In the UK and USA in 2016 more than 263,000 primary knee replacements were performed. Around 20% of patients report chronic post-surgical pain (CPSP) at three or more months after total knee replacement (TKR). A large proportion of adults with all types of chronic musculoskeletal pain do not use services for a number of reasons, despite being in constant or daily pain. Given the high prevalence of CPSP, there is potentially a large hidden population with an unexpressed need for care, experiencing ongoing pain and disability; understanding why they do not use health services may herald further insight into why many remain dissatisfied with knee replacement surgery. The aim of this study is to understand why some people with CPSP after TKR do not access services or make little use of healthcare. We conducted face-to-face in-depth interviews with 34 patients from 2 high-volume orthopaedic hospitals in England, to investigate their experience of long-term pain after knee replacement; their knowledge and understanding of CPSP; and their decisions about consulting for CPSP. The sample size was based on achievement of saturation and participants provided written informed consent. Interviews were transcribed and analysed using an inductive thematic approach with double coding for rigor. Ethical approval for the study was granted by the West Midlands Solihull Research Ethics Committee (15/WM/0469). A core theme within the analysis suggests that participants do not seek healthcare because they believe that nothing further can be done, either by themselves or by healthcare professionals. Surgeons' satisfaction with the knee surgery and reassurances that pain would improve, left patients feeling uncertain about whether to re-consult, and some assumed that further consultation could lead to further surgery or medication, which they wish to avoid. Some participants' comorbidities took precedence over their knee pain when seeking healthcare. Others felt they had received their “share” of healthcare resources and that others were more deserving of treatment. People's descriptions of pain varied, from dull, or aching to shooting pains. Many described their pain as “discomfort” rather than pain. The majority described pain that was better than their pre-surgical pain, though others described pain that was worse, which they believed to be nerve damage. Many expressed disappointment in the outcome of their TKR. Expectations of pain varied, where most had expected some post-surgical pain, others underestimated it, and some had expected to be completely pain free following their TKR. Our analysis suggests that the reasons that some people with CPSP after TKR do not consult are varied and complex, spanning psychosocial, structural, moral, and organisational domains. There was an overriding sense that further consultation would be futile or may lead to unwanted treatment. Results suggest that improved information for patients about CPSP and appropriate post-surgical healthcare services may help patients and clinicians to manage this condition more effectively.

Background

Around 1% of patients who have hip replacement have deep prosthetic joint infection afterwards. Infection is treated with antibiotics and revision surgery. We aimed to characterise the impact of deep joint infection and its treatment, to identify treatment preferences, and to describe surgeons' treatment decisions.

Joint arthroplasty is a common surgical procedure, with over 185,000 primary hip and knee arthroplasties performed in England, Wales and Northern Ireland in 2014. After total hip or knee arthroplasty, about 1% of patients develop deep prosthetic joint infection (PJI), which usually requires further major operations to clear the infection. Although PJI affects only a small percentage of patients it is one of the most devastating complications associated with this procedure. Research evidence has focussed on clinical effectiveness of revision surgery while there has been less focus on the impact on patients and support needs. Using a systematic review approach, the aim of this study was to assess support needs and evaluate what interventions are routinely offered to support patients undergoing treatment for PJI following hip or knee arthroplasty.

We systematically searched MEDLINE, Embase, Web of Science, PsycINFO, Cinahl, Social Science Citation Index, and The Cochrane Library from 1980 to February 15, 2015 for observational (prospective cohort, nested case-control, case-control, and retrospective cohort) studies, qualitative studies, and clinical trials that report on the support needs and interventions for patients being treated for PJI or other major adverse occurrences following joint arthroplasty. Data were extracted by two independent investigators and consensus reached with involvement of a third.

Of 4,161 potentially relevant citations, we identified one case-control, one prospective cohort and two qualitative studies for inclusion in the synthesis. Patients report that PJI and treatment had a profoundly negative impact affecting physical, emotional, social and economic aspects of their lives. No study evaluated support interventions for PJI or other major adverse occurrences following hip and knee arthroplasty.

The interpretation of study results is limited by variation in study design, outcome measures and the small number of relevant eligible studies. Findings show that patients undergoing treatment for PJI have extensive physical, psychological, social and economic support needs. Our review highlights a lack of evidence about support strategies for patients undergoing treatment for PJI and other adverse occurrences. There is a need to design, implement and evaluate interventions to support these patients.

Around 20% of patients who have total knee replacement find that they experience long-term pain afterwards. There is a pressing need for better treatment and management for patients who have this kind of pain but there is little evidence about how to improve care. To address this gap we are developing a complex intervention comprising a clinic to assess potential causes of a patient's long-term pain after knee replacement and onwards referral to appropriate, existing services. The Medical Research Council recommends that development of complex interventions include several stages of development and refinement and involvement of stakeholders. This study comprises the penultimate stage in the comprehensive development of this intervention. Earlier stages included a survey of current practice, focus groups with healthcare professionals, a systematic review of the literature and expert deliberation.

Healthcare professionals from diverse clinical backgrounds with experience of caring for patients with long-term pain after knee replacement were sent a study information pack. Professionals who wished to participate were asked to return their signed consent form and completed study questionnaire to the research team. Participants rated the appropriateness of different aspects of the assessment process and care pathway from 1–9 (not appropriate to very appropriate). Data were collated and a document prepared, consisting of anonymised mean appropriateness ratings and summaries of free-text comments. This document was then discussed in 4 facilitated meetings with healthcare professional held at the future trial centres. A summary report and revised care pathway was then prepared and sent to participants for further comments.

