N/A
Completed N=36
Green Sun Medical Dynamic Scoliosis Brace
Source: ClinicalTrials.gov NCT03641469 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Percentage of Participants With Acceptable GSM In-Brace Correction — 100 Percentage acceptable GSM correction
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Acceptable GSM In-Brace Correction |
100 | — |
| PRIMARY Percentage of Participants With Curve Stability or Progression at 3-month Follow-up |
18 | — |
| PRIMARY Unanticipated Adverse Events |
1 | — |
| SECONDARY Change in Brace-related Quality of Life Scores (Brace Questionnaire) |
3.82 | — |
| SECONDARY Change in Quality of Life Scores |
5.36 | — |
| SECONDARY Difference in Vital Capacity Measured in TLSO and GSM Brace |
82.81 | — |
Eligibility Criteria
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
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Data sourced from ClinicalTrials.gov (NCT03641469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.