Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis

Study Overview
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Brief Summary
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A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.

Detailed Description
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This study is designed as a multicenter, prospective, non-randomized, single arm observational study. A temperature probe and data logger will be attached to the Providence brace to monitor patient compliance wear time. Subjects will be blinded to temperature sensor readings to maximize objectivity of brace wear.

Official Title
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Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis

Conditions
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Adolescence Idiopathic Scoliosis

Intervention / Treatment
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* Device: Providence Nighttime Bracing System
* Device: Providence Nighttime Bracing System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject/guardian is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form; Clinical/radiographic diagnosis of adolescence idiopathic scoliosis; Male/female; Skeletally immature (Risser grade 0, 1, or 2); Cobb angle between 25-40 degrees; Pre-menarchal or post-menarchal by no more than 1 year at the time of diagnosis; Curve apex caudal to T6 vertebrae; Physical and mental ability to adhere to bracing protocol; Have agreed to refuse participation in another clinical trial for the duration of the study. Exclusion Criteria: History of previous surgical intervention or other invasive treatment for AIS; History of orthotic treatment or other brace wear for the treatment of AIS; Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature; Tumor or malignant tumor in the spine; Inability to communicate clearly in the English language; Subjects with a Risser score ≥ 3; Plans to relocate within the next 2 years; Any subject the Principle Investigator deems as an unfit candidate.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescence idiopathic scoliosis<br>Patients must be at least 10 years of age with a risser score of 0, 1, or 2 | Device: Providence Nighttime Bracing System<br>* Providence Nighttime Bracing System<br>Device: Providence Nighttime Bracing System<br>* The Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curve progression | The percentage of patients who have ≤5o curve progression and the percentage of patients who have ≥6 o progression at maturity; The percentage of patients with curves exceeding 45o at maturity and the percentage who have had surgery recommended/undergone; 2 year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery. Routine follow-up visits will be scheduled 6 months apart (1st visit after brace fitting, 6, 12, 18 and 24 months) up to 24 months. At each of these visits, the patient will undergo a history & physical, PA radiographs, Cobb Angle assessment, Adams Forward Bending test, Neurological examination, outcome questionnaire's, concomitant medications, and adverse event recordings. | subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | A temperature data logger will record and monitor patient compliance of brace wear. To not create undue awareness to these recordings patients will be informed the temperature readings are being monitored for patient comfort and ease of brace wear. Reconciliation of data logger recordings will be conducted every 3 months. | subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system | 
| Functionality | Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI (Pediatric Outcomes Data Collection Instrument) | subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system | 
| physical health and personal image | Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI (Pediatric Outcomes Data Collection Instrument) | subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Providence, Adolescence Idiopathic Scoliosis, nighttime Bracing