Green Sun Medical Dynamic Scoliosis Brace

Last updated: January 31, 2025
Sponsor: Green Sun medical
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Green Sun Dynamic Brace

Clinical Study ID

NCT03641469
1.0
  • Ages 10-15
  • Female

Study 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

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. Ability to read and write English

  6. Age 10-15 years

  7. Female sex

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Green Sun Dynamic Brace
Phase:
Study Start date:
May 24, 2018
Estimated Completion Date:
May 02, 2024

Study 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.

Connect with a study center

  • Children's Hospital of Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Shriners Children's Southern California

    Pasadena, California 91105
    United States

    Site Not Available

  • Shriners Hospitals for Children - Northern California

    Sacramento, California 95817
    United States

    Site Not Available

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Children's Mercy Kansas City

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Shriners Children's St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • National Scoliosis Center

    Fairfax, Virginia 22031
    United States

    Site Not Available

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