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Scoliosis is defined as a lateral curvature of the spine measuring greater than 10 degrees. The most common type of scoliosis is Idiopathic Scoliosis, in which curves develop in an otherwise normally developing person. Adolescent Idiopathic Scoliosis (AIS) effects young adults ages 10 to skeletal maturity, and effects females disproportionately.

Currently, two of the most widely used forms of non-operative treatment are observation and treatment with an orthosis. A TLSO is a common orthosis used in scoliosis treatment. It provides corrective forces to the growing spine to slow or stop progression or to provide improvement of the deformity. Physical deformities with progressing scoliosis include un-level shoulders, asymmetric waist line, and rotational prominences of the spine. When untreated scoliosis progresses significantly in adolescenc. It increases the likelihood of continued progression in adulthood. Over time this can lead to other medical issues, including cardiopulmonary compromise and degenerative arthritis in the spine.

It is clear that treatment needs to positively affect outcomes to be of any value. Positive outcomes are a result of attenuated curve progression. These include an improved or maintained physical appearance and the avoidance of spine fusion surgery if the curve can be maintained below a desired level (usually approximately 50 degrees). Thus, the use of a TLSO is an attempt to alter the natural history of AIS, and provide positive outcomes. Despite numerous clinical studies on the subject of brace treatment of AIS, there remains confusion and disagreement as to its effectiveness. There is also confusion as to the optimal starting time, wearing time, weaning schedule, and optimal brace design.

Eligible subjects will be drawn from patients attending Gillette Childrens Specialty Healthcare Clinic or Twin Cities Spine Center and identified as having AIS. Subjects will have met the criteria for treatment with a TLSO which includes, but is not limited to, curve severity of greater than 20 degrees, and a risk of progression due to significant amount of remaining growth based on age, onset of menses, Tanner sign, and Risser sign.

Based on data and sample sizes from existing studies, we estimate that 300 subjects will provide the required data to confirm the role of TLSO wear on curve progression. Interim analyses will be conducted following the completion of 100 subjects in order to confirm/revise the estimated subject number.