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Background There is an ongoing debate regarding optimal fixation of total knee arthroplasty (TKA), however cost has not been addressed as profoundly. Therefore, the current study primarily aimed to compare costs and cost-effectiveness 1 year after cemented or uncemented TKA. A secondary objective was to compare short-term functional outcomes between both groups. Methods A posthoc prospective observational multicenter cohort study of 60 cemented and 50 uncemented Low Contact Stress (LCS) knee systems. Outcome was evaluated using the EuroQol5D-3 L (EQ5D) index, in order to calculate quality adjusted life years (QALYs). Total costs were calculated considering direct costs within the hospital setting (inpatient cost) as well as direct and indirect costs outside the hospital. Cost-effectiveness (total costs per QALY), Oxford Knee Score (OKS) and Numeric Rating Scale (NRS) were compared between cemented and uncemented cases at 1 year after surgery. HealthBASKET project, a micro-costing approach, represents the Dutch costs and situation and was used to calculate hospital stay. (In) direct costs outside the healthcare (medical cost and productivity cost) were determined using two validated questionnaires. Results Median costs per QALY were similar between cemented and uncemented TKA patients (€16,269 and €17,727 respectively; p  = 0.50). Median OKS (44 and 42; p  = 0.79), EQ5D (0.88 and 0.90; p  = 0.82) and NRS for pain (1.0 and 1.0; p  = 0.48) and satisfaction (9.0 and 9.0; p  = 0.15) were also comparable between both groups. Conclusion For this type of knee implant (LCS), inpatient hospital costs and costs after hospitalization were comparable between groups.

Purpose End-stage knee osteoarthritis (OA) results in total knee arthroplasty (TKA) surgery. The decision to perform TKA is not well defined, resulting in variation of indications among orthopaedic surgeons. Non-operative treatment measures are often not extensively used. Aim of this study was to investigate factors influencing the decision to perform TKA by Dutch orthopaedic surgeons. Methods Three case vignettes, each case divided into two versions, being identical except for information on age (younger and older age), pain (mild and severe pain) or radiological OA (low and high grade) were developed. A questionnaire including these three case vignettes was sent to 599 Dutch orthopaedic surgeons, who were randomised to either one of the two versions. The orthopaedic surgeons were asked whether TKA would be the next step in treatment. Furthermore, from a list of patient factors they were asked how strong these factors would influence the decision to perform TKA. Results 54 % of the orthopaedic surgeons completed the questionnaire ( n  = 326). Orthopaedic surgeons indicated to perform TKA significantly more often at higher age (73.3 vs. 45.5 %, p  < 0.001). In the presence of mild pain, orthopaedic surgeons were slightly more reluctant to perform a TKA compared to severe pain (57.0 vs. 64.0 %, n.s.). Mild radiological OA made surgeons more reluctant to perform TKA compared to severe OA (9.7 vs. 96.9 %, p  < 0.001). Conclusion Old age and severe radiological OA are variables which are considered to be important in the decision to perform a TKA. Pain symptoms of moderate or severe pain are unequivocal when considering a TKA. Level of evidence Economic/decision analysis, Level III.

Introduction Bisphosphonates are currently the medical treatment most often used in children with osteogenesis imperfecta (OI). The purpose of this retrospective pre–post study was to evaluate the efficacy of treatment with bisphosphonates. We measured the effect by evaluating the number of outpatient department consultations and operative interventions before and after treatment with bisphosphonates in children with OI. Methods and materials Outpatient department consultation and operative intervention frequencies before and after treatment with bisphosphonates were registered. Children who had at least 2 years of medical records before treatment and at least 2 years after treatment were used in this study. Results Of 118 children who were treated with bisphosphonates, 51 (23 boys and 28 girls) fulfilled the inclusion criteria. Statistical analysis revealed a significant decrease in outpatient department consultations (P < 0.000) and operative intervention (P < 0.003) before and after bisphosphonate treatment. Conclusion The pre-post design of our study shows a significant reduction of the number of outpatient department consultations and operative interventions in patients with OI after treatment with bisphosphonates.

