The aim of this study was to describe the prevalence and patterns of neuropathic pain over one year in a cohort of patients with chronic post-surgical pain at three months following total knee arthroplasty (TKA). Between 2016 and 2019, 363 patients with troublesome pain, defined as a score of ≤ 14 on the Oxford Knee Score pain subscale, three months after TKA from eight UK NHS hospitals, were recruited into the Support and Treatment After Replacement (STAR) clinical trial. Self-reported neuropathic pain and postoperative pain was assessed at three, nine, and 15 months after surgery using the painDETECT and Douleur Neuropathique 4 (DN4) questionnaires collected by postal survey.Aims
Methods
There is a need to develop approaches to reduce chronic pain after total knee replacement. There is an established link between disturbed sleep and pain. We tested the feasibility of a trial evaluating the clinical and cost-effectiveness of a pre-operative sleep assessment and complex intervention package for improving long-term pain after TKR. REST was a feasibility multi-centre randomised controlled trial with embedded qualitative study and health economics. Participants completed baseline measures and were randomised to usual care or the intervention, a tailored sleep assessment and behavioural intervention package delivered by an extended scope practitioner three months pre-operatively with a follow-up call up at four-weeks. Patient reported outcomes were assessed at baseline, one-week pre-surgery, and 3-months post-surgery.Abstract
Introduction
Methodology
Approximately 15–20% of patients report chronic pain three months after total knee replacement (TKR). The STAR care pathway is a clinically important and cost-effective personalised intervention for patients with pain 3 months after TKR. The pathway comprises screening, assesment, onward referral for treatment and follow-up over one year. In a multicentre randomised controlled trial comparing the pathway with usual care, the pathway improved pain at 6 and 12 months. This study examined the longer-term clinical and cost-effectiveness of the STAR care pathway. STAR trial participants were followed-up at a median of 4 years post-randomisation. Co-primary outcomes were self-reported pain severity and interference in the replaced knee, assessed with the Brief Pain Inventory (BPI). Resource use from electronic hospital records was valued with UK reference costs.Abstract
Introduction
Methodology
Total knee replacement (TKR) aims to reduce pain and functional limitations. Despite a good outcome for many, 15–20% patients report chronic pain three months after TKR. The STAR Care Pathway is a clinically important and cost effective treatment to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. The care pathway is delivered by specially trained Extended Scope Practitioners (ESPs). There is a gap between research findings and translation into practice. This work shows how the STAR trial findings were implemented into NHS practice at a single centre and the further work required to enable national implementation. Trial findings were presented to NHS managers with a business case for an implementation pilot. Trial documentation was adapted for use in usual care using the COM-B model for behaviour change and evidence-based approaches to increase the return of postal questionnaires. Trial sites were contacted to understand their capacity to implement the intervention locally.Abstract
Introduction
Methodology
Total knee replacement (TKR) is a successful operation for many patients, however 15–20% of patients experience chronic post-surgical pain (CPSP). Many will experience neuropathic characteristics. We describe the prevalence and patterns of neuropathic pain in a cohort of patients with CPSP three months after TKR. Between 2016–2019, 363 patients with troublesome pain, ≤14 on Oxford Knee score pain subscale, at three months after TKR from eight NHS hospitals were recruited into the Support and Treatment After Replacement (STAR) trial. Self-reported neuropathic pain was assessed at three, nine and fifteen months after surgery using painDETECT and Douleur Neuropathique 4 (DN4).Abstract
Introduction
Methodology
Prosthetic joint infection (PJI) is an uncommon but serious complication of hip replacement. Over 1,000 operations are performed annually in the United Kingdom for PJI following hip replacement, using either one- or two-stage revision arthroplasty. It is unclear which is preferred by patients and which has the best long-term outcome. This qualitative study aims to describe patient experiences of treatment and recovery following one- and two-stage revision arthroplasty for PJI within the context of a pragmatic randomised controlled trial comparing these two approaches. Semi-structured interviews were conducted with 32 patients undergoing one- or two-stage revision treatment for PJI as part of a UK multi-centre randomised controlled trial. Patients were recruited from 12 participating National Health Service (NHS) Orthopaedic Departments and were interviewed 2–4 months after their first revision surgery and again approximately 18 months later. Final sample size was justified on the basis of thematic saturation. All patients consented to the interview being audio-recorded, transcribed, anonymised and analysed using an inductive thematic approach. Ethical approval was provided by NRES Committee South-West Frenchay, 14/SW/116. Patients in both the one- and two-stage treatment groups described