Adolescent Idiopathic Scoliosis
Conditions
Keywords
Adolescent Idiopathic Scoliosis, thoracolumbosacral orthosis, spinal orthotic, health-related quality of life, treatment adherence
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.
Interventions
DEVICEGreen Sun Dynamic Brace
Change from standard-of-care TLSO to GSM brace
Sponsors
Green Sun medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The outcomes assessor will be blinded to brace type when measuring the out-of-brace x-ray.
Intervention model description
Current TLSO users will crossover to use of the GSM brace.
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 15 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Unanticipated Adverse Events | Up to 1 year | Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Green Sun Dynamic Brace Eligible subjects treated with a TLSO at baseline | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Green Sun Dynamic Brace | — |
|---|---|---|
| Age, Categorical <=18 years | 34 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Out-of-brace Cobb angle at Baseline | 30.68 degrees STANDARD_DEVIATION 9.16 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 34 participants | — |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 1 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
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.
Time frame: Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days
Population: 24 subjects had x-rays in the TLSO and the GSM taken within a 60-day time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Green Sun Dynamic Brace | Percentage of Participants With Acceptable GSM In-Brace Correction | 100 Percentage acceptable GSM correction |
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).
Time frame: Baseline to ~3 mo Follow-up
Population: 28 patients had baseline out-of-brace x-rays taken within 6 months of enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Green Sun Dynamic Brace | Percentage of Participants With Curve Stability or Progression at 3-month Follow-up | 18 Participants |
Primary
Unanticipated Adverse Events
Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues
Time frame: Up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Green Sun Dynamic Brace | Unanticipated Adverse Events | 1 number of AE's reported |
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.
Time frame: Baseline to Visit 3 (3-4 months post-baseline)
Population: 14 subjects with both baseline and follow-up BrQ scores for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Green Sun Dynamic Brace | Change in Brace-related Quality of Life Scores (Brace Questionnaire) | 3.82 Units on the scale |
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.
Time frame: Baseline to Visit 3 (3-4 months post-baseline)
Population: 12 subjects had baseline and follow-up ISYQOL scores for analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Green Sun Dynamic Brace | Change in Quality of Life Scores | 5.36 change in percentage QOL |
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.
Time frame: Baseline
Population: Participants tested prior to March 2020, after which spirometry testing was stopped due to COVID
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Green Sun Dynamic Brace | Difference in Vital Capacity Measured in TLSO and GSM Brace | 82.81 milliliters | Standard Deviation 470.8 |