SHINE 2
Research type
Research Study
Full title
SHINE-2: Screening the Hips in Newborns. The Use of an Acoustic Device to Identify Developmental Hip Dysplasia in Babies
IRAS ID
324933
Contact name
Daniel Perry
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
ISRCTN10735430
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Summary of Research
Developmental dysplasia of the hip (DDH) is a spectrum of disease. One per 1000 babies have a frankly dislocated hip, and 2-3% are diagnosed with some degree of hip dysplasia(1). DDH is associated with premature osteoarthritis and is the reason for 10% of all hip replacements, and is the most commonly identified cause of hip osteoarthritis in those under 60 years old(2). Early diagnosis is crucial to determine whether surgery is required in childhood, and to maximise outcomes in adulthood. If DDH is identified early in infancy, it can usually be rectified with a removable splint, worn for just a few weeks.
The UK uses a nationwide selective ultrasound screening programme for DDH(3). 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 assess competence, and have high variability amongst clinicians. The NSC estimates that around two in three hip dislocations are missed on screening(4).
The alternative approach is universal ultrasound screening, which is practiced in some parts of mainland Europe. A Cochrane review has highlighted the costly nature of the alternative and high levels of false positives that this would generate(5). The NSC therefore does not recommend universal ultrasound screening, opting for the current selective screening model acknowledging the flaws. A new screening tool is needed, which that better fulfils the Wilson and Jungner criteria for screening(6), i.e. the test needs to be simple, safe, precise, validated and cost-effective – and one that ideally is reproducible even with minimal training.
Through a prior study (SHINE), we have demonstrated sound transmission to be an effective tool to identify infant hips that are dislocated. SHINE2 will develop the techniques to refine the screening tool, to progress the technology to Technology Readiness Level (TRL) 4. Alongside this, we will demonstrate the market opportunities for such a device and develop a health economic model to demonstrate the potential value of the tool to society. We will also engage with industry, whilst protecting any IP generated. It is anticipated that SHINE2 will bring the device to the point that the technology is finalised, and a commercial product can be conceived.
Summary of Results
Developmental dysplasia of the hip (DDH) is a condition where a baby’s hip joint does not form properly. It affects about 1 in 100 newborns, and if missed, can cause arthritis and disability later in life. Detecting DDH early is vital, but the current screening methods are not perfect. Clinical examination can miss cases, and ultrasound – the gold standard test – requires trained staff and is expensive to deliver as a national screening programme.
The SHINE study set out to test a new idea: could we use harmless sound waves to detect DDH in newborns? The prototype SHINE device worked by sending sound across the hip and measuring how it travelled through the joint. The hope was that hips with DDH would change the sound pattern in a way that could be picked up quickly, cheaply, and by staff with minimal training.
We tested the device in a clinical trial at Alder Hey Children’s Hospital. It was safe, easy to use, and did not cause distress to babies. The device reliably recorded sound signals – but when we analysed the data, the results were disappointing. The differences between normal and abnormal hips were too small and inconsistent to make the device useful as a screening test.
In short: while the SHINE device was safe and worked technically, it did not provide the clear, reliable results needed to diagnose DDH. The study has therefore been stopped.
Although the findings were negative, they are still important. They show that sound transmission does not appear a practical way to screen babies for DDH, suggesting future researchers focus on more promising technologiesREC name
HSC REC A
REC reference
23/NI/0066
Date of REC Opinion
26 Jun 2023
REC opinion
Further Information Favourable Opinion