Clinical trial NCT06647225: Using Artificial Intelligence to Screen for Hip Dysplasia
Official title: Artificial Intelligence Augmented Ultrasound for Developmental Dysplasia of the Hip: a Validity Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Dysplasia of Hip
Keywords: hip dysplasia
artificial intelligence
ultrasound
screening
infants
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 240
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo the artificial intelligence ultrasound measures in addition to standard care.
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to learn if an ultrasound scan using artificial intelligence can accurately screen for hip dysplasia. Researchers will compare the artificial intelligence ultrasound results to the standard ultrasound measures to see if the artificial intelligence ultrasound scan can accurately screen for hip dysplasia.

It will also seek to understand how parents feel about their children undergoing this scan.

Participants will:

* Have an additional ultrasound performed on their child at their scheduled outpatient's appointment for hip dysplasia
* Complete a short questionnaire about the experience of having the measurement performed on their child

Detailed description: Initial screening for Developmental Dysplasia of the Hip (DDH) in Australia is performed most often by general practitioners and paediatricians shortly after birth and by maternal child health care nurses (MCHN) throughout the first year of life. These physical examinations consist of the Ortolani and Barlow tests and the examination of the thigh and gluteal creases. A recent meta-analysis reported the sensitivity of these tests as 36%, which indicates there is potential for a large proportion of cases to go undetected when solely relying on these examinations. Moreover, there currently are no formalised processes by which standards of practice are taught, assessed, or maintained. Thus, there is a clear need for a less operator-dependent screening protocol that can be performed within the current models of infant care. While some countries utilise universal ultrasound screening, this too is limited by access to care, as devices are not portable and thus cannot be used in current care models. Furthermore, it requires a specialist operator, substantially increasing cost. The screening program's limited nature, combined with the need for more consensus among international healthcare providers regarding the best method for managing DDH, has produced highly mixed clinical practices.

One part of the solution is optimising screening protocols for DDH in existing care models. Each state in Australia has established MCHN care protocols that provide access care for young children. While physical screening for DDH in these visits is standard practice, there remains considerable scope for improvement in the accuracy and reliability of these screening methods. Selective screening relies on several clinical associations with DDH to identify which patients receive ultrasound screening. Still, it has been shown to detect only 50% of infants with dysplasia. The MCHN screening program relies on clinical examination alone to detect dysplasia, an inferior identification method. Universal screening has a higher rate of detection of dysplasia but is expensive, single point in time (so misses the development of dysplasia) and results in higher levels of treatment.

A possible solution is portable artificial intelligence (AI)-augmented ultrasound. Recently technology has been developed to support a portable ultrasound device to screen DDH that uses AI-enabled technology to screen for DDH rapidly and accurately. Prior data has demonstrated that physicians and nurses could operate the device following training from expert sonographers. With its low-cost and ease of operation (with simple training) by healthcare providers such as MCHNs, it could significantly augment the physical screening. Thus, there is clear potential for an affordable, repeatable, and accessible screening methodology to be translated into clinical care. Initial Canadian data is promising. Pilot data suggests that DDH detection rates with this technology is on par with the detection rates of orthopaedic specialists. However, as this study was performed in a community setting and only those participants referred to orthopaedic clinics had a standard ultrasound measure performed, this pilot was unable to compare this screening technique with current gold standard diagnostic measures across the whole cohort, nor determine device sensitivity or predictive values. To demonstrate that this technology is fit for purpose, it is imperative that the rate of false negatives is also understood, as this is what will lead to late presentation, - which is what screening ultimately endeavours to prevent. Moreover, in an Australian context an important consideration in a wider roll-out is whether this technology would be accepted for uptake by clinicians and parents.

The proposed project will seek to gather pilot data to assess the validity and feasibility of this technology within a population of infants aged 4-20 weeks flagged at risk for DDH and referred to the Royal Children's Hospital. This will enable the recruitment of a sufficient number of cases of DDH to determine the sensitivity of the device. While the sensitivity and specificity of the device in this at-risk population may not be generalizable to the wider community the information gathered will then inform and refine a larger study of this technology in a community setting such as tertiary (birthing hospitals) and primary (MCHN clinics) care. If it can be demonstrated that it is feasible to implement this technology into existing care models, there is clear scope for this technology to revolutionize DDH screening. Thus, this project seeks to determine how well the device performs (sensitivity, specificity and predictive value) and the the clinical acceptability of this measure within the patient population.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the VicHip study
* Is 4-20 weeks of age at enrolment
* Is attending The Royal Children's Hospital for the purpose of the potential diagnosis of DDH
* Has a diagnostic (standard) hip ultrasound on the day of their out-patient appointment
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

Participants will be excluded from enrolment if:

• They are currently receiving treatment for DDH

Primary outcomes:
measure: Artificial Intelligence augmented ultrasound screening test capability: Sensitivity
timeFrame: 1 day, both ultrasound scans will be performed on the same day
measure: Artificial Intelligence augmented ultrasound screening test capability: Specificity
timeFrame: 1 day, both ultrasound scans will be performed on the same day
measure: Artificial Intelligence augmented ultrasound screening test capability: Positive predictive value (PPV)
timeFrame: 1 day, both ultrasound scans will be performed on the same day
measure: Artificial Intelligence augmented ultrasound screening test capability: Negative predictive value (NPV)
timeFrame: 1 day, both ultrasound scans will be performed on the same day
Secondary outcomes:
measure: Factors associated with differences in device sensitivity
timeFrame: 1 day, all data will be collected from day of scan
measure: Factors associated with differences in device specificity
timeFrame: 1 day, all data will be collected from day of scan
measure: Factors associated with differences in device positive predictive value
timeFrame: 1 day, all data will be collected from day of scan
measure: Factors associated with differences in device negative predictive value
timeFrame: 1 day, all data will be collected from day of scan
measure: Device operator reliability in performing successful scans
timeFrame: 12 months or entire study duration
measure: Acquisition of successful scans
timeFrame: 12 months or entire study duration
measure: Time taken to acquire scan
timeFrame: 1 day, calculated at time of scan
measure: Caregiver perspectives on their infant undergoing the artificial intelligence augmented ultrasound
timeFrame: 1 day, caregivers will be asked to complete immediately following the scan
measure: Operator perspectives on performing the artificial intelligence augmented ultrasound
timeFrame: At the conclusion of their involvement in the study device (up to 12 months)
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Leo T Donnan
role: PRINCIPAL_INVESTIGATOR
References: