NCT01370057终止不适用
The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Curve progression
研究概览
简要总结
The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.
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)
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
- •Confirmed Diagnosis of AIS
- •Age ≥10, ≤15 years old
- •Risser 0, 1 or 2
- •Primary Cobb angle between 20 and 40 degrees (inclusive)
- •Apex (of at least one of the primary curves) caudal to T7
- •Pre-menarchal OR post-menarchal by ≤1 year
- •Physical and mental ability to adhere to bracing protocol
排除标准
- •Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature
- •A history of previous surgical or orthotic treatment
- •Inability to read and understand Chinese
研究组 & 干预措施
Treatment Group
Experimental
Treatment with bracing
干预措施: Thoraco-lumbo-sacral Orthosis (Device)
Control Group
No Intervention
Watchful waiting without bracing
结局指标
主要结局
Curve progression
时间窗: Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected
Curve progression to Cobb angle of 50 degrees or more
次要结局
未报告次要终点
研究者
CHENG Chun-yiu Jack
Professor
Chinese University of Hong Kong
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Personalized Prevention and Treatment Strategies for Adolescent Idiopathic Scoliosis Via a Comprehensive Health Management PlatformNCT06314594Hangzhou Medical College76
终止
不适用
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth PeriodAdolescent Idiopathic ScoliosisJuvenile Idiopathic ScoliosisNCT04992845Spino Modulation Inc.44
终止
2 期
Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine SurgeryAdolescent Idiopathic ScoliosisMultimodal AnalgesiaOpioid Induced HyperalgesiaRemifentanilDexmedetomidinePosterior Spinal FusionNCT06096181Cedars-Sinai Medical Center13
已完成
不适用
ACtive Treatment for Idiopathic AdolescenT Scoliosis: a feasibility studyAdolescent idiopathic scoliosis (AIS)Musculoskeletal DiseasesJuvenile idiopathic scoliosisISRCTN90480705niversity of Warwick (UK)50
Unknown
不适用
Impact of Age on Surgical Outcome of Adolescent Idiopathic ScoliosisScoliosisNCT02819245Nanjing University School of Medicine300