NCT01375218已完成4 期
Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Resolution of instability
研究概览
简要总结
The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.
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
- — 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0-2 months of age
- •Nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound
排除标准
- •Ages greater than 2 months
- •Neurological condition
- •Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound
- •Chromosomal abnormality
研究组 & 干预措施
Plastizote Brace
Active Comparator
干预措施: Plastizote Brace (Other)
Pavlik Brace
Active Comparator
干预措施: Pavlik Brace (Other)
结局指标
主要结局
Resolution of instability
时间窗: 3-4 week interval
Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage
次要结局
- Resolution of instability(6 month interval)
研究者
研究点 (1)
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