Fairfax, Virginia 22031


Purpose:

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.


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 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.


Criteria:

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. Female sex (85% of the AIS population is female) 6. Ability to read and write English 7. Age 10-15 years Exclusion Criteria: 1) Parents/patients who decline participation and/or do not sign the consent/assent documents 2) Pregnant women


NCT ID:

NCT03641469


Primary Contact:

Principal Investigator
Luke Stikeleather, BSW, CO
National Scoliosis Center

Luke Stikeleather, BSW, CO
Phone: (703) 849-8808
Email: luke@nationalscoliosiscenter.com


Backup Contact:

Email: lori-dolan@uiowa.edu
Lori Dolan, PhD
Phone: 319-356-1075


Location Contact:

Fairfax, Virginia 22031
United States

Luke Stikeleather, BSW, CO
Phone: 703-849-8808
Email: luke@nationalscoliosiscenter.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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