Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Radiographic measurements of curve angles and balance.
研究概览
简要总结
There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no scientific evidence supporting the superiority of one size rod relative to the other. This study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.
详细描述
For the correction of Juvenile and Adolescent idiopathic scoliosis, companies offer and surgeons use varying rod sizes not based on scientific evidence, but because of personal preference, availability and company loyalty. To date there has been no literature evaluating the benefit or harm of one rod size versus the other. Our dual-arm prospective study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm stainless steel instrumentation rods. These are both standard rods used in the community for this particular procedure, thus no additional risk exists for the patient. The results of this study will help guide surgeons in their decision making process when faced with the multitude of options offered by implant manufactures.
Comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves.
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
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis
- •Anticipated spinal fusion surgery
排除标准
- •Individuals younger than 11 years and older than 18 years
- •Individuals with scoliosis carrying additional diagnoses of illness.
结局指标
主要结局
Radiographic measurements of curve angles and balance.
时间窗: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
次要结局
- Scoliosis Research Society-30 (SRS-30) questionnaire(Pre-operatively, 6 wks post-op, 1 & 2 year post-op.)
研究者
Terri Green
Clinical Data Coordinator
Shriners Hospitals for Children