Pilot Study on the Evaluation of Sound Conduction of Healthy Infant Hips and Those With Developmental Dysplasia of the Hip (DDH)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Difference in soundwaves on the Actuator on patella, sensor on sacrum
研究概览
简要总结
The objective of this study is to collect data that will be used to later design a method for the early diagnosis of diagnosis of developmental dysplasia of the hip (DDH).
详细描述
This will be a prospective study using an acoustic listening technique in combination with a standard clinical examination of DDH.
For both the clinical cases and healthy children that are enrolled, that all subjects will have an ultrasound completed for comparison to the use of the studied tuning fork method. The gold standard is POCUS (point of care ultrasound as performed by the pediatric orthopedic surgeon). Collected data will be compared to POCUS as performed by an expert and this is standard of care. Healthy subjects will be referred for evaluation and found to be healthy on subsequent US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants included in this study must be born at full term with a gestational age of 0-6 months
- •Infants of both genders will be included
- •Infants must have been screened for DDH.
排除标准
- •Infants born prematurely
- •Infants greater than six months of age.
- •Nonviable neonates and neonates of uncertain viability
结局指标
主要结局
Difference in soundwaves on the Actuator on patella, sensor on sacrum
时间窗: Study visit 1 (Day 1)
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Difference in soundwaves on the Actuator on patella, sensor on anterior superior iliac crest of pelvis
时间窗: Study visit 1 (Day 1)
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Difference in soundwaves on the Actuator on greater trochanter, sensor on sacrum
时间窗: Study visit 1 (Day 1)
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
Difference in soundwaves on the Actuator on greater trochanter, sensor on anterior superior iliac crest
时间窗: Study visit 1 (Day 1)
Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings
次要结局
未报告次要终点