Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
1 other identifier
observational
100
1 country
2
Brief Summary
A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedApril 21, 2015
April 1, 2015
1.8 years
August 22, 2014
April 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Compliance
subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Functionality
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
subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system
Study Arms (1)
Adolescence idiopathic scoliosis
Patients must be at least 10 years of age with a risser score of 0, 1, or 2
Interventions
Providence Nighttime Bracing System
Eligibility Criteria
up to 100 adolescent male/female will be enrolled at up to 4 sites in the US. Patients must be at least 10 years of age. Participants who receive treatment must have been diagnosed with adolescent idiopathic scoliosis without other significant spinal pathology. Appropriate participant selection will be accomplished through the integration of clinical and radiological parameters while ruling out other confounding sources of back pain or curvature. Subjects will be included who demonstrate a Cobb angle between 25-40 degrees. Participants must have radiographic evidence of a Risser grade of 0, 1, or 2. All chronic disease process and other possible sources for spinal curvature will be excluded by thorough history and physical examination.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OrthoGeorgialead
Study Sites (2)
Georgia Pediatric Orthopaedics
Macon, Georgia, 31201, United States
OrthoGeorgia
Macon, Georgia, 31201, United States
Study Officials
- PRINCIPAL INVESTIGATOR
William B Dasher, MD
OrthoGeorgia
- PRINCIPAL INVESTIGATOR
Eric D Lincoln, DO
Georgia Pediatric Orthopaedics
- PRINCIPAL INVESTIGATOR
Winston R Jeshuran, MD
OrthoGeorgia
- PRINCIPAL INVESTIGATOR
Wayne Kelley, MD
OrthoGeorgia
- PRINCIPAL INVESTIGATOR
Randolph Devereaux, PhD
Mercer University School of Medicine
- PRINCIPAL INVESTIGATOR
Hamza H Awad, MD, PhD
Mercer University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic Spine Surgeon
Study Record Dates
First Submitted
August 22, 2014
First Posted
August 28, 2014
Study Start
October 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
April 21, 2015
Record last verified: 2015-04