Green Sun Medical Dynamic Scoliosis Brace (GSM)

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Device: Green Sun Dynamic Brace

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
    • Pasadena, California, United States, 91105
      • Shriners Children's Southern California
    • Sacramento, California, United States, 95817
      • Shriners Hospitals for Children - Northern California
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Healthcare of Atlanta
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Shriners Children's St. Louis
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • National scoliosis center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Green Sun Dynamic Brace; 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; Change from standard-of-care TLSO to GSM brace

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brace-related Quality of Life Scores (Brace Questionnaire)	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.	Baseline to Visit 3 (3-4 months post-baseline)
Change in Quality of Life Scores	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.	Baseline to Visit 3 (3-4 months post-baseline)
Difference in Vital Capacity Measured in TLSO and GSM Brace	Lung vital capacity measured in the TLSO and in the GSM brace to estimate chest wall movement difference. Positive difference favors GSM.	Baseline

Collaborators and Investigators

• Sponsor: Green Sun medical
• Collaborators: Children's Healthcare of Atlanta; Children's Hospital Los Angeles; Shriners Children's Southern California
• Investigators: Principal Investigator: Jamie Haggard, Green Sun medical

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: health-related quality of life; treatment adherence; Adolescent Idiopathic Scoliosis; thoracolumbosacral orthosis; spinal orthotic
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No