Tourniquets for the use of total knee arthroplasty : are patients aware of the risks?

Background: Tourniquets are routinely used in total knee arthroplasty (TKA) with an estimated use by up to 93% of surgeons. Advantages include the ability to provide a bloodless field of view to facilitate cement application and increase the success of the procedure. Overall reduction in blood loss is another perceived advantage; however recent research has demonstrated no measurable reduction and conversely a substantial increase in complications such as deep vein thrombosis and systemic emboli. Given the significant complications of tourniquet use we aim to identify patients' views on tourniquets and of emphasis their awareness of the possible risks involved prior to the procedure. Method: A questionnaire - based study was carried out on 35 patients attending an elective orthopaedic centre for TKA surgery. Ethical approval was granted by NRES committee - East of England (REC Ref: 14/EE/1265). Patients were provided with an information sheet detailing the reasons for the tourniquet use and the associated risks and benefits. They were then provided with a questionnaire to ascertain their views and previous understanding of the subject. Simple statistical measures were implemented to analyse the data. Results: Only 32% of patients were aware of the use of tourniquets during the operation. 19% were aware of the benefits prior to reading the information sheet provided with 29% understanding the risks involved prior to their procedure. Finally we found 97% of patients would like more information on the use of tourniquets preoperatively. Conclusion: Tourniquets are widely used in TKA surgery; however, they carry significant risks which are not clearly relayed preoperatively to all patients. Given that 91,000 TKA operations are performed per year we believe it is of paramount importance that all patients are appropriately counselled on the risks and benefits of its use and fully informed consent, including risks of tourniquet use, should be obtained prior to the procedure

The prevalence of cam hip morphology in a general population sample

Objective Cam hip morphology is associated with femoroacetabular impingement (FAI) syndrome and causes hip osteoarthritis (OA). We aimed to assess the prevalence of cam hip morphology in a sample representative of the general population, using a measure with a predefined diagnostic accuracy. Design Patients aged 16–65, who were admitted to a major trauma centre and received a computed tomography (CT) pelvis were retrospectively screened for eligibility. Subjects with proximal femoral, acetabular or pelvic fractures and those who were deceased were excluded. Eligible subjects were divided into 10 groups based on gender and age. 20 subjects from each group were included. Subjects' index of multiple deprivation (IMD) and ethnicity were recorded. CT imaging was assessed and alpha angles (a measure of cam morphology) measured in the anterosuperior aspect of the femoral head neck junction. An alpha angle greater than 60° was considered to represent cam morphology. This measure and technique has a predefined sensitivity of 80% and specificity of 73% to detect cam morphology associated with FAI syndrome. The prevalence of cam morphology was reported as a proportion of subjects affected with 95% confidence intervals. Results 200 subjects were included. The sample was broadly representative of the UK general population in terms of IMD. 155 subjects (86%) identified as white. Cam morphology was present in 47% (95% CI 42,51) of subjects. Conclusions In this sample, broadly representative of the UK general population 47% of subjects had cam hip morphology; a hip shape associated with FAI syndrome and OA

Outcome measures used in arthroplasty trials : systematic review of the 2008 and 2013 literature

Background/objective: Previously published literature assessing the reporting of outcome measures used in joint replacement randomised controlled trials (RCTs) has revealed disappointing results. It remains unknown as to whether international initiatives have led to any improvement in the quality of reporting and/or a reduction in the heterogeneity of outcome measures used. Our objective was to systematically assess and compare primary outcome measures and risk of bias of joint replacement RCTs published in 2008 and 2013. Methods: We searched MEDLINE, EMBASE and CENTRAL for RCTs investigating adult patients undergoing joint replacement surgery. Two authors independently identified eligible trials, extracted data and assessed risk of bias using the Cochrane tool. Results: Seventy RCTs (30 in 2008; 40 in 2013) met the eligibility criteria. There was no significant difference in the number of trials judged to be at low overall risk of bias (N=6, 20%) in 2008 compared with six (15%) in 2013 (χ2 =0.302, P=0.75). Significantly more trials published in 2008 did not specify a primary outcome measure (N=25, 83%) compared with 18 (45%) trials in 2013, χ2 = 10.6316, P=0.001). When specified, there was significant heterogeneity in the measures used to assess primary outcomes. Conclusion: While less than a quarter of trials published in both 2008 and 2013 were judged to be at low overall risk of bias, significantly more trials published in 2013 specified a primary outcome. Although this might represent a temporal trend towards improvement, the overall frequency of primary outcome reporting and the wide heterogeneity in primary outcomes reported remain suboptimal

