Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647225
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Using Artificial Intelligence to Screen for Hip Dysplasia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Artificial Intelligence Augmented Ultrasound for Developmental Dysplasia of the Hip a Validity Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 outpatients appointment for hip dysplasia
Complete a short questionnaire about the experience of having the measurement performed on their child
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 outpatients 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 programs 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 4-16 weeks flagged at risk for DDH and referred to the Royal Childrens 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
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 4-16 weeks flagged at risk for DDH and referred to the Royal Childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None