ObjectiveTo assess the effectiveness of a prospective multifaceted quality improvement intervention on patient outcomes after total hip and knee arthroplasty (THA and TKA).DesignCluster randomised controlled trial nested in a national registry. From 1 January 2018 to 31 May 2020 routinely submitted registry data on revision and patient characteristics were used, supplemented with hospital data on readmission, complications and length of stay (LOS) for all patients.Setting20 orthopaedic departments across hospitals performing THA and TKA in The Netherlands.Participants32 923 patients underwent THA and TKA, in 10 intervention and 10 control hospitals (usual care).InterventionThe intervention period lasted 8 months and consisted of the following components: (1) monthly updated feedback on 1-year revision, 30-day readmission, 30-day complications, long (upper quartile) LOS and these four indicators combined in a composite outcome; (2) interactive education; (3) an action toolbox including evidence-based quality improvement initiatives (QIIs) to facilitate improvement of above indicators; and (4) bimonthly surveys to report on QII undertaken.Main outcome measuresThe primary outcome was textbook outcome (TO), an all-or-none composite representing the best outcome on all performance indicators (ie, the absence of revision, readmissions, complications and long LOS). The individual indicators were analysed as secondary outcomes. Changes in outcomes from pre-intervention to intervention period were compared between intervention versus control hospitals, adjusted for case-mix and clustering of patients within hospitals using random effect binary logistic regression models. The same analyses were conducted for intervention hospitals that did and did not introduce QII.Results16,314 patients were analysed in intervention hospitals (12,475 before and 3,839 during intervention) versus 16,609 in control hospitals (12,853 versus 3,756). After the intervention period, the absolute probability to achieve TO increased by 4.32% (95% confidence interval (CI) 4.30-4.34) more in intervention than control hospitals, corresponding to 21.6 (95%CI 21.5-21.8), i.e., 22 patients treated in intervention hospitals to achieve one additional patient with TO. Intervention hospitals had a larger increase in patients achieving TO (ratio of adjusted odds ratios 1.24, 95%CI 1.05-1.48) than control hospitals, a larger reduction in patients with long LOS (0.74, 95%CI 0.61-0.90) but also a larger increase in patients with reported 30-day complications (1.34, 95%CI 1.00-1.78). Intervention hospitals that introduced QII increased more in TO (1.32, 95%CI 1.10-1.57) than control hospitals, with no effect shown for hospitals not introducing QII (0.93, 95%CI 0.67-1.30).ConclusionThe multifaceted QI intervention including monthly feedback, education, and a toolbox to facilitate QII effectively improved patients achieving TO. The effect size was associated with the introduction of (evidence-based) QII, considered as the causal link to achieve better patient outcomes.Trial registration number NCT04055103.

Total knee replacement (TKR) is increasingly performed in short term hospital stay, making same day mobilization an important issue is after surgery. This implies little joint effusion by reducing intra-articular blood loss, which will enhance knee range of motion. The application of a topical fibrin sealant on the intraoperative bare bone and synovial tissue may contribute to better early full mobilization and thus improved functional outcomes. Since ambulation with a fully extended knee is less strenuous, we hypothesized that patients who received fibrin sealant would demonstrate improved early knee extension after six weeks compared to patients who received standard care. A multicenter randomized controlled trial in a consecutive series of osteoarthritis patients scheduled for TKR surgery. Participants were randomized to receive fibrin sealant or not before closing the knee joint capsule. Primary outcome was change in knee extension angle(°) at short term (2 weeks) follow-up (cExt). Secondary outcomes were 6-week extension angle, knee flexion angle, hemoglobin loss, blood transfusion rates, complication rates, the Knee Society Score, and the KOOS and EQ5D questionnaires. When data on primary outcome became available from 250 patients, an interim analysis was performed by an independent Data Safety Monitoring Board for safety and effectivity assessment. This analysis showed that sufficient patients were included to detect a cExt of 10° between both groups. Inclusion was stopped however, all in the meantime included patients were treated according to their randomization. A total of 466 were available for analysis. Both groups were comparable in terms of baseline characteristics. The estimated mean cExt difference was 0.2° (95%CI -0.5 to 0.9). No differences in secondary outcomes were found. No beneficial effects or side effects were found of a topically applied fibrin sealant during TKR surgery. These results discourage the clinical use of a fibrin sealant in TKR. Dutch Trial Register, NTR2500.