prolonged hospital stays, with burdensome antibiotics and brief physiotherapy treatment. However, following discharge home and during recovery, participants undergoing two-stage revision with an ‘empty hip' or with a spacer reported being physically restricted in almost every aspect of their daily life, resulting in inactivity and confinement to home. Mobility aids were not sufficiently available through the health service for these patients. A key difference is that those with a spacer reported more pain than those without. Approximately one year following their second-stage revision, participants described being more independent and active, but two directly attributed muscle weakness to the lengthy period without a hip and described resulting falls or dislocations that had complicated their recovery. In contrast, those undergoing one-stage revision and CUMARS appeared to be more alike, reporting better mobility, functionality and independence, although still limited. Participants in these groups also reported minimal or no pain following their revision. A key difference between CUMARS and one-stage revision was the uncertainty of whether a second operation was necessary, which participants described as “hanging over them”, while those in the two-stage empty hip or spacer group described a more positive anticipation of a second definitive operation as it marked an end to what was described as a detachment from life. Our findings highlight the differences between patient experiences of recovery following revision arthroplasty, and how this is influenced by the surgical approach and presence or lack of spacers. An understanding of lived experiences following one- and two-stage surgical interventions will complement knowledge about the clinical effectiveness of these different types of revision surgery.
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.
To aid recovery, rehabilitation is an important adjunct to surgery. Acknowledging the MRC framework for complex interventions we assessed the evidence-base for components of comprehensive rehabilitation in total hip (THR) and total knee replacement (TKR) pathways. We conducted systematic reviews and meta-analyses of randomised controlled trials (RCT) of pre-surgical exercise and education, occupational therapy and post-operative physiotherapy. In feasibility RCTs we explored acceptability of pain self-management and occupational therapy before THR, and physiotherapy after TKR. We searched trial registers for ongoing RCTs.Background
Methods
Inpatient physiotherapy is routinely provided after total knee replacement (TKR) surgery to enhance recovery prior to discharge. However, the provision of outpatient physiotherapy is variable in the UK, and the longer-term benefits of outpatient physiotherapy are unclear. This study aimed to evaluate the feasibility of conducting a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of group-based outpatient physiotherapy after TKR. Patients listed for primary TKR were recruited prior to surgery. Patients who decided not to participate were asked about their reasons for non-participation. Patients were randomised to attend a newly developed post-operative physiotherapy class plus usual care or usual care alone. Patients allocated to the intervention group were invited to attend a weekly one-hour physiotherapy class, starting at 6 weeks after surgery and running over 6 consecutive weeks. The group classes were run by two physiotherapists within an outpatient gym, and involved task-orientated and individualised exercises. Classes ran on a rolling system, allowing new patients to join each week. Participants completed an evaluation questionnaire after the final class. Outcomes assessment was by questionnaire prior to surgery and 2 weeks, 3 months and 6 months after surgery. Outcomes related to function, pain, balance, self-efficacy, participation, quality of life and resource use.Background
Methods
Chronic pain after joint replacement is common, affecting approximately 10% of patients after total hip replacement (THR) and 20% of patients after total knee replacement (TKR). Heightened generalised sensitivity to nociceptive input could be a risk factor for the development of this pain. The primary aim of this study was to investigate whether preoperative widespread pain sensitivity was associated with chronic pain after joint replacement. Data were analysed from 254 patients receiving THR and 239 patients receiving TKR. Pain was assessed preoperatively and at 12 months after surgery using the Western Ontario and McMaster Universities Osteoarthritis Pain Scale. Preoperative widespread pain sensitivity was assessed through measurement of pressure pain thresholds (PPTs) at the forearm using an algometer. Statistical analysis was conducted using linear regression and linear mixed models, and adjustments were made for confounding variables.Background
Methods
To investigate whether the interaction between pre-operative widespread hyperalgesia and radiographic osteoarthritis (OA) was associated with pain severity before and after total hip replacement (THR) and total knee replacement (TKR). Data were analysed from 232 patients receiving THR and 241 receiving TKR. Pain was assessed pre-operatively and at 12 months post-operatively using the WOMAC Pain Scale. Widespread hyperalgesia was assessed through forearm pressure pain thresholds (PPTs) measured using an algometer. The severity of radiographic OA was evaluated using the Kellgren and Lawrence scheme. Statistical analysis was conducted using linear regression and multilevel models, and adjusted for confounding variables.Background
