Objectives

Despite the fact that research fraud and misconduct are under scrutiny in the field of orthopaedic research, little systematic work has been done to uncover and characterise the underlying reasons for academic retractions in this field. The purpose of this study was to determine the rate of retractions and identify the reasons for retracted publications in the orthopaedic literature.

Introduction. Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine with unclear etiology. Due to the asymmetry of lateral curves, there are differences in the muscle activation between the convex and concave sides. This study utilized a comprehensive thoracic spine and ribcage musculoskeletal model to improve the biomechanical understanding of the development of AIS deformity and approach an explanation of the condition. Methods. In this study, we implemented a motion capture model using a generic rigid-body thoracic spine and ribcage model, which is kinematically determinate and controlled by spine posture obtained, for instance, from radiographs. This model is publicly accessible via a GitHub repository. We simulated gait and standing models of two AIS (averaging 15 years old, both with left lumbar curve and right thoracic curve averaging 25 degrees) and one control subject. The marker set included extra markers on the sternum and the thoracic and lumbar spine. The study was approved by the regional Research Ethics Committee (Journal number: H17034237). Results. We investigated the difference between the muscle activation on the right and left sides including erector spinae (ES), psoas major (PS), and multifidus (MF). Results of the AIS simulations indicated that, on average throughout the gait cycle, the right ES, left PS and left MF had 46%, 44%, and 23% higher activities compared to the other side, respectively. In standing, the ratios were 28%, 40%, and 19%, respectively. However, for the control subject, the differences were under 7%, except ES throughout the gait, which was 17%. Conclusion. The musculoskeletal model revealed distinct differences in force patterns of the right and left sides of the spine, indicating an instability phenomenon, where larger curves lead to higher muscle activations for stabilization. Acknowledgement. The project is funded by the European Union's Horizon 2020 program through Marie Skłodowska-Curie grant No. [764644]

Introduction. Polyacrylamide hydrogel (iPAAG. 1. ), is CE marked for treating symptomatic knee osteoarthritis (OA), meeting the need for an effective, long-lasting, and safe non-surgical option. This study evaluates the efficacy and safety of a single 6 ml intra-articular injection of iPAAG in participants with moderate to severe knee OA over a 5-year post-treatment period, presenting data from the 4-year follow up. Method. This prospective multicentre study (3 sites in Denmark) involved 49 participants (31 females) with an average age of 70 (range 44 – 86 years). They received a single 6 mL iPAAG injection. All participants provided informed consent and re-consented to continue after 1 year. The study followed GCP principles and was approved by Danish health authorities and local Health Research Ethics committees. Twenty-seven participants completed the 4-year follow-up. The study evaluated WOMAC pain, stiffness, function, and Patient Global Assessment (PGA) of disease impact. Changes from baseline were analysed using a mixed model for repeated measurement (MMRM). Sensitivity analyses were applied on the extension data, where the MMRM analysis was repeated only including patients in the extension phase and an ANCOVA model was used, replacing missing values at 4-years with baseline values (BOCF). Results. The planned MMRM analysis (n=49) revealed a statistically significant decrease in WOMAC pain subscale scores (-22.0; 95%CI: -29.5; -14.4) from baseline to 4-years. Analysis of the extension phase (n=27) showed similar results (-21.8; 95%CI: -29.0; -14.6) compared to the initial analysis. Furthermore, BOCF analysis indicated a statistically significant reduction in WOMAC pain subscale scores from baseline (-13.0 units). Four new adverse events were reported between the 3-year and 4-year visits; none were related to treatment. Conclusions. This study shows that single injections of 6 ml intra-articular iPAAG were well tolerated and continued to provide clinically important effectiveness at 4-years after treatment. Acknowledgements. The study was sponsored by Contura International A/S

