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Background and purpose: The amount of information publicly available from arthroplasty registries is large but could be used more effectively. This project aims to improve the knowledge concerning existing registries to facilitate access, transparency, harmonization, and reporting. Methods: Within the International Society of Arthroplasty Registries (ISAR) we aimed at developing, testing, adopting, and making publicly available a short, standardized registry description with items considered relevant for stakeholders using a cross-sectional study survey. Items were chosen based on a literature review and expert advice, selected by 9 ISAR working group members, tested iteratively in 3 registries, and commented upon by 4 external experts. All 29 ISAR member registries as of July 2023 were invited to participate in the project. Results: Included items covered general descriptive information regarding registries, information related to governance, outcomes, data quality, data access, and registry production. The template was adopted, completed, and made publicly available by 25 of the 29 registries. Of those, 2/3 were national registries. 23 captured both hip and knee arthroplasties and 10 captured shoulder arthroplasties. Most registries had public reporting of data quality, methods, and results. Data was accessible in all but 2 registries, mainly as aggregated data. Important items relevant to registry quality for researchers to consistently indicate in scientific papers include scope, inclusion criteria, outcomes definitions, coverage/completeness, and validation processes. Conclusion: This ISAR initiative implemented a short, standardized description to facilitate appropriate use of orthopedic registry data worldwide relevant for a diverse group of stakeholders including researchers, industry, public health and regulatory agencies.

Background: Syndesmotic instability is a significant concern in the management of unstable ankle fractures, occurring in approximately 10% to 13% of these cases. Early recognition and stabilization of syndesmotic injuries are essential to ensure optimal long-term outcomes. Several techniques are currently in use, often involving complex procedure and/or costly devices. Our study presents a syndesmosis fixation technique using K-wires that is both simple and cost-effective. Methods: This is a retrospective single-center case series. Three hundred seventy-seven ankle fractures with intraoperative syndesmosis instability and subsequent syndesmosis fixation with a K-wire were treated between 2002 and 2012. Of the 377 patients, 51 died and we were able to obtain long-term questionnaire completions from 94 patients (29% of presumed living patients), with a mean follow-up of 10.6 ± 3.0 years. Results: The mean age was 46.6 ± 18.5 years; 42% were Danis-Weber type B and 58% type C fractures. Syndesmosis fixation failure was observed in 9 (2%) patients, and 5 (1%) patients had K-wire displacement without loss of syndesmosis reduction. The Manchester-Oxford Foot Questionnaire (MOXFQ) was obtained 10±3 years after surgery. The mean MOXFQ pain score was 25.9 ± 25.4, the mean functional score was 18 ± 24.8, and the mean social score was 13.7 ± 22.2. Conclusion: We report long-term (10.6 ± 3 years) functional outcomes using a validated patient-reported questionnaire in patients who underwent syndesmosis fixation with 2 K-wires for unstable ankle fractures. In the subset of patients we were able to find in follow-up, we found low rates of syndesmosis fixation failure, low pain scores, and excellent functional outcomes. The availability and low cost of these implants make this technique an accessible and cost-effective solution to consider for syndesmosis fixation. Level of Evidence: Level IV, retrospective case series.

Background and purpose: Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory agencies websites. It is unknown whether problems triggering safety notices identify the same implants as those identified by registries as “outlier.” We aimed to assess the extent to which safety notices and outlier identification in registries signal the same or different TKA implants. Methods: The CORE-MD tool, an automated web scraper tool, was used to collect safety notices related to TKA implants on 13 national Ministries of Health websites and regulatory agencies. Safety notices were defined according to the Medical Device Regulation (MDR) as “a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.” Identified TKA outliers, defined as having a significantly higher revision risk than other comparable TKA implants, were extracted from registry reports. Results: 787 safety notices for 38 TKA implants and 35 TKA outliers were identified, together identifying 47 unique TKA implants. 26 (55%) TKA implants had safety notices and were also outliers, 12 (26%) TKA implants had only safety notices, and 9 (19%) were outliers only. TKA implants with safety notices only had similar types of problems to TKA outliers with safety notices, with “Manufacturing/Packaging/Shipping” problems being most frequent (44%). Cumulative revision risks (1/5/10 years) were lower for TKA implants with safety notices only than for TKA outliers with safety notices. Conclusion: 55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of publicly released safety notices, with safety notices pointing to TKA implants not identified by registries as potentially having a higher risk of failure. This suggests that safety notices and registry outlier data measure different aspects of safety and performance.

