NCT00273598已完成2 期
Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- - Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
研究概览
简要总结
Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of two instrumentation systems for the treatment of adolescent idiopathic scoliosis.
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
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-18 years
- •Diagnosis of idiopathic scoliosis requiring posterior instrumentation and fusion(including those also requiring anterior release with or without anterior instrumentation) who could receive either the USS or the Moss Miami system
- •Patients with scoliosis and an incidental finding of conus < L1-2 disc level, provided they have no symptoms or signs
- •Patients with scoliosis and an incidental finding of a small syrinx (provided the syrinx is non-progressive and does not require neurosurgical treatment)
- •Patients with non-progressive spondylolysis
排除标准
- •Spinal cord abnormalities with any neurologic symptoms or signs
- •Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
- •Primary muscle diseases, such as muscular dystrophy
- •Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, etc.)
- •Primary abnormalities of bones(e.g. osteogenesis imperfecta)
- •Congenital scoliosis
结局指标
主要结局
- Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
次要结局
- Physical function
- Deformity, based on clinical exam and spinal radiographs
- Clinicians' ratings of clinical photographs
- Surgeons' global satisfaction with the instrumentation system
- Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization
- Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)
研究者
James Wright
Surgeon-in-Chief & Chief of Perioperative Services
The Hospital for Sick Children
研究点 (2)
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