Green Sun Medical Dynamic Scoliosis Brace

NCT03641469 | Completed Results FDA Device

• 1 other identifier: 2.0
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent Idiopathic Scoliosis; thoracolumbosacral orthosis; spinal orthotic; health-related quality of life; treatment adherence

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Acceptable GSM In-Brace Correction

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

  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

  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).

  Baseline to ~3 mo Follow-up

• Unanticipated Adverse Events

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

  Up to 1 year

Secondary Outcomes (3)

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

  Baseline to Visit 3 (3-4 months post-baseline)

• Change in Quality of Life Scores

  Baseline to Visit 3 (3-4 months post-baseline)

• Difference in Vital Capacity Measured in TLSO and GSM Brace

  Baseline

Study Arms (1)

Green Sun Dynamic Brace

EXPERIMENTAL

Historical measures of brace effectiveness (in- and out-of-brace Cobb angles), wear time, and brace-related quality of life will be compared to those measured after the subject is fit with a Green Sun dynamic brace.

Device: Green Sun Dynamic Brace

Interventions

Green Sun Dynamic Brace DEVICE

Change from standard-of-care TLSO to GSM brace

Green Sun Dynamic Brace

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Green Sun medical: lead

Study Sites (7)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Shriners Children's Southern California

Pasadena, California, 91105, United States

Location

Shriners Hospitals for Children - Northern California

Sacramento, California, 95817, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Shriners Children's St. Louis

St Louis, Missouri, 63110, United States

Location

National Scoliosis Center

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

1. Enrollment and data collection was interrupted by COVID (e.g. spirometry testing was suspended) 2. Of the 11 subjects who did not complete the 30 day visit (\>75 days of follow-up), 6 were among the first 10 subjects enrolled.The GSM brace underwent design and materials changes during the trial, especially during the evaluation of the first 10 subjects. 3. One study site shut down before all subjects had finished the protocol, resulting in missing data (n=2)

Results Point of Contact

• Title: James A. Arthur
• Organization: Green Sun Medical

jarthur@greensunmedical.com

720-202-3621

Study Officials

• Jamie Haggard

  Green Sun medical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The outcomes assessor will be blinded to brace type when measuring the out-of-brace x-ray.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Current TLSO users will crossover to use of the GSM brace.

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: August 22, 2018
• Study Start: May 24, 2018
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)