SHINE: Sensing the Hips of Newborns
Research type
Research Study
Full title
SHINE: Sensing the Hips of Newborns. The use of acoustic transmission to identify developmental hip dysplasia in babies.
IRAS ID
235075
Contact name
Daniel Perry
Contact email
Sponsor organisation
The University of Liverpool
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
Developmental Dysplasia of the Hip (DDH) is a spectrum of disease. 1 in 1000 new-borns have a completely dislocated hip, and 2-3% of new-borns are diagnosed with some degree of hip dysplasia. DDH is associated with premature osteoarthritis and is the cause of 10% of all hip replacements, and a third of replacements in those under 60 years old. In the UK around 1,200 total hip replacements per year occur as a result of DDH, which is more than that for all inflammatory arthropathies combined.The UK uses a nationwide selective ultrasound screening programme for DDH. Clinical examination is universal and if abnormal is followed by ultrasound screening. Clinical examination involves several screening manoeuvres, which the National Screening Committee (NSC) acknowledges are poor tests as they are difficult to teach, difficult to monitor or assessor competence, and have high variability amongst clinicians. The NSC estimates that around two in three hip dislocations are missed on screening.
The alternative approach is universal ultrasound screening. Universal ultrasound screening an expensive test requiring specialist clinicians, and has a high false-positive treatment rate. The NSC does not recommend universal ultrasound screening, instead opting for a selective screening model acknowledging the flaws.
There is widespread uncertainty about how to best screen children for DDH. The national screening committee and a Cochrane review both highlight major deficiencies in the current selective-ultrasound screening model, however acknowledge the costly nature of the alternative (universal ultrasound screening) and high levels of false positive that this would generate. A new screening tool is therefore urgently needed, which that better fulfils the Wilson and Jungner criteria, i.e. the test needs to be simple, safe, precise, validated and cost-effective – and one that ideally is reproducible even with minimal training.
Sound transmission through the hips has previously been demonstrated to be an effective tool to identify infant hips that are dislocated. Despite the apparent efficacy, the development of this technique stalled owing to limits surrounding the availability of technology in the late 1980s. To our knowledge, there are no other groups that are working with the transmission of sound to enhance the screening programme in DDH.
Summary of Results
Aims
To develop a device that can detect hip dysplasia (dislocated hips) amongst babies using vibration. The device must be sensitive to identify dislocated hips, though specific such that there are few false negatives.Collaborators
Prof Dan Perry, University of Liverpool.
Dr Badr Abdullah, Liverpool John Moores University.
Prof Andy Shaw, Liverpool John Moores University.Was the aim met?
Yes. The University of Liverpool, LJMU and Alder Hey Children’s Hospital collaborated in the development of this technology that has the potential to transform the national screening process. This technology relies on the transfer of sound across the hip joint, to determine whether a hip is normal or abnormal. We have successfully developed a functioning proof-of-concept device and trialled this amongst 167 infants and we are confident the technology has the potential to secure significant benefits to patients, the NHS and other international healthcare providers. This functioning proof of concept device has been developed with off the shelf components and used to conduct the initial studies – though it is cumbersome as it requires multiple users (including an engineer) to be present to administer the examination, which has caused a bottle neck in our ability to collect data from patients with abnormal hips In the operating theatre (with the child asleep) we can be confident that the device works – with very different traces evident for normal and abnormal hips. However, to develop the device further we need to produce a prototype which can readily be used in the outpatient clinic (by a nurse practitioner or clinician). If the device could be used by a single-user in the outpatient department, this would enable us to collect large volumes of patient data quickly to refine the thresholds for normal/ abnormal, and produce sufficient data to support a patent application.Dissemination
Due to the planned protection of the IP, we have been unable to share any of the results. However, we have shared our interest in this work at the NIPE conference and have kept in touch with our PPI partners at STEPS UK.Future work.
We have recently secured £200k from the University of Liverpool and Alder Hey to continue to develop this work. This will further hardware and software development to create a functional prototype to be used in the outpatient setting. This will lead towards a commercially viable medical device, along with appropriate design controls and process to ensure medical device approval and CE mark achievement. This next stage of work will include: 1) Module specification 2) Integrated feasibility 3) Calibration and functional evaluation 4) Final prototype development 5) Regulatory Review 6) Market Analysis 7) Commercialisation & Investment Plan The outcome of this project will be a highly accurate and clinically validated screening device for detecting DDH, developed in partnership between academia and the NHS. The device will be easy to use and will include a positioner to help correctly comfortably position a new-born baby and align the device for accurate analysis.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0060
Date of REC Opinion
15 Feb 2018
REC opinion
Favourable Opinion