[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630483":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":22,"locations":21,"responsibleParty":28,"collaborators":21,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":38,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":21,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":57,"whyStopped":21,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":21},{"fullName":5,"class":6},"Pentacomp Systemy Informatyczne S.A","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Ultrasound Assessment with AI-Supported Analysis","AI-supported analysis of hip ultrasound images (software application) compared with physician assessment using the Graf method.",[12],"Device: AI-supported hip ultrasound analysis",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","AI-supported hip ultrasound analysis","Software for supporting the diagnostic assessment of developmental dysplasia of the hip (DDH) in infants during pre-luxation visits",[9],[20],"Prelux",null,[23],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Pure Clinical Sp. z o.o.","CONTACT","+48 739 262 242","MDsafety@pureclinical.eu",{"type":29,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100630483","evaluation-of-a-software-application-for-assessment-of-developmental-dysplasia-of-the-hip-100630483",false,"NCT07488260","Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip","Evaluation of the Concordance Between the Software Application and Standard Ultrasound Assessment in Classifying Hip Types in Infants Screened for Developmental Dysplasia of the Hip (DDH)","EPA-DDH","Inclusion Criteria:\n\n1. Participants whose Parent(s) or Legally Authorized Representative(s) have provided written informed consent;\n2. Participants who need to undergo routine DDH screening and receive an ultrasound as part of the clinical investigation;\n3. Participants of either sex aged between 4 weeks and 6 months weeks.\n\nExclusion Criteria:\n\n1. Participants with open wounds, ulcers, burns, viral or bacterial infections at the site intended for examination;\n2. 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;\n3. Participants with history of trauma, surgical intervention, or post-traumatic\u002Fpost-surgical condition in the area to be examined.",true,"ALL","4 Weeks","6 Months",{"count":43,"type":44},150,"ESTIMATED","INTERVENTIONAL",[47],"NA","The goal of this prospective, multicentre clinical investigation is to evaluate whether an artificial intelligence (AI)-supported software application can assist clinicians in the diagnostic assessment of developmental dysplasia of the hip (DDH) during routine ultrasound screening in infants.\n\nThe main questions it aims to answer are: Does the diagnostic classification generated by the application agree with the classification obtained by physicians using standard ultrasound examination according to the Graf method? Can the application reliably identify key anatomical landmarks and angles required for DDH assessment?\n\nResearchers 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.\n\nParticipants will:\n\nundergo a routine hip ultrasound examination performed by a physician according to the Graf method,\n\nhave ultrasound images analyzed by the application,\n\nhave the AI-generated results compared with the physician's assessment.",[50],"Developmental Dysplasia of the Hip (DDH)",[52,53,54,55,56],"Developmental Dysplasia of the Hip","DDH","Hip Ultrasound","Graf Method","Artificial Intelligence","NOT_YET_RECRUITING","2026-04-02",{"date":60,"type":61},"2026-04-08","ACTUAL",{"date":63,"type":44},"2026-07",{"date":65,"type":44},"2027-01",{"name":5,"class":6}]