Evaluation of the Concordance Between the Prelux and Standard Ultrasound Assessment in Classifying Hip Types in Infants Screened for Developmental Dysplasia of the Hip (DDH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Diagnostic agreement rate between the Prelux and the standard ultrasound assessment conducted by physicians
研究概览
简要总结
The goal of this prospective, multicentre clinical investigation is to evaluate whether an artificial intelligence (AI)-supported software application (Prelux) can assist clinicians in the diagnostic assessment of developmental dysplasia of the hip (DDH) during routine ultrasound screening in infants.
The main questions it aims to answer are: Does the diagnostic classification generated by the Prelux application agree with the classification obtained by physicians using standard ultrasound examination according to the Graf method? Can the Prelux application reliably identify key anatomical landmarks and angles required for DDH assessment?
Researchers will compare the AI-generated diagnostic results with those obtained from standard ultrasound examinations performed by physicians to evaluate the level of agreement between the two approaches.
Participants will:
undergo a routine hip ultrasound examination performed by a physician according to the Graf method,
have ultrasound images analyzed by the Prelux application,
have the AI-generated results compared with the physician's assessment.
详细描述
The purpose of this prospective, multicentre clinical investigation is to evaluate the effectiveness of the Prelux application in routine clinical settings, specifically by comparing the application-generated diagnostic results with those obtained from standard ultrasound examinations conducted by physicians.
The IMD was chosen for clinical evaluation because its AI algorithms have shown promising results in identifying key anatomical landmarks, justifying its transition from development to clinical investigation. This study has been designed based on comprehensive pre-clinical verification and validation data, including reliability, usability, and cybersecurity testing, to demonstrate the device's effectiveness in supporting clinicians during DDH assessment. Unlike traditional physical medical devices, the IMD is a digital solution composed of several integrated modules, including a Physician Portal, an AI diagnostic suite, and a Decision-Support Module. The potential indications for using AI-based diagnostic tools like the IMD are extensive in pediatric orthopedics. Such digital tools could increasingly be used to support the early identification of DDH, which affects approximately
1 in 100 infants. Early detection is critical, as late diagnosis could be associated with degenerative joint disease and the need for complex surgical interventions. In cases of routine screening, AI-based diagnostic tools are expected to help maintain the integrity of the diagnostic workflow by ensuring that only high-quality, standard-plane images are used for classification. In future clinical practice, AI-supported tools may meaningfully improve diagnostic quality and efficiency, potentially setting new standards for early intervention.
Within this framework, the IMD represents a new generation of diagnostic aids that enhance the benefits of ultrasound screening, especially for high-risk groups (female sex, breech presentation, or family history).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants whose Parent(s) or Legally Authorized Representative(s) have provided written informed consent;
- •Participants who need to undergo routine DDH screening and receive an ultrasound as part of the clinical investigation;
- •Participants of either sex aged between 4 weeks and 6 months weeks.
排除标准
- •Participants with open wounds, ulcers, burns, viral or bacterial infections at the site intended for examination;
- •Participants with significant anatomical abnormalities (e.g. cerebral palsy, joint contracture, suppurative coxitis, other hip or limb deformities, or teratological hip dysplasia) that may affect the feasibility or accuracy of the examination;
- •Participants with history of trauma, surgical intervention, or post-traumatic/post-surgical condition in the area to be examined.
结局指标
主要结局
Diagnostic agreement rate between the Prelux and the standard ultrasound assessment conducted by physicians
时间窗: Day 0
The proportion of cases in which the classification generated by the Prelux exactly matches the classification determined by the physicians
次要结局
未报告次要终点