Green Sun Medical Dynamic Scoliosis Brace

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2024-05-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The outcomes assessor will be blinded to brace type when measuring the out-of-brace x-ray.

Study Groups

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Green Sun Dynamic Brace

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.

Group Type EXPERIMENTAL

Green Sun Dynamic Brace

Intervention Type DEVICE

Change from standard-of-care TLSO to GSM brace

Interventions

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Green Sun Dynamic Brace

Change from standard-of-care TLSO to GSM brace

Intervention Type DEVICE

Eligibility Criteria

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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

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Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No