| 1. |
- Allentoft, Morten E., et al.
(författare)
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Population genomics of post-glacial western Eurasia
- 2024
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Ingår i: Nature. - 0028-0836 .- 1476-4687. ; 625:7994, s. 301-311
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Tidskriftsartikel (refereegranskat)abstract
- Western Eurasia witnessed several large-scale human migrations during the Holocene1–5. Here, to investigate the cross-continental effects of these migrations, we shotgun-sequenced 317 genomes—mainly from the Mesolithic and Neolithic periods—from across northern and western Eurasia. These were imputed alongside published data to obtain diploid genotypes from more than 1,600 ancient humans. Our analyses revealed a ‘great divide’ genomic boundary extending from the Black Sea to the Baltic. Mesolithic hunter-gatherers were highly genetically differentiated east and west of this zone, and the effect of the neolithization was equally disparate. Large-scale ancestry shifts occurred in the west as farming was introduced, including near-total replacement of hunter-gatherers in many areas, whereas no substantial ancestry shifts happened east of the zone during the same period. Similarly, relatedness decreased in the west from the Neolithic transition onwards, whereas, east of the Urals, relatedness remained high until around 4,000 bp, consistent with the persistence of localized groups of hunter-gatherers. The boundary dissolved when Yamnaya-related ancestry spread across western Eurasia around 5,000 bp, resulting in a second major turnover that reached most parts of Europe within a 1,000-year span. The genetic origin and fate of the Yamnaya have remained elusive, but we show that hunter-gatherers from the Middle Don region contributed ancestry to them. Yamnaya groups later admixed with individuals associated with the Globular Amphora culture before expanding into Europe. Similar turnovers occurred in western Siberia, where we report new genomic data from a ‘Neolithic steppe’ cline spanning the Siberian forest steppe to Lake Baikal. These prehistoric migrations had profound and lasting effects on the genetic diversity of Eurasian populations.
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| 2. |
- Bulow, Erik, et al.
(författare)
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Prediction of Early Periprosthetic Joint Infection After Total Hip Arthroplasty
- 2022
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Ingår i: Clinical Epidemiology. - : Informa UK Limited. - 1179-1349. ; 14, s. 239-253
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To develop a parsimonious risk prediction model for periprosthetic joint infection (PJI) within 90 days after total hip arthroplasty (THA). Patients and Methods: We used logistic LASSO regression with bootstrap ranking to develop a risk prediction model for PJI within 90 days based on a Swedish cohort of 88,830 patients with elective THA 2008-2015. The model was externally validated on a Danish cohort with 18,854 patients. Results: Incidence of PJI was 2.45% in Sweden and 2.17% in Denmark. A model with the underlying diagnosis for THA, body mass index (BMI), American Society for Anesthesiologists (ASA) class, sex, age, and the presence of five defined comorbidities had an area under the curve (AUC) of 0.68 (95% CI: 0.66 to 0.69) in Sweden and 0.66 (95% CI: 0.64 to 0.69) in Denmark. This was superior to traditional models based on ASA class, Charlson, Elixhauser, or the Rx Risk V comorbidity indices. Internal calibration was good for predicted probabilities up to 10%. Conclusion: A new PJI prediction model based on easily accessible data available before THA was developed and externally validated. The model had superior discriminatory ability compared to ASA class alone or more complex comorbidity indices and had good calibration. We provide a web-based calculator (https://erikbulow.shinyapps.io/thamortpred/) to facilitate shared decision making by patients and surgeons.
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| 3. |
- Hoogervorst, Lotje A., et al.
(författare)
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Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle : A Systematic Review
- 2023
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Ingår i: International Journal of Health Policy and Management. - : Kerman University of Medical Sciences. - 2322-5939. ; 12:1, s. 1-11
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Forskningsöversikt (refereegranskat)abstract
- 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 Conformite Europeenne (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.
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| 4. |
- Irmola, Tero, et al.
