in close contact and are joined by a structure of flexible elements. These flexible (or elastic) elements generate stabilizing forces, providing the necessary immobilization while allowing relative motion of the semi-rigid segments. To date, this brace has been tested in the lab on healthy volunteers. This study will recruit patients currently using a TLSO and compare the curve correction achieved in the GSM brace to that in their current brace. After 3 months in the GSM brace, the out-of-brace Cobb angle will be measured and compared to that at enrollment. Safety will be continually assessed. Brace-related quality of life (comfort, stress, interference with activities) will be self-reported. Adherence to the brace prescription will be measured using an in-brace temperature monitor.

Adolescent Idiopathic Scoliosis, thoracolumbosacral orthosis, spinal orthotic, health-related quality of life, treatment adherence

Historical measures of brace effectiveness (in- and out-of-brace Cobb angles), wear time, and brace-related quality of life will be compared to those measured after the subject is fit with a Green Sun dynamic brace.

identify unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues

Inclusion Criteria: Diagnosis of AIS Current treatment with a TLSO, of ≥5 months' duration Existing 3D surface scan of torso and out-of-brace x-ray within the past 6 months One curve apex below T7 Female sex (85% of the AIS population is female) Ability to read and write English Age 10-15 years Exclusion Criteria: 1) Parents/patients who decline participation and/or do not sign the consent/assent documents 2) Pregnant women -