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New treatment option for Idiopathic Scoliosis
Official title A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis.
ClinicalTrials.gov ID: NCT07574632
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if the RESILIENT Scoliosis Brace System works to treat children with idiopathic scoliosis. It will also learn about the safety, comfort, and usability of the brace.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 16
You may be able to join if
- Diagnosis of Idiopathic Scoliosis (IS)
- Age of 9 - 16 years when brace treatment is prescribed
- Primary right apex main thoracic scoliosis curve with an apex of T6 or lower
- Cobb angle, as measured on a standing PA spine x-ray, 20 degrees or larger and 30 degrees or less, obtained no more than 6 weeks prior to trial...
- Sanders Skeletal Maturity Score of 1-5
You likely can't join if
- Scoliosis other than idiopathic scoliosis: e.g. Neuromuscular, Congenital, or Syndrome Related
- Age less than 9 years or older than 16 years
- Sanders Skeletal Maturity Score of 6 or greater
- Primary Left apex thoracic scoliosis
- Primary lumbar scoliosis
- Primary Right Thoracic curve with an apex above T6
See the full eligibility criteria
- Diagnosis of Idiopathic Scoliosis (IS)
- Age of 9 - 16 years when brace treatment is prescribed
- Primary right apex main thoracic scoliosis curve with an apex of T6 or lower
- Cobb angle, as measured on a standing PA spine x-ray, 20 degrees or larger and 30 degrees or less, obtained no more than 6 weeks prior to trial enrollment.
- Sanders Skeletal Maturity Score of 1-5
- No prior brace treatment or surgery for scoliosis
- Patient \& guardian select the RESILIENT brace for treatment
- The guardian must confirm that there is cellular connectivity at the place(s) where the patient lives
- Scoliosis other than idiopathic scoliosis: e.g. Neuromuscular, Congenital, or Syndrome Related
- Age less than 9 years or older than 16 years
- Sanders Skeletal Maturity Score of 6 or greater
- Primary Left apex thoracic scoliosis
- Primary lumbar scoliosis
- Primary Right Thoracic curve with an apex above T6
- Inability to remove and apply the brace independently
- Inability to respond to written and verbal questions
- Patient \& Guardian select traditional TLSO for treatment
- Guardian confirms there is no cellular connectivity at the place(s) where the patient lives
The study team makes the final eligibility decision.
Where it's taking place
- Wilmington, Delaware, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wilmington, Delaware, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.