ACTRN12612000316808尚未招募未知
A prospective, multi-center, non-randomized post approval study to evaluate the performance of the Kspine Pedicle Screw System for correction and fusion of Adolescent Idiopathic Scoliosis
Kspine0 个研究点目标入组 20 人开始时间: 2012年3月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 11 Years 至 18 Years（—）
- 性别
- All
入选标准
- •Subject has AIS with Lenke type 1A or 1B main thoracic curve
- •Cobb angle between 40 and 65 degrees
- •Curve must reduce to greater than or equal to 50 % on lateral bend x-ray
- •Subject does not have hyper-kyphotic thoras defined as greater than or equal to 50 degree angle on lateral x-ray
- •Sanders score 3 - 7
排除标准
- •hyper-kyphotic thorax (greater than or equal to 50 degrees)
- •History of metabolic bone disease affecting bone structure
- •Previous spine surgery
- •Active infection
- •Pregnant or planning to become pregnant during the study
研究者
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