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
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
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.
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.
Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times for THR can be considerable, and patients often experience significant pain during this time. A pain self-management intervention may provide patients with the skills to enable them to manage their pain and its impact more effectively before surgery. However, studies of arthritis self-management programmes have faced challenges because of low recruitment rates, poor intervention uptake, and high attrition rates. This study aimed to evaluate the feasibility of a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Specific objectives were to assess trial design, ascertain recruitment and retention rates, identify barriers to participation, refine data collection methods, and evaluate uptake and patient satisfaction with the course. Patients listed for THR in an elective orthopaedic centre Bristol, UK were sent a postal invitation about the study. Participants were randomised to attend a pain self-management course plus standard care or standard care only using a computer-generated randomisation system. The pain self-management course was delivered by Arthritis Care and consisted of two half-day group sessions prior to surgery and one full-day group session 2–4 months after surgery. A structured course evaluation questionnaire was completed by participants. Outcomes assessment was by postal questionnaire prior to surgery and 1-month, 3-months and 6-months after surgery. Self-report resource use data were collected using a diary prior to surgery and inclusion of resource use questions in the 3-month and 6-month post-operative questionnaires. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Postal invitations were sent to 385 eligible patients and 88 patients consented to participate (23% recruitment rate). Participants had a mean age of 66 years and 65% were female. Brief interviews with 57 non-participants revealed the most common reasons for non-participation were perceptions about the intervention and difficulties in getting to the hospital for the course. Of the 43 patients randomised to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and patients enjoyed the group format. Retention of participants was acceptable, with 83% completing follow-up. Questionnaire return rates were high (76–93%), with the exception of the pre-operative resource use diary (35%). Completion rates for the resource use questions varied by category and allowed for an economic perspective from the health and social care payer to be taken. Undertaking feasibility work for a RCT is labour-intensive; however this study highlights the importance of conducting such work. Postal recruitment resulted in a low recruitment rate and brief interviews with non-participants provided valuable information on barriers to participation. Embedding collection of resource use data within questionnaires resulted in higher completion rates than using resource use diaries. While patients who attended the course gave positive feedback, attendance was low. Findings from this feasibility study enable us to design successful definitive group-based RCTs in the future.
Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total knee replacement (TKR). To assess the effectiveness of peri-operative LAI for pain management in patients receiving TKR we conducted a systematic review, fully powered randomised controlled trial (RCT) and economic evaluation. We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving TKR. Two reviewers screened abstracts and extracted data. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. Authors were contacted if required. When feasible, we conducted meta-analysis with studies analysed separately if a femoral nerve block (FNB) was provided. In the APEX RCT, we randomised 316 patients awaiting TKR to standard anaesthesia which included FNB, or to the same regimen with additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline). Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation. Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires. In the systematic review, 23 studies including 1,439 patients were identified. Compared with patients receiving no intervention, LAI reduced WOMAC-Pain by standardised mean difference (SMD) −0.40 (95%CI −0.58, −0.22; p<0.001) at 24 hours at rest and by SMD −0.27 (95%CI −0.50, −0.05; p=0.018) at 48 hours during activity. In three studies there was no difference in pain at any time point between randomised groups where all patients received FNB. Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Few studies reported long-term outcomes. In the APEX RCT, pain levels in hospital were broadly similar between groups. Overall opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. There were no differences in pain outcomes between groups at 12 months. In the economic evaluation, LAI was marginally associated with lower costs. Using the NICE £20,000 per QALY threshold, the incremental net monetary benefit was £264 (95%CI, −£710, £1,238) and the probability of being cost-effective was 62%. Although LAI appeared to have some benefit for reduced pain in hospital after TKR there was no evidence of pain control additional to that provided by femoral nerve block, however it would be cost-effective at the current NICE thresholds.
Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total hip replacement (THR). We assessed the effectiveness of LAI using a systematic review and a fully powered randomised controlled trial (RCT) with economic evaluation. We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving THR. Two reviewers screened abstracts, extracted data, and liaised with authors. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. If feasible, we conducted meta-analysis. In the APEX RCT, we randomised 322 patients awaiting THR to receive additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline) or standard anaesthesia alone. Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation. Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires. In the systematic review, we identified 13 studies (909 patients). Patients undergoing THR receiving LAI experienced greater pain reduction at 24 hours at rest, standardised mean difference (SMD) −0.61 (95%CI −1.05, −0.16; p=0.008) and at 48 hours during activity, SMD −0.43 (95%CI −0.78, −0.09; p=0.014). Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Long-term outcomes were not a focus of these studies. In the APEX RCT, pain levels in hospital were broadly similar between groups, probably due to patient-controlled analgesia. Opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. Patients receiving LAI were less likely to report severe pain at 12 months than those receiving standard care, odds ratio 10.2 (95%CI 2.1, 49.6; p=0.004). Complications were similar between groups. In the economic evaluation, LAI was associated with lower costs and greater cost-effectiveness than standard care. Using a £20,000 per QALY threshold, the incremental net monetary benefit was £1,125 (95%CI £183, £2,067) and the probability of being cost-effective was greater than 98 %. The evidence suggests that peri-operative LAI is a cost-effective intervention for reducing acute and chronic post-surgical pain after THR.
Total knee arthroplasty (TKA) remains a safe and effective intervention for the treatment of arthritis of the knee. It does, however, carry risks including death. Studies have compared the incidence of death following TKA to standardised mortality ratios of matched populations. This often suggests that TKA is protective to health in the immediate post operative phase, attributed to the lower incidence of co-morbidities in patients undergoing surgery. In an attempt to remove this “well patient effect”, we compared the incidence of death in the first 30 and 90 days following primary TKA to that of a comparable population added to a waiting list for the same procedure. All primary TKAs undertaken, and all patients added to a waiting list for the same procedure, in a single unit between 2000 and 2007 were recorded. Death rates at 30 and 90 days were compared in each group. The 30 and 90 day mortality following primary TKA were 0.295% and 0.565% respectively, compared to a 30 and 90 day mortality of 0.055% and 0.316% seen in a population of patients awaiting operation. When stratified for age, surgery conferred an excess surgical mortality in all age groups over the age of 60. Factors associated with an increased mortality following operation include male gender and increasing age. Previous studies have suggested that TKA is associated with a decreased risk of death. This study demonstrates an increased risk of death associated with surgery in comparison to a similar population deemed fit enough to undergo operation. Primary TKA carries an excess surgical mortality of 0.24% at 30 days and 0.25% at 90 days, a 5.36 and 1.79 times greater risk of death when compared to patients awaiting the same procedure. This information will greatly assist orthopaedic surgeons when counselling patients as to the risks of surgery.
Regardless of their expectations concerning level of pain following TKR, those participants who perceived an improvement in pain as a result of their TKR were less likely to expect a cure for their residual pain and were either very well or reasonably well adjusted to the pain. Nevertheless, those who had moderate expectations of outcome were more likely to perceive an improvement than those with high expectations. Those individuals who reported having held high expectations of TKR outcome and subsequently experienced increased pain were likely to experience distress in relation to their pain; those who also felt that a cure for their current pain may be possible experienced particularly high levels of distress.
Total knee arthroplasty represents one of the greatest advances in modern orthopaedic surgery and remains one of the safest and most effective interventions for the treatment of crippling arthritis of the knee. It does, however, carry significant risk including death. Conventional studies have compared the incidence of death following knee arthroplasty to standardised mortality ratios of age and sex matched populations. This often raises aberrant results suggesting that knee arthroplasty is protective to health in the immediate post operative phase, attributed to the observation that patients undergoing surgery suffer fewer co morbidities than the population in general. In an attempt to remove this “well patient effect”, we compared the incidence of death in the first 30 and 90 days following primary total knee arthroplasty to the incidence of death in a comparable population added to a waiting list for the same procedure. All primary total knee arthroplasties undertaken, and all patients added to a waiting list for the same procedure, in a single unit between 2000 and 2007 were recorded. Death rates at 30 and 90 days of those on the waiting list were compared to death rates after surgery. The 30 and 90 day mortality following primary total knee arthroplasty were 0.295% and 0.565% respectively. This compares to a 30 and 90 day mortality of 0.055% and 0.316% seen in a population of patients awaiting operation. When stratified for age, surgery conferred an excess surgical mortality in all age groups over the age of 60. Factors associated with an increased mortality following operation include male gender and increasing age. Previous studies, where incidence of death is compared to standardised mortality ratios, have erroneously suggested that arthroplasty is associated with a decreased risk of death. This study demonstrates an increased risk of death associated with surgery in comparison to a similar population deemed fit enough to undergo operation. Primary total knee arthroplasty carries an excess surgical mortality of 0.24% at 30 days and 0.25% at 90 days, a 5.36 and 1.79 times greater risk of death respectively when compared to patients awaiting the same procedure. This information will greatly assist orthopaedic surgeons when counselling patients as to the risks of surgery.
