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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06647225




Registration number
NCT06647225
Ethics application status
Date submitted
14/10/2024
Date registered
17/10/2024

Titles & IDs
Public title
Using Artificial Intelligence to Screen for Hip Dysplasia
Scientific title
Artificial Intelligence Augmented Ultrasound for Developmental Dysplasia of the Hip: a Validity Study
Secondary ID [1] 0 0
107227
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental Dysplasia of Hip 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Artificial intelligence augmented ultrasound

Other: All active participants - All participants will undergo an AI-augmented ultrasound and there will be no active comparator


Treatment: Devices: Artificial intelligence augmented ultrasound
The hip ultrasound is performed using a handheld device (Exo Iris) that uses a pocket-sized ultrasound probe and is run through an application on an IoS (Apple mobile) operation system. . A real-time algorithm detects and records the anatomical landmarks. When there are enough images for analysis the operator is notified that the scan is complete. From here, the images are then classified as: the hips as "healthy", "follow-up recommended," or "suboptimal (repeat scan)".
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Artificial Intelligence augmented ultrasound screening test capability: Sensitivity
Timepoint [1] 0 0
1 day, both ultrasound scans will be performed on the same day
Primary outcome [2] 0 0
Artificial Intelligence augmented ultrasound screening test capability: Specificity
Timepoint [2] 0 0
1 day, both ultrasound scans will be performed on the same day
Primary outcome [3] 0 0
Artificial Intelligence augmented ultrasound screening test capability: Positive predictive value (PPV)
Timepoint [3] 0 0
1 day, both ultrasound scans will be performed on the same day
Primary outcome [4] 0 0
Artificial Intelligence augmented ultrasound screening test capability: Negative predictive value (NPV)
Timepoint [4] 0 0
1 day, both ultrasound scans will be performed on the same day
Secondary outcome [1] 0 0
Factors associated with differences in device sensitivity
Timepoint [1] 0 0
1 day, all data will be collected from day of scan
Secondary outcome [2] 0 0
Factors associated with differences in device specificity
Timepoint [2] 0 0
1 day, all data will be collected from day of scan
Secondary outcome [3] 0 0
Factors associated with differences in device positive predictive value
Timepoint [3] 0 0
1 day, all data will be collected from day of scan
Secondary outcome [4] 0 0
Factors associated with differences in device negative predictive value
Timepoint [4] 0 0
1 day, all data will be collected from day of scan
Secondary outcome [5] 0 0
Device operator reliability in performing successful scans
Timepoint [5] 0 0
12 months or entire study duration
Secondary outcome [6] 0 0
Acquisition of successful scans
Timepoint [6] 0 0
12 months or entire study duration
Secondary outcome [7] 0 0
Time taken to acquire scan
Timepoint [7] 0 0
1 day, calculated at time of scan
Secondary outcome [8] 0 0
Caregiver perspectives on their infant undergoing the artificial intelligence augmented ultrasound
Timepoint [8] 0 0
1 day, caregivers will be asked to complete immediately following the scan
Secondary outcome [9] 0 0
Operator perspectives on performing the artificial intelligence augmented ultrasound
Timepoint [9] 0 0
At the conclusion of their involvement in the study device (up to 12 months)

Eligibility
Key inclusion criteria
* Enrolled in the VicHip study
* Is 4-16 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.
Minimum age
4 Weeks
Maximum age
16 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from enrolment if:

• They are currently receiving treatment for DDH

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leo T Donnan
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Natalie K Hyde, BBiomedSc (Hons), PhD
Address 0 0
Country 0 0
Phone 0 0
61 3 9936 6246
Fax 0 0
Email 0 0
natalie.hyde@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
The researchers may choose to share data with other groups that are using the same device, all IPD would be deidentified and would be subject to further ethical approval. The researchers have sought consent from participants to allow data collected to be used for future research.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06647225