Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip

NCT07488260 | Not Yet Recruiting

• 2 other identifiers: PC-MD-CIP-0092022/ABM/02/00004 - 00
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Developmental Dysplasia of the Hip (DDH)

Keywords

Developmental Dysplasia of the Hip; DDH; Hip Ultrasound; Graf Method; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0

Study Arms (1)

Ultrasound Assessment with AI-Supported Analysis

OTHER

AI-supported analysis of hip ultrasound images (software application) compared with physician assessment using the Graf method.

Device: AI-supported hip ultrasound analysis

Interventions

AI-supported hip ultrasound analysis DEVICE

Software for supporting the diagnostic assessment of developmental dysplasia of the hip (DDH) in infants during pre-luxation visits

Also known as: Prelux

Ultrasound Assessment with AI-Supported Analysis

Eligibility Criteria

• Age: 4 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pentacomp Systemy Informatyczne S.A: lead

Related Publications (2)

• 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.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Pure Clinical Sp. z o.o.

CONTACT

+48 739 262 242; MDsafety@pureclinical.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04