Green Sun Medical Dynamic Scoliosis Brace

Adolescent Idiopathic Scoliosis Clinical Trial

— GSM  

Official title:

Green Sun Medical Dynamic Scoliosis Brace

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03641469
• Other study ID #: 1.0
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: May 24, 2024

Study information

• Verified date: September 2023
• Source: Green Sun medical
• Contact: Matthew Thompson
• Phone: 415-722-4872
• Email: matt[@]greensunmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 24, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 15 Years

Eligibility

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. Female sex (85% of the AIS population is female)

6. Ability to read and write English

7. Age 10-15 years

Exclusion Criteria:

1) Parents/patients who decline participation and/or do not sign the consent/assent documents 2) Pregnant women

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Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Green Sun Dynamic Brace
Change from standard-of-care TLSO to GSM brace

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	National Scoliosis Center	Fairfax	Virginia
United States	Children's Mercy Kansas City	Kansas City	Missouri
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Shriners Children's Southern California	Pasadena	California
United States	Shriners Hospitals for Children - Northern California	Sacramento	California
United States	Shriners Children's St. Louis	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Green Sun medical	Children's Healthcare of Atlanta, Children's Hospital Los Angeles, Shriners Children's Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unanticipated adverse events	identify unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues	Through study completion, an average of 18 months
Primary	Difference between in-brace curve correction	Cobb angle in the TLSO compared to in the GSM brace	Baseline (TLSO measurement) to 1 week after GSM brace delivery (GSM measurement)
Primary	Change in Out-of-brace Cobb angle	Change in Cobb angle from baseline to end of study	Baseline to study completion, an average of 18 months
Secondary	Change in Brace-related quality of life scores (Brace Questionnaire)	Change in Brace Questionnaire scores	Baseline to study completion, an average of 18 months
Secondary	Difference in Chest wall range of motion measured by vital capacity	Lung vital capacity measured in the TLSO and in the GSM brace	Baseline