REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial.

OBJECTIVES: To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement. DESIGN: Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study. SETTING: Two National Health Service (NHS) secondary care hospitals in England and Wales. PARTICIPANTS: Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0-28 on the Sleep Condition Indicator questionnaire. INTERVENTION: The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals. OUTCOME MEASURES: The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients. RESULTS: Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable. CONCLUSIONS: This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible. TRIAL REGISTRATION NUMBER: ISRCTN14233189.

Experiences of recovery and a new care pathway for people with pain after total knee replacement: qualitative research embedded in the STAR trial.

BACKGROUND: Approximately 20% of people experience chronic postsurgical pain after total knee replacement. The STAR randomised controlled trial (ISCRTN92545361) evaluated the clinical- and cost-effectiveness of a new multifaceted and personalised care pathway, compared with usual care, for people with pain at three months after total knee replacement. We report trial participants' experiences of postoperative pain and the acceptability of the STAR care pathway, which consisted of an assessment clinic at three months, and up to six follow-up telephone calls over 12 months. METHODS: Semi-structured interviews were conducted with 27 people (10 men, 17 women) between February 2018 and January 2020. Participants were sampled purposively from the care pathway intervention group and interviewed after completion of the final postoperative trial questionnaire at approximately 15 months after knee replacement. Interviews were audio-recorded, transcribed, anonymised and analysed using inductive thematic analysis. FINDINGS: Many participants were unprepared for the severity and impact of postoperative pain, which they described as extreme and constant and that tested their physical and mental endurance. Participants identified 'low points' during their recovery, triggered by stiffening, pain or swelling that caused feelings of anxiety, depression, and pain catastrophising. Participants described the STAR assessment clinic as something that seemed "perfectly normal" suggesting it was seamlessly integrated into NHS care. Even in the context of some ongoing pain, the STAR care pathway had provided a source of support and an opportunity to discuss concerns about their ongoing recovery. CONCLUSIONS: People who have knee replacement may be unprepared for the severity and impact of postoperative pain, and the hard work of recovery afterwards. This highlights the challenges of preparing patients for total knee replacement and suggests that clinical attention is needed if exercise and mobilising is painful beyond the three month postoperative period. The STAR care pathway is acceptable to people with pain after total knee replacement.

The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial.

BACKGROUND: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. METHODS: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0-10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. FINDINGS: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was -0·65 (95% CI -1·17 to -0·13; p=0·014) and the mean between-group difference in the BPI interference score was -0·68 (-1·29 to -0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. INTERPRETATION: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. FUNDING: National Institute for Health Research.

Screening to Identify Postoperative Pain and Cross-Sectional Associations Between Factors Identified in This Process With Pain and Function, Three Months After Total Knee Replacement.

OBJECTIVE: To describe the screening and recruitment process of a randomized trial and evaluate associations with knee pain and function 3 months after total knee replacement (TKR). METHODS: In order to screen for a multicenter trial, a total of 5,036 patients were sent the Oxford Knee Score (OKS) questionnaire 10 weeks post-TKR. Patients who reported pain in their replaced knee (score of ≤14 on the OKS pain component) completed a second OKS questionnaire 12 weeks post-TKR. Those patients who were still experiencing pain 12 weeks post-TKR completed a detailed questionnaire 13 weeks post-TKR. These data were used to characterize pain in a cross-sectional analysis. Multivariable regression was performed in order to identify factors associated with pain and function at 13 weeks post-TKR. RESULTS: We received OKS questionnaires from 3,058 of 5,063 TKR patients (60%), and 907 of the 3,058 (30%) reported pain in their replaced knee 10 weeks post-TKR. By 12 weeks, 179 of 553 patients (32%) reported improved pain (score of >14 on the OKS pain component). At 13 weeks, 192 of 363 patients (53%) who completed a detailed questionnaire reported neuropathic pain, 94 of 362 (26%) reported depression symptoms, and 95 of 363 (26%) anxiety symptoms. More severe pain at 13 weeks postoperatively was associated with poorer general health, poorer physical health, more pain worry, and lower satisfaction with surgery outcome. More severe functional limitation was associated with higher levels of depression, more pain worry, lower satisfaction with surgery outcome, and higher pain acceptance. CONCLUSION: Screening after TKR identified individuals with pain. We identified several potential targets (physical and mental health outcomes, acceptance of pain, and quality of life) for tailored intervention to improve outcomes for patients. Future trials of multidisciplinary interventions warranted.

Chronic pain after total knee arthroplasty.