Abstract. Introduction. Skeletal muscle wasting is an important clinical issue following acute traumatic injury, and can delay recovery and cause permanent functional disability particularly in the elderly. However, the fundamental mechanisms involved in trauma-induced muscle wasting remain poorly defined and therapeutic interventions are limited. Objectives. To characterise local and systemic mediators of skeletal muscle wasting in elderly patients following acute trauma. Methods. Experiments were approved by a local NHS Research Ethics Committee and all participants provided written informed consent. Vastus lateralis biopsies and serum samples were taken from human male and female patients shortly after acute trauma injury in lower limbs (n=6; mean age 78.7±4.4 y) and compared to age-matched controls (n=6; mean age 72.6±6.3 y). Atrogenes and upstream regulators (MuRF1; MAFbx; IL6, TNFα, PGC-1α) mRNA expression was assessed in muscle samples via RT-qPCR. Serum profiling of inflammatory markers (e.g. IL6, TNFα, IL1β) was further performed via multiplex assays. To determine whether systemic factors induced by trauma directly affect muscle phenotype, differentiated primary human myotubes were treated in vitro with serum from controls or trauma patients (pooled; n=3 each) in the final 24 hours of differentiation. Cells were then fixed, stained for myogenin and imaged to determine minimum ferret diameter. Statistical significance was determined at P<0.05. Results. There was an increase in skeletal muscle mRNA expression for E3 ligase MAFbx and inflammatory cytokine IL-6 (4.6 and 21.5-fold respectively; P<0.05) in trauma patients compared to controls. Expression of myogenic determination factor MyoD and regulator of mitochondrial biogenesis PGC-1α was lower in muscle of trauma patients vs controls (0.5 and 0.39-fold respectively; P<0.05). In serum, trauma patients showed increased concentrations of circulating pro-inflammatory cytokines IL-6 (14.5 vs. 0.3 pg/ml; P<0.05) and IL-16 (182.7 vs. 85.2 pg/ml; P<0.05) compared to controls. Primary myotube experiments revealed serum from trauma patients induced atrophy (32% decrease in diameter) compared to control serum-treated cells (P<0.001). Conclusion. Skeletal muscle from patients following acute trauma injury showed greater expression of atrophy and inflammatory markers. Trauma patient serum exhibited higher circulating pro-inflammatory cytokine concentrations. Primary human myotubes treated with serum from trauma patients showed significant atrophy compared to healthy serum-treated controls. We speculate a mechanism(s) acting via circulating factors may contribute to skeletal muscle pathology following acute trauma. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Introduction and Objective. Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appear to improve several outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary objective of this trial is to determine the effectiveness of THA followed by standard care compared to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT, on changes in hip pain and function, in patients with severe hip OA after 6 months. Materials and Methods. This is a protocol for a multicentre, parallel-group, assessor blinded, randomised controlled superiority trial. Patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA or PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40-meter fast-paced walk test, 30-second chair stand test, and number of serious adverse events. Results. The trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158) in February 2019 and registration was performed at . ClinicalTrials.gov. (NCT04070027) in August 2019. Recruitment was initiated on the 2. nd. of September 2019 and the final deadline will be on the 30. th. of June 2021, or when a sample size of 120 patients has been accomplished. Conclusions. The results of the current trial are expected to enable evidence-based recommendations, which may be used to facilitate the shared-decision making process in the discussion of treatment strategy for the individual patient with severe hip OA. All results will be presented in peer-reviewed scientific journals and international conferences

