Washington University School of Medicine, St. Louis, Missouri, is participating in a national trial to determine whether spinal orthoses for adolescents with scoliosis are effective in preventing the condition from progressing and, if so, which patients benefit most from the devices.
The medical center is one of 25 sites across the United States and Canada participating in the trial, called the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST), one of the first clinical trials in pediatric orthopedics funded by the National Institutes of Health.
Adolescent idiopathic scoliosis (AIS) occurs with no known cause in children from 10-18 years old. It is the most common type of scoliosis and is more commonly seen in girls. Severe scoliosis can cause back pain and difficulty breathing.
“Even though bracing to slow down curve progression in patients with AIS has been the standard of care in the United States for about 30 years, the treatment’s effectiveness remains unclear,” said study collaborator Matthew B. Dobbs, MD, a Washington University pediatric orthopedic surgeon at St. Louis Children’s Hospital. “There are patients who use bracing, yet their curve progression continues, while other patients with AIS who don’t use bracing do not experience any curve progression.”
Participants are randomly assigned to either wear a brace at least 18 hours a day or to have regularly scheduled follow-up visits and X-rays to track curve progression. Spinal curves that progress to 50 degrees indicate a high risk for continued curve progression throughout adulthood. In these cases, spinal fusion surgery is usually recommended to correct the curve.
“The occurrence of AIS is about one in 1,000, and its prevalence is ten to one in girls. Only about ten percent of these patients require surgical intervention,” Dobbs said. Patients between 10 and 15 years old with a curve between 20 degrees and 40 degrees have traditionally been treated with bracing until they reach skeletal maturity, which can be up to six years if the girl is ten or 11 years old, Dobbs said.
“That means patients are wearing braces at a time in their life when they don’t want to be different from their peers,” Dobbs said. “It can be quite a traumatic decision, which is one reason why this study is so important. In addition, the bracing is expensive, and the orthosis needs to be refitted or replaced as patients grow.”
Although the study findings could be at different ends of a spectrum-either bracing works and needs to be used for all patients with AIS, or bracing doesn’t work at all and should be abandoned as a treatment-Dobbs said he expects an outcome somewhere in the middle.
“I anticipate we will discover that bracing works for certain types of curves, which means we can become much more selective in prescribing it as a treatment,” he said. “Whatever the findings, however, this will be a major step forward in our understanding of how to treat this relatively common disorder.”
To be eligible to enroll in the study, patients must be between ten and 15 years old (either male or female). Inclusion criteria include diagnosis of AIS; pre-menarchal or post-menarchal by no more than one year; physical and mental ability to adhere to bracing treatment; and documented insurance coverage and/or personal willingness to pay for treatment. Patients who have a diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature or a history of previous surgical or orthotic treatment for AIS are not eligible for the study. Once accepted into the study, patients will be followed at Washington University School of Medicine and St. Louis Children’s Hospital. Two visits per year are required for X-rays and evaluation.
For additional information, call 314.454.4113.
