Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip (EPA-DDH)

April 2, 2026 updated by: Pentacomp Systemy Informatyczne S.A

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)

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.

The 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?

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 application,

have the AI-generated results compared with the physician's assessment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this prospective, multicentre clinical investigation is to evaluate the effectiveness of the 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 (investigational medical device) 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).

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants whose Parent(s) or Legally Authorized Representative(s) have provided written informed consent;
  2. Participants who need to undergo routine DDH screening and receive an ultrasound as part of the clinical investigation;
  3. Participants of either sex aged between 4 weeks and 6 months weeks.

Exclusion Criteria:

  1. Participants with open wounds, ulcers, burns, viral or bacterial infections at the site intended for examination;
  2. 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;
  3. Participants with history of trauma, surgical intervention, or post-traumatic/post-surgical condition in the area to be examined.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ultrasound Assessment with AI-Supported Analysis
AI-supported analysis of hip ultrasound images (software application) compared with physician assessment using the Graf method.
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
Other Names:
  • Prelux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic agreement rate between the software application and the standard ultrasound assessment conducted by physicians
Time Frame: Day 0
The proportion of cases in which the classification generated by the application exactly matches the classification determined by the physicians
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pentacomp Systemy Informatyczne S.A

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • M. Schams, R. Labruyère, A. Zuse, and M. Walensi, "Diagnosing developmental dysplasia of the hip using the Graf ultrasound method: risk and protective factor analysis in 11,820 universally screened newborns," Eur. J. Pediatr., vol. 176, no. 9, pp. 1193-1200, Sep. 2017, doi: 10.1007/S00431-017-2959-Z/METRICS. [26] Y. R. Kang and J. Koo, "Ultrasonography of the pediatric hip and spine," Ultrasonography, vol. 36, no. 3, p. 239, Jul. 2017, doi: 10.14366/USG.16051.
  • D. H. Uçar, Z. U. Işklar, U. Kandemir, and Y. Tümer, "Treatment of developmental dysplasia of the hip with Pavlik harness: prospective study in Graf type IIc or more severe hips," J. Pediatr. Orthop. B, vol. 13, no. 2, pp. 70-74, Mar. 2004, doi: 10.1097/01202412-200403000-00002. S. R. Thomas, J. H. Wedge, and R. B. Salter, "Outcome at forty-five years after open reduction and innominate osteotomy for late-presenting developmental dislocation of the hip," Journal of Bone and Joint Surgery, vol. 89, no. 11, pp. 2341-2350, 2007, doi: 10.2106/JBJS.F.00857

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-MD-CIP-009
  • 2022/ABM/02/00004 - 00 (Other Grant/Funding Number: Medical Research Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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