Anxiety has been linked to increased generalisation of threat expectations to perceptually similar stimuli. Such generalisation can arise either from a failure to distinguish threatening from non-threatening stimuli (perceptual mechanism) or from the transfer of learned values between stimuli (value-based mechanism). Yet, how these mechanisms contribute to generalisation remains unclear. Here we assess how participants ( n  = 140) generalise outcome expectancies to perceptually similar stimuli, using personalised stimulus spaces. Computational modelling revealed that individuals differ in the extent to which they generalise value and in the underlying value function. We further found that stronger generalisation in trait anxiety was best explained by greater reliance on value transfer. In this work, we characterise individual differences in the generalisation of aversive stimuli and link stronger generalisation in trait anxiety to preferential reliance on value transfer. Anxiety is associated with increased generalisation of threat to similar stimuli. This paper used computational modelling to dissociate perceptual mistakes from value generalisation and links stronger value-transfer to trait anxiety.

PurposeLumbar spinal fusion surgery (LSFS) is common for lumbar degenerative disorders. The objective was to develop clinical prediction rules to identify which patients are likely to have a favourable outcome to inform decisions regarding surgery and rehabilitation.MethodsA prospective observational study recruited 600 (derivation) and 600 (internal validation) consecutive adult patients undergoing LSFS for degenerative lumbar disorder through the British Spine Registry. Definition of good outcome (6 weeks, 12 months) was reduction in pain intensity (Numerical Rating Scale, 0–10) and disability (Oswestry Disability Index, ODI 0–50) > 1.7 and 14.3, respectively. Linear and logistic regression models were fitted and regression coefficients, Odds ratios and 95% CIs reported.ResultsLower BMI, higher ODI and higher leg pain pre-operatively were predictive of good disability outcome, higher back pain was predictive of good back pain outcome, and no previous surgery and higher leg pain were predictive of good leg pain outcome; all at 6 weeks. Working and higher leg pain were predictive of good ODI and leg pain outcomes, higher back pain was predictive of good back pain outcome, and higher leg pain was predictive of good leg pain outcome at 12 months. Model performance demonstrated reasonable to good calibration and adequate/very good discrimination.ConclusionsBMI, ODI, leg and back pain and previous surgery are important considerations pre-operatively to inform decisions for surgery. Pre-operative leg and back pain and work status are important considerations to inform decisions for management following surgery. Findings may inform clinical decision making regarding LSFS and associated rehabilitation.

Background Less than 1% of all primary TKAs are performed with an all-polyethylene tibial component, although recent studies indicate all-polyethylene tibial components are equal to or better than metal-backed ones. Questions/purposes We asked whether the metal-backed tibial component was clinically superior to the all-polyethylene tibial component in primary TKAs regarding revision rates and clinical functioning, and which modifying variables affected the revision rate. Methods We systematically reviewed the literature for clinical studies comparing all-polyethylene and metal-backed tibial components used in primary TKAs in terms of revision rates, clinical scores, and radiologic parameters including radiostereometric analysis (RSA). Meta-regression techniques were used to explore factors modifying the observed effect. Our search yielded 1557 unique references of which 26 articles were included, comprising more than 12,500 TKAs with 231 revisions for any reason. Results Meta-analysis showed no differences between the all-polyethylene and metal-backed components except for higher migration of the metal-backed components. Meta-regression showed strong evidence that the all-polyethylene design has improved with time compared with the metal-backed design. Conclusions The all-polyethylene components were equivalent to metal-backed components regarding revision rates and clinical scores. The all-polyethylene components had better fixation (RSA) than the metal-backed components. The belief that metal-backed components are better than all-polyethylene ones seems to be based on studies from earlier TKAs. This might no longer be true for modern TKAs. Level of Evidence Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