Treatment for femoroacetabular impingement : a qualitative method for exploring equipoise amongst hip arthroscopy surgeons

R : URGENT The published literature suggests uncertainty about whether operative or nonoperative treatments are best for femoroacetabular impingement (FAI). Without the same level of uncertainty (equipoise) amongst surgeons, a RCT will be challenging. A qualitative study was conducted to explore the level of equipoise amongst arthroscopic FAI surgeons. In phase 1, 14 hip arthroscopy surgeons were interviewed and asked to make treatment decisions based on real life cases that included actively recruiting patients to a theoretical RCT. In phase 2, 9 hip arthroscopy hip surgeons participating in a pilot RCT were interviewed about their experiences so far of taking part in a pilot RCT. Five surgeons took part in both phase 1 and 2. Sixteen (89%) surgeons believed that they were in equipoise and that a RCT was required to generate superior scientific evidence and guidelines for the care. Despite this 5 (36%) surgeons showed a lack of active clinical equipoise when faced with real life case scenarios or discussing involvement with a pilot RCT. Some of the reasons behind surgeons’ lack of equipoise, ranged from lack of belief in the FAI pathology, to personal enthusiasm and gut instinct about the efficacy of surgery on one hand; but conservatism on the other. Although many would like a RCT to guide care, there may be particular challenges amongst this same population when actively recruiting patients to a RCT. Qualitative methodology can be used to help design surgical RCTs and address any subsequent difficulties with recruitment

Impact of COVID-19 on clinical outcomes for patients with fractured hip

AIMS: There are reports of a marked increase in perioperative mortality in patients admitted to hospital with a fractured hip during the COVID-19 pandemic in the UK, USA, Spain, and Italy. Our study aims to describe the risk of mortality among patients with a fractured neck of femur in England during the early stages of the COVID-19 pandemic. Methods: We completed a multicentre cohort study across ten hospitals in England. Data were collected from 1 March 2020 to 6 April 2020, during which period the World Health Organization (WHO) declared COVID-19 to be a pandemic. Patients ≥ 60 years of age admitted with hip fracture and a minimum follow-up of 30 days were included for analysis. Primary outcome of interest was mortality at 30 days post-surgery or postadmission in nonoperative patients. Secondary outcomes included length of hospital stay and discharge destination. Results: In total, 404 patients were included for final analysis with a COVID-19 diagnosis being made in 114 (28.2%) patients. Overall, 30-day mortality stood at 14.4% (n = 58). The COVID-19 cohort experienced a mortality rate of 32.5% (37/114) compared to 7.2% (21/290) in the non-COVID cohort (p < 0.001). In adjusted analysis, 30-day mortality was greatest in patients who were confirmed to have COVID-19 (odds ratio (OR) 5.64, 95% confidence interval (CI) 2.95 to 10.80; p < 0.001) with an adjusted excess risk of 20%, male sex (OR 2.69, 95% CI 1.37 to 5.29; p = 0.004) and in patients with ≥ two comorbidities (OR 4.68, CI 1.5 to 14.61; p = 0.008). Length of stay was also extended in the COVID-19 cohort, on average spending 17.6 days as an inpatient versus 12.04 days in the non-COVID-19 group (p < 0.001). Conclusion: This study demonstrates that patients who sustain a neck of femur fracture in combination with COVID-19 diagnosis have a significantly higher risk of mortality than would be normally expected