Background and purpose: National joint replacement registries were developed for prospective monitoring of outcomes and post-market surveillance of implants. Increasingly registry data informs practice. However, analysis of a registry can only be as good as the data it captures on the population of interest. We aimed to analyze completeness of reporting of hip and knee replacement procedures for all national registries worldwide. Methods: We analyzed annual reports and data provided following written requests to all active national hip and knee replacement registries. Coverage was defined as the proportion of hospitals in the country that participate in the registry. Procedure completeness was defined as the proportion of procedures successfully captured by the registry. Results: 14 national registries were included, spanning years 2004 to 2022. Coverage was complete in 10. Median procedure completeness for primary hip and knee replacement across all years was 96.5% (interquartile range [IQR] 94.0–97.7%). Median procedure completeness for revisions was 88.5% (IQR 81.0–92.5%). The terminology used and method of calculation of completeness estimates in the registries were variable. Conclusion: National hip and knee replacement registry data generally reflects excellent coverage (full in 10 of 14 registries) and completeness (primary procedures 96.5% and revisions 88.5%) over the last 2 decades.

Abstract Background Arthroplasty registries are rarely used to inform encounters between clinician and patient. This study is part of a larger one which aimed to develop an information tool allowing both to benefit from previous patients’ experience after total hip arthroplasty (THA). This study focuses on generating the information tool specifically for pain outcomes. Methods Data from the Geneva Arthroplasty Registry (GAR) about patients receiving a primary elective THA between 1996 and 2019 was used. Selected outcomes were identified from patient and surgeon surveys: pain walking, climbing stairs, night pain, pain interference, and pain medication. Clusters of patients with homogeneous outcomes at 1, 5, and 10 years postoperatively were generated based on selected predictors evaluated preoperatively using conditional inference trees (CITs). Results Data from 6,836 THAs were analysed and 14 CITs generated with 17 predictors found significant (p

Background and purpose: Younger recipients of total hip arthroplasty (THA) highly prioritize returning to preoperative levels of physical activity (PA). Surgeons have tended to give cautious advice concerning high-impact sports participation, but there have been few long-term studies. The purpose of our study was to investigate the risk of revision arthroplasty in relation to postoperative PA levels. Methods: Patients registered in the Geneva Arthroplasty Register (GAR) who had elective THA when they were aged < 65 years were studied. Postoperative PA was collected prospectively 5-yearly using the UCLA activity scale. Cox proportional hazards models were used to estimate associations between PA and risk of revision THA. Results: Amongst 1,370 eligible subjects, median age at THA 58 years (interquartile range 51–61), UCLA scores were available for 973 (71%). During follow-up over 15 years, there were 79 revisions, giving a cumulative risk of 7.4% (95% confidence interval [CI] 5.8–9.4). After adjusting for covariates, we found an increased risk of revision for each unit increase in postoperative PA (HR 1.2, CI 1.1–1.4), and among people performing the most intensive PA (HR 2.7, CI 1.3–5.6) compared with those who were inactive. Conclusion: The overall risk of revision was small but intensive and moderate PA may be associated with an increased risk of revision.

