Approximately 20-25% of patients having joint replacement in the UK have moderate-severe frailty. Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively with exercise and protein supplementation could improve post-operative outcomes. Prior to conducting a randomised controlled trial (RCT), a feasibility study was necessary to inform trial design and delivery. We conducted a randomised feasibility study with embedded qualitative work. Patients aged ≥65 years, frail and undergoing THR or TKR were recruited from three UK hospitals. Participants were randomly allocated on a 1:1 ratio to the intervention or usual care group. The intervention group had a 1:1 appointment with a physiotherapist and were provided with a home-based, tailored daily exercise programme and a daily protein supplement for 12 weeks before their operation, supported by six telephone calls from a physiotherapist. Questionnaires were administered at baseline and 12 weeks after randomisation. Interviews were conducted with 19 patients. Feasibility outcomes were eligibility and recruitment rates, intervention adherence, and acceptability of the trial and the intervention.Introduction
Method
Hip prosthetic joint infection (PJI) is a debilitating complication following joint replacement surgery, with significant impact on patients and healthcare systems. The INFection ORthopaedic Management: Evidence into Practice (INFORM: EP) study, builds upon the 6-year INFORM programme by developing evidence-based guidelines for the identification and management of hip PJI. A panel of 21 expert stakeholders collaborated to develop best practice guidelines based on evidence from the previous INFORM research programme. An expert consensus process was used to refine guidelines using RAND/UCLA criteria. The guidelines were then implemented over a 12-month period through a Learning Collaborative of 24 healthcare professionals from 12 orthopaedic centres in England. Qualitative interviews were conducted with 17 members of the collaborative and findings used to inform the development of an implementation support toolkit. Patient and public involvement contextualised the implementation of the guidelines. The study is registered with the ISCRTN (34710385).Introduction
Methods
During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.Aims
Methods
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
Hip prosthetic joint infection (PJI) is a debilitating complication following joint replacement surgery, with significant impact on patients and healthcare systems. The INFection ORthopaedic Management: Evidence into Practice (INFORM:EP) study, builds upon the 6-year INFORM programme by developing evidence-based guidelines for the identification and management of hip PJI. A panel of 21 expert stakeholders collaborated to develop best practice guidelines based on evidence from INFORM \[1\]. An expert consensus process was used to refine guidelines using RAND/UCLA criteria. The guidelines were then implemented over a 12-month period through a Learning Collaborative of 24 healthcare professionals from 12 orthopaedic centres in England. Qualitative interviews were conducted with 17 members of the collaborative and findings used to inform the development of an implementation support toolkit. Patient and public involvement contextualised the implementation of the guidelines. The study is registered with the ISCRTN (34710385). The INFORM guidelines, structured around the stages of PJI management, were largely supported by surgeons, although barriers included limited awareness among non-surgical team members, lack of job planning for multidisciplinary teams, and challenges in ensuring timely referrals from primary care. Psychological support for patients was identified as a critical gap. Advanced Nurse Practitioners and multidisciplinary team (MDT) coordinators were seen as potential bridges to address these knowledge gaps. The guidelines were also viewed as a useful tool for service development. This study presents the first evidence-based guidelines for hip PJI management, offering a comprehensive approach to prevention, treatment, and postoperative care. Effective implementation is crucial, involving wider dissemination amongst primary and community care, as well as non-specialist treatment centres. Further resources are needed to ensure job planning for MDTs and psychological support for patients. Overall, this study lays the foundation for improved PJI management, benefiting patients and healthcare systems.
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
Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively via protein supplementation and exercise has the potential to improve outcomes after joint replacement. Before conducting a randomised controlled trial (RCT), a feasibility study is necessary to address key uncertainties and explore how to optimise trial design. Joint PREP is a feasibility study for a multicentre, two-arm, parallel group, pragmatic, RCT to evaluate the clinical and cost-effectiveness of prehabilitation for frail patients undergoing total hip or knee replacement. Sixty people who are ≥65 years of age, frail and scheduled to undergo total hip or knee replacement at 2–3 NHS hospitals will be recruited and randomly allocated on a 1:1 ratio to the intervention or usual care group. The intervention group will be given a daily protein supplement and will be asked to follow a home-based, tailored daily exercise programme for 12 weeks before their operation, supported by fortnightly telephone calls from a physiotherapist. Embedded qualitative research with patients will explore their experiences of participating, reasons for non-participation and/or reasons for withdrawal or treatment discontinuation.Abstract
Introduction
Methodology
People from ethnic minority backgrounds are underserved in healthcare and research. We co-developed a checklist to promote good practice for inclusive community patient and public involvement (PPI). We worked with three community groups in Bristol to develop the checklist – Dhek Bhal (South Asian community), Malcolm X Elders (African Caribbean community) and My Friday Coffee Morning (predominantly Somali women). We worked with group leaders to better understand the needs of the groups. We visited each group at least three times and used informal and open discussions tailored to how each group preferred to work. We paid for community leaders’ time, interpretation and transport where needed, as well as contributing towards activities and catering as suggested by group leaders.Abstract
Introduction
Methods
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
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.