This editorial considers the shortcomings of assessing outcome after joint replacement only by the survival of the implant.
The median satisfaction score was 100 (interquartile range 75–100). However, within the individual outcome domains dissatisfaction rates were: 9% for pain; 12% for overall outcome; 14% for ADLs; and 17% for leisure activities. To explore differences in satisfaction with age, patients were divided into 3 age groups: <
60 years, 60–80 years and >
80 years. The respective rates of dissatisfaction among the age groups were 13%, 11% and 14%, which were not significantly different (p=0.33). In an analysis of gender and satisfaction, significantly more females were dissatisfied than men (14% vs 10%, p=0.01). When pain, function, quality of life, mental health and physical health were compared between patients who were satisfied (n=1834) and dissatisfied (n=251) with their overall outcome, all outcomes were significantly worse in the dis-satisfied patient group (p<
0.001 for all outcomes).
The aim of this study was to determine patient-reported outcomes after arthroscopic rotator cuff repair with a new knot-free technique. A questionnaire was completed by 50 patients who underwent an arthroscopic rotator cuff repair with a knot-free technique. Validated questionnaires included the Oxford Shoulder Score (12–60, good to poor) and SF-36 (0–100, poor to good). Patients also completed a 100mm VAS (0–100, good to poor) to rate the following domains: daytime pain, night-time pain, movement, strength, well-being, ability to do ADLs, participation in sports, ability to do leisure activities and whether they felt their shoulder was back to the way it was before the problem started. The mean length of follow-up was 15 months (range 7–25 months). The mean age of patients was 62 years (range 36–78) and 70% were male. The mean OSS was 22 (SD 10). Mean scores for the 8 domains of the SF-36 were: 74 for physical functioning, 71 for role physical, 66 for bodily pain, 67 for general health, 57 for vitality, 82 for social functioning, 85 for role emotional and 81 for mental health. The mean VAS for the 9 outcome domains were as follows: 16 for night-time pain and daytime pain, 19 for movement, 21 for ability to do ADLs, 22 for well-being, 23 for whether the shoulder was back to the way it was, 28 for ability to do leisure activities, 29 for strength and 33 for ability to participate in sports. In conclusion, patients reported excellent post-operative OSS with the knot-free technique. The SF-36 revealed that patients had high social and emotional functioning and good physical outcomes were reported on the VAS for pain, ADLs and movement. However, going back to an expected level of sport is not always achievable.
Pain: the prevalence of poor outcomes were 6% of patients with a THR, 4% with a hip resurfacing, 12% with a TKR, 9% with a UKR and 31% with a patellar resurfacing. Function: the prevalence of poor outcomes were 12% of patients with a THR, 4% with a hip resurfacing, 16% with a TKR, 9% with a UKR and 35% with a patellar resurfacing. Hip-related quality of life: the prevalence of poor outcomes were 26% of patients with a THR, 12% with a hip resurfacing, 33% with a TKR, 32% with a UKR and 67% with a patellar resurfacing. Satisfaction: the prevalence of poor outcomes were 13% of patients with a THR, 8% with a hip resurfacing, 17% with a TKR, 11% with a UKR and 45% with a patellar resurfacing.
North Bristol Trust Small Grants Scheme provided funding for the consumables for this study.