Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
NCT ID: NCT02227537
Last Updated: 2015-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2014-10-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adolescence idiopathic scoliosis
Patients must be at least 10 years of age with a risser score of 0, 1, or 2
Providence Nighttime Bracing System
Providence Nighttime Bracing System
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.
Interventions
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Providence Nighttime Bracing System
Providence Nighttime Bracing System
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
10 Years
14 Years
ALL
No
Sponsors
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OrthoGeorgia
OTHER
Responsible Party
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William Dasher, MD
Orthopaedic Spine Surgeon
Principal Investigators
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William B Dasher, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoGeorgia
Eric D Lincoln, DO
Role: PRINCIPAL_INVESTIGATOR
Georgia Pediatric Orthopaedics
Winston R Jeshuran, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoGeorgia
Wayne Kelley, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoGeorgia
Randolph Devereaux, PhD
Role: PRINCIPAL_INVESTIGATOR
Mercer University School of Medicine
Hamza H Awad, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mercer University School of Medicine
Locations
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Georgia Pediatric Orthopaedics
Macon, Georgia, United States
OrthoGeorgia
Macon, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OG12-04-13
Identifier Type: -
Identifier Source: org_study_id
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