Adolescent Idiopathic ScoliosisGSMNCT03641469
Green Sun Medical Dynamic Scoliosis Brace
A study testing Green Sun Dynamic Brace in people with Adolescent Idiopathic Scoliosis, run by Green Sun medical at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Green Sun Dynamic Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 May 2018to 2 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
National Scoliosis Center
Fairfax, Virginia, 22031
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Shriners Children's Southern California
Pasadena, California, 91105
Shriners Hospitals for Children - Northern California
Sacramento, California, 95817
Shriners Children's St. Louis
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Green Sun Dynamic Brace
- Keywords
- Adolescent Idiopathic Scoliosis, thoracolumbosacral orthosis, spinal orthotic, health-related quality of life, treatment adherence
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Sun Dynamic BraceDevice
Change from standard-of-care TLSO to GSM brace
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Green Sun Dynamic Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: Up to 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start24 May 2018
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Current TLSO users will crossover to use of the GSM brace.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Sun medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamie Haggard, Principal investigator, Green Sun medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641469
- Sponsor's protocol ID
- 2.0
- Acronym
- GSM
- Status last verified
- May 2025
- First submitted
- 31 May 2018
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Sun Medical Dynamic Scoliosis Brace
- ClinicalTrials.gov ID
- NCT03641469
- Acronym / sponsor ID
- GSM / 2.0
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, thoracolumbosacral orthosis, spinal orthotic, health-related quality of life, treatment adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Green Sun medicalIndustry (pharma, biotech, devices)
- Study start
- 24 May 2018 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Current TLSO users will crossover to use of the GSM brace.
| Arm | Type | Receives |
|---|---|---|
| Green Sun Dynamic Brace | Experimental | Device: Green Sun Dynamic BraceHistorical 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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green Sun Dynamic BraceChange from standard-of-care TLSO to GSM brace | Device | Green Sun Dynamic Brace |
Primary outcome
Percentage of Participants With Acceptable GSM In-Brace Correction
Time frame: 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.
Percentage of Participants With Curve Stability or Progression at 3-month Follow-up
Time frame: 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).
Unanticipated Adverse Events
Time frame: Up to 1 year
Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues
3 secondary outcomes
Change in Brace-related Quality of Life Scores (Brace Questionnaire)
Time frame: Baseline to Visit 3 (3-4 months post-baseline)
Change in Quality of Life Scores
Time frame: Baseline to Visit 3 (3-4 months post-baseline)
Difference in Vital Capacity Measured in TLSO and GSM Brace
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Haggard principal investigator
Green Sun medical
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Sun Dynamic Brace in people with Adolescent Idiopathic Scoliosis, run by Green Sun medical at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Acceptable GSM In-Brace Correction (time frame: Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.