(författare)
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Association between fixation type and revision risk in total knee arthroplasty patients aged 65 years and older : a cohort study of 265,877 patients from the Nordic Arthroplasty Register Association 2000–2016
- 2021
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 92:1, s. 91-96
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose — The population of the Nordic countries is aging and the number of elderly patients undergoing total knee arthroplasty (TKA) is also expected to increase. Reliable fixation methods are essential to avoid revisions. We compared the survival of different TKA fixation concepts with cemented fixation as the gold standard. Patients and methods — We used data from the Nordic Arthroplasty Register Association (NARA) database of 265,877 unconstrained TKAs performed for patients aged ≥ 65 years with primary knee osteoarthritis between 2000 and 2016. Kaplan–Meier (KM) survival analysis with 95% confidence intervals (CI) and the Cox multiple-regression model were used to compare the revision risk of the fixation methods. Results — Cemented fixation was used in 243,166 cases, uncemented in 8,000, hybrid (uncemented femur with cemented tibia) in 14,248, and inverse hybrid (cemented femur with uncemented tibia) fixation in 463 cases. The 10-year KM survivorship (95% CI) of cemented TKAs was 96% (96 − 97), uncemented 94% (94 − 95), hybrid 96% (96 − 96), and inverse hybrid 96% (94 − 99), respectively. Uncemented TKA was associated with increased risk of revision compared with the cemented TKA; the adjusted hazard ratio was 1.3 (95% CI 1.1 − 1.4). Interpretation — Cemented, hybrid, and inverse hybrid TKAs showed 10-year survival rates exceeding 95%. Uncemented fixation was associated with an increased risk of revision in comparison with cemented fixation. As both hybrid and inverse hybrid fixation were used in only a limited number of TKAs, indicating possibility of selection bias in their favor, cemented TKA still remains the gold standard, as it works reliably in the hands of many.
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| 5. |
- Irmola, Tero, et al.
(författare)
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Impact of the Nordic Arthroplasty Register Association (NARA) collaboration on demographics, methods and revision rates in knee arthroplasty : a register-based study from NARA 2000–2017
- 2022
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 93, s. 866-873
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose — We have previously observed differences in treatment and outcome of knee arthroplasties in the Nordic countries. To evaluate the impact of Nordic collaboration in the last 15 years we aimed to compare patient demographics, methods, and revision rates in primary knee arthroplasties among the 4 Nordic countries. Patients and methods — We included 535,051 primary knee arthroplasties reported 2000–2017 from the Nordic Arthroplasty Register Association (NARA) database. Kaplan–Meier analysis (KM) and restricted mean survival time (RMST) analysis were used to evaluate the cumulative revision rate (CRR) and RMST estimates with 95% confidence intervals (CI) and to compare countries in relation to risk of revision for any reason. Results — After 2010, the increase in incidence of knee arthroplasty plateaued in Sweden and Denmark but contin-ued to increase in Finland and Norway. In 2017 the incidence was highest in Finland with 226 per 105 person-years, while it was less than 150 per 105 in the 3 other Nordic coun-tries. In total knee arthroplasties performed for osteoarthri-tis (OA), overall CRR at 15 years for revision due to any reason was higher in Denmark (CRR 9.6%, 95% CI 9.2−10), Norway (CRR 9.1%, CI 8.7−9.5), and Finland (CRR 7.0%, CI 6.8−7.3) compared with Sweden (CRR 6.6%, CI 6.4−6.8). There were differences among the countries in use of implant brand and type, fixation, patellar component, and use of unicompartmental knee arthroplasty. Interpretation — We evinced a slowing growth of incidence of knee arthroplasties in the Nordic countries after 2010 with Finland having the highest incidence. We also noted substantial differences among the 4 Nordic countries, with Sweden having a lower risk of revision than the other countries. No impact of NARA could be demonstrated and CRR did not improve over time.
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| 6. |
- Leta, Tesfaye H., et al.