Background and purpose: International variation exists in the types of shoulder replacement used for treatment of specific diseases. Implant choice continues to evolve without high-quality evidence. Our aim was to evaluate trends in incidence rates of shoulder replacement and assess any recent changes in practice between countries by using registry data. Methods: Patient characteristics, indication and year of surgery, type of replacement, and collection methods of patient-reported outcomes (PROMs) was extracted from 11 public joint registries. Meta-analyses examined use of reverse total shoulder replacement (RTSR) for osteoarthritis, cuff tear arthropathy, and acute fracture; use of anatomical total shoulder replacement (TSR) for osteoarthritis; and use of humeral hemiarthroplasty for fracture. Results: The annual growth rate of shoulder replacements performed is 6–15% (2011–2019). The use of RTSR has almost doubled (93%). RTSR is now universally performed for cuff tear arthropathy (97.3%, 95% confidence interval [CI] 96.0–98.1). Its use for avascular necrosis, trauma, and inflammatory arthropathy is increasing. The use of RTSR was similar (43.1%, CI 30.0–57.2) versus TSR (44.7%, CI 31.1–59.1) for osteoarthritis. The types of PROMs used, collection time points, and response rates lack standardization. COVID-19 had a varying inter-registry impact on incidence rates. Conclusion: The incidence of shoulder replacements has grown. Use of RTSR has increased for all disease indications despite limited high-quality evidence driving this change in indications outside of cuff arthropathy. Consequently, less variation is observed in international practice. Existing differences now relate to use of newer implant types and methodology of PROMs collection, which prevents international comparison and outcome analysis.

Background The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.Methods Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.Results Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.Conclusion European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021. Methods: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology. Conclusion: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.

With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process. The EFORT Implant and Patient Safety Initiative WG1 ‘Introduction of Innovation’, combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745. Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies. Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely. Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) – which has to be considered for a specific device – has been successfully completed. Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated.

Background and purpose: We aimed to evaluate the long-term predictive value of radiographic abnormality and/or hip pain assessed 5 years following primary total hip arthroplasty (THA) and the occurrence of revision for aseptic loosening between 5 and 25 years postoperatively. Patients and methods: We included all primary THAs performed between 1996 and 2011 (same uncemented cup, polyethylene-ceramic bearing, 28 mm head, cemented stem) and prospectively enrolled in the institutional registry, for whom baseline and follow-up radiographs were available. At 5 years radiographically we assessed femoral osteolysis and/or stem migration. Pain was evaluated with the Harris Hip pain subscore. Kaplan–Meier survival and Cox regression analyses were performed. Results: 1,317 primary THAs were included. 25 THAs (2%) were revised for aseptic stem loosening. Any abnormal radiographic sign at 5 years was present in 191 THAs (14%). Occasional hip pain was reported by 20% and slight to severe pain by 12% of patients at 5 years. In patients < 60 years, 10 of the 12 later revised for aseptic stem loosening had abnormal radiographs at 5 years vs. 5 of the 13 later revised in those ≥ 60 years. Hazard ratios (HR) were 34 (95% confidence interval [CI] 7–155) in younger vs. 4 (CI 1–11) in the older group. HR for association of hip pain at 5 years with future revision was 3 (CI 1–5). Conclusion: The presence of abnormal radiographic signs 5 years after THA was strongly associated with later revision for aseptic stem loosening, especially in patients < 60 years. The association between pain at 5 years and future revision was much weaker.

Total hip and knee replacement are effective operations for the management of end-stage arthritis. There are increasing numbers of these operations being performed, and the rate of increase is anticipated to continue into the future (1, 2, 3, 4). There is also a substantial rise in the lifetime risk of a person receiving a total hip or knee replacement and this has been shown in several countries (5, 6, 7, 8). There are a large number of joint replacement prostheses on the market available for use and not all perform the same. Many have no published outcomes. Joint replacement registries provide an appropriate way to monitor the real-world outcomes of these procedures and can provide comparative data on the rates of revision for specific prostheses. Revisions are generally defined in joint registries as a removal or exchange of a prosthesis or part thereof and provide an unambiguous record of a problem with the joint replacement. There are many factors that affect revision rates. Non-device-related issues may include patient factors, surgical technique, surgeon experience and volume of cases. Device-related factors may contribute to the variation in the rates of revision with individual prostheses.

