Corrigendum: Similar outcome with a new anteverted or a straight standard stem: a randomized study of 72 total hip arthroplasties evaluated with clinical variables, radio-stereometry, and DXA up to 2 years.

When we checked our data in our article "Similar outcome with a new anteverted or a straight standard stem: a randomized study of 72 total hip arthroplasties evaluated with clinical variables, radiostereometry, and DXA up to 2 years" by Karin Rilby, Maziar Mohaddes, Emma Nauclér, and Johan Kärrholm, Acta Orthop 2021; 92, Published online October 21, 2021 we noticed that the numbers in Table 7 (Supplementary data) were incorrect. We have not been able to fully reconstruct the reason for this error. We are sorry for this mistake. Even if the corrected numbers are different the overall conclusions will be same and also the statistical significances.

Patient-reported Outcomes After Primary Total Hip Arthroplasty Are Not Affected by the Sex of the Surgeon: A Register-based Study of 8,383 Procedures in Western Sweden.

INTRODUCTION: Female surgeons remain a minority within the field of orthopaedics, particularly in certain specialties such as arthroplasty. There is no scientific evidence on whether the surgeon's sex affects the patient-reported outcome after orthopaedic surgery such as total hip arthroplasty (THA). We therefore aimed to investigate the association between surgeon sex and health-related quality of life after THA. METHODS: Data on primary THAs performed between 2008 and 2016 were collected from 10 hospitals in western Sweden. The data were linked with the Swedish Hip Arthroplasty Register, a regional patient register and the National Board of Health and Welfare, resulting in a data set that included surgeon-related and patient-related data. The outcome of the study was the change in health-related quality of life, measured with the 3-level version of EQ-5D (EQ-5D-3L) Index and EQ-visual analog scale (VAS), before and 1-year after THA. Mixed models, using hierarchical linear regression adjusted for patient sex, age, preoperative health-related quality of life and Charnley classification, were fitted to estimate the gain in EQ-5D-3L Index and EQ-VAS with 95% confidence intervals based on surgeon sex. RESULTS: In total, 8,383 primary THAs were done for osteoarthritis by 193 surgeons. Of those, 37 were women and 156 were men. The regression model was showed that patients operated by female surgeons had a ß-coefficient of gain in EQ-5D-3L Index of -0.001 (-0.022 to 0.021) and a ß-coefficient of gain in EQ VAS of 0.004 (-0.023 to 0.030), compared with patients operated by male surgeons. Similar results were obtained in a sensitivity analysis including attendings only. DISCUSSION: Patients undergoing primary THA reported similar gain in health-related quality of life regardless of surgeon sex. Based on our results, health-related quality of life after primary THA was not associated with the sex of the operating surgeon.

Conversion to Arthroplasty After Internal Fixation of Nondisplaced Femoral Neck Fractures: Results from a Swedish Register Cohort of 5,428 Individuals 60 Years of Age or Older.

BACKGROUND: Although most nondisplaced or minimally displaced femoral neck fractures are routinely treated with internal fixation, high rates of secondary surgical procedures are common, especially in the elderly population. Primary arthroplasty in elderly patients has been proposed as an alternative treatment to reduce the need for a secondary surgical procedure. The objective of this study was to describe the rate of conversion to arthroplasty within 5 years after internal fixation of nondisplaced femoral neck fractures in patients ≥60 years of age. METHODS: In this observational cohort study of prospectively collected data from the Swedish Fracture Register (SFR) between 2012 and 2018, cross-matched with the Swedish Arthroplasty Register (SAR), 5,428 nondisplaced femoral neck fractures in patients ≥60 years of age were included. Competing risk analysis was used to estimate conversion rates to arthroplasty and mortality in various age groups at 1, 2, and 5 years. RESULTS: The cumulative incidence function (CIF) for conversion to arthroplasty was 6.3% at 1 year, 8.1% at 2 years, and 10.1% at 5 years. The conversion rates within 2 years were 6.5% in 60 to 69-year-olds, 9.6% in 70 to 79-year-olds, and 7.8% in ≥80-year-olds. Women had a higher risk of conversion; the hazard ratio (HR) was 1.49 (95% confidence interval [CI], 1.19 to 1.87). The cumulative mortality was 21.3% (95% CI, 20.3% to 22.5%) at 1 year, 31.3% (95% CI, 30.0% to 32.6%) at 2 years, and 54.9% (95% CI, 53.1% to 56.7%) at 5 years. Mortality was higher in men at all time points, and the adjusted 1-year HR was 1.79 (95% CI, 1.61 to 2.00). CONCLUSIONS: One in 10 patients ≥60 years of age treated with internal fixation for a nondisplaced femoral neck fracture underwent conversion to arthroplasty within 5 years, and more than one-half of the conversions occurred within the first year. The risk of conversion was highest in women and in patients 70 to 79 years of age. These data warrant further studies in this frail patient group to identify subgroups of patients who would benefit from primary arthroplasty for nondisplaced femoral neck fractures. LEVEL OF EVIDENCE: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

The Influence of Surgeon Sex on Adverse Events Following Primary Total Hip Arthroplasty: A Register-Based Study of 11,993 Procedures and 200 Surgeons in Swedish Public Hospitals.