Background. Bone is a hierarchically structured hard tissue that consists of approximately 70 wt% low-crystallinity hydroxyapatite. Intricate tubular channels, such as Haversian canals, Volkman's canals, and canaliculi are a preserved feature of bone microstructure. These structures provide pathways for vasculature and facilitate cell-to-cell communication processes, together supporting viability of cellular components and aiding in remodeling processes. Unfortunately, many commercial bone augmentation materials consist of highly crystalline phases that are absent of the structuring present within the native tissue they are replacing. This work reports on a the development of a novel bone augmentation material that is able to generate biologically analogous tubular calcium phosphate mineral structures from hydrogel-based spheres that can be packed into defects similar to those encountered in vivo. Experimental. Calcium loaded spheres were made by adding 5 wt% agar powder to 1 M calcium nitrate solutions, before heating the mixture to 80–90 oC and feeding droplets of gel into a reservoir of liquid nitrogen. Deposition of tubular mineral was initiated by exposure to ammonium phosphate solutions at concentrations between 500 mM and 1 M, and was characterized by micro-XRF mapping, XRD and SEM techniques. For an ex vivo model, human bone tissue was collected from patients undergoing elective knee replacement surgery. The United Kingdom National Research Ethics Service (East of Scotland Research Ethics Service) provided ethical approval (11/ES/1044). The augmented defect of the model was characterised by micro-XRF mapping and micro-CT techniques. Results and Discussion. Immersion of calcium-loaded hydrogel spheres in physiological solutions rich in phosphate promotes the release of calcium rich streams from the sphere surface, resulting in the precipitation of tubule structures. Micro-XRF mapping, XRD and SEM, revealed tubules possessed hierarchically structuring and consisted of low-crystallinity hydroxyapatite, making them analogous in composition and structure to incritate features of bone microstructure. When brought into close proximity with one another, spheres become fused in a matter of minutes by the entanglement and subsequent interstitial mineralisation of the mineral tubules. Micro-XRF mapping and micro-CT analysis of an augmented ex vivo human tissue defect model demonstrated the extensive deposition of low-crystallinity tubular mineral throughout a tissue defect. Conclusions. This is possibly the first example of a bone augmentation material that is able to generate biologically analogous structures in situ, and therefore may serve as a better scaffold for bone formation over synthetic alternatives. Moreover, the formation of structured mineral aids in achieving rapid hardening of the augmenting calcium-loaded hydrogel shperes within the defect space

In the UK and USA in 2016 more than 263,000 primary knee replacements were performed. Around 20% of patients report chronic post-surgical pain (CPSP) at three or more months after total knee replacement (TKR). A large proportion of adults with all types of chronic musculoskeletal pain do not use services for a number of reasons, despite being in constant or daily pain. Given the high prevalence of CPSP, there is potentially a large hidden population with an unexpressed need for care, experiencing ongoing pain and disability; understanding why they do not use health services may herald further insight into why many remain dissatisfied with knee replacement surgery. The aim of this study is to understand why some people with CPSP after TKR do not access services or make little use of healthcare. We conducted face-to-face in-depth interviews with 34 patients from 2 high-volume orthopaedic hospitals in England, to investigate their experience of long-term pain after knee replacement; their knowledge and understanding of CPSP; and their decisions about consulting for CPSP. The sample size was based on achievement of saturation and participants provided written informed consent. Interviews were transcribed and analysed using an inductive thematic approach with double coding for rigor. Ethical approval for the study was granted by the West Midlands Solihull Research Ethics Committee (15/WM/0469). A core theme within the analysis suggests that participants do not seek healthcare because they believe that nothing further can be done, either by themselves or by healthcare professionals. Surgeons' satisfaction with the knee surgery and reassurances that pain would improve, left patients feeling uncertain about whether to re-consult, and some assumed that further consultation could lead to further surgery or medication, which they wish to avoid. Some participants' comorbidities took precedence over their knee pain when seeking healthcare. Others felt they had received their “share” of healthcare resources and that others were more deserving of treatment. People's descriptions of pain varied, from dull, or aching to shooting pains. Many described their pain as “discomfort” rather than pain. The majority described pain that was better than their pre-surgical pain, though others described pain that was worse, which they believed to be nerve damage. Many expressed disappointment in the outcome of their TKR. Expectations of pain varied, where most had expected some post-surgical pain, others underestimated it, and some had expected to be completely pain free following their TKR. Our analysis suggests that the reasons that some people with CPSP after TKR do not consult are varied and complex, spanning psychosocial, structural, moral, and organisational domains. There was an overriding sense that further consultation would be futile or may lead to unwanted treatment. Results suggest that improved information for patients about CPSP and appropriate post-surgical healthcare services may help patients and clinicians to manage this condition more effectively

