Overview

This trial is active, not recruiting.

Condition adolescent idiopathic scoliosis
Treatments brace, observation
Phase phase 3
Sponsor University of Iowa
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date February 2007
End date August 2014
Trial size 500 participants
Trial identifier NCT00448448, R01 AR052113, R01AR052113

Summary

Adolescent idiopathic scoliosis (AIS) is a structural curve of the spine with no clear underlying cause. Bracing is currently the standard of care for preventing curve progression and treating AIS. However, the effectiveness of bracing remains unclear. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.
brace
Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months.
(Active Comparator)
Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
observation
Clinical, radiographic, and self-report follow-up every 6 months.

Primary Outcomes

Measure
Progression of Cobb angle to greater than 50 degrees (proxy for surgical indication)
time frame: Measured throughout study
Cessation of skeletal growth
time frame: Measured throughout study

Secondary Outcomes

Measure
Clinical measures
time frame: Measured every 6 months
Radiographic measures
time frame: Measured every 6 months
Psychosocial measures
time frame: Measured every 6 months

Eligibility Criteria

Male or female participants from 10 years up to 15 years old.

Inclusion Criteria: - Diagnosis of AIS - Skeletally immature (Risser grade 0, 1, or 2) - Pre-menarchal or post-menarchal by no more than 1 year - Primary Cobb angle between 20 and 40 degrees - Curve apex caudal to T7 vertebrae - Physical and mental ability to adhere to bracing protocol - Ability to read and understand English, Spanish, or French - Documented insurance coverage and/or personal willingness to pay for treatment Exclusion Criteria: - Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature - History of previous surgical or orthotic treatment for AIS

Additional Information

Official title Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
Principal investigator Stuart L. Weinstein, MD
Description AIS is characterized by a lateral curvature of the spine greater than 10 degrees plus rotation of the spinal vertebrae. AIS is found in adolescents between the age of 10 and time of skeletal maturity. Progression of a spinal curve to 50 degrees suggests a high risk for continued curve progression throughout adulthood and usually indicates the need for spinal fusion surgery. Only about 10 percent of adolescents with AIS end up having curves that progress and require surgical intervention. While certain risk factors for curve progression have been identified, there is no reliable way of estimating the likelihood of needing surgery. Bracing is currently the standard of care for treating AIS. However, the effectiveness of bracing remains unclear, and it is unknown which adolescents in particular may benefit from bracing. Therefore, adolescents undergo bracing without knowing their likelihood of avoiding surgery. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS. The study will also evaluate the best dosing and duration schedule and how bracing affects quality of life, functioning, and psychosocial adjustment among participants. Participation in this study will last until a participant reaches skeletal maturity or their spinal curve progresses to 50 degrees, after which usual care will continue. Participants will either be 1)randomly assigned to a treatment or 2) may decline randomization and choose their own treatment arm. Study visits will occur every 6 months at an orthopaedic surgeon's office and will include x-rays, a clinical exam, and questionnaires. Participants assigned to braces will be instructed to wear the brace at least 18 hours per day. Temperature monitors placed in the brace will be used to determine the actual wear time by each participant.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University of Iowa.