BACKGROUND: Stereotypes may prevail, but little is known about the influence that the sex of an orthopaedic surgeon may have on outcomes. In a recently published study, there were no differences in the rate of adverse events following total hip arthroplasties (THAs) performed by female or male orthopaedic surgeons. The objective of the present study was to investigate whether there was any difference in adverse events within 90 days following a primary THA performed by either a male or female surgeon in Sweden. METHODS: A retrospective study was performed to evaluate primary THAs performed for osteoarthritis between 2008 and 2016 at 10 hospitals in western Sweden. Local hospital data were linked with the Swedish Hip Arthroplasty Register (SHAR) and with a regional patient register. Data collected from local hospitals and the SHAR included surgeon-related information (e.g., sex, annual volume, and level of training) and patient-related information (e.g., age, sex, and Elixhauser comorbidity index). Adverse events were retrieved from the regional patient register. The definition of adverse events followed the SHAR definition of adverse events. Mixed models were used to investigate the impact of surgeon sex on adverse events. RESULTS: A total of 11,993 primary THAs were performed by 200 surgeons, of whom 17.5% were women. The proportions of adverse events within 90 days were similar for female (6%) and male (7%) surgeons. No association was found between surgeon sex and adverse events (adjusted odds ratio, 0.72; 95% confidence interval, 0.52 to 1.00) when all surgeons (both attendings and residents) were included in the analysis. A sensitivity analysis that included attendings only yielded similar results (adjusted odds ratio, 0.88; 95% confidence interval, 0.60 to 1.29). CONCLUSIONS: Despite a small tendency toward lower rates of adverse events at 90 days after THAs performed by female surgeons, there was no significant association between surgeon sex and the risk of adverse events following THA. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

No difference in outcome or migration but greater loss of bone mineral density with the Collum Femoris Preserving stem compared with the Corail stem: a randomized controlled trial with five-year follow-up.

AIMS: The aim of this study was to compare the mid-term patient-reported outcome, bone remodelling, and migration of a short stem (Collum Femoris Preserving; CFP) with a conventional uncemented stem (Corail). METHODS: Of 81 patients who were initially enrolled, 71 were available at five years' follow-up. The outcomes at two years have previously been reported. The primary outcome measure was the clinical result assessed using the Oxford Hip Score (OHS). Secondary outcomes were the migration of the stem, measured using radiostereometric analysis (RSA), change of bone mineral density (BMD) around the stem, the development of radiolucent lines, and additional patient-reported outcome measures (PROMs). RESULTS: There were no statistically significant differences between the groups regarding PROMs (median OHS (CFP 45 (interquartile range (IQR) 35 to 48); Corail 45 (IQR 40 to 48); p = 0.568). RSA showed stable stems in both groups, with little or no further subsidence between two and five years. Resorption of the femoral neck was evident in nine patients in the CFP group and in none of the 15 Corail stems with a collar that could be studied. Dual X-ray absorbiometry showed a significantly higher loss of BMD in the proximal Gruen zones in the CFP group (mean changes in BMD: Gruen zone 1, CFP -9.5 (95% confidence interval (CI) -14.8 to -4.2), Corail 1.0 (95% CI 3.4 to 5.4); Gruen zone 7, CFP -23.0 (95% CI -29.4 to -16.6), Corail -7.2 (95% CI -15.9 to 1.4). Two CFP stems were revised before two years' follow-up due to loosening, and one Corail stem was revised after two years due to chronic infection. CONCLUSION: The CFP stem has a similar clinical outcome and subsidence pattern when compared with the Corail stem. More pronounced proximal stress-shielding was seen with the CFP stem, suggesting diaphyseal fixation, and questioning its femoral neck-sparing properties in the long term. Cite this article: Bone Joint J 2022;104-B(5):581-588.

Type 2 Diabetes, Glycemic Control, and Their Association With Dementia and Its Major Subtypes: Findings From the Swedish National Diabetes Register.

