Green Sun Medical Dynamic Scoliosis Brace
- Conditions
- Adolescent Idiopathic Scoliosis
- Interventions
- Device: Green Sun Dynamic Brace
- Registration Number
- NCT03641469
- Lead Sponsor
- Green Sun medical
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
- 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
- One curve apex below T7
- Ability to read and write English
- Age 10-15 years
- Female sex
- Parents/patients who decline participation and/or do not sign the consent/assent documents 2) Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Green Sun Dynamic Brace 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.
- Primary Outcome Measures
Name Time Method Difference between in-brace curve correction Baseline (TLSO measurement) to 1 week after GSM brace delivery (GSM measurement) Cobb angle in the TLSO compared to in the GSM brace
Change in Out-of-brace Cobb angle Baseline to study completion, an average of 18 months Change in Cobb angle from baseline to end of study
Unanticipated adverse events Through study completion, an average of 18 months identify unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues
- Secondary Outcome Measures
Name Time Method Difference in Chest wall range of motion measured by vital capacity Baseline Lung vital capacity measured in the TLSO and in the GSM brace
Change in Brace-related quality of life scores (Brace Questionnaire) Baseline to study completion, an average of 18 months Change in Brace Questionnaire scores
Trial Locations
- 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
Children's Mercy Kansas City
🇺🇸Kansas City, Missouri, United States
Shriners Children's St. Louis
🇺🇸Saint Louis, Missouri, United States
National Scoliosis Center
🇺🇸Fairfax, Virginia, United States