Green Sun Medical Dynamic Brace

NCT04877236 | Withdrawn DMC FDA Device

• 1 other identifier: CHLA-19-00293
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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 innovative design of this brace should provide an equivalent degree of correction of the scoliotic curvature as a rigid TLSO, with increased acceptability to the patient via improved comfort and spinal/chest wall mobility. Increased acceptability promotes increased adherence to treatment. This is a pilot study to collect preliminary short-term data concerning the safety and performance of the GSM brace in a sample of subjects with AIS who are currently being treated with a TLSO. The study will use clinical exams, x-rays, monitoring equipment, and questionnaires to primarily assess safety and performance. Secondary endpoints include spinal ROM and lung vital capacity assessment, as well as data validation. The study involves 3 visits, a performance check phone call, and 4 follow up calls over a four month span. This is a pilot study and no formal hypothesis testing will be done. Descriptive statistics of selected variables will be calculated.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (5)

• Cobb Angle (Visit 2)

  Visit 2 GSM in-brace Cobb angle compared to that in the TLSO at baseline

  Visit 2 (1 week after baseline)

• Cobb Angle (Visit 3)

  2\. Visit 3 out of brace Cobb angle compared to measurements from the most recent out of brace radiograph

  Visit 3 (3 months after Baseline)

• GSM Brace wear time

  3\. Average hours of GSM brace wear per day over the 3 month trial period (temperature monitor data)

  Visit 3 (3 months after baseline)

• Brace questionnaire

  Change in scores on the Brace Questionnaire from baseline to the 3 month Visit. Brace questionnaire minimum/maximum values: 0-34 min/max values; lower score is defined as positive feeling/outcome of brace wear while higher score shows negative feeling/outcome towards brace.

  Visit 3 (3 months after baseline)

• Italian Spine Youth Quality of Life

  Change in scores of the Italian Spine Youth Quality of Life (ISYQOL) from baseline to the 3 month Visit. ISYQOL minimum/maximum values: 1-10 min/max values; lower value is defined as disliking brace while higher value is defined as "loving" brace.

  Visit 3 (3 months after baseline)

Secondary Outcomes (3)

• % Full Vital Capacity Lung Function Test

  Visit 1 (baseline)

• Range of Motion (flexion, extension, side bend)

  Visit 1 (baseline)

• Accelerometer data

  Visit 3 (3 months after baseline)

Study Arms (1)

Green Sun Medical Brace

EXPERIMENTAL

This study only has one arm, administration of the Green Sun Medical Whisper Brace.

Device: Green Sun Medical Brace

Interventions

Green Sun Medical Brace DEVICE

All patients in the study will receive the Green Sun Medical Whisper Brace. Each GSM brace will be custom-fabricated via computer-assisted design using the 3D torso scans and a treatment plan (e.g. placement of corrective forces) devised by the treating orthotist as inputs. The brace components are then assembled. Once fabricated, the GSM brace will be fit to the subject by representatives of the manufacturer and in consultation with the treating orthotist. The GSM brace will be prescribed for the same number of hours per day as was the TLSO (generally 18-22 hours per day, individualized based on patient characteristics). Subjects and the family will be shown how to don and doff the brace, how to clean the brace cover, how to remove the temperature monitor, and how to remove the iButton and how to replace batteries in the GSM sensor board.

Green Sun Medical 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. If no scan exists, patient must be willing to undergo a scan to allow fabrication of the GSM brace.
• One curve apex below T7
• Female sex (85% of the AIS population is female)
• Ability to read and write English
• Age 10-15 years

You may not qualify if:

• Parents/patients who decline participation and/or do not sign the consent/assent documents
• Pregnant women
• Patients who are unwilling or unable to return for follow-up visits
• Patients who are unable to read and write in English.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Study Officials

• Kenneth Illingworth, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 7, 2021
• Study Start: November 21, 2019
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)