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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-16
SponsorThinks Works, PBC

About this trial

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. The main questions it aims to answer are:

* Can the RESILIENT brace prevent the spinal curve from progressing beyond 35 degrees during growth? * How much does the brace correct the curve when it is first worn (in-brace correction)? * How well do participants follow the prescribed brace wear time and force levels? * How does wearing the brace affect quality of life and daily activities?

Researchers will study a single group of participants using the RESILIENT brace and evaluate outcomes over time using standard clinical assessments, including X-rays and patient-reported questionnaires.

Participants will:

* Be fitted with the RESILIENT brace and instructed on how to use it * Wear the brace daily according to physician recommendations throughout their growth period * Attend clinic visits at approximately 4-6 weeks after starting treatment and then about every 6 months for follow-up evaluations * Undergo standard-of-care spine X-rays to monitor curve progression * Complete questionnaires about their quality of life and experience with the brace * Have brace wear time and applied forces monitored using sensors embedded in the device

Participants will be followed from the start of brace treatment until they are done growing and have completed treatment.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • The RESILIENT scoliosis brace system

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Thinks Works, PBC

Lead sponsor

Setting Scoliosis Straight Foundation

Collaborator

Nemours Children's Hospital

Collaborator