CompletedNot Applicable

Green Sun Medical Dynamic Scoliosis Brace

United States36 participantsStarted 2018-05-24

Plain-language 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.

Who can participate

Age range10 Years – 15 Years

SexFEMALE

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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

What they're measuring

Percentage of Participants With Acceptable GSM In-Brace Correction

Timeframe: 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

Timeframe: Baseline to ~3 mo Follow-up

Unanticipated Adverse Events

Timeframe: Up to 1 year

Trial details

NCT IDNCT03641469

SponsorGreen Sun medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-02

Results submitted2025-04-08

View on ClinicalTrials.gov More Adolescent Idiopathic Scoliosis trials