Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021). Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings. The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training. We conclude that a full RCT with economic analysis will be both feasible and practicable, although mechanisms to safely implement potential changes to practice because of RCT findings may need consideration by the wider arthroplasty community.
The decision to undertake total hip replacement (THA) in a child is complex and daunting. This is augmented by the paucity of data on potential quality of life (QoL) improvement and functional outcomes. Therefore, the aim of this study was to ascertain whether outcomes after surgery are influenced by the nature of the primary diagnosis. This was a prospective, consecutive cohort study of patients under the age of 18 years undergoing THA by a single arthroplasty surgeon in collaboration with colleagues at a regional paediatric hospital. Patient electronic notes, radiographs and PROMS (EQ5D-Y, Oxford Hip Score (OHS) and modified Harris Hip Score(mHHS)) were reviewed. Twenty-two THAs were performed in patients less than 18 years (median 15 (range 10.7–17.9), with 7 patients undergoing bilateral surgery. Mean follow-up was 2 years. Thirteen of the THAs were undertaken for systemic conditions effecting multiple joints (Mucopolysaccharidoses, Mucolipidosis and Scwachman-Diamond syndrome) with the hip the worst affected joint and 9 for single joint disease (AVN, Perthes, dysplasia and idiopathic chondrolysis). PROMS scores showed reliable improvements with no differences between the two groups. Health related QoL was calculated from EQ5D-Y and indicated an overall improvement of 1.06(0.879–1.25). 6 patients were wheelchair users preop. All patients were independent walkers at follow-up. One patient underwent successful revision surgery for aseptic acetabular loosening. There were no other complications. THA in children leads to a significant positive impact on QoL as measured with validated PROMS scores. Patients with systemic conditions can benefit just as much as those with single joint disease. Further follow-up is required to understand the long-term outcomes.