Abstract Background Ankle fractures are a common injury and the main cause of post-traumatic ankle arthritis. The prevalence of obesity is increasing worldwide, and this population is known to have poorer short and midterm outcomes after ankle fractures. Our objective is to assess long-term patient-reported outcomes in patients with operatively treated ankle fractures, and the effect of BMI on these results using the new and validated patient-reported outcome questionnaire, the Manchester Oxford foot and ankle questionnaire (MOXFQ). Methods We performed a retrospective review of all ankle fractures treated operatively in a ten-year period from 2002–2012. The MOXFQ and SF-12 were sent to all patients and were obtained, on average, 11.1 years after surgery (range 5.3–16.2 years). Results Two thousand fifty-five ankle fractures were reviewed, of which 478 (34%) patients completed the questionnaires. The mean age was 48.1 ± 15.5 years, 52% were men and the mean BMI was 26.1 ± 4.5 kg/m2. Of the 478, 47% were of normal weight, 36% were overweight, and 17% were obese. Overall, 2.1% were type A, 69.9% B, and 24.9% type C fractures. There were no significant differences in the type of fracture between the BMI groups. Comparing obese and non-obese patients, there were large differences in MOXFQ pain (33 ± 29 vs. 18.7 ± 22.1, effect size 0.55), and function scores (27.3 ± 29 vs. 12.5 ± 21.1, effect size 0.58). No differences in complications and reoperations rates were observed. The BMI value at surgery correlated more strongly with the MOXFQ pain score than the BMI at follow-up (Spearman’s Rho 0.283 vs. 0.185, respectively). Conclusion These findings reveal that obese patients have significant worse long-term outcomes, namely increased pain, poorer function, and greater impairment in everyday life after an operatively treated ankle fracture. Moreover, pain and function linearly declined with increasing BMI. Our findings appear to indicate that increased BMI at surgery is an important contributor to adverse outcome in the operative management of rotational ankle fractures. Level of evidence III.

Abstract Background Objectives were first to evaluate by education level one-year trajectories of pain, function and general health, as well as hospital resource and medication needs in patients undergoing primary total hip arthroplasty (THA); and second, to evaluate whether outcome differences are related to existing baseline differences in health and disease severity. Methods We included all primary THAs from a public hospital-based prospective arthroplasty registry, performed in a high-income country 2010 to 2017. Education was classified in three levels: ≤8years of schooling (low), 9-12years (medium), and ≥13years (high). Pain and function prior to and one-year after surgery were assessed with the Western Ontario McMaster Universities score (WOMAC) and general health with the 12-item short-form health survey (SF-12). Results Overall 963 patients were included, 340 (35.3%) with low, 306 (31.8%) with medium, and 317 (32.9%) with high education. With increasing educational level preoperative scores for pain, function and SF-12 mental health component increased. One year after surgery improvement was observed in all education categories for WOMAC pain and function, SF-12 mental and physical component. However, absolute postoperative scores remained lower in all four domains for the low education group. After adjustment for baseline characteristics differences were much attenuated and no longer significant. There was also greater resource need in low educated patients. Conclusions The inferior absolute results one year after surgery in less educated patients were largely due to older age, worse preoperative health and greater symptom severity calling for greater attention to timely and equal management, for more targeted perioperative care and increased support for the lower education group.

Background and purpose — Prior to primary total knee arthroplasty (pTKA), 6–34% of patients have undergone surgical procedure(s) of their knee. We investigated whether history of previous surgeries influences the risk of revision of pTKA, the risk according to the type of previous surgery, and how previous surgery influences specific causes of revision and the time of revision. Patients and methods — This is a prospective cohort study from the Geneva Arthroplasty Registry. All pTKA between 2000 and 2016 were included and followed until December 31, 2019. Outcomes were risk of revision, evaluated using Kaplan–Meier survival and Cox and competing risks regression, the specific causes, and time of revision. Results — Of 3,945 pTKA included (mean age 71 years, 68% women), 21% had a history of previous surgery, with 8.3% revisions vs. 4.3%, at 3–20 years’ follow-up (mean 8.6). 5- and 10-year cumulative failure by previous surgery (yes vs. no) were 6.6% (95% CI 5.1–8.5) vs. 3.3% (CI 2.7–4.0), and 8.4% (CI 6.6–10.6) vs. 4.5% (CI 3.8–5.4). Baseline differences explained only part of the higher risk (adjusted HR 1.5, CI 1.1–2.1). The risk of failure was higher for all causes of revision considered. Patients in the previous surgery group had a higher risk of an early revision. Interpretation — A history of previous surgery adversely affected the outcome with a 1.5 times higher cumulative risk of all-cause revision over the course of up to 20 years after index surgery. The increased risk was seen for all causes of revision and was highest in the first years.

