Willingness to undergo surgery again validated clinically important differences in health-related quality of life after total hip replacement or total knee replacement surgery

AbstractObjectivesTo determine clinically important differences (CIDs) in health-related quality of life (HRQoL) after total hip replacement (THR) or total knee replacement (TKR) surgery, using the Short Form 36 (SF-36).Study Design and SettingSF-36 scores were collected 2 weeks before and at 1.5–6 years after joint replacement in 586 THR and 400 TKR patients in a multicenter cohort study. We calculated distribution-based CIDs (0.8 standard deviations of the preoperative score) for each SF-36 subscale. Responders (patients with an improvement in HRQoL ≥ CID of a particular subscale) were compared with nonresponders using an external validation question: willingness to undergo surgery again.ResultsCIDs for THR/TKR were physical functioning (PF), 17.9/16.7; role-physical (RP), 31.1/33.4; bodily pain (BP), 16.8/16.2; general health, 15.5/15.7; vitality, 17.3/16.7; social functioning (SF), 22.0/19.9; role-emotional, 33.7/33.6; and mental health, 14.8/14.1. CIDs of PF, RP, BP, and SF were validated by the validation question.ConclusionValid and precise CIDs are estimated of PF, RP, BP, and SF, which are relevant in HRQoL subscales for THR and TKR patients. CIDs of all other subscales should be used cautiously

Why and when suffering increases the perceived likelihood of fortuitous rewards

Cultural practices and anecdotal accounts suggest that people expect suffering to lead to fortuitous rewards. To shed light on this illusory ‘suffering–reward’ association, we tested why and when this effect manifests. Across three vignette studies in which we manipulated the degree of suffering experienced by the protagonist, we tested a ‘just‐world maintenance’ explanation (suffering deserves to be compensated) and a ‘virtuous suffering’ explanation (suffering indicates virtues, which will be rewarded). Our findings revealed that the illusory ‘suffering–reward’ association (1) could serve as a way for people to cope with just‐world threats posed by the suffering of innocent victims, and (2) manifested when the suffering was not caused by the victim's own behaviour and not readily attributable to bad luck. Taken together, these findings not only provide evidence for the existence of the illusory ‘suffering–reward’ association but also elucidate its psychological underpinnings

Take it or leave it for something better? Responses to fair offers in ultimatum bargaining

We investigated if responders accept a 50-50 split in a modified version of the ultimatum game, in which rejection yields a higher payoff (€7) than accepting the equal offer (€5). Therefore, the decision to accept the 50-50 split in this modified ultimatum game cannot be perceived as a self-interest act, as opposed to the standard game, in which acceptance may reflect resignation in the knowledge that the equal split is the best one can expect. A substantial proportion of responders accepts the equal split in this modified game (Study 1), which clearly establishes egalitarian preferences. Further studies show that the willingness to accept is not an artifact of indifference towards the extra payoff (Study 2), but reflects true concerns for proposers’ outcomes (Study 3)

All-polyethylene tibial components in TKA in rheumatoid arthritis: a 25-year follow-up study

PURPOSE: There is renewed interest in the all-polyethylene tibial component in total knee arthroplasty (TKA). Long-term results of this prosthesis in rheumatoid arthritis (RA) patients, however, are limited. Therefore, we studied 104 primary cemented all-polyethylene tibial TKA in 80 consecutive RA patients for up to 25 years to determine the long-term survival of all-polyethylene tibial components in patients suffering from end stage RA. METHODS: We estimated revision rates according the revision rate per 100 observed component years used in national joint registries. Kaplan-Meier was used to estimate survival curves. RESULTS: During the 25-year follow-up, three revisions for tibial component loosening were performed. The mean revision rate of all-polyethylene tibial components with revision for aseptic loosening as the endpoint was 0.09 per 100 observed component years. This corresponds to a revision rate of 0.9% after ten years and 2.25% after 25 years. Survivorship according to Kaplan-Meier was 100% at ten years and 87.5% at 25 years [95% confidence interval (CI) 64.6-100)]. CONCLUSION: This study shows good long-term results of all-polyethylene tibial TKA in patients with RA. RA patients with multiple-joint inflammation may be less physically active than osteoarthritis patients, resulting in a lower demand on the prosthesis, and these patients may, indeed, be good candidates for all-polyethylene tibial TKA. Our results suggest that all-polyethylene tibial TKA could be a successful and cost-saving treatment for end-stage knee arthritis in RA patients.Optimising joint reconstruction management in arthritis and bone tumour patient

The Exeter femoral stem continues to migrate during its first decade after implantation: 10–12 years of follow-up with radiostereometric analysis (RSA)

Optimising joint reconstruction management in arthritis and bone tumour patient

Similar risk of complete revision for infection with single-dose versus multiple-dose antibiotic prophylaxis in primary arthroplasty of the hip and knee:results of an observational cohort study in the Dutch Arthroplasty Register in 242,179 patients