Background. Although there are predictive equations that estimate the total fat mass obtained from multiple-site ultrasound (US) measurements, the predictive equation of total fat mass has not been investigated solely from abdominal subcutaneous fat thickness. Therefore, the aims of this study were; (1) to develop regression-based prediction equations based on abdominal subcutaneous fat thickness for predicting fat mass in young- and middle-aged adults, and (2) to investigate the validity of these equations to be developed. Methods. The study was approved by the Local Research Ethics Committee (Decision number: GO 19/788). Twenty-seven males (30.3 ± 8.7 years) and eighteen females (32.4 ± 9.5 years) were randomly divided into two groups as the model prediction group (19 males and 12 females) and the validation group (8 males and 6 females). Total body fat mass was determined by dual-energy X-ray absorptiometry (DXA). Abdominal subcutaneous fat thickness was measured by US. The predictive equations for total fat mass from US were determined as fat thickness (in mm) × standing height (in m). Statistical analyses were performed using R version 4.0.0. The association between the total fat mass and the abdominal subcutaneous fat thickness was interpreted using the Pearson test. The linear regression analysis was used to predict equations for total body fat mass from the abdominal subcutaneous fat thickness acquired by US. Then these predictive equations were applied to the validation group. The paired t-test was used to examine the difference between the measured and the predicted fat masses, and Lin's concordance correlation coefficient (CCC) was used as a further measure of agreement. Results. There was a significant positive moderate correlation between the total fat mass and the abdominal subcutaneous fat thickness × height in the model prediction group of males (r = 0.588, p = 0.008), whereas significant positive very strong correlation was observed in the model prediction group of females (r = 0.896, p < 0.001). Predictive equations for DXA-measured total body fat mass from abdominal subcutaneous fat thickness using US were as follows: for males “Fat mass-DXA = 0.276 × (Fat thickness-US × Height) + 17.221” (R. 2. = 0.35, SEE = 3.6, p = 0.008); for females “Fat mass-DXA = 0.694 x (Fat thickness-US × Height) + 7.085” (R. 2. = 0.80, SEE = 2.8, p < 0.001). When fat mass prediction equations were applied to the validation groups, measured- and estimated-total fat masses in males and females were found similar (p = 0.9, p = 0.5, respectively). A good level of agreement between measurements in males and females was attained (CCC = 0.84, CCC = 0.76, respectively). Conclusion. We developed and validated prediction equations that are convenient for determining total fat masses in young- and middle-aged adults using abdominal subcutaneous fat thickness obtained from the US. The abdominal subcutaneous fat thickness obtained from a single region by US might provide a noninvasive quick and easy evaluation not only in clinical settings but also on the field

Background. There is a 20% dissatisfaction rate with knee replacements. Calls for tools that can pre-operatively identify patients at risk of being dissatisfied postoperatively have been widespread. However, it is unclear what sort of information patients would want from such a tool, how it would affect their decision making process, and at what part of the pathway such a tool should be used. Methods. Using focus groups involving 12 participants and in-depth interviews with 10 participants, we examined the effect outcome prediction has by providing fictitious predictions to patients at different stages of treatment. A qualitative analysis of themes, based on a constant comparative method, is used to analyse the data. This study was approved by the Dyfed Powys Research Ethics Committee (13/WA/0140). Results. Our results demonstrate several interesting findings. Firstly, patients who have received information from friends and family are unwilling to adjust their expectation of outcome down (i.e. to a worse outcome), but highly willing to adjust it up (to a better outcome). This is an example of the optimism bias, and suggests the effect on expectation of any poor outcome prediction would be blunted. Secondly, patients generally wanted a “bottom line” outcome, rather than lots of detail. Thirdly, patients who were earlier in their treatment for osteoarthritis were more likely to find the information useful, and for it to affect their decision, than patients later in their pathway. Conclusion. An outcome prediction tool would have most effect targeted towards people at the start of their treatment pathway, with a “bottom line” prediction of outcome. However, any effect on expectation and decision making of a poor outcome prediction is likely to be blunted by the optimism bias. Level of Evidence. 4

