Evaluating the RESILIENT Semi-Rigid Brace to Limit Curve Progression in Children Aged 9 to 16 with Idiopathic Scoliosis

What this Trial Is About

Researchers are evaluating the RESILIENT Scoliosis Brace System in children with idiopathic scoliosis to see if it can prevent the spinal curve from worsening beyond 35 degrees during growth. This study also aims to learn about the safety, comfort, and usability of this semi-rigid, adjustable brace while monitoring how well participants follow the prescribed wear time and force levels. The study focuses on children aged 9 to 16 years with specific types of scoliosis and skeletal maturity scores. Participants will be fitted with the RESILIENT brace, which includes sensors to track force and wear time. They will wear the brace daily as recommended by their physician throughout their growth period. Clinic visits will occur about 4 to 6 weeks after starting treatment and then approximately every 6 months. Standard spine X-rays will be taken to monitor curve progression, and participants will complete questionnaires about quality of life and their experience with the brace. During the study, participants will be followed from the beginning of brace treatment until they finish growing and complete treatment, which may take up to 36 months. Researchers will evaluate treatment success based on spine curve progression at skeletal maturity and examine in-brace curve correction, brace use compliance, and changes in curve magnitude after treatment ends. Quality of life will be assessed using patient-reported measures throughout the study, and an exit survey will be completed at study completion.

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.