Green Sun Medical Dynamic Scoliosis Brace

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Exclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Acceptable GSM In-Brace Correction	Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days	Acceptable GSM in-brace correction was defined as a difference of 10 degrees or less between the TLSO and GSM in-brace Cobb angles.
Unanticipated Adverse Events	Up to 1 year	Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues
Percentage of Participants With Curve Stability or Progression at 3-month Follow-up	Baseline to ~3 mo Follow-up	Curve stability is defined as progression of 10 degrees or less between the Cobb angle at baseline and at follow-up after GSM wear (Baseline Cobb angle minus follow-up Cobb angle).

Secondary Outcome Measures

Name	Time	Method
Change in Brace-related Quality of Life Scores (Brace Questionnaire)	Baseline to Visit 3 (3-4 months post-baseline)	Change in Brace Questionnaire (BrQ) scores from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). Total scores range from 20 to 100, with higher scores suggesting better quality-of-life during bracing. A positive change score suggests increased brace-related QOL related to exposure to the GSM brace.
Change in Quality of Life Scores	Baseline to Visit 3 (3-4 months post-baseline)	Change in scores on the Italian Spine Youth Quality of Life (ISYQOL) measure from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). The total scores range from 0 to 100% where 100% indicates no problems related to spine or bracing issues. A positive change score suggests increased QOL related to exposure to the GSM brace.
Difference in Vital Capacity Measured in TLSO and GSM Brace	Baseline	Lung vital capacity measured in the TLSO and in the GSM brace to estimate chest wall movement difference. Positive difference favors GSM.

Locations (7): Children's Hospital of Los Angeles
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Los Angeles, California, United States
Shriners Children's Southern California
🇺🇸
Pasadena, California, United States
Shriners Hospitals for Children - Northern California
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Sacramento, California, United States
Children's Healthcare of Atlanta
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Atlanta, Georgia, United States
Children's Mercy Kansas City
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Kansas City, Missouri, United States
Shriners Children's St. Louis
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Saint Louis, Missouri, United States
National Scoliosis Center
🇺🇸
Fairfax, Virginia, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States