A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Providence Nighttime Bracing System
The Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis.
Georgia Pediatric Orthopaedics
Macon, Georgia, United States
RECRUITINGOrthoGeorgia
Macon, Georgia, United States
RECRUITINGCurve 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.
Time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
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.
Time frame: 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")
Time frame: 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")
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Time frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system