Background and purpose — A challenge comparing outcomes from total hip arthroplasty between countries is variation in preoperative characteristics, particularly comorbidity. Therefore, we investigated between-country variation in comorbidity in patients based on ASA class distribution, and determined any variation of ASA class to mortality risk between countries. Patients and methods — All arthroplasty registries collecting ASA class and mortality data in patients with elective primary THAs performed 2012–2016 were identified. Survival analyses of the influence of ASA class on 1-year mortality were performed by individual registries, followed by meta-analysis of aggregated data. Results — 6 national registries and 1 US healthcare organization registry with 418,916 THAs were included. There was substantial variation in the proportion of ASA class III/IV, ranging from 14% in the Netherlands to 39% in Finland. Overall, 1-year mortality was 0.93% (95% CI 0.87–1.01) and increased from 0.2% in ASA class I to 8.9% in class IV. The association between ASA class and mortality measured by hazard ratios (HR) was strong in all registries even after adjustment for age and sex, which reduced them by half in all registries. Combined adjusted HRs were 2.0, 6.1, and 22 for ASA class II–IV vs. I, respectively. Associations were moderately heterogeneous across registries. Interpretation — We observed large variation in ASA class distribution between registries, possibly explained by differences in background morbidity and/or international variation in access to surgery. The similar, strong mortality trends by ASA class between countries enhance the relevance of its use as an indicator of comorbidity in international registry studies.

Abstract Background Ankle fractures are common, and their incidence has been increasing. Previous epidemiological studies have been conducted in the US, Scandinavia, and Scotland. Our objectives were to provide a current epidemiological overview of operatively treated ankle fractures and to evaluate the influence of age, sex, lifestyle factors, and comorbidities on fracture types. Methods We performed a population-based epidemiological study of all ankle fractures treated operatively in a 10- year period from 2002 to 2012. Results Two thousand forty-five ankle fractures were operated upon. Men and women differed significantly in age (median 41 vs. 57 years old), obesity (16% vs. 23%), diabetes (5% vs. 10%), smoking (45% vs. 24%), and accident type (daily activities 48% vs. 79%, transportation 24% vs. 9%, sports 21% vs. 8%) respectively. Overall, there were 2% Weber A, 77% Weber B, and 21% Weber C fractures; 54% were uni-, 25% bi-, and 21% trimalleolar; 7.5% of all fractures were open. Weber C fractures were much more frequent among men and with higher BMI (lowest vs. highest category: 14% vs. 32%), but slightly less frequent with older age and among current smokers. Trimalleolar fractures were twice as frequent in women and increased with age. Conclusion Men and women differed substantially in age, lifestyle factors, comorbidities, accident type, and type of ankle fracture. Male sex and higher BMI were more frequently associated with Weber C fractures, whereas female sex and older age were associated with trimalleolar fracture. The risk for severe fracture increased linearly with the degree of obesity.

