Automatic Characterization of the Neonatal Hip Using Ultrasound Imaging
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Alpha angles automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip
研究概览
简要总结
Ultrasound imaging (US), a radiation-free imaging modality, is currently used in diagnosis of developmental dysplasia of the hip (DDH) in infants. The current protocol involves manually identifying specific measures that are prone to error, and may give rise to false positives. We aim to use 2-dimensional (2D) and 3-dimensional (3D) ultrasound imaging to create an automatic measurement procedure that we hope will reduce the errors in measurement and increase reliability.
详细描述
STUDY OBJECTIVES To investigate the use of a novel approach for accurate and automatic extraction of bone, cartilage and muscle surfaces from 3D US images, and to automatically characterize the infant DDH hip. To evaluate the performance of the 3D US-based approach, we will be comparing the results with regular 2D US images of the same patients from the radiology archives at our institution.
HYPOTHESIS We hypothesize that automatically extracted bone/cartilage boundaries can provide useful information about DDH, enable more reliable and reproducible diagnoses, and reduce false diagnostic positives and negatives of DDH. Using 3D US may reveal clinically significant disease or dysplasia metrics that have the potential to change diagnostic procedures.
AIMS:
- To determine if automatically extracted 3D bone/cartilage surfaces provide useful information (i.e., disease or dysplasia metrics) during the assessment of DDH and provide better visualization of the infant hip anatomy in comparison to regular 2D US-based DDH assessment.
- To determine if diagnosing DDH using the 3D US images reduces the operator dependent false positive and false negative rates.
- To determine if 3D US-based dysplasia metrics are as valuable in tracking disease progression as 2D US-based dysplasia metrics.
RESEARCH METHOD Parents and their infants that have been referred to the Orthopaedic Clinic at our institution for suspected or diagnosed DDH will be approached by the Orthopaedic Department's research staff to participate in the study. We are hoping to reach an n=75 as we expect 33% will be lost to follow up. Once eligible infants have been identified by clinical staff, the research staff will outline the study and will obtain informed consent. The parents will be informed of the four additional scan sessions that we would like to collect. Two separate orthopaedic surgeons will each perform one of the 3D and one 2D scan sessions, so as to assess inter-rater reliability. In order to assess intra-rater reliability, each scan session will consist of 2 successive scans.
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
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with suspected DDH at our institution
- •Ages 0 to 4 months of age
排除标准
- •US not performed at our institution
- •No diagnosis of DDH or not suspected of having DDH
- •Other congenital hip abnormalities or genetic syndromes
- •Patient/family does not live in the Lower Mainland
结局指标
主要结局
Alpha angles automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip
时间窗: Baseline
Alpha angles automatically extracted from 3D US images as a measure of dysplasia of the infant hip
时间窗: Baseline
次要结局
- Beta angles automatically extracted from 3D US images as a measure of dysplasia of the infant hip(Baseline)
- Femoral head coverage automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip(Baseline)
- Beta angles automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip(Baseline)
- Femoral head coverage automatically extracted from 3D US images as a measure of dysplasia of the infant hip(Baseline)
研究者
Kishore Mulpuri
Pediatric Orthopaedic Surgeon
British Columbia Children's Hospital