Bracing is currently the standard of care for the treatment of adolescent idiopathic scoliosis (AIS). Despite many years of research, the effectiveness of bracing is still in doubt, and it is not known with any certainty, which, if any, patients with AIS will respond favorably to bracing. Many risk factors for curve progression have been observed, yet the science of bracing has not advanced to the point where reliable estimates of the risk of progression to surgery are possible for an individual patient, or even for a group of patients presenting with a common set of risk factors. Therefore, patients undergo this treatment without knowing the probability of success or failure. We argue a randomized trial of bracing is urgently required to document its improvement over natural history in terms of surgery rates, to better define the subpopulation most likely to benefit, and to define the optimal dosing and duration schedule. Therefore, we propose a multicenter, randomized, controlled study to quantify the effectiveness of bracing relative to observation alone for the treatment of adolescent idiopathic scoliosis (AIS). The primary aim of the study will be to measure the relative risk of curve progression to greater than 50 degrees in the two treatment arms. This outcome is significant because it indicates a high risk for continued curve progression throughout adulthood, and is therefore the parameter at which fusion and instrumentation are generally indicated. We will concurrently measure and compare the quality of life and psychosocial adjustment of these adolescents. We will also estimate the relationship between bracing dose (wear time) and curve response and to develop a predictive model for the outcome of curve progression. 23 states in the U.S. mandate school screening, which leads to an estimated cost of $41 million dollars annually. If bracing is not effective, these programs could be eliminated and the resources directed toward other adolescent health or social problems. On the other hand, discovering the most effective dosing schedules and ordering more appropriate treatment could lead to a decrease in the surgery rate and diminish the associated burden to the Medicaid budget. Therefore, this study, whether positive or negative, will have substantial impact on public health.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
5R01AR052113-05
Application #
7911736
Study Section
Special Emphasis Panel (ZAR1-YZW-K (O2))
Program Officer
Panagis, James S
Project Start
2006-09-01
Project End
2012-08-31
Budget Start
2010-09-01
Budget End
2012-08-31
Support Year
5
Fiscal Year
2010
Total Cost
$610,924
Indirect Cost
Name
University of Iowa
Department
Orthopedics
Type
Schools of Medicine
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
Schwieger, Traci; Campo, Shelly; Weinstein, Stuart L et al. (2016) Body Image and Quality of Life and Brace Wear Adherence in Females With Adolescent Idiopathic Scoliosis. J Pediatr Orthop :
Schwieger, Traci; Campo, Shelly; Weinstein, Stuart L et al. (2016) Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976) 41:311-9
Khan, Irfan; Zimmerman, Bridget; Brophy, Patrick et al. (2014) Masking of syndrome of inappropriate antidiuretic hormone secretion: the isonatremic syndrome. J Pediatr 165:722-6
Weinstein, Stuart L; Dolan, Lori A; Wright, James G et al. (2013) Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 369:1512-21
Weinstein, Stuart L; Dolan, Lori A; Wright, James G et al. (2013) Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST). Spine (Phila Pa 1976) 38:1832-41