Despite a good outcome for many patients, approximately 20% of patients experience chronic pain after total knee arthroplasty (TKA).Chronic pain after TKA can affect all dimensions of health-related quality of life, and is associated with functional limitations, pain-related distress, depression, poorer general health and social isolation.In both clinical and research settings, the approach to assessing chronic pain after TKA needs to be in-depth and multidimensional to understand the characteristics and impact of this pain. Assessment of this pain has been inadequate in the past, but there are encouraging trends for increased use of validated patient-reported outcome measures.Risk factors for chronic pain after TKA can be considered as those present before surgery, intraoperatively or in the acute postoperative period. Knowledge of risk factors is important to guide the development of interventions and to help to target care. Evaluations of preoperative interventions which optimize pain management and general health around the time of surgery are needed.The causes of chronic pain after TKA are not yet fully understood, although research interest is growing and it is evident that this pain has a multifactorial aetiology, with a wide range of possible biological, surgical and psychosocial factors that can influence pain outcomes.Treatment of chronic pain after TKA is challenging, and evaluation of combined treatments and individually targeted treatments matched to patient characteristics is advocated. To ensure that optimal care is provided to patients, the clinical- and cost-effectiveness of multidisciplinary and individualized interventions should be evaluated. Cite this article: EFORT Open Rev 2018;3:461-470. DOI: 10.1302/2058-5241.3.180004.

Analysis Of The KLIC-score; An Outcome Predictor Tool For Prosthetic Joint Infections Treated With Debridement, Antibiotics And Implant Retention.

Background: Debridement, antibiotics and implant retention (DAIR) forms the primary treatment modality for early prosthetic joint infection (PJI). The KLIC score has been proposed as a risk stratification tool for use in predicting outcome of prosthetic knee infections. Our aim was to determine the accuracy of this scoring system at an independent tertiary PJI centre in a typical DAIR population. Methods: Between 2008 and 2015, patients with infected knee prostheses treated with DAIR were identified. The patient notes and blood tests were reviewed retrospectively and the 'KLIC-score' was calculated and correlated with outcome. The end point for early failure was defined as: 1) the need for unscheduled surgery, 2) infection-related death ≤12 months from debridement or 3) the need for suppressive antibiotic treatment. Results: 59 patients received DAIR procedures for knee PJI. Treatment was successful in 41 patients (69%) with early failure in 18 patients (31%). Patients deemed high-risk (KLIC-score ≥7) had notably higher failure rates (60%) than those scoring <7 (28%). No relationship can be drawn between KLIC-scores of <7 and failure rates. Conclusions: The KLIC-score applied retrospectively was able to predict patients with the highest risk of early failure but provides little information in patients with scores of <7.

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

BACKGROUND: Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. METHODS: This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway. DISCUSSION: If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement. TRIAL REGISTRATION: ISRCTN registry ( ISRCTN92545361 ), prospectively registered on 30 August 2016.

Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway.

BACKGROUND: Approximately 20% of people who have total knee replacement experience chronic pain afterwards, but there is little evidence about effective interventions for managing this type of pain. This article describes the systematic development and refinement of a complex intervention for people with chronic pain after knee replacement. The intervention is a care pathway involving an assessment clinic and onward referral, with telephone follow-up as required. In the design of this multistage study, we chose to focus on ensuring that the intervention was deliverable, implementable and acceptable. METHODS: In line with the UK Medical Research Council's recommendations for comprehensive development of complex interventions, multiple phases of work were undertaken. Following on from initial development work to design the intervention, the draft intervention content was refined through consensus questionnaires with 22 health professionals and discussion at meetings with 18 healthcare professionals. Testing of intervention delivery and acceptability to patients was undertaken by two health professionals delivering the assessment clinic to ten patients. Views about future implementation within the context of a randomised trial were evaluated through a questionnaire based on the Normalisation Measure Development (NoMAD) instrument with ten health professional stakeholders. RESULTS: Consensus work with health professionals ensured the components of the intervention were appropriate and informed a number of substantive changes to improve the intervention. Testing of intervention delivery identified a number of logistical issues that were then addressed in the development of a comprehensive intervention training manual. Engagement with stakeholders indicated that the intervention could be successfully implemented in a clinical setting for evaluation in a randomised trial. CONCLUSIONS: This work has informed the development and refinement of a complex intervention for people with chronic pain after knee replacement. The next stage is to evaluate the clinical and cost-effectiveness of the STAR care pathway in a multicentre randomised trial.

Repair of Torn Avascular Meniscal Cartilage Using Undifferentiated Autologous Mesenchymal Stem Cells: From In Vitro Optimization to a First-in-Human Study.

