Developmental Dysplasia of the Hip (DDH)EPA-DDHNCT07488260
Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip
A study testing AI-supported hip ultrasound analysis in people with Developmental Dysplasia of the Hip (DDH), run by Pentacomp Systemy Informatyczne S.A.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 weeks to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of the Hip (DDH)
- What is being tested?
- AI-supported hip ultrasound analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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.
Read the 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).
- Conditions
- Developmental Dysplasia of the Hip (DDH)
- Being tested
- AI-supported hip ultrasound analysis
- Keywords
- Developmental Dysplasia of the Hip, DDH, Hip Ultrasound, Graf Method, Artificial Intelligence
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-supported hip ultrasound analysisDevice
Also called Prelux
Software for supporting the diagnostic assessment of developmental dysplasia of the hip (DDH) in infants during pre-luxation visits
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Assessment with AI-Supported Analysis | Other | AI-supported analysis of hip ultrasound images (software application) compared with physician assessment using the Graf method. Receives: Device: AI-supported hip ultrasound analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic agreement rate between the software application and the standard ultrasound assessment conducted by physicians
The proportion of cases in which the classification generated by the application exactly matches the classification determined by the physicians
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the Hip (DDH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pentacomp Systemy Informatyczne S.A
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488260
- Sponsor's protocol ID
- PC-MD-CIP-009
- Other IDs
- 2022/ABM/02/00004 - 00
- Acronym
- EPA-DDH
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schams M, Labruyere R, Zuse A, Walensi M. 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. 2017 Sep;176(9):1193-1200. doi: 10.1007/s00431-017-2959-z. Epub 2017 Jul 17.
PubMed 28717864D. 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 at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07488260
- Acronym / sponsor ID
- EPA-DDH / PC-MD-CIP-009
- Conditions
- Developmental Dysplasia of the Hip (DDH)
- Keywords
- Developmental Dysplasia of the Hip, DDH, Hip Ultrasound, Graf Method, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pentacomp Systemy Informatyczne S.AUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Assessment with AI-Supported Analysis | Other | Device: AI-supported hip ultrasound analysisAI-supported analysis of hip ultrasound images (software application) compared with physician assessment using the Graf method. |
Who may qualify
- Ages
- 4 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-supported hip ultrasound analysisAlso: PreluxSoftware for supporting the diagnostic assessment of developmental dysplasia of the hip (DDH) in infants during pre-luxation visits | Device | Ultrasound Assessment with AI-Supported Analysis |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 28717864Schams M, Labruyere R, Zuse A, Walensi M. 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. 2017 Sep;176(9):1193-1200. doi: 10.1007/s00431-017-2959-z. Epub 2017 Jul 17.
- BackgroundD. 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing AI-supported hip ultrasound analysis in people with Developmental Dysplasia of the Hip (DDH), run by Pentacomp Systemy Informatyczne S.A.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pure Clinical Sp. z o.o. (+48 739 262 242, MDsafety@pureclinical.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic agreement rate between the software application and the standard ultrasound assessment conducted by physicians (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07488260, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.