A new ceramic-on-ceramic hip resurfacing implant is being tested against standard total hip replacement in a randomised trial to see which gets patients back to meeting the World Health Organization's physical activity guidelines. This matters because current metal-on-metal hip resurfacing—which often allows higher activity levels than total hip replacement—is now available only to men with larger hips, due to risks from metal ion release. The ceramic version, called H1, avoids that problem. The trial will randomly assign patients to receive either the H1 resurfacing or a standard total hip replacement, then measure at 12 months whether each group achieves the WHO target of 150 minutes of moderate or 75 minutes of vigorous exercise per week. The study will also compare complication rates. If the H1 resurfacing proves superior for activity levels and non-inferior for safety, it could expand access to a more active recovery for the majority of hip replacement patients currently excluded from metal-on-metal devices. The results will be submitted to NICE for technology appraisal, and could shift surgical practice toward a procedure that reduces long-term complications and, potentially, all-cause mortality in this patient group.
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Research question Are patients who have had a hip resurfacing (HRA) more likely to attain the World Health Organisation (WHO) Physical Activity Guidelines than those who have had a total hip arthroplasty (THA)? Background In 2020 WHO published guidance on physical activity and sedentary behaviour. They advised that all adults should attain a minimum level of physical activity to maintain good health. People who achieve these physical activity levels have reduced risk of all-cause death, heart disease, cancer and type-2 diabetes. Research has shown that patients who have HRA surgery score higher in activity questionnaires, walk faster and have more 'normal' gait compared to patients who have THA. In order to understand how unbiased and meaningful these findings are, we are proposing to compare the proportion of patients achieving the WHO Physical Activity Guidelines after HRA, with those who have had THA. The benefits of HRA have been demonstrated using metal-on-metal (MoM) devices which are now only available for men with larger hips owing to metal ion release. This withdrawal has left deprived the majority of patients from accessing this beneficial technology. We have developed a ceramic-on-ceramic (CoC) HRA, H1 , which has been shown not to cause elevated blood metal ions. Aims and objectives The aim of this project is to compare post-operative activity levels at 12 months between patients who have had H1 HRA surgery and patients who have had THA surgery. The metric for comparison is whether or not the patient has achieved the WHO Physical Activity Guidelines of undertaking 150 minutes of moderate, or 75 minutes of vigorous exercise per week. In addition composite clinical success, including complication rate, will be compared between at 12 months. Objectives: To demonstrate superiority of H1 HRA compared to THA regarding achievement of WHO Physical Activity Guidelines To demonstrate non-inferiority of H1 HRA compared to THA regarding composite clinical success Methods The study is designed as a multi-centre prospective double blinded randomised clinical investigation. The investigation will have two arms into which patients will be randomised: H1 HRA and THA. Timelines for delivery This project is 30 months long. This comprises 12m to prepare for the trial, 6m to recruit and operate on the patients, and 12m to follow up each patient. Anticipated impact and dissemination The research output of this study is a report comparing outcomes of the H1 HRA to the gold standard of THA in terms of patient activity levels and composite clinical success. These outputs will be communicated directly to NICE as part of an application for Technology Appraisal, to the orthopaedic community through conferences and journal publications, and also disseminated to the wider general public. In the short term we hope the outputs of this work will lead to increased implantations of HRAs. In the medium term this should present as a reduction in complications for hip replacement surgery. In the long term this should present in a reduction in all-cause mortality for patients who have had hip replacement surgery.
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