Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis

OrthoGeorgia

Status

Unknown

Conditions

Adolescence Idiopathic Scoliosis

Treatments

Device: Providence Nighttime Bracing System

Study type

Observational

Funder types

Other

Identifiers

NCT02227537

OG12-04-13

Details and patient eligibility

About

A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.

Full 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 compliance wear time. Subjects will be blinded to temperature sensor readings to maximize objectivity of brace wear.

Enrollment

100 estimated patients

Sex

All

Ages

10 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.