NCT01019109已完成不适用
Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 3
- 主要终点
- Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes
研究概览
简要总结
The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also, this study wants to find out the effects this system has on the physical appearance and quality of life for patients with scoliosis.
详细描述
The aim of this study is to evaluate the clinical, functional and radiographic outcomes following the reduction of idiopathic scoliosis.
The following will be evaluated
- The 3D correction of scoliosis:
- Reduction of scoliosis in the coronal plane (Cobb angles)
- Correction in the sagittal plane (kyphotic and lordotic angles)
- Correction of the axial vertebral rotation in the transverse plane
- The functional and aesthetic outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic scoliosis requiring posterior spinal instrumentation and fusion
- •Male and female
- •Exclusion criteria:
- •Neuromuscular or degenerative scoliosis
- •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, Neurofibroma)
- •Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- •Congenital scoliosis
- •Scoliosis requiring anterior release
- •Previous spinal surgery
- •Patient who is unable to complete a self-administered patient questionnaire
排除标准
- 未提供
结局指标
主要结局
Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes
时间窗: Preoperative, 6 weeks, 6 months, 1 year and 2 Years
次要结局
- Functional and aesthetic outcomes(Preoperative, 6 months and 2 years)
- Perioperative and postoperative complications(Continuous during follow-up)
研究者
研究点 (3)
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