Clinical trial NCT03641469: Green Sun Medical Dynamic Scoliosis Brace
Official title: Green Sun Medical Dynamic Scoliosis Brace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent Idiopathic Scoliosis
thoracolumbosacral orthosis
spinal orthotic
health-related quality of life
treatment adherence
Lead sponsor: Green Sun medical
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 36
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Current TLSO users will crossover to use of the GSM brace.
Primary purpose: TREATMENT

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.

Eligibility 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. 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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Primary outcomes:
measure: Percentage of Participants With Acceptable GSM In-Brace Correction
timeFrame: Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days
measure: Percentage of Participants With Curve Stability or Progression at 3-month Follow-up
timeFrame: Baseline to ~3 mo Follow-up
measure: Unanticipated Adverse Events
timeFrame: Up to 1 year
Secondary outcomes:
measure: Change in Brace-related Quality of Life Scores (Brace Questionnaire)
timeFrame: Baseline to Visit 3 (3-4 months post-baseline)
measure: Change in Quality of Life Scores
timeFrame: Baseline to Visit 3 (3-4 months post-baseline)
measure: Difference in Vital Capacity Measured in TLSO and GSM Brace
timeFrame: Baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Pasadena
country: United States
facility: Shriners Children's Southern California
state: California
city: Sacramento
country: United States
facility: Shriners Hospitals for Children - Northern California
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Shriners Children's St. Louis
state: Missouri
city: Fairfax
country: United States
facility: National Scoliosis Center
state: Virginia
Study officials:
affiliation: Green Sun medical
name: Jamie Haggard
role: PRINCIPAL_INVESTIGATOR
References: