Green Sun Medical Dynamic Scoliosis Brace

Green Sun medical36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adolescent Idiopathic Scoliosis

Interventions

Green Sun Dynamic BraceDEVICE

Change from standard-of-care TLSO to GSM brace

Eligibility

Sex: FEMALEMin age: 10 YearsMax age: 15 Years

Medical Language ↔ Plain English

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 Criteria: 1\) 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 \-

Locations (7)

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

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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

Time frame: Up to 1 year

Secondary Outcomes

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

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.

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

Change in Quality of Life Scores

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.

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

Data from ClinicalTrials.gov

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