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Completed

NCT Number: NCT03641469

Green Sun Medical Dynamic Scoliosis Brace

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis Behavior Health Behavior Treatment Adherence and Compliance

Age range

10 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Green Sun Dynamic Brace

Device

Change from standard-of-care TLSO to GSM brace

Primary outcomes

  1. Percentage of Participants With Acceptable GSM In-Brace Correction

    Time frame: Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days

    Acceptable GSM in-brace correction was defined as a difference of 10 degrees or less between the TLSO and GSM in-brace Cobb angles.

  2. Percentage of Participants With Curve Stability or Progression at 3-month Follow-up

    Time frame: Baseline to ~3 mo Follow-up

    Curve stability is defined as progression of 10 degrees or less between the Cobb angle at baseline and at follow-up after GSM wear (Baseline Cobb angle minus follow-up Cobb angle).

  3. Unanticipated Adverse Events

    Time frame: Up to 1 year

    Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues

Secondary outcomes

  1. Change in Brace-related Quality of Life Scores (Brace Questionnaire)

    Time frame: Baseline to Visit 3 (3-4 months post-baseline)

    Change in Brace Questionnaire (BrQ) scores from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). Total scores range from 20 to 100, with higher scores suggesting better quality-of-life during bracing. A positive change score suggests increased brace-related QOL related to exposure to the GSM brace.

  2. Change in Quality of Life Scores

    Time frame: Baseline to Visit 3 (3-4 months post-baseline)

    Change in scores on the Italian Spine Youth Quality of Life (ISYQOL) measure from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). The total scores range from 0 to 100% where 100% indicates no problems related to spine or bracing issues. A positive change score suggests increased QOL related to exposure to the GSM brace.

  3. Difference in Vital Capacity Measured in TLSO and GSM Brace

    Time frame: Baseline

    Lung vital capacity measured in the TLSO and in the GSM brace to estimate chest wall movement difference. Positive difference favors GSM.

Sponsors and collaborators

Lead sponsor

Green Sun medical

Industry

Registry information

Acronym: GSM

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2018
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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