Idiopathic Scoliosis
Conditions
Keywords
scoliosis, brace, idiopathic scoliosis, flexible brace, semi-rigid brace, adolescent idiopathic scoliosis, AIS, IS
Brief 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.
Interventions
DEVICEThe 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.
Sponsors
Thinks Works, PBC
Setting Scoliosis Straight Foundation
Nemours Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
No
Inclusion 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-Brace Curve Correction at Initial Follow-up | 4 to 6 weeks | 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. | From brace initiation through completion of treatment, approximately up to 36 months | 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 | From baseline to 4 to 6 months after brace discontinuation | 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 | Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months | 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. |
| Scoliosis Research Society-22 (SRS-22) Score | Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months | Patient-reported scoliosis-related quality of life measured using the SRS-22 questionnaire. |
| Patient and Parent Clinical Trial Completion Exit Survey | This survey will be given to patients at the completion of their participation in the study, approximately 24 months. | When the patient has completed the clinical trial the patient and parent(s)/guardians will be given a survey to assess their overall experience with the brace treatment. It has questions with numerical rating scores from 1-5 with 1 being the best outcome score and questions with descriptive ratings from very positive-very negative, strongly agree-strongly disagree, very likely-very unlikely, extremely willing-not willing. |
Countries
United States
Contacts
CONTACTAvery Patient Experience Liaison, Thinks Works
CONTACTRyan C. Murdock, MD, MS. CEO of Thinks Works.
PRINCIPAL_INVESTIGATORSuken A. Shah, MD
Nemours Hospital for Children
Outcome results
None listed