Status:
UNKNOWN
Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
Lead Sponsor:
OrthoGeorgia
Conditions:
Adolescence Idiopathic Scoliosis
Eligibility:
All Genders
10-14 years
Brief Summary
A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02227537
Start Date
October 1 2014
End Date
August 1 2016
Last Update
April 21 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgia Pediatric Orthopaedics
Macon, Georgia, United States, 31201
2
OrthoGeorgia
Macon, Georgia, United States, 31201