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Green Sun Medical Dynamic Brace

NCT04877236 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

DEVICE

Green Sun Medical Brace

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.

Sponsors & Collaborators

Principal Investigators

  • Kenneth Illingworth, MD · Children's Hospital Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-21
Primary Completion
2021-12-31
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877236 on ClinicalTrials.gov