Periprosthetic hip-joint infection is a multifaceted and highly detrimental outcome for patients and clinicians. The incidence of prosthetic joint infection reported within two years of primary hip arthroplasty ranges from 0.8% to 2.1%. Costs of treatment are over five-times greater in people with periprosthetic hip joint infection than in those with no infection. Currently, there are no national evidence-based guidelines for treatment and management of this condition to guide clinical practice or to inform clinical study design. The aim of this study is to develop guidelines based on evidence from the six-year INFection and ORthopaedic Management (INFORM) research programme. We used a consensus process consisting of an evidence review to generate items for the guidelines and online consensus questionnaire and virtual face-to-face consensus meeting to draft the guidelines.Aims
Methods
Restoring native hip anatomy and biomechanics is important to create a well-functioning total hip arthroplasty (THA). Hip offset and leg length are regarded as the most important biomechanical characteristics. This study investigated their association with clinical outcomes including patient reported outcome measures (PROMs) and functional tests. This prospective cohort study was conducted in 77 patients undergoing primary THA (age=65±11 years). Hip offset and leg length were measured on anteroposterior radiographs of the hip pre- and postoperatively. Participants completed the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) and performed functional tests (i.e. gait, single leg stance, sit-to-stand, block step-up) preoperatively, and 3 and 12 months postoperatively. A wearable motion sensor was used to derive biomechanical parameters. Associations between radiographic and functional outcomes were investigated with the Spearman's rho correlation coefficient. Subgroup comparisons were conducted for patients with more than 15% decreased or increased femoral offset after THA. Differences in postoperative offset and leg length had little impact on clinical outcomes. Femoral offset subgroups demonstrated no significantly different WOMAC function scores. In functional tests, patients with >15% decreased femoral offset after THA demonstrated more sagittal plane motion during block step-up (14.43° versus 10.66°; p=0.04) while patients with >15% increased femoral after THA demonstrated more asymmetry of frontal plane motion during block step-up (34.05% versus 14.18%; p=0.03). To create a well-functioning THA, there seems to be a reasonable safe zone regarding the reconstruction of offset and leg length.
The aim of this study was to determine the outcomes and survivorship of the Triathlon knee replacement at 7 years after surgery. A cohort of 266 patients receiving a Triathlon knee replacement were assessed before surgery and at 3 months, 1 year, 2 years, 3 years, 5 years and 7 years post-operation. Patient-reported outcomes were assessed using the WOMAC, KOOS Knee-Related Quality of Life scale, Satisfaction Scale and questions on kneeling ability and whether they regretted having the operation. Data on survivorship was collected from self-report and medical records. At 7 years after surgery, 32 patients were deceased, and 17 patients were withdrawn. Of the 217 patients remaining in the study, 164 (76%) returned a completed study questionnaire. At 7 years after surgery, 92% of patients reported an improvement in their WOMAC Pain score greater than the minimally clinically important improvement (defined as improvement of ≥9 points from before surgery) and 82% reported this in their WOMAC Function score (defined as improvement of ≥12 points). Knee-related quality of life was good, with a mean score of 66.8 (SD 26.0) (0–100 scale, worst to best). A high percentage of patients (89%) were somewhat or very satisfied with their outcome at 7 years. Survivorship with revision as the endpoint was 96.4% (95% CI 93.2–98.1%) at 7 years post-operation. Five percent of patients regretted having their operation and 68% reported much difficulty or an inability to kneel. In conclusion, this study observed good long-term patient outcomes and survivorship of the Triathlon knee replacement.
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
Total knee replacement (TKR) is an effective operation for many patients, however approximately 20% of patients experience chronic pain and functional limitations in the months and years following their TKR. If modifiable pre-operative risk factors could be identified, this would allow patients to be targeted with individualised care to optimise these factors prior to surgery and potentially improve outcomes. Psychosocial factors have also been found to be important in predicting outcomes in the first 12 months after TKR, however their impact on long-term outcomes is unknown. This study aimed to identify pre-operative psychosocial predictors of patient-reported and clinician-assessed outcomes at one year and five years after primary TKR. 266 patients listed for a Triathlon TKR because of osteoarthritis were recruited from pre-operative assessment clinics at one orthopaedic centre. Knee pain and function were assessed pre-operatively and at one and five years post-operative using the WOMAC Pain score, WOMAC Function score and American Knee Society Score (AKSS) Knee score. Pre-operative depression, anxiety, catastrophizing, pain self-efficacy and social support were assessed using patient-reported outcome measures. Statistical analyses were conducted using multiple linear regression and mixed effect linear regression, and adjusted for confounding variables.Background
Patients and 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
There is a paucity of long term data concerning the pre and postoperative patient reported function of total knee replacement. The aim of this study was to determine the mortality, implant survivorship, patient reported function and satisfaction in a cohort of 114 patients, from a single centre, who received a Kinemax total knee replacement more than 15 years ago. Patients completed a questionnaire incorporating validated disease- and joint-specific scores, patient satisfaction and overall health preoperatively, at 3 months, 1 year, 2 years and a minimum of 15 years following surgery. NHS National Strategic Tracing Service, hospital and primary care records were used to establish mortality and for implant survivorship in deceased patients.Background
Methods