What does a good RCT recruitment consultation look like? A new simple six-step model to promote information sharing and recruitment to RCTs

Objective: The mode of delivery of trial information is a key determinant of recruitment to randomised controlled trials (RCTs), which can be modified in order to encourage patients to participate. This paper presents the development and initial validation of a simple six-step model to support recruitment. Study design and setting: 92 recruitment consultations with 60 new patients were recorded and analysed during a pilot RCT comparing surgical and non-surgical interventions for hip impingement. Recordings were analysed using techniques of thematic analysis and focused conversation analysis pioneered in previous studies. Analysis of recordings continued during the full-scale trial. Results: The pilot study was successful, with 70% of patients approached across 9 centres agreeing to take part in the RCT, and the full-scale trial has achieved 75% recruitment in 19 centres. A simple six-step model providing a framework for good recruitment practice was developed at the pilot phase and then validated, and tested in the main trial. The model enabled recruiters to explain the design and conduct of the RCT and provide reassuring information for patients in the context of consultations very different from routine practice. Conclusion: The six-step model provides a useful framework for recruitment to RCTs. It encourages the implementation of good RCT recruitment practice and provides strategies to support recruiters. The model requires further testing in a wide range of RCTs and clinical contexts

Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.

Background It is not known, whether outcome reporting in trials of total joint arthroplasty in the recent years is adequate or not. Our objective was to assess whether outcomes reported in total joint replacement (TJR) trials fulfil the Outcome Measures in Rheumatology (OMERACT) Filter 2.0. Methods We systematically reviewed all TJR trials in adults, published in English in 2008 or 2013. Searches were conducted in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE. Two authors independently applied the inclusion criteria for the studies, and any disagreement was resolved with a third review author. All outcome measures were abstracted using a pre-piloted standardised data extraction form and assessed for whether they mapped to one of the three OMERACT Filter 2.0 core areas: pathophysiological, life impact, and death. Results From 1635 trials identified, we included 70 trials (30 in 2008 and 40 in 2013) meeting the eligibility criteria. Twenty-two (31%) trials reported the three essential OMERACT core areas. Among the 27 hip replacement surgery trials and 39 knee replacement surgery trials included, 11 hip (41%) and nine knee (23%) trials reported all three essential OMERACT core areas. The most common outcome domains/measures were pain (20/27, 74%) and function (23/27, 85%) in hip trials and pain (26/39, 67%) and function (27/39, 69%) in knee trials. Results were similar for shoulder and hand joint replacement trials. Conclusions We identified significant gaps in the measurement of OMERACT core outcome areas in TJR trials, despite the majority reporting outcome domains of pain and function. An international consensus of key stakeholders is needed to develop a core domain set for reporting of TJR trials

Surgical tourniquet use in total knee replacement surgery : a survey of BASK members

Traditionally, a surgical tourniquet is used during total knee replacement (TKR) surgery to help provide a bloodless field, and some surgeons believe this improves the quality of component cementation.[1] In 2003 over 93% of TKRs reported in the National Joint Registry were performed with a tourniquet.[2] However, now, evidence is emerging that using a tourniquet increases the risk of post-operative venous thromboembolism and is associated with higher levels of post-operative pain.[3] In addition, echogenic material, suggestive of emboli has been observed in the brain following surgical tourniquet deflation in total knee replacement surgery. It is thought that this may occur despite the absence of a patent foramen ovale, likely through pulmonary shunts.[4] The aim of this study was to capture contemporary surgical practice and establish the extent to which BASK members undertake total knee replacement surgery with the aid of a tourniquet. We also aimed to establish those members who would consider changing their practice as part of a research study to evaluate the benefits and risks of tourniquets