(författare)
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Periprosthetic Joint Infection After Total Knee Arthroplasty With or Without Antibiotic Bone Cement
- 2024
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Ingår i: JAMA Network Open. - 2574-3805. ; 7:5, s. 2412898-2412898
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Tidskriftsartikel (refereegranskat)abstract
- Importance: Despite increased use of antibiotic-loaded bone cement (ALBC) in joint arthroplasty over recent decades, current evidence for prophylactic use of ALBC to reduce risk of periprosthetic joint infection (PJI) is insufficient. Objective: To compare the rate of revision attributed to PJI following primary total knee arthroplasty (TKA) using ALBC vs plain bone cement. Design, Setting, and Participants: This international cohort study used data from 14 national or regional joint arthroplasty registries in Australia, Denmark, Finland, Germany, Italy, New Zealand, Norway, Romania, Sweden, Switzerland, the Netherlands, the UK, and the US. The study included primary TKAs for osteoarthritis registered from January 1, 2010, to December 31, 2020, and followed-up until December 31, 2021. Data analysis was performed from April to September 2023. Exposure: Primary TKA with ALBC vs plain bone cement. Main Outcomes and Measures: The primary outcome was risk of 1-year revision for PJI. Using a distributed data network analysis method, data were harmonized, and a cumulative revision rate was calculated (1 - Kaplan-Meier), and Cox regression analyses were performed within the 10 registries using both cement types. A meta-analysis was then performed to combine all aggregated data and evaluate the risk of 1-year revision for PJI and all causes. Results: Among 2 168 924 TKAs included, 93% were performed with ALBC. Most TKAs were performed in female patients (59.5%) and patients aged 65 to 74 years (39.9%), fully cemented (92.2%), and in the 2015 to 2020 period (62.5%). All participating registries reported a cumulative 1-year revision rate for PJI of less than 1% following primary TKA with ALBC (range, 0.21%-0.80%) and with plain bone cement (range, 0.23%-0.70%). The meta-analyses based on adjusted Cox regression for 1 917 190 TKAs showed no statistically significant difference at 1 year in risk of revision for PJI (hazard rate ratio, 1.16; 95% CI, 0.89-1.52) or for all causes (hazard rate ratio, 1.12; 95% CI, 0.89-1.40) among TKAs performed with ALBC vs plain bone cement. Conclusions and Relevance: In this study, the risk of revision for PJI was similar between ALBC and plain bone cement following primary TKA. Any additional costs of ALBC and its relative value in reducing revision risk should be considered in the context of the overall health care delivery system.
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| 7. |
- Leta, Tesfaye H., et al.
(författare)
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The use of antibiotic-loaded bone cement and systemic antibiotic prophylactic use in 2,971,357 primary total knee arthroplasties from 2010 to 2020: an international register-based observational study among countries in Africa, Europe, North America, and Oceania
- 2023
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Ingår i: Acta Orthopaedica. - 1745-3674 .- 1745-3682. ; 94, s. 416-425
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose — Antibiotic-loaded bone cement (ALBC) and systemic antibiotic prophylaxis (SAP) have been used to reduce periprosthetic joint infection (PJI) rates. We investigated the use of ALBC and SAP in primary total knee arthroplasty (TKA). Patients and methods — This observational study is based on 2,971,357 primary TKAs reported in 2010–2020 to national/regional joint arthroplasty registries in Australia, Den-mark, Finland, Germany, Italy, the Netherlands, New Zealand, Norway, Romania, South Africa, Sweden, Switzerland, the UK, and the USA. Aggregate-level data on trends and types of bone cement, antibiotic agents, and doses and duration of SAP used was extracted from participating registries. Results — ALBC was used in 77% of the TKAs with variation ranging from 100% in Norway to 31% in the USA. Palacos R+G was the most common (62%) ALBC type used. The primary antibiotic used in ALBC was gentamicin (94%). Use of ALBC in combination with SAP was common practice (77%). Cefazolin was the most common (32%) SAP agent. The doses and duration of SAP used varied from one single preoperative dosage as standard practice in Bolzano, Italy (98%) to 1-day 4 doses in Norway (83% of the 40,709 TKAs reported to the Norwegian arthroplasty register). Conclusion — The proportion of ALBC usage in primary TKA varies internationally, with gentamicin being the most common antibiotic. ALBC in combination with SAP was common practice, with cefazolin the most common SAP agent. The type of ALBC and type, dose, and duration of SAP varied among participating countries.
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| 8. |
- Niemeläinen, Mika J., et al.