Background and purpose - The optimal type and duration of antibiotic prophylaxis for primary arthroplasty of the hip and knee are subject to debate. We compared the risk of complete revision (obtained by a 1- or 2-stage procedure) for periprosthetic joint infection (PJI) after primary total hip or knee arthroplasty between patients receiving a single dose of prophylactic antibiotics and patients receiving multiple doses of antibiotics for prevention of PJI. Patients and methods - A cohort of 130,712 primary total hip and 111,467 knee arthroplasties performed between 2011 and 2015 in the Netherlands was analyzed. We linked data from the Dutch arthroplasty register to a survey collected across all Dutch institutions on hospital-level antibiotic prophylaxis policy. We used restricted cubic spline Poisson models adjusted for hospital clustering to compare the risk of revision for infection according to type and duration of antibiotic prophylaxis received. Results - For total hip arthroplasties, the rates of revision for infection were 31/10,000 person-years (95% CI 28-35), 39 (25-59), and 23 (15-34) in the groups that received multiple doses of cefazolin, multiple doses of cefuroxime, and a single dose of cefazolin, respectively. The rates for knee arthroplasties were 27/10,000 person-years (95% CI 24-31), 40 (24-62), and 24 (16-36). Similar risk of complete revision for infection among antibiotic prophylaxis regimens was found when adjusting for confounders. Interpretation - In a large observational cohort we found no apparent association between the type or duration of antibiotic prophylaxis and the risk of complete revision for infection. This does question whether there is any advantage to the use of prolonged antibiotic prophylaxis beyond a single dose.Orthopaedics, Trauma Surgery and Rehabilitatio

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).

In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent 'conformity assessment' organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details - which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081

Minor influence of humeral component size on torsional stiffness of the Souter-Strathclyde total elbow prosthesis

The use of Souter-Strathclyde total elbow prostheses is a well-studied replacement therapy for reconstruction of the elbow, but loosening of the humeral component is still of concern at long-term follow-up. In this study we looked at the effect of humeral component size and bone mineral density with respect to the bone size, torsional stiffness and torque to failure in cadaveric bones. Fourteen cadaveric humeri were available for testing purposes and four different humeral component size categories were used. First, we calculated the bone quality using dual-energy X-ray absorptiometry (DEXA). The torsional stiffness of the prosthetic humeri was measured during two mechanical tests: Firstly, the applied torque was recorded during a torsion fatigue test. The change of torsional stiffness between the tenth and last cycle was calculated. Secondly, a simple torsion test was performed and the torque to failure was recorded. No significant differences in outcome were seen between sizes of humeral components, even after correction for the bone size. Torsional stiffness and torque to failure were significantly correlated with bone mineral density and not with component size. In conclusion, bone quality seems to be a major eminent factor in the fixation of the humeral component in elbow replacement surgery

Radiostereometry and new prostheses

Optimising joint reconstruction management in arthritis and bone tumour patient

Total hip arthroplasties in the Dutch Arthroplasty Register (LROI) and the Nordic Arthroplasty Register Association (NARA): comparison of patient and procedure characteristics in 475,685 cases

Background and purpose — Collaborations between arthroplasty registries are important in order to create the possibility of detecting inferior implants early and improve our understanding of differences between nations in terms of indications and outcomes. In this registry study we compared patient and procedure characteristics, and revision rates in the Nordic Arthroplasty Register Association (NARA) database and the Dutch Arthroplasty Register (LROI). Patients and methods — All total hip arthroplasties (THAs) performed in 2010–2016 were included from the LROI (n = 184,862) and the NARA database (n = 290,823), which contains data from Denmark, Norway, Sweden, and Finland. Descriptive statistics and Kaplan–Meier survival analyses based on all reasons for revision and stratified by fixation were performed and compared between countries. Results — In the Netherlands, the proportion of patients aged < 55 years (9%) and male patients (34%) was lower than in Nordic countries (< 55 years 11–13%; males 35–43%); the proportion of osteoarthritis (OA) (87%) was higher compared with Sweden (81%), Norway (77%), and Denmark (81%) but comparable to Finland (86%). Uncemented fixation was used in 62% of patients in the Netherlands, in 70% of patients in Denmark and Finland, and in 28% and 19% in Norway and Sweden, respectively. The 5-year revision rate for THAs for OA was lower in Sweden (2.3%, 95% CI 2.1–2.5) than in the Netherlands (3.0%, CI 2.9–3.1), Norway (3.8%, CI 3.6–4.0), Denmark (4.6%, CI 4.4–4.8), and Finland (4.4%, CI 4.3–4.5). Revision rates in Denmark, Norway, and Finland were higher for all fixation groups. Interpretation — Patient and THA procedure characteristics as well as revision rates evinced some differences between the Netherlands and the Nordic countries. The Netherlands compared best with Denmark in terms of patient and procedure characteristics, but resembled Sweden more in terms of short-term revision risk. Combining data from registries like LROI and the NARA collaboration is feasible and might possibly enable tracking of potential outlier implants.publishedVersio