Status:
WITHDRAWN
Green Sun Medical Dynamic Brace
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
FEMALE
10-15 years
Phase:
NA
Brief Summary
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 wi...
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 wi...
Eligibility Criteria
Inclusion
- 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. If no scan exists, patient must be willing to undergo a scan to allow fabrication of the GSM brace.
- One curve apex below T7
- Female sex (85% of the AIS population is female)
- Ability to read and write English
- Age 10-15 years
Exclusion
- Parents/patients who decline participation and/or do not sign the consent/assent documents
- Pregnant women
- Patients who are unwilling or unable to return for follow-up visits
- Patients who are unable to read and write in English.
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04877236
Start Date
November 21 2019
End Date
July 1 2022
Last Update
November 18 2023
Active Locations (1)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027