Background. While many studies have investigated long-term outcomes after lower limb arthroplasty, rather less is known about the trajectory of short-term outcomes in the first post-operative year. It is difficult for a surgeon to know when, in terms of disease severity, it is best to operate, or to make an accurate prediction of the patient pattern of post-operative recovery. We explored the trajectory of change in pain and function following primary hip and knee arthroplasty and the influence of pre-operative self-reported symptoms on post-operative improvements. Methods. A prospective UK cohort study of 164 patients undergoing primary hip (n=80) or knee (n=84) arthroplasty. WOMAC pain and function measures were collected pre-operatively and at 3 and 12 months post-operatively. Hip and knee arthroplasties were analysed separately, and patients were split into two groups: those with high or low symptoms pre-operatively. Multilevel regressions were used for each outcome (pain and function), and the trajectory of change (0–3 months and 3–12 months) charted. The study was approved by Southwest 4 Research Ethics Committee (09/H0102/72) and all patients provided informed, written consent. The authors have no competing interests to disclose. Results. Most improvement after hip arthroplasty occurred within the first 3 months post-operative. One year after surgery there was no difference in the outcomes between patients with high or low pain/function scores pre-operatively. Similarly, most improvement after knee arthroplasty occurred in the first 3 months. Improvement was greater for those patients with worse pre-operative functional disability and pain, although these patients never ‘caught-up’ with those with less severe pre-operative symptoms. Conclusions. Earlier intervention may be warranted for patients undergoing knee arthroplasty compared to hip arthroplasty to achieve the best post-operative patient-reported outcomes. Level of evidence. 2b, Individual cohort study

Background. 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. Methods. 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. Results. Using existing approaches, baseline and change scores are underestimated, and the variance of baseline and change scores overestimated in comparison to MLM approaches. MLM increases the proportion of individuals defined as responding in RTN, MID, and OO criteria compared to existing approaches. Using MLM with the MCID criteria reduces the number of individuals identified as responders. Conclusion. MLM improves the estimation of the standard deviation of baseline and change scores by explicitly incorporating measurement error into the model, and avoiding regression to the mean when making individual predictions. Using refined definitions of responsiveness may lead to a reduction in misclassification when attempting to predict who does and does not respond to an intervention, and clarifies the similarities between existing methods. Approvals. The APEX trials were registered as an International Standardised Randomised Controlled Trial (96095682), approved by Southampton and South West Hampshire Research Ethics Committee (09/H0504/94) and all participants provided informed written consent

Background. 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. Methods. 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. Results. In both the THR and TKR cohort, lower PPTs (heightened widespread pain. sensitivity) were significantly associated with higher preoperative pain severity. Lower PPTs were also significantly associated with higher pain severity at 12 months after surgery in the THR cohort. However, PPTs were not associated with the change in pain severity from preoperative to 12 months postoperative in either the TKR or THR cohort. Conclusions. These findings suggest that although preoperative widespread pressure pain sensitivity is associated with pain severity before and after joint replacement, it is not a predictor of the amount of pain relief that patients gain from joint replacement surgery, independent of preoperative pain severity. Level of Evidence. 2. Approvals. The APEX trials were registered as an International Standardised Randomised Controlled Trial (96095682), approved by Southampton and South West Hampshire Research Ethics Committee(09/H0504/94) and all participants provided informed written consent