(författare)
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The effect of fixation type on the survivorship of contemporary total knee arthroplasty in patients younger than 65 years of age : a register-based study of 115,177 knees in the Nordic Arthroplasty Register Association (NARA) 2000–2016
- 2020
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 91:2, s. 184-190
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose — Cemented fixation is regarded as the gold standard in total knee arthroplasty (TKA). Among working-age patients, there has been controversy regarding the optimal fixation method in TKA. To address this issue, we conducted a register-based study to assess the survivorship of cemented, uncemented, hybrid, and inverse hybrid TKAs in patients aged < 65 years. Patients and methods — We used the Nordic Arthroplasty Register Association data of 115,177 unconstrained TKAs performed for patients aged < 65 years with primary knee osteoarthritis over 2000–2016. Kaplan–Meier (KM) survival analysis with 95% confidence intervals (CI) and Cox multiple-regression model with adjustment for age, sex, and nation were used to compare fixation methods in relation to revision for any reason. Results — The 10-year KM survivorship of cemented TKAs was 93.6% (95% CI 93.4–93.8), uncemented 91.2% (CI 90.1–92.2), hybrid 93.0% (Cl 92.2–93.8), and inverse hybrid 96.0% (CI 94.1–98.1). In the Cox model, hybrid TKA showed decreased risk of revision after 6 years’ follow-up compared with the reference group (cemented) (hazard ratio [HR] 0.5 [CI 0.4–0.8]), while uncemented TKAs showed increased risk of revision both < 1 year (HR 1.4 [1.1–1.7]) and > 6 years’ (HR 1.3 [1.0–1.7]) follow-up compared to the reference. Interpretation — Both cemented and hybrid TKAs had 10-year survival rates exceeding 92–>93% in patients aged < 65 years. Cemented TKA, however, was used in the vast majority (89%) of the operations in the current study. As it performs reliably in the hands of many, it still deserves the status of gold standard for TKA in working-age patients.
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| 9. |
- Pedersen, Alma B., et al.
(författare)
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Similar early mortality risk after cemented compared with cementless total hip arthroplasty for primary osteoarthritis : data from 188,606 surgeries in the Nordic Arthroplasty Register Association database
- 2021
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 92:1, s. 47-53
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose — Current literature indicates no difference in 90-day mortality after cemented compared with cementless total hip arthroplasty (THA). However, previous studies are hampered by potential selection bias and suboptimal adjustment for comorbidity confounding. Therefore, we examined the comorbidity-adjusted mortality up to 90 days after cemented compared with cementless THA performed due to osteoarthritis. Patients and methods — Using the Nordic Arthroplasty Register Association database, 2005–2013, we included 108,572 cemented and 80,034 cementless THA due to osteoarthritis. We calculated the Charlson comorbidity index of each patient based on data from national patient registers. The Kaplan–Meier method was used to estimate unadjusted all-cause mortality. Cox regression was used to estimate hazard ratios (HR) with 95% confidence intervals (CI) for 14, 30-, and 90-day mortality comparing cemented with cementless THA, adjusting for age, sex, comorbidity, nation, and year of surgery. Results — Cumulative all-cause mortality within 90 days was 0.41% (CI 0.37–0.46) after cemented and 0.26% (CI 0.22–0.30) after cementless THA. The adjusted HR for cemented vs. cementless fixation was 0.97 (CI 0.79–1.2), and similar risk estimates were obtained for mortality within 14 (adjusted HR 0.91 [CI 0.64–1.3]) and 30 days (adjusted HR 0.94 [CI 0.71–1.3]). We found no clinically relevant differences in mortality between cemented and cementless THA in analyses stratified by age, sex, Charlson comorbidity index, or year of surgery. Interpretation — After adjustment for comorbidity as an important confounder, we observed similar early mortality between the 2 fixation techniques.
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| 10. |
- Van Steenbergen, Liza N, et al.
(författare)
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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.
- 2021
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Ingår i: Acta orthopaedica. - : Medical Journals Sweden AB. - 1745-3682 .- 1745-3674. ; 92:1, s. 15-22
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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