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.
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.
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
Single group
The RESILIENT scoliosis brace system
DeviceThe RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time.
Treatment Success Based on Curve Progression at Skeletal Maturity
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.
In-Brace Curve Correction at Initial Follow-up
Percent reduction in the primary right main thoracic Cobb angle on standing in-brace posteroanterior spine radiographs obtained at the 4- to 6-week follow-up visit, compared with baseline standing radiographs obtained prior to brace treatment.
Measurement of brace use compliance as a percentage of prescribed use.
Percent compliance with prescribed daily brace wear time and prescribed apex strap force, as measured by force sensors integrated into the brace and recorded in the monitoring system.
Change in Curve Magnitude Following Completion of Brace Treatment
Percent change in the primary right main thoracic Cobb angle from baseline to the final follow-up radiograph obtained after brace discontinuation.
PROMIS Pediatric Quality of Life Scores
Patient-reported outcomes measured using PROMIS pediatric modules. Theses are rated using a numeric rating scale. Physical function-mobility is scored 1-4 with 4 being the best outcome score. Peer relationships is scored 1-5 with 5 being the best outcome score. Depressive symptoms is scored 1-5 with 1 being the best outcome score.
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Thinks Works, PBC
Lead sponsor
Setting Scoliosis Straight Foundation
Collaborator
Nemours Children's Hospital
Collaborator