Protocol for a single-centre randomised controlled trial of multimodal periarticular anaesthetic infiltration versus single-agent femoral nerve blockade as analgesia for total knee arthroplasty: Perioperative Analgesia for Knee Arthroplasty (PAKA)

Introduction: Total knee arthroplasty (TKA) surgery causes postoperative pain. The use of perioperative injections around the knee containing local anaesthetic, opiates and non-steroidal anti-inflammatory drugs has increased in popularity to manage pain. Theoretical advantages include reduced requirements for analgesia and earlier mobilisation. We propose a single-centre randomised controlled trial of multimodal periarticular anaesthetic infiltration versus femoral nerve anaesthetic blockade as analgesia for TKA. The aim is to determine, in patients undergoing TKA, if there is a difference in patient-reported pain scores on the visual analogue scale (VAS) prior to physiotherapy on day 1 postoperatively between treatment groups. Methods and analysis: Patients undergoing a primary unilateral TKA at University Hospitals Coventry and Warwickshire Hospitals will be assessed for eligibility. A total of 264 patients will provide 90% power to detect a difference of 12 mm on the VAS on day 1 postoperatively at the 5% level. The trial will use 1:1 randomisation, stratified by mode of anaesthetic. Primary outcome measure will be the VAS for pain prior to physiotherapy on day 1. Secondary outcome measures include VAS on day 2, total use of opiate analgesia up to 48 h, ordinal pain scores up to 40 min after surgery, independent functional knee physiotherapist assessment on days 1 and 2. Oxford knee Scores (OKS), EuroQol (EQ-5D) and Douleur Neuropathic Pain Scores (DN2) will be recorded at baseline, 6 weeks and 12 months. Adverse events will be recorded up to 12 months. Analysis will investigate differences in VAS on day 1 between the two treatment groups on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are less than 0.05. Ethics and dissemination: NRES Committee West Midlands, 23 September 2013 (ref: 13/WM/0316). The results will be disseminated via peer-reviewed publications and conference presentations. Trial registration numbers: ISRCTN 60611146 and EUDRACT Number 2013-002439-10 (protocol code number PAKA-33601-AS117013); Pre-results

A pragmatic randomised controlled trial comparing the efficacy of a femoral nerve block and periarticular infiltration for early pain relief following total knee arthroplasty

Aims The aim of this study was to compare the effectiveness of a femoral nerve block and a periarticular infiltration in the management of early post-operative pain after total knee arthroplasty (TKA). Patents and methods A pragmatic, single centre, two arm parallel group, patient blinded, randomised controlled trial was undertaken. All patients due for TKA were eligible. Exclusion criteria included contraindications to the medications involved in the study and patients with a neurological abnormality of the lower limb. Patients received either a femoral nerve block with 75 mg of 0.25% levobupivacaine hydrochloride around the nerve, or periarticular infiltration with 150 mg of 0.25% levobupivacaine hydrochloride, 10 mg morphine sulphate, 30 mg ketorolac trometamol and 0.25 mg of adrenaline all diluted with 0.9% saline to make a volume of 150 ml. Results A total of 264 patients were recruited and data from 230 (88%) were available for the primary analysis. Intention-to-treat analysis of the primary outcome measure of a visual analogue score for pain on the first post-operative day, prior to physiotherapy, was similar in both groups. The mean difference was -0.7 (95% confidence interval (CI) -5.9 to 4.5; p = 0.834). The periarticular group used less morphine in the first post-operative day compared with the femoral nerve block group (74%, 95% CI 55 to 99). The femoral nerve block group reported 39 adverse events, of which 27 were serious, in 31 patients and the periarticular group reported 51 adverse events, of which 38 were serious, in 42 patients up to six weeks post-operatively. None of the adverse events were directly attributed to either of the interventions under investigation. Conclusion Periarticular infiltration is a viable and safe alternative to femoral nerve block for the early post-operative relief of pain following TKA. Cite this article: Bone Joint J 2017;99-B:904-11