Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
Status unconfirmed
Conditions studied: Adolescence Idiopathic Scoliosis
In brief
A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.
Key facts
- Study ID
- NCT02227537
- Run by
- OrthoGeorgia
- People needed
- 100
- Starts
- 2014-10-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2015-04-21
Who can join
Age: 10 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Georgia Pediatric Orthopaedics — Macon, Georgia, United States (enrolling)
- OrthoGeorgia — Macon, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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