Green Sun Medical Dynamic Scoliosis Brace

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.

Inclusion Criteria:

1. Diagnosis of AIS

2. Current treatment with a TLSO, of ≥5 months' duration

3. Existing 3D surface scan of torso and out-of-brace x-ray within the past 6 months

4. One curve apex below T7

5. Female sex (85% of the AIS population is female)

6. Ability to read and write English

7. Age 10-15 years

Exclusion Criteria:

1) Parents/patients who decline participation and/or do not sign the consent/assent
documents 2) Pregnant women