IntroductionPotential predictors of poor outcome will be measured at baseline: (1) preoperatively to develop a clinical prediction model to predict which patients are likely to have favourable outcome following lumbar spinal fusion surgery (LSFS) and (2) postoperatively to predict which patients are likely to have favourable long-term outcomes (to inform rehabilitation).Methods and analysisProspective observational study with a defined episode inception of the point of surgery. Electronic data will be collected through the British Spine Registry and will include patient-reported outcome measures (eg, Fear-Avoidance Beliefs Questionnaire) and data items (eg, smoking status). Consecutive patients (≥18 years) undergoing LSFS for back and/or leg pain of degenerative cause will be recruited. Exclusion criteria: LSFS for spinal fracture, inflammatory disease, malignancy, infection, deformity and revision surgery. 1000 participants will be recruited (n=600 prediction model development, n=400 internal validation derived model; planning 10 events per candidate prognostic factor). The outcome being predicted is an individual’s absolute risk of poor outcome (disability and pain) at 6 weeks (objective 1) and 12 months postsurgery (objective 2). Disability and pain will be measured using the Oswestry Disability Index (ODI), and severity of pain in the previous week with a Numerical Rating Scale (NRS 0–10), respectively. Good outcome is defined as a change of 1.7 on the NRS for pain, and a change of 14.3 on the ODI. Both linear and logistic (to dichotomise outcome into low and high risk) multivariable regression models will be fitted and mean differences or ORs for each candidate predictive factor reported. Internal validation of the derived model will use a further set of British Spine Registry data. External validation will be geographical using two spinal registries in The Netherlands and Switzerland.Ethics and disseminationEthical approval (University of Birmingham ERN_17-0446A). Dissemination through peer-reviewed journals and conferences.

Background Fulani ethnic group individuals are less susceptible than sympatric Mossi ethnic group, in term of malaria infection severity, and differ in antibody production against malaria antigens. The differences in susceptibility to malaria between Fulani and Mossi ethnic groups are thought to be regulated by different genetic backgrounds and offer the opportunity to compare haematological parameters, Tregs and γδT cell profiles in seasonal and stable malaria transmission settings in Burkina Faso. The study was conducted at two different time points i.e. during the high and low malaria transmission period. Results Two cross-sectional surveys were undertaken in adults above 20 years belonging either to the Fulani or the Mossi ethnic groups 1) at the peak of the malaria transmission season and 2) during the middle of the low malaria transmission season. Full blood counts, proportions of Tregs and γδ T cells were measured at both time-points. As previously shown the Fulani and Mossi ethnic groups showed a consistent difference in P. falciparum infection rates and parasite load. Differential white blood cell counts showed that the absolute lymphocyte counts were higher in the Mossi than in the Fulani ethnic group at both time points. While the proportion of CD4+CD25 high was higher in the Fulani ethnic group at the peak of malaria transmission season ( p = 0.03), no clear pattern emerged for T regulatory cells expressing FoxP3 + and CD127 low . However CD3 + γδ + subpopulations were found to be higher in the Fulani compared to the Mossi ethnic group, and this difference was statistically significant at both time-points ( p = 0.004 at low transmission season and p = 0.04 at peak of transmission). Conclusion Our findings on regulatory T cell phenotypes suggest an interesting role for immune regulatory mechanisms in response to malaria. The study also suggests that TCRγδ + cells might contribute to the protection against malaria in the Fulani ethnic group involving their reported parasite inhibitory activities.