Background and purpose: The influence of postoperative limping on patient satisfaction and amount of limping reduction following THA are not well documented. We (1) assessed if postoperative limping is associated with satisfaction 5 years after THA performed via the lateral or anterior approach; (2) evaluated the influence of surgical approach on amount of limping reduction following THA. Patients and methods: We conducted a prospective cohort study of primary elective THAs performed in 2002–2013. Limping was assessed before and 5 years after surgery using the Harris Hip limping sub-score. Satisfaction was assessed at 5 years on a 5-point Likert scale. We compared proportions of satisfied patients among groups of limping. Evolution of limping before and after surgery was noted. Analyses were performed overall and stratified by pain and surgical approach. We used univariate and multivariate logbinomial regression models. Results: 1,257 patients were included (mean age 70 years). 81% had surgery via a lateral and 19% via an anterior approach. Before THA, 60% had moderate to severe limping and all reported pain. After THA, limping and pain improved; 9% of patients were dissatisfied. In multivariate analysis stratified on pain level, limping was associated with higher dissatisfaction. Similar results were obtained after lateral vs. anterior approach. Interpretation: Postoperative limping impacts patient satisfaction after THA. The association varied by degree of limping and absence or presence of pain. It was independent of surgical approach. 5 years after THA occurrence of limping was largely reduced after both a lateral and an anterior approach, with low evidence of a greater reduction under an anterior approach.

Abstract Background The purpose of this study was to evaluate the association between epidemiological, clinical and radiographic factors of patients with tibial shaft fractures and the occurrence of acute compartment syndrome. Methods 270 consecutive adult patients sustaining 273 tibial shaft fractures between January 2005 and December 2009 were included in this retrospective cohort study. The outcome measure was acute compartment syndrome. Patient-related (age, sex), fracture-related (high- vs. low-energy injury, isolated trauma vs. polytrauma, closed vs. open fracture) and radiological parameters (AO/OTA classification, presence or absence of a noncontiguous tibial plateau or pilon fracture, distance from the centre of the tibial fracture to the talar dome, distance between tibial and fibular fracture if associated, and angulation, translation and over-riding of main tibial fragments) were evaluated regarding their potential association with acute compartment syndrome. Univariate analysis was performed and each covariate was adjusted for age and sex. Finally, a multivariable logistic regression model was built, and odds ratios and 95% confidence intervals were obtained. Statistical significance was defined as p

Background and purpose — Data from several joint replacement registries suggest that the rate of early revision surgery after primary total hip arthroplasty (THA) is increasing. The ASA class, now widely recorded in arthroplasty registries, may predict early revision. We investigated the influence of ASA class on the risk of revision and other reoperation within 3 months and within 5 years of primary THA. Patients and methods — We used data from the Geneva and Swedish Hip Arthroplasty Registries, on primary elective THAs performed in 1996–2016 and 2008–2016, respectively. 5,319 and 122,241 THAs were included, respectively. Outcomes were all-cause revision and other reoperations evaluated using Kaplan–Meier survival and Cox regression analyses. Results — Within 3 months after surgery, higher ASA class was associated with greater risk of revision and other reoperation. 3-month cumulative incidences of revision by ASA class I, II, and III–IV respectively, were 0.6%, 0.7%, and 2.3% in Geneva and 0.5%, 0.8%, and 1.6% in Sweden. 3-month cumulative incidences of other reoperation were 0.4%, 0.7%, and 0.9% in Geneva and 0.2%, 0.4%, and 0.7% in Sweden. Adjusted hazard ratios (ASA III–IV vs. I) for revision within 3 months were 2.7 (95% CI 1.2–5.9) in Geneva and 3.3 (CI 2.6–4.0) in Sweden. Interpretation — Assessment of ASA class of patients prior to THA will facilitate risk stratification. Targeted risk-reduction strategies may be appropriate during the very early postoperative period for patients identified as at higher risk. Systematically recording ASA class in arthroplasty registries will permit risk adjustment and facilitate comparison of revision rates internationally.

