Green Sun Medical Dynamic Scoliosis Brace (GSM)

Green Sun Medical

Status: Completed

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Device: Green Sun Dynamic Brace

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03641469

2.0

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: Female

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

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. Ability to read and write English
6. Age 10-15 years
7. Female sex

Exclusion criteria

1. Parents/patients who decline participation and/or do not sign the consent/assent documents 2) Pregnant women 3) Unwilling or unable to return for follow-up visits

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Green Sun Dynamic Brace

Experimental group

Description:

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.

Treatment:

Device: Green Sun Dynamic Brace