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The high failure rate of metal-on-metal hip implants led to worldwide concern. Collaborative research between Newcastle University and University Hospital of North Tees identified design features that are considered to have contributed to the failure. The research helped to inform policy makers both nationally, such as the Medicines and Healthcare products Regulatory Agency (MHRA), and internationally, such as the US Food and Drug Administration (FDA). The final outcome was a worldwide withdrawal of one design of implant (the DePuy ASR) and a ban in several countries of a set of implants sharing common features (large head metal-on-metal total hip replacements). The research has reduced the risk of harm to patients who will now receive products with a significantly lower failure rate, and will have financial implications for implant manufacturers and healthcare providers.
UCL research into metal-on-metal (MOM) hip replacements has developed evidence affecting the 1.5 million patients with MOM hips worldwide and led, indirectly, to a change in the regulation of all medical devices by the US Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Direct impacts include stimulation of the first global retrieval programme for medical implants, [text removed for publication], and the development of a change in the MHRA protocol used to monitor all UK MOM hip patients. These have led to improvements in the quality of patients' lives after redo surgery, and supported litigation cases worth billions of dollars against health providers — including Johnson & Johnson — to fund compensation and earlier-than-expected redo hip operations. Public awareness of issues with MOM hips has been stimulated through widespread media coverage and creation of information resources by charities and regulatory bodies.
Research into the field of metal-on-metal (MoM) arthroplasty (joint replacement) conducted at the University of Bristol in conjunction with the National Joint Registry of England and Wales (NJR) has led to a fundamental change in the practice of arthroplasty around the world and in the clinical follow up of patients. High failure rates have been identified nationally in England and Wales for MoM total hip arthroplasty and certain designs of resurfacing arthroplasty in work conducted by our department. Deleterious systemic effects of wear debris produced by these implants have also been identified by our research. The use of these devices has declined from 14% of procedures in 2008 to less than 1% in 2012. Citing our research, national bodies including NICE (2014), the MHRA (2011 & 2012), the UK Department of Health (2012), British Orthopaedic Association (2011 & 2012), NJR (2012), British Hip Society (2011 & 2012) and the US Food and Drug Administration (FDA) (2013) have issued guidance suggesting the restricted use of such devices or close surveillance of patients in whom these devices have been implanted.
The University of Southampton's world-leading record in bioengineering continues to deliver significant benefits, resulting from recent research crucial to the development, pre-clinical verification and CE-marking of a revolutionary hip-resurfacing implant. In the wake of growing concerns over some previous implant designs, this work has positively impacted on a wide range of audiences: over 9800 patients have received the new implants with excellent early clinical results at two years' follow-up. Within 4 years UK PLC benefited with considerable additional turnover [exact figure removed for publication], a majority from abroad, and the technology attracted three years of investment for a start-up company at Southampton Science Park. This award-winning knowledge transferring research has been widely acknowledged as an example of best practice, and has increased appreciation of science and technology further through outreach.
Metal-on-metal hip resurfacing was developed in the 1990s to provide a long-term solution for young, active patients with hip disease. After observing severe adverse soft tissue reactions (pseudotumours) occurring in a growing percentage of patients with metal-on-metal resurfacing, researchers from the University of Oxford highlighted the problem and identified key patient, surgical and implant related risk factors. Clinical guidelines have been introduced to emphasise the risks, and several implants have been withdrawn from the market by the manufacturers. This research has led to a dramatic decrease in the use of metal-on-metal bearings in hip replacement.
Over 100,000 hip joint replacements are performed each year in the UK. The correct restoration of joint centre is critical to the successful outcome of total hip replacements. Failure to do so results in dislocation, increased wear and leg length discrepancy.
In collaboration with QUB, over 4,000 patient-specific custom hip prostheses were manufactured and implanted at Musgrave Park Hospital, Belfast, leading to accurate restoration of anatomical joint centre.
As a consequence a new surgical instrument has been developed and utilised in more than 4,000 surgeries. Surgical costs are reduced compared to the alternative of computer-aided surgery. The DePuy Synthes Companies are funding the development of a later version of this surgical instrument
Our research has developed improved hip replacement fixation techniques, which have improved the biomechanical stability of implanted artificial joints. These techniques have been employed by orthopaedic surgeons, for example at Mid-Essex Hospitals Services Trust (MEHT), in primary and revision total hip replacement operations. As a result, the number of patients requiring revision hip surgery due to cup loosening has fallen by 50%. Additionally, these techniques have reduced the recovery time per operation by 3-5 days, which in addition to benefitting the patient have also resulted in an average saving per operation of £1,200.
Research at UCL on human haemolytic anaemias known as the `hereditary stomatocytoses' has improved diagnosis of these conditions, meaning that patients now avoid unnecessary and potentially life-threatening splenectomies, and inappropriate investigation and treatment for raised potassium levels. Identification of a common single nucleotide polymorphism that causes apparently normal red blood cells to leak salt when cooled (as is normal procedure with donated blood) has raised awareness of this issue in the NHS Blood and Transfusion service, with the result that individuals with this condition have been identified among existing donors, and work is underway to develop a screening method to exclude such individuals from donating blood that cannot be stored safely. Finally, the research has facilitated diagnosis of the recessive metabolic disorder phytosterolaemia by blood count, allowing these individuals to be given appropriate dietary treatment to control their cholesterol levels.
This case study outlines the impact of novel omega-3 fatty acid therapy for sickle cell disease on health and policy. 128 patients on the treatment since 2010, and another 300 who started to receive it in June 2012 have seen remarkable improvements in health and quality of life as assessed by reductions in hospital admission and absence from work/school due to the disease. A panel of experts set up by the Ministry of Health of Sudan to evaluate the evidence recommended the integration of the therapy in the management of the disease in a policy report dated December 20, 2012. The Ministry has accepted the recommendation.
A low-cost, efficient, blood cell salvage technology (HemoSep) has resulted from research carried out at Strathclyde between 2008 and 2013. The novel technology has been patented and licensed to Brightwake Ltd., who manufacture the device in the UK and market it through a global distribution network. HemoSep has now been used in clinical centres across Europe, North America, and South Africa since its commercial launch in late 2012. The use of the device has been shown to reduce the need for donor blood transfusions in open-heart surgical patients by at least 1 unit (450 ml) with an associated reduction in transfusion related complications such as heightened inflammatory response and bleeding. The reduction in blood transfusions associated with the use of HemoSep has a considerable cost benefit to healthcare providers (in North America blood costs up to $1600 per unit). In addition, commercialisation of HemoSep has led to the creation of new manufacturing, marketing and sales jobs in the UK and overseas.