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
- 1
- 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
研究组 & 干预措施
Comprehensive Ultrasound Group
Children in the comprehensive ultrasound protocol group will follow the current standardized treatment protocol used at the Hospital for Sick Children in Toronto, Canada. For children presenting with stable hip dysplasia, Pavlik harness (PH) treatment is initiated at the initial visit (week 0) and runs for a total of 12 weeks. Children return to clinic at weeks 2, 5, 8 and 12 for clinical and ultrasound examinations to ensure that the harness is fitting correctly, to screen for PH complications and to monitor acetabular development.
干预措施: Standard Ultrasound Imaging (Other)
Limited Ultrasound Group
Children in the limited ultrasound protocol group will receive the same treatment as described for the comprehensive ultrasound group above, except the ultrasound imaging conducted at weeks 2, 5 and 8 will be omitted. Children will still return to clinic at 2, 5, and 8 weeks for clinical examination, which includes the assessment of the Pavlik harness fit and screening for complications.
干预措施: Limited Ultrasound Imaging (Other)
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