28 professionals completed the questionnaire and/or attended a meeting. Participants included surgeons, physiotherapists, nurses, pain specialists and rheumatologists. Mean appropriateness scores ranged from 6.9 to 8.4. Taking a score of 7–9 as agreement, consensus was achieved that the assessment should be performed at 3 months post-operative by an extended scope practitioner/nurse, treatment be guided by a standardised assessment of pain, and treatment individualised. There was also agreement that referrals in the care pathway to surgical review, GP and pain clinics were appropriate. Nurse-led/self-monitoring was rated lower (6.9) because of considerations about the need to ensure that patients receive appropriate support, follow-up and referral to other services.

This work demonstrates the research methods that can be used to refine the design of a complex intervention. The process and findings enable refinement of an intervention for patients with long-term pain after knee replacement. The next stage of intervention development will assess the acceptability and reliability of the assessment process, and the usability of the intervention's standard operating procedures. The intervention will then be evaluated by a larger research team in a multi-centre randomised controlled trial, starting in late 2016.

Around 1% of the 185,000 primary hip and knee arthroplasties performed in the UK are followed by prosthetic joint infection (PJI). Although PJI affects a small percentage of patients, it is one of the most devastating complications associated with this procedure. Treatment usually involves further major surgery which can adversely affect patients' quality of life. Understanding current service provision provides valuable information needed to design and evaluate support interventions for patients. The aim of this survey was to identify usual care pathways and support in UK NHS orthopaedic centres for this population.

The 20 highestvolume UK NHS orthopaedic centresfor hip and knee arthroplasty account for 33–50% of all cases treated for prosthetic joint infection. Infection leads at each centre were invited to participate in a survey about usual care provision and support for PJI. Questions exploredfollow up time-points; use of standard outcome measures; multidisciplinary care plans; supportive in-patient care and care after treatment; and onward referrals. Survey responses were recorded on a standardised proforma. Data were entered into Excel for analysis, then reviewed and coded into categories and frequency statistics to describe categorical data. A descriptive summary was developed based on these categories.

Eleven of the highestvolume orthopaedic centres completed the survey. Follow-up of patients varied greatly across centres; some centres reviewed patients at weekly or 2 week intervals, while all centres saw patients at 6 weeks. Long-term follow-up varied across centres from 3–4 monthsto 12 monthly. Length of follow-up period varied from until the infection had cleared toindefinitely. Follow-up timepoints were only standardised in 4 out of 11 centres. Only 1 centre had a dedicated infection clinic. Advice on who patients should contact if they had concerns included the consultant, community nurse, extended scope practitioner or the ward, while 3 centres told patients to avoid calling their GP. Only half of the centres routinely used standardised outcome measures with patients with PJI. The majority of centres provided standard physiotherapy and occupational therapy (OT) to in-patients while approximately half also offered social support. Only one centre provided dedicated physiotherapy and OT on a separate infection ward. Three centres provided hospital at home or community services to patients in-between operative stages. Only 3 out of 11 centres stated they had specific multidisciplinary care plans in place for patients. Once discharged most patients were provided with physiotherapy, OT and social services if needed. Common barriersto referral included complexities of referring patients outside the hospital catchment area;lack of availability of community services, and shortage of staff including physiotherapists. Delays in rehab and social services could also be problematic.

Findings show wide variation intreatment pathways and support for patients treated for PJI, both as inpatients and in the community. Only one of the 11 centreswho participated had a dedicated infection clinic. Only one centre suggested they individualised their physiotherapy support. A number of barriers exist to referring patients on to other support services after revision surgery.

Around 1% of total hip replacements are follow by prosthetic joint infection (PJI). There is uncertainty about best treatment method for PJI, and the most recent high quality systematic reviews in unselected patients indicates that re-infection rates following one-stage and two-stage revision arthroplasty are relatively similar. In the absence of evidence randomised controlled trials will help to identify the most clinically and cost-effective treatment for PJI. Before such trials are conducted, there is a need to establish reasons for current practice and to identify whether trials are feasible. This study aimed to deliver research that would inform trial design. Specifically, we aimed to characterise consultant orthopaedic surgeons' decisions about performing either one-stage or two-stage exchange arthroplasty for patients with PJI after hip replacement and to identify whether a randomised trial comparing one-stage with two-stage revision would be possible.

Semi-structured interviews were conducted with 12 consultant surgeons from 5 high-volume National Health Service (NHS) orthopaedic departments in the UK. Surgeons were sampled on the basis that they perform revision surgery for PJI after hip arthroplasty and final sample size was justified on the basis of thematic saturation. Surgeons were interviewed face-to-face (n=2) or via telephone (n=10). The interview study took place before design of a multicentre prospective randomised controlled trial comparing patient and clinical outcomes after one-stage or two-stage revision arthroplasty. Data were audio-recorded, transcribed, anonymised and analysed using a thematic approach, with 25% of transcripts independently double-coded.

Results: There is no standard surgical response to the treatment of PJI and surgeons manage a complex balance of factors when choosing a surgical strategy. These include multiple patient-related factors, their own knowledge and expertise, available infrastructure and the infecting organism. Surgeons questioned whether evidence supports the emergence of two-stage revision as a method. They described the use of loosely cemented articulating spacers as a way of managing uncertainty about best treatment method. All surgeons were supportive of a randomised trial to compare one-stage and two-stage revision surgery for PJI after hip replacement. Surgeons reported that they would put patients forward for randomisation when there was uncertainty about best treatment.

Surgeons highlighted the need for evidence to support their choice of revision. Some surgeons now use revision methods that can better address both clinical outcomes and patients' quality of life, such as loosely cemented articulating spacers. Surgeons thought that a randomised controlled trial comparing one-stage and two-stage exchange joint replacement is needed and that randomisation would be feasible. The next stage of the work was to design a multi-centre randomised controlled trial, this has been achieved and the trial is now ongoing in the UK.