Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 383
- 试验地点
- 45
- 主要终点
- Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor(s) are blinded to the treatment assignment.
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- •History of previous surgical or orthotic treatment for AIS
研究组 & 干预措施
Brace
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.
干预措施: Brace (Device)
Observation
Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
干预措施: Observation (Other)
结局指标
主要结局
Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)
时间窗: Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.
次要结局
未报告次要终点
研究者
Stuart L. Weinstein, MD
Professor of Orthopaedics and Rehabilitation
University of Iowa