Background. Knee replacement surgery is currently facing three dilemmas: a high dissatisfaction rate; increasing demand with financial constraints; and variation in utilisation. A patient centred approach, usually achieved through shared decision-making, has the potential to help address these dilemmas. However, such an approach requires an understanding of the factors involved in patient decision-making. This is the first study examining decision-making in knee replacements that includes patients at different stages of decision-making – this is critical when considering decision-making as a process. We base our findings in a theoretical model, proposed by Elwyn et al, that highlights the distinction between deliberation and decision-making, and propose modifications to this model specific to knee replacement decision-making. Methods. This study used two focus groups of six patients each and in-depth interviews with 10 patients to examine the factors that affect patient decision-making and their interaction at different points in the decision-making process. A qualitative analysis of themes, based on a constant comparative method, is used to analyse the data. This study was approved by the Dyfed Powys Research Ethics Committee (13/WA/0140). Results. We describe 10 themes that affect patient deliberation over the decision: decision-making style; coping strategies; expectation of outcome; decision-making stress; personal situation; preferred model of care; trust in doctor; sources of information; mental state; and loss of control. We add to Elwyn's model by demonstrating the boundary between deliberation and decision-making is the decision-making threshold. Conclusion. This study provides increased detail on a theoretical model that can be used to describe decision-making, and an understanding of the factors that affect decision-making for patients considering knee replacement. Such an understanding will aid patient centred care, and has particular relevance in developing interventions aimed at delivering information. This is likely to affect the satisfaction rate, demand, and utilisation of knee replacements. Level of evidence. 4

Background. To investigate whether the interaction between pre-operative widespread hyperalgesia and radiographic osteoarthritis (OA) was associated with pain severity before and after total hip replacement (THR) and total knee replacement (TKR). Methods. Data were analysed from 232 patients receiving THR and 241 receiving TKR. Pain was assessed pre-operatively and at 12 months post-operatively using the WOMAC Pain Scale. Widespread hyperalgesia was assessed through forearm pressure pain thresholds (PPTs) measured using an algometer. The severity of radiographic OA was evaluated using the Kellgren and Lawrence scheme. Statistical analysis was conducted using linear regression and multilevel models, and adjusted for confounding variables. Results. Pre-operative. In knee patients, there was weak evidence that the effect of PPTs on pain severity was greater in patients with more severe OA compared to patients with less severe OA (Grade 3 OA: ß=0.96 vs Grade 4 OA: ß=4.03). However, in hip patients, the effect of PPTs on pain severity did not differ with the extent of radiographic OA (Grade 3 OA: ß=3.95 vs Grade 4 OA: ß=3.67). Post-operative. Patients undergoing TKR with less severe OA who had lower PPTs (greater widespread hyperalgesia) benefitted less from surgery than patients with higher PPTs (Grade 3 OA: ß=2.28). Conversely, patients undergoing THR with more severe OA who had lower PPTs benefited more from surgery than patients with higher PPTs (Grade 4 OA: ß=−2.92). Conclusion. Central sensitisation may be a determinant of how much patients benefit from joint replacement, but the effect varies by joint and severity of structural joint changes. Level of Evidence. 2. Approvals. The APEX trials were registered as an International Standardised Randomised Controlled Trial (96095682), approved by Southampton and South West Hampshire Research Ethics Committee (09/H0504/94) and all participants provided informed written consent

Objective. 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. Methods. 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). Results. Patients with high levels of pre-operative pain were more likely to report chronic pain after THR (β=0.195; p=0.02) and TKR (β=0.759; p<0.0001). Acute post-operative pain-on-movement was not associated with chronic pain after TKR or THR after adjusting for pre-operative pain, however acute pain-at-rest was associated with chronic pain after THR (β=0.20; p<0.0002) but not TKR after adjusting for pre-operative pain. Analysis of pain-at-rest and pain-on-movement highlighted differences between THR and TKR patients. Chronic pain after THR was weakly associated with pain-at-rest during the pre-operative (β=0.11; p=0.068) and acute post-operative period (β=0.21; p<0.0001). In contrast, chronic-pain after TKR was strongly associated with the severity of pain-on-movement during the pre-operative period (β=0.51; p=0.001). Conclusions. SEM illustrated the different patterns of association between measures of pain over time in patients undergoing THR and TKR for osteoarthritis. These findings highlight the importance of future work which explore the mechanisms underlying pain-on-movement and pain-at-rest. Level of Evidence. 2. Approvals. The APEX trials were registered as an International Standardised Randomised Controlled Trial (96095682), approved by Southampton and South West Hampshire Research Ethics Committee(09/H0504/94) and all participants provided informed written consent