Methods
While many studies have investigated long-term outcomes after lower limb arthroplasty, rather less is known about the trajectory of short-term outcomes in the first post-operative year. It is difficult for a surgeon to know when, in terms of disease severity, it is best to operate, or to make an accurate prediction of the patient pattern of post-operative recovery. We explored the trajectory of change in pain and function following primary hip and knee arthroplasty and the influence of pre-operative self-reported symptoms on post-operative improvements. A prospective UK cohort study of 164 patients undergoing primary hip (n=80) or knee (n=84) arthroplasty. WOMAC pain and function measures were collected pre-operatively and at 3 and 12 months post-operatively. Hip and knee arthroplasties were analysed separately, and patients were split into two groups: those with high or low symptoms pre-operatively. Multilevel regressions were used for each outcome (pain and function), and the trajectory of change (0–3 months and 3–12 months) charted. The study was approved by Southwest 4 Research Ethics Committee (09/H0102/72) and all patients provided informed, written consent. The authors have no competing interests to disclose.Background
Methods
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. In a qualitative study in the UK we interviewed 19 patients who had infection after hip replacement and 12 orthopaedic surgeons specialising in infection. Face-to-face interviews with patients explored experience of infection, treatment and recovery. Interviews with surgeons explored treatment decisions. With consent, interviews were audio-recorded, transcribed and anonymised. Once imported into QSR NVivo software, data were analysed using constant comparison.Background
Methods
There is limited information about the extent to which the association between pre-operative and chronic post-operative pain is mediated via pain-on-movement or pain-at-rest. We explored these associations in patients undergoing total hip (THR) and total knee (TKR) replacement. 322 and 316 patients receiving THR and TKR respectively were recruited into in a single centre UK cohort (APEX) study. Pre-operative, acute post-operative and 12-month pain severity was measured using self-reported pain instruments. The association between pre-operative / acute pain and chronic post-operative pain was investigated using structural equation modelling (SEM).Objective
Methods
Total hip replacement (THR) and total knee replacement (TKR) are usually effective at relieving pain; however, 7–23% of patients experience chronic post-surgical pain. These trials aimed to investigate the effect of local anaesthetic wound infiltration on pain severity at 12 months after primary THR or TKR for osteoarthritis. Between November 2009 and February 2012, 322 patients listed for THR and 316 listed for TKR were recruited into a single-centre double-blind randomised controlled trial. Participants were randomly assigned (1:1) to receive local anaesthetic infiltration and standard care or standard care alone. Participants and outcomes assessors were masked to group allocation. The primary outcome was pain severity on the WOMAC Pain scale at 12 months post-surgery. Analyses were conducted using intention-to-treat and per-protocol approaches. Ethics approval was obtained from Southampton and South West Hampshire Research Ethics Committee.Background
Methods
This article reviews four commonly used approaches to assess patient responsiveness to a treatment or therapy [Return To Normal (RTN), Minimal Important Difference (MID), Minimal Clinically Important Difference (MCID), OMERACT-OARSI (OO)], and demonstrates how each of the methods can be formulated in a multi-level modelling (MLM) framework. Data from the Arthroplasty Pain Experience (APEX) cohort study was used. Patients undergoing total hip and knee replacement completed the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire prior to surgery and then at 3, 6 and 12 months after surgery. We compare baseline scores, change scores, and proportion of individuals defined as “responders” using traditional and multi-level model (MLM) approaches to patient responsiveness.Background
Methods
Physical functioning in patients undergoing hip surgery is commonly assessed in three ways: patient-reported outcome measure (PROM), performance test, or clinician-administered measure. It is recommended that several types of measures are used concurrently to capture an extended picture of function. Patient fatigue and burden, time, resources and logistical constraints of clinic and research appointments mean that collecting multiple measures is seldom feasible, leading to focus on a limited number of measures, if not a single one. While there is evidence that performance-tests and PROMs do not fully correlate, correlations between PROMs, performance tests and clinician-administrated measures are yet to be evaluated. It is also not known if the associations between function and patient characteristics depend on how function is measured. The aim of our study was to use different measures to assess function in the same group of patients before their hip surgery to determine 1. how well PROMs, performance tests and clinician-administrated measures correlate with one another and 2. Whether these measures are associated with the same