Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
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California
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Los Angeles、California、美国、90020
- Shriners Hospitals for Children - Los Angeles
-
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis
- Anticipated spinal fusion surgery
Exclusion Criteria:
- Individuals younger than 11 years and older than 18 years
- Individuals with scoliosis carrying additional diagnoses of illness.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:1
Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod.
|
Posterior spinal fusion using a 5.5 or 6.35 size rod
|
|
有源比较器:2
Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod.
|
Posterior spinal fusion using a 5.5 or 6.35 size rod
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Radiographic measurements of curve angles and balance.
大体时间:Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
|
Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Scoliosis Research Society-30 (SRS-30) questionnaire
大体时间:Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
|
Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
|
合作者和调查者
调查人员
- 研究主任:Norman Otsuka, MD、Shriners Hospitals for Children - Los Angeles
- 首席研究员:Richard Bowen, MD、Shriners Hospitals for Children - Los Angeles
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- SHCLA-0123
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