Meniscal cartilage tears are common and predispose to osteoarthritis (OA). Most occur in the avascular portion of the meniscus where current repair techniques usually fail. We described previously the use of undifferentiated autologous mesenchymal stem cells (MSCs) seeded onto a collagen scaffold (MSC/collagen-scaffold) to integrate meniscal tissues in vitro. Our objective was to translate this method into a cell therapy for patients with torn meniscus, with the long-term goal of delaying or preventing the onset of OA. After in vitro optimization, we tested an ovine-MSC/collagen-scaffold in a sheep meniscal cartilage tear model with promising results after 13 weeks, although repair was not sustained over 6 months. We then conducted a single center, prospective, open-label first-in-human safety study of patients with an avascular meniscal tear. Autologous MSCs were isolated from an iliac crest bone marrow biopsy, expanded and seeded into the collagen scaffold. The resulting human-MSC/collagen-scaffold implant was placed into the meniscal tear prior to repair with vertical mattress sutures and the patients were followed for 2 years. Five patients were treated and there was significant clinical improvement on repeated measures analysis. Three were asymptomatic at 24 months with no magnetic resonance imaging evidence of recurrent tear and clinical improvement in knee function scores. Two required subsequent meniscectomy due to retear or nonhealing of the meniscal tear at approximately 15 months after implantation. No other adverse events occurred. We conclude that undifferentiated MSCs could provide a safe way to augment avascular meniscal repair in some patients. Registration: EU Clinical Trials Register, 2010-024162-22. Stem Cells Translational Medicine 2017;6:1237-1248.

Prevention of acute kidney injury through accurate fluid balance monitoring.

Acute kidney injury (AKI) is associated with increased patient morbidity, mortality and an extended hospital stay. The financial burden to the National Health Service is high and it can affect up to one in five inpatients. Optimal fluid balance management is essential for the prevention of AKI and this can be particularly challenging in the patient with trauma. Our aim was to reduce the rate of AKI in patients with traumatic injuries in the regional trauma centre. We developed new fluid balance charts and documented how well these were completed. The number of AKI alerts per month was calculated on our pathology system. Scenario training was delivered at handover meetings and an e-learning tool was designed at three levels: healthcare assistants; nurses; and medical staff, dietetics and pharmacists. Educational posters were placed in clinical areas and patient information leaflets produced. Junior doctors were regularly informed of AKI rates on the ward. The number of AKI alerts on our trauma ward declined from 50 in January 2016 to 19 in November 2016. The mean monthly rate of AKI fell 33% following the invention (P<0.001). Completion of fluid balance charts improved; 6 hourly urine output documentation increased from 36% to 68% and running 1 hourly output increased from 80% to 96%. Calculation of total daily fluid balance rose from 12% to 72%, before decreasing to 32%. This highlighted the need for continued encouragement. Improved fluid balance monitoring led to a reduction in the prevalence of AKI in patients admitted to this trauma centre.

Plates, Screws, or Combination? Radiologic Outcomes After Lisfranc Fracture Dislocation.

Traditionally, Lisfranc fracture dislocations have been treated with transarticular screw fixation. A more recent development has been the use of dorsal bridging plates. The aim of the present study was to compare the radiologic outcomes for these 2 methods. Currently, no data comparing the outcomes of these 2 treatment options have been reported. A total of 62 patients were treated for Lisfranc fracture dislocations during a 6-year period. The inclusion criteria included ≥6 months of follow-up data available. Each fracture was classified using the Hardcastle classification system. Each fracture was also allocated into 1 of 4 groups: transarticular screw fixation, dorsal plating, a combination of plate and screw fixation, and nonoperative management. The outcome measures included the Kellgren-Lawrence grading of osteoarthritis and the Wilppula classification of anatomic reduction. In terms of results, radiologic osteoarthritis is not associated with the type of injury according to the Hardcastle classification nor with having an open or closed fracture. The Hardcastle classification is not associated with the type of fixation used. Fractures fixed with a combination of plates and screws had a 3.01 (95% confidence interval 1.036 to 8.74) increased risk of having stage 3 or 4 radiologic osteoarthritis compared with being fixed solely with bridging plates (p = .009). Multivariate analysis revealed that this increased risk of osteoarthritis was dependent on the quality of reduction, with good reductions having a 18.2 (95% confidence interval 15.9 to 21.8) times decreased risk of severe osteoarthritis compared with fair or poor reductions, independent of the type of fixation used (p < .0001). No radiologic benefits were found when comparing plate or screw fixation for Lisfranc fracture dislocations (although screw fixation might be associated with a less planus foot and fewer complications). Instead, a good anatomic reduction was the only predictor of the radiologic outcome, and the Hardcastle classification of fractures did not predict the surgery type or radiologic outcome. Finally, treatment with combination plates and screws resulted in worse radiologic outcomes, possibly owing to more complex fracture patterns.