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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Green Sun Dynamic Brace | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green Sun Dynamic Brace | Device | Change from standard-of-care TLSO to GSM brace |
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| 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 |
| 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. |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Jamie Haggard | Green Sun medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Shriners Children's Southern California |
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36 patients with AIS were enrolled at 6 centers across the US. Recruitment opened May 2018 and continued until January 2024. Enrollment and study procedures were interrupted for several months by COVID in 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Green Sun Dynamic Brace | TLSO at Baseline followed by GSM brace for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Excluding 2 enrolled but ineligible subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Green Sun Dynamic Brace | Eligible subjects treated with a TLSO at baseline |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 24 subjects had x-rays in the TLSO and the GSM taken within a 60-day time frame. | Posted | Number | Percentage acceptable GSM correction | Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days |
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Up to 1 year
Any untoward or unfavorable medical occurrence in a participant, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Teams were asked to continuously surveil for AE's during study visits and phone contacts; all AE's were to be reported using a standard case report form. AE's prior to switch to GSM brace at baseline were not recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Green Sun Dynamic Brace | Use of the Green Sun Dynamic Brace | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pressure point of skin related to device | Skin and subcutaneous tissue disorders | SNOMEDCT_US_2024_09_ | Systematic Assessment | Subject reported skin irritation in the left axillary area while wearing the GSM brace. The brace was altered and the irritation was resolved without need for medical intervention. Classified as "mild", "expected", "related" to the device. |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James A. Arthur | Green Sun Medical | 720-202-3621 | jarthur@greensunmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2021 | Mar 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Current TLSO users will crossover to use of the GSM brace.
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The outcomes assessor will be blinded to brace type when measuring the out-of-brace x-ray.
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| 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 |
| Pasadena |
| California |
| 91105 |
| United States |
| Shriners Hospitals for Children - Northern California | Sacramento | California | 95817 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | United States |
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | United States |
| Shriners Children's St. Louis | St Louis | Missouri | 63110 | United States |
| National Scoliosis Center | Fairfax | Virginia | 22031 | United States |
| Protocol Violation |
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| Lost to Follow-up |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Out-of-brace Cobb angle at Baseline | Baseline Cobb angle measurements (from x-ray taken within 180 days prior to baseline) not available for 6 subjects | Mean | Standard Deviation | degrees |
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| Primary | 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). | 28 patients had baseline out-of-brace x-rays taken within 6 months of enrollment | Posted | Count of Participants | Participants | Baseline to ~3 mo Follow-up |
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| Primary | Unanticipated Adverse Events | Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues | Posted | Number | number of AE's reported | Up to 1 year |
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| Secondary | 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. | 14 subjects with both baseline and follow-up BrQ scores for analysis. | Posted | Median | Full Range | Units on the scale | Baseline to Visit 3 (3-4 months post-baseline) |
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| Secondary | 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. | 12 subjects had baseline and follow-up ISYQOL scores for analysis | Posted | Median | Full Range | change in percentage QOL | Baseline to Visit 3 (3-4 months post-baseline) |
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| Secondary | 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. | Participants tested prior to March 2020, after which spirometry testing was stopped due to COVID | Posted | Mean | Standard Deviation | milliliters | Baseline |
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| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
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Agreements are not uniform across the sites. The most restrictive agreement states that the site PI and sponsor agree present results only together with the other clinical study sites unless specific written permission is obtained in advance from Sponsor up to 1 year post-completion. After that, the PI can publish/present independently if Sponsor is given the opportunity to review and comment prior to dissemination.