Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip : Improvement or Overtreatment ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Normal or abnormal hip ultrasound
研究概览
简要总结
The aim of this study is to prove the improvement of pubo-femoral distance by early abduction splintage in one-month-old infants with developmental dysplasia of the hip (with a clinical stable hip but an abnormal hip ultrasonography).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term infants
- •Infants between 1 and 2 months of age at inclusion
- •Clinically stable hip
- •Pathological ultrasonography : pubo-femoral distance >6mm and bony rim percentage <50%
- •Non objection of the family
排除标准
- •Clinically unstable hip
- •Normal ultrasonography
- •Neuro-orthopedic disease
- •Postural deformity of the pelvis
- •Participation refusal
结局指标
主要结局
Normal or abnormal hip ultrasound
时间窗: 2 months
A normal or abnormal hip ultrasound will be base on two outcomes : * Pubo-femoral distance (ultrasonographic measurement) : distance between the pubic bone and the cartilaginous femoral head, considered as normal if lower than 6mm. * Bony rim percentage (ultrasonographic measurement) : percentage of the cartilaginous femoral head covered by the acetabular roof, considered as normal if higher than 50% (or equal to 50%). * Data of pubo-femoral distance and bony rim percentage will be pooled to determine if the ultrasound is normal or not for each patient. If one out of two is abnormal, ultrasound is considered abnormal. Statistics will be based on this qualitative value : normal or abnormal ultrasound.
次要结局
未报告次要终点