A Non-Inferiority Trial Assessing a Limited Ultrasound Protocol in the Treatment of Developmental Dysplasia of the Hip
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- International Hip Dysplasia Institute Score
研究概览
简要总结
Developmental Dysplasia of the Hip (DDH) is a common diagnosis in children that if untreated may lead to degeneration and arthritis of the hip joint at a young age. Ultrasound imaging is used to monitor progress of the developing hip joint during treatment. Initial data from our practice suggests that interim ultrasounds do not alter the course or outcome of treatment. Additionally, these ultrasounds add significant time to clinic visits and carry a substantial cost to the health care system. The goal of this study is to determine if limiting the number of ultrasounds during treatment results in the same outcomes while also evaluating the amount of time and money saved by omitting the ultrasounds.
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 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 0-6 months at time of diagnosis
- •Clinical and Ultrasound diagnosis of stable developmental dysplasia of the hip
- •Children with dislocated/ unstable DDH will be included once the hip becomes stable
- •Treated with Pavlik harness
- •Assessed and treated at the SickKids Baby Hip Clinic
排除标准
- •Underlying neuromuscular disease
- •Teratologic hip dysplasia
- •Prior treatment at other institutions
- •Non-compliance with treatment protocol
结局指标
主要结局
International Hip Dysplasia Institute Score
时间窗: When patient reaches 1 year of age
The International Hip Dysplasia Institute (IHDI) grade will be measured from a radiograph of the pelvis. The score classifies hips into one of four groups based on the position of the proximal femoral metaphysis in relation to the acetabulum. The scores grade severity from Grade 1 as the mildest type to Grade 4 as the most severe type of hip dislocation.
Acetabular Index
时间窗: When patient reaches 1 year of age
Acetabular Index will be measured on a supine anteroposterior (AP) radiograph of the pelvis
次要结局
- Complication Rate(Through study completion, an average of two years)
- Health Care Costs(Through study completion, an average of two years)
- Hospital Appointment Duration(Through study completion, an average of two years)
研究者
Simon Kelley
Orthopaedic Surgeon
The Hospital for Sick Children