NCT01600183Unknown不适用
Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
Unfo Ltd.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Healing of the MTA
研究概览
简要总结
This is a prospective, randomized, control, open label study in which up to 50 subjects with metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard casting or using the UNFO-s device for total time of 20 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with an acute MTA that did not receive any treatment for this condition
- •Consenting parents
- •Ages 1-4 months
排除标准
- •Participation in another clinical trial.
- •Neuromuscular disorders
- •Any condition which in the opinion of the investigator renders the subject ineligible for study participation.
结局指标
主要结局
Healing of the MTA
时间窗: 20 weeks
Healing of the MTA: straightening of the foot with apprx. 10% overcorrection
次要结局
- safety of the UNFO-s device(7 months)
研究者
研究点 (1)
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