patient characteristics. We conducted a cross-sectional analysis of the pre-operative information of 125 participants listed for hip replacement. The WOMAC function subscale, Harris Hip Score (HHS) and walk-, step- and balance-tests were assessed by questionnaire or during a clinic visit. Participant socio-demographics and medical characteristics were also collected. Correlations between functional measures were investigated with correlation coefficients (r). Regression models were used to test the association between the patient's characteristics and each of the three types of functional measures. None of the correlations between the PROM, clinician-administrated measure and performance tests were very high (r<0.90). The highest correlations were found between the WOMAC-function and the HHS (r=0.7) or the Walk-test (r=0.6), and between the HHS and the walk-test(r=0.7). All the other performance-tests had low correlations with the other measures(r ranging between 0.3 and 0.5). The associations between patient characteristics and functional scores varied by type of measure. Psychological status was associated with the WOMAC function (p-value<0.0001) but not with the other measures. Age was associated with the performance test measures (p-value ranging from ≤0.01 to <0.0001) but not with the WOMAC function. The clinician-administered (HHS) measure was not associated with age or psychological status. When evaluating function prior to hip replacement clinicians and researchers should be aware that each assessment tool captures different aspects of function and that patient characteristics should be taken into account. Psychological status influences the perception of function; patients may be able to do more than they think they can do, and may need encouragement to overcome anxiety. A performance test like a walk-test would provide a more comprehensive assessment of function limitations than a step or balance test, although performance tests are influenced by age. For the most precise description of functional status a combination of measures should be used. Clinicians should supplement their pre-surgery assessment of function with patient-reported measure to include the patient's perspective.
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.
Patients report similar or better pain and function before revision hip arthroplasty than before primary arthroplasty but poorer outcomes after revision surgery. The trajectory of post-operative recovery during the first 12 months and any differences by type of surgery have received little attention. We explored the trajectories of change in pain and function after revision hip arthroplasty to 12-months post-operatively and compared them with those observed after primary hip arthroplasty. We conducted a single-centre UK cohort study of patients undergoing primary (n = 80) or revision (n = 43) hip arthroplasty. WOMAC pain and function scores and 20-metres walking time were collected pre-operatively, at 3 and 12-months post-operatively. Multilevel regression models were used to chart and compare the trajectories of post-operative change (0–3 months and 3–12 months) between the types of surgery. Patients undergoing primary arthroplasty had a total hip replacement (n=74) or hip resurfacing (n=6). Osteoarthritis was the indication for surgery in 92% of primary cases. Patients undergoing revision arthroplasty had revision of a total hip arthroplasty (n=37), hemiarthroplasty (n=2) or hip resurfacing (n=4). The most common indication for revision arthroplasty was aseptic loosening (n=29); the remaining indications were pain (n=4), aseptic lymphocyte-dominated vasculitis-associated lesion (n=4) or other reasons (n=6). Primary (87%) and revision arthroplasties (98%) were mostly commonly performed via a posterior surgical approach. The improvements in pain and function following revision arthroplasty occurred within the first 3-months following operation (WOMAC-pain, p<0.0001; WOMAC-function, p<0.0001; timed 20-metres walk, p<0.0001) with no evidence of further change beyond this initial period (p>0.05) While the pattern of recovery after revision arthroplasty was similar to that observed after primary arthroplasty, improvements in the first 3-months were smaller after revision compared to primary arthroplasty (p<0.0001). Patients listed for revision surgery reported lower pre-operative pain levels (p=0.03) but similar post-operative levels (p=0.268) compared to those undergoing primary surgery. At 12-months post-operation patients who underwent a revision arthroplasty had not reached the same level of function achieved by those who underwent primary arthroplasty (WOMAC-function p=0.015; Time walk p=0.004). Patients undergoing revision hip arthroplasty should be informed that the majority of their improvement will occur in the first 3-months following surgery and that the expected improvement will be less marked than that experienced following primary surgery. More research is now required to 1.) identify whether specific in-patient and post-discharge rehabilitation tailored towards patients undergoing revision arthroplasty would improve or achieve equivalent outcomes to primary surgery and 2.) whether patients who are achieving limited improvements at 3-months post-operative would benefit from more intensive rehabilitation. This will become all the more important with the increasing volume of revision surgery and the high expectations of patients who aspire to a disease-free and active life.
