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| Name | Class |
|---|---|
| Setting Scoliosis Straight Foundation | OTHER |
| Nemours Children's Hospital | OTHER |
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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:
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:
Participants will be followed from the start of brace treatment until they are done growing and have completed treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RESILIENT Scoliosis Brace System | Experimental | Patients will be fitted with a novel semi-rigid, low-profile, adjustable, and modular scoliosis brace with embedded sensors measuring force and wear time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The RESILIENT scoliosis brace system | Device | The RESILIENT brace is a novel semi-rigid (flexible), concealable, adjustable and modular brace with embedded sensors measuring force and wear time. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to skeletal maturity (approximately up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avery Patient Experience Liaison, Thinks Works | Contact | 844-542-7374 | hello@thinksworks.com | |
| Ryan C. Murdock, MD, MS. CEO of Thinks Works. | Contact | info@thinksworks.com |
| Name | Affiliation | Role |
|---|---|---|
| Suken A. Shah, MD | Nemours Hospital for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours/Alfred I. duPont Hospital for Children | Recruiting | Wilmington | Delaware | 19803 | United States |
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|
| 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. |
| From brace initiation through completion of treatment, approximately up to 36 months |
| 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. | From baseline to 4 to 6 months 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. | Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months |
| Scoliosis Research Society-22 (SRS-22) Score | Patient-reported scoliosis-related quality of life measured using the SRS-22 questionnaire. | Baseline and longitudinal follow-up visits throughout the study, approximately up to 36 months |
| Patient and Parent Clinical Trial Completion Exit Survey | 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. | This survey will be given to patients at the completion of their participation in the study, approximately 24 months. |
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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