N/A N=36 Treatment

Green Sun Medical Dynamic Scoliosis Brace

Adolescent Idiopathic Scoliosis

Bottom Line

View on ClinicalTrials.gov: NCT03641469 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Percentage of Participants With Acceptable GSM In-Brace Correction — 100 Percentage acceptable GSM correction

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Green Sun Dynamic Brace (Device)
Age: Pediatric · 10+ yrs
Sex: Female
Sponsor: Green Sun medical
Primary completion: May 2024

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	—

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.

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

View full record on ClinicalTrials.gov →

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.