Background. Articular cartilage has poor repair properties and poses a significant challenge in orthopaedics. Damage as a result of disease or injury frequently leads to formation of an osteochondral defect. Conventional repair methods, including allograft, autograft and microfracture, have a number of disadvantages in terms of cost, associated technical challenges and the requirement for multiple operations. A novel tri-layered scaffold developed in our lab, addresses this issue as it closely matches the structure and composition of osteochondral tissue. Methods. In vivo assessment was carried out in a caprine model by creating 6 mm × 6 mm defects in the medial femoral condyle and lateral trochlear ridge of each joint. Defects were implanted with the tri-layered scaffold and for comparison also with a market-leading scaffold, while some of defects were left empty, acting as a control. Assessment was carried out at 3 month, 6 month and 12 month time points. The quality of the repair at the various time points was graded macroscopically and microscopically by histological staining of the samples and also assessed using micro-CT (computed tomography) analysis. Results. From 3 to 6 months the tri-layered scaffold group showed improved macroscopic repair compared to the empty defect group. Greater levels of bone formation in the tri-layered scaffold group were evident on micro-CT evaluation, and this was confirmed by histological staining. Finally, at 12 months superior results were seen in the tri-layered scaffold group with formation of hyaline-like cartilage within the defect and regeneration of the subchondral bone. Conclusions. Positive results to date show that the tri-layered to be a promising method for cartilage repair and regeneration by promoting natural cartilage re-growth. It negates the need for other biological agents such as genes and growth factors by stimulating the native tissue osteochondral repair mechanism. Level of evidence. Animal research. Ethics Approval. The Ethics Committee of the University College Dublin (UCD) (AREC-P-11-31) approved this study and the Irish Government Department of Health (B100/4317) granted an animal license

Adductor canal blocks offer an alternative to femoral nerve block for postoperative pain relief in knee arthroplasty. They may reduce the risk of quadriceps weakness, allowing earlier mobilisation of patients postoperatively. However, little is known about the effect of a tourniquet on the distribution of local anaesthetic in the limb. Ultrasound-guided adductor canal blocks were performed on both thighs of five human cadavers. Left and right thighs of each cadaver were randomised to tourniquet or no tourniquet for one hour. Iohexol radio-opaque contrast (Omnipaque 350) was substituted for the local anaesthetic for X-Ray imaging. All limbs underwent periodic flexion and extension during this hour to simulate positioning during surgery. The cadavers were refrozen. Fiducial markers were inserted into the frozen tissue. X-rays were obtained in 4 planes (AP, lateral 45° oblique/medial oblique, lateral). University Research Ethics Approval was obtained and cadavers were all pre-consented for research, imaging and photography according to the Anatomy Act (1984). Analysis of radiographs showed contrast distribution in all thighs to be predominantly on the medial aspect of the thighs. The contrast margins were entire and well circumscribed, strongly suggesting it was largely contained within the aponeurosis of the adductor canal. Tourniquets appeared to push the contrast into a narrower and more distal spread along the length of the thigh compared to a more diffuse spread for those without. Proximal spread towards the femoral triangle was reduced in limbs without tourniquets. The results suggest that contrast material may remain within the adductor canal structures during adductor canal blocks. Tourniquets may cause greater distribution of contrast proximally and distally in the thigh, but this does not appear to be clinically significant. Further studies might include radio-stereo photometric analysis using the fiducial markers in the limbs and in vivo studies to show the effect of haemodynamics on distribution