Abstract Background Mental health has been shown to improve after total hip arthroplasty (THA). Little is known about the role of pain and function in this context. We assessed whether change in mental health was associated with improvement in pain and function 1 year post-surgery. Methods This prospective study included patients enrolled in a THA registry from 2010 to 2014. We examined the mental component score (MCS) before and 1 year post-surgery, and 1-year change, in association with Western Ontario McMaster Universities (WOMAC) pain and function scores. All scores were normalized, ranging from 0 to 100 (larger score indicating better outcome). Analyses were adjusted for potential confounders. Results Our study included 610 participants, of which 53% were women. Descriptive statistics are as follows: the average (SD) for age (years) was 68.5 (11.8), and for BMI was 26.9 (4.9). In addition, the MCS average (SD) at baseline was 44.7 (11.2), and at 1-year after THA was 47.5 (10.5). The average change from baseline to 1-year post-THA in MCS was 2.8 (95% CI: 1.9, 3.6), for an effect size of 0.26. As for the WOMAC pain score, the average change from baseline to 1-year post-THA was 44.2 (95%CI: 42.4, 46.0), for an effect size of 2.5. The equivalent change in WOMAC function was 38.1 (95% CI: 36.2, 40.0), for an effect size of 2.0. Results from multivariable analysis controlling for covariates showed that an improvement of 10 points in the 1-year change in pain score resulted in a 0.78 point (95%: CI 0.40, 1.26) increase in the 1-year change in MCS, whereas a 10-point improvement in the 1-year change in function was associated with a 0.94 point (95% CI: 0.56, 1.32) increase. Conclusions Mental health significantly improved from baseline to 1-year post-THA. Greater improvement in pain and function was associated with greater improvement in mental health 1 year post-THA.

Background and purpose — The number of shoulder registries increases. We assessed international trends in use of shoulder arthroplasty, and described the current state of procedure selection and outcome presentation as documented in national and regional joint registries. Methods — Published reports from 9 population-based shoulder arthroplasty registries (country/region: Norway, Sweden, New Zealand, Denmark, California, Australia, Emilia-Romagna, Germany, and United Kingdom) were analyzed. Data were extracted on age, sex, disease indication, type of surgical procedure, surgical volume, and outcomes. Results — Shoulder arthroplasty incidence rate in 2012 was 20 procedures/105 population with a 6-fold variation between the highest (Germany) and lowest (United Kingdom) country. The annual incidence rate increased 2.8-fold in the past decade. Within the indications osteoarthritis, fracture, and cuff-tear arthropathy variations in procedure choice between registries were large. Outcomes evaluation focused on revision in all registries, but different measures and strata were used. Only Australia provided revision rates for prosthesis brands stratified by both indication and procedure. Finally, in 2 registries with available data surgeons performed on average 10–11 procedures yearly. Interpretation — Annual incidence rates of shoulder arthroplasty have almost tripled over the past decade. There is wide variation in procedure selection for the major indications, a low average surgeon volume, a substantial number of brands with small annual volume, and large variation in outcome presentation. The internationally increasing registry activity is an excellent basis for improving the so far weak evidence in shoulder arthroplasty.

Abstract Background The serious adverse events associated with metal on metal hip replacements have highlighted the importance of improving methods for monitoring surgical implants. The new European Union (EU) device regulation will enforce post-marketing surveillance based on registries among other surveillance tools. Europe has a common regulatory environment, a common market for medical devices, and extensive experience with joint replacement registries. In this context, we elaborate how joint replacement registries, while building on existing structure and data, can better ensure safety and balance risks and benefits. Main text Actions to improve registry-based implant surveillance include: enriching baseline and diversifying outcomes data collection; improving methodology to limit bias; speeding-up failure detection by active real-time monitoring; implementing risk-benefit analysis; coordinating collaboration between registries; and translating knowledge gained from the data into clinical decision-making and public health policy. Conclusions The changes proposed here will improve patient safety, enforce the application of the new legal EU requirements, augment evidence, improve clinical decision-making, facilitate value-based health-care delivery, and provide up-to-date guidance for public health.

Abstract Background The aim of the study was to evaluate the relation between demographic, injury-related, clinical and radiological factors of patients with tibial plateau fractures and the development of acute compartment syndrome. Methods All consecutive adult patients with intra-articular tibial plateau fractures admitted in our urban academic medical centre between January 2005 and December 2009 were included in this retrospective cohort study. The main outcome measurement was the development of acute compartment syndrome. Results The charts of 265 patients (mean age 48.6 years) sustaining 269 intra-articular tibial plateau fractures were retrospectively reviewed. Acute compartment syndrome occurred in 28 fractures (10.4%). Four patients presented bilateral tibial plateau fractures; of them, 2 had unilateral, but none had bilateral acute compartment syndrome. Non-contiguous tibia fracture or knee dislocation and higher AO/OTA classification (type 41-C) were statistically significantly associated with the development of acute compartment syndrome in multivariable regression analysis, while younger age (

The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA).

