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.

Condition(s) studied

Investigational drug(s) / intervention(s)

The RESILIENT scoliosis brace system: The RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time.

Study summary

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

Primary outcome measure(s)

• Treatment Success Based on Curve Progression at Skeletal Maturity — From baseline to skeletal maturity (approximately up to 36 months)
  Treatment success is defined as a right main thoracic Cobb angle less than or equal to 35 degrees at skeletal maturity. Treatment failure is defined as progression of the curve to greater than 35 degrees at any time during the treatment period. Cobb angle measurements are obtained from standing posteroanterior spine radiographs and assessed by independent reviewers blinded to patient information. Skeletal maturity is defined as a Sanders Skeletal Maturity Score of ≥7B, absence of longitudinal height increase over the preceding 6 months, and, for female participants, at least 18 months post-menarche.

Trial sites (1)

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