Background. Around 1% of patients who have hip replacement have deep prosthetic joint infection afterwards. Infection is treated with antibiotics and revision surgery. We aimed to characterise the impact of deep joint infection and its treatment, to identify treatment preferences, and to describe surgeons' treatment decisions. Methods. In a qualitative study in the UK we interviewed 19 patients who had infection after hip replacement and 12 orthopaedic surgeons specialising in infection. Face-to-face interviews with patients explored experience of infection, treatment and recovery. Interviews with surgeons explored treatment decisions. With consent, interviews were audio-recorded, transcribed and anonymised. Once imported into QSR NVivo software, data were analysed using constant comparison. Results. Patients with deep joint infection described mobility loss, pain, loss of valued activities, changes to home environments/moving into care, negative impact on personal relationships and financial strain. Physical and psychological trauma was associated with revision surgery and antibiotic treatment. Patients had strong preferences for treatment options, emphasising impact of surgery, side effects of antibiotics and duration of treatment as key considerations. Although eradication of infection was important, patients felt that reducing impact of treatment was high priority and identified a need for more support. Surgeons' treatment decisions focused on patient characteristics and nature of infection to prioritise eradication of infection. During patients' recovery surgeons' were concerned about possible return of infection and patients' mobility and function. Conclusion. Infection after joint replacement causes physical and psychological trauma. Balancing patients' preferences for reducing impact of treatment with surgeons' emphasis on eradication of infection should be an important consideration in care. There is also need to develop new interventions to support patients with infection. Level of evidence. Level 3 – Qualitative Research. Funding statement. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (grant number: RP-PG-1210-12005). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Ethics. This study has been given a favourable opinion for conduct in the NHS by the National Research Ethics Service Committee South West – Exeter 14/SW/0072

Background. 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. Methods. 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. Results. In the hip trial, patients in the intervention group had significantly less pain at 12 months post-operative than patients in the standard care group (differences in means 4.74; 95% CI 0.95, 8.54; p=0.015), although the difference was not clinically significant. Post-hoc analysis found that patients in the intervention group were more likely to have none to moderate pain than severe pain at 12 months than those in the standard care group (odds ratio 10.19; 95% CI 2.10, 49.55; p=0.004). In the knee trial, there was no strong evidence that the intervention influenced pain severity at 12 months post-operative (difference in means 3.83; 95% CI −0.83, 8.49; p=0.107). Conclusions. In conclusion, routine use of infiltration could be beneficial in improving long-term pain relief for some patients after THR. Level of evidence. Randomised controlled trial. Funding. This article presents independent research funded by the National Institute for Health Research (NIHR) in England under its Programme Grants for Applied Research programme (RP-PG-0407-10070). The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The research team acknowledge the support of the NIHR, through the Comprehensive Clinical Research Network

Introduction. The transition from resident to registrar constitutes a steep learning curve in most medical practitioners’ careers, regardless of speciality. We aimed to determine whether a six-week orthopaedic surgical skills course could increase resident skills and confidence prior to transitioning to orthopaedic registrar within the Gold Coast University Hospital, Queensland, Australia. Materials. Unaccredited registrars, orthopaedic trainees, and orthopaedic consultants, through a departmental peer reviewed process and survey, developed a six-session course (“Registrar Academy”) that included basic knowledge and essential practical skills training for residents with an interest in becoming orthopaedic registrars. This course was implemented over a 3-month period and assessed. Mixed method quantitative and qualitative evidence was sought via a 14-item and 18-item Likert scale questionnaire coupled with open-ended questions. Ethical approval was granted by our institutions Human Research and Ethics Comittee, reference no.: HREC/16/QGC336. Results/Discussion. Results were qualitatively synthesised using quantitative and qualitative data. Thirteen residents participated in the course. All residents agreed to statements indicating they felt unprepared to work as an orthopaedic registrar and were not confident in performing various core tasks required. After completing the course, residents indicated greater confidence or comfort in all these areas and felt better prepared for the transition to registrar. There was broad approval of the course among participants. Every participant who completed the final questionnaire agreed or strongly agreed that they enjoyed the course and that it taught usable, reproducible practical skills and increased their orthopaedic knowledge. This group also uniformly agreed or strongly agreed that the course improved their patient care and patient safety. Conclusion. Residents feel unprepared for their transition to orthopaedic registrar and lack confidence in several core competencies. A supplemental “Registrar Academy” within an institution is an effective way to improve knowledge, confidence, and practical skills for residents wishing to transition to a registrar position