Green Sun Medical Dynamic Scoliosis Brace

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Green Sun Medical Dynamic Scoliosis Brace

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Device: Green Sun Dynamic Brace


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Current TLSO users will crossover to use of the GSM brace.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green Sun Dynamic Brace<br>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. | Device: Green Sun Dynamic Brace<br>* Change from standard-of-care TLSO to GSM brace<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unanticipated adverse events | identify unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues | Through study completion, an average of 18 months | 
| Difference between in-brace curve correction | Cobb angle in the TLSO compared to in the GSM brace | Baseline (TLSO measurement) to 1 week after GSM brace delivery (GSM measurement) | 
| Change in Out-of-brace Cobb angle | Change in Cobb angle from baseline to end of study | Baseline to study completion, an average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brace-related quality of life scores (Brace Questionnaire) | Change in Brace Questionnaire scores | Baseline to study completion, an average of 18 months | 
| Difference in Chest wall range of motion measured by vital capacity | Lung vital capacity measured in the TLSO and in the GSM brace | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent Idiopathic Scoliosis, thoracolumbosacral orthosis, spinal orthotic, health-related quality of life, treatment adherence