Abstract — The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question (“During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?”; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome (“How satisfied are you with your [right/left] [hip/knee] replacement?”; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data.

Background and purpose — Obesity increases the risk of deep infection after total joint arthroplasty (TJA). Our objective was to determine whether there may be body mass index (BMI) and weight thresholds indicating a higher prosthetic joint infection rate. Patients and methods — We included all 9,061 primary hip and knee arthroplasties (mean age 70 years, 61% women) performed between March 1996 and December 2013 where the patient had received intravenous cefuroxime (1.5 g) perioperatively. The main exposures of interest were BMI (5 categories:

BackgroundPatient-reported outcomes are increasingly used in evaluations of joint replacement surgery, but it is unclear if symptoms of osteoarthritis (i.e., pain and dysfunction) influence health perceptions similarly before and after surgery.MethodsIn this prospective study based on a hospital-based arthroplasty registry, patients with primary total hip or knee arthroplasty (THA, N = 990, and TKA, N = 907) completed the WOMAC Pain and Function scales, and the SF12 Physical and Mental Component Scores (PCS and MCS), before surgery and one year later. Associations between WOMAC and SF12 scales were examined using mixed linear regression models.ResultsAll patient-reported outcomes improved following total joint arthroplasty, but the associations between symptom scales and global health perceptions were altered. Mental health scores at a given level of pain or function were lower after surgery than before, by about 4-5 points, a clinically meaningful and statistically significant difference. In contrast, the associations between WOMAC scales and the PCS remained stable. These findings were observed in both cohorts of patients.ConclusionsAfter total joint arthroplasty, mental health scores were lower than would have been expected given the symptomatic improvement. This suggests that relationships between patient-reported outcomes are context-dependent, and that care should be exerted when interpreting changes in patient-reported outcomes over time.

PurposeOsteoarthritis (OA) is a common and heterogeneous arthritic disorder. Patients suffer pain and their joints are characterized by articular cartilage loss and osteophyte formation. Risk factors for OA include age and obesity with inflammation identified as a key mediator of disease pathogenesis. Interleukin-17A (IL-17) is a pro-inflammatory cytokine that has been implicated in inflammatory diseases such as rheumatoid arthritis. IL-17 can upregulate expression of inflammatory cytokines and adipocytokines. The aim of this study was to evaluate IL-17 levels in the synovial fluid of patients with end-stage knee and hip OA in relation to inflammation- and pain-related cytokines and adipocytokines in synovial fluid and serum, and clinical and radiographic disease parameters.MethodsThis is a cross-sectional study of 152 patients undergoing total hip and knee arthroplasty for OA. IL-17, IL-6, leptin, adiponectin, visfatin, resistin, C-C Motif Chemokine Ligand 2 (CCL2), C-C Motif Chemokine Ligand 7 (CCL7) and nerve growth factor (NGF) protein levels were measured in synovial fluid and serum using enzyme-linked immunosorbent assay (ELISA). Baseline characteristics included age, sex, body mass index, co-morbidities, pain and function, and radiographic analyses (OA features, K&L grade, minimal joint space width).Results14 patients (9.2%) had detectable IL-17 in synovial fluid. These patients had significantly higher median concentrations of IL-6, leptin, resistin, CCL7 and NGF. Osteophytes, sclerosis and minimum joint space width were significantly reduced in patients with detectable IL-17 in synovial fluid. No differences were found in pain, function and comorbidities. IL-17 concentrations in synovial fluid and serum were moderately correlated (r = 0.482).ConclusionThe presence of IL-17 in the synovial fluid therefore identifies a substantial subset of primary end-stage OA patients with distinct biological and clinical features. Stratification of patients on the basis of IL-17 may identify those responsive to therapeutic targeting.