OBJECTIVE: Type 2 diabetes has been associated with high dementia risk. However, the links to different dementia subtypes is unclear. We examined to what extent type 2 diabetes is associated with dementia subtypes and whether such associations differed by glycemic control. RESEARCH DESIGN AND METHODS: We used data from the Swedish National Diabetes Register and included 378,299 patients with type 2 diabetes and 1,886,022 control subjects matched for age, sex, and county randomly selected from the Swedish Total Population Register. The outcomes were incidence of Alzheimer disease, vascular dementia, and nonvascular dementia. The association of type 2 diabetes with dementia was stratified by baseline glycated hemoglobin (HbA1c) in patients with type 2 diabetes only. Cox regression was used to study the excess risk of outcomes. RESULTS: Over the follow-up (median 6.8 years), dementia developed in 11,508 (3.0%) patients with type 2 diabetes and 52,244 (2.7%) control subjects. The strongest association was observed for vascular dementia, with patients with type 2 diabetes compared with control subjects having a hazard ratio [HR] of 1.34 (95% CI 1.28, 1.41). The association of type 2 diabetes with nonvascular dementia was more modest (HR 1.10 [95% CI 1.07, 1.13]). However, risk for Alzheimer disease was lower in patients with type 2 diabetes than in control subjects (HR 0.94 [95% CI 0.90, 0.99]). When the analyses were stratified by circulating concentrations of HbA1c, a dose-response association was observed. CONCLUSIONS: The association of type 2 diabetes with dementia differs by subtypes of dementia. The strongest detrimental association is observed for vascular dementia. Moreover, patients with type 2 diabetes with poor glycemic control have an increased risk of developing vascular and nonvascular dementia.

Longitudinal study of patients' health-related quality of life using EQ-5D-3L in 11 Swedish National Quality Registers.

OBJECTIVE: To compare problems reported in the five EQ-5D-3L dimensions and EQ VAS scores at baseline and at 1-year follow-up among different patient groups and specific diagnoses in 11 National Quality Registers (NQRs) and to compare these with the general population. DESIGN: Longitudinal, descriptive study. PARTICIPANTS: 2 66 241 patients from 11 NQRs and 49 169 participants from the general population were included in the study. PRIMARY AND SECONDARY OUTCOME MEASURES: Proportions of problems reported in the five EQ-5D-3L dimensions, EQ VAS scores of participants' own health and proportions of participants and mean/median EQ VAS score in the Paretian Classification of Health Change (PCHC) categories. RESULTS: In most of the included registers, and the general population, problems with pain/discomfort were the most frequently reported at baseline and at 1-year follow-up. Mean EQ VAS score (SD) ranged from 45.2 (22.4) among disc hernia patients to 88.1 (15.3) in wrist and hand fracture patients at baseline. They ranged from 48.9 (20.9) in pulmonary fibrosis patients to 83.3 (17.4) in wrist and hand fracture patients at follow-up. The improved category of PCHC, improvement in at least one dimension without deterioration in any other, accounted for the highest proportion in several diagnoses, corresponding with highest improvement in mean EQ VAS score. CONCLUSIONS: The study documented self-reported health of several different patient groups using the EQ-5D-3L in comparing with the general population. This demonstrated the important role of patient-reported outcomes in routine clinical care, to assess and follow-up health status and progress within different groups of patients. The EQ-5D-3L descriptive system and EQ VAS have an important role in providing a 'common denominator', allowing comparisons across NQRs and specific diagnoses. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT04359628).

Similar outcome with a new anteverted or a straight standard stem: a randomized study of 72 total hip arthroplasties evaluated with clinical variables, radiostereometry, and DXA up to 2 years.

Background and purpose - The anatomical uncemented stem, SP-CL (Static Physiologicus - CementLess), designed to facilitate insertion and to avoid stress concentration at solitary contact points, has been on the market since 2014 but is not well documented. We studied its clinical performance, migration, and associated bone remodeling in a randomized controlled trial, with the Corail stem as control. Patients and methods - 79 patients (80 hips) were primarily recruited and 71 patients (72 hips, 36 SP-CL, 36 Corail) attended the last follow-up at 2 years. The Oxford Hip Score (OHS) was the primary outcome. In addition, we assessed stem migration, changes in bone mineral density, and development of radiolucencies by RSA, DXA, and conventional radiography. Results - At 2 years Oxford Hip Score was similar between the SP-CL and Corail stem. At 2 years the SP-CL stems showed a median distal migration of 0.23 mm (-0.1 to 5.2) and the Corail stems of 0.11 mm (-0.4 to 4.4). The SP-CL stems showed slightly more loss of bone mineral density in Gruen region 7 (p = 0.003). Interpretation - We found no difference in clinical results between the SP-CL and the well-documented Corail stem. The same stem stability was reached between 1 and 2 years postoperatively for both stems. As a next step we think that the SP-CL stem should be studied in a multi-center setting, before being accepted for general use.

Dual mobility cups do not reduce the revision risk for patients with acute femoral neck fracture: A matched cohort study from the Swedish Arthroplasty Register.

INTRODUCTION: Dual mobility cups (DMC) are gaining in popularity, as a method to reduce the risk of dislocation after fracture-related hip arthroplasty. Our aim was to compare revision rate in general, as well as due to dislocation and infection, after DMC and conventional THA due to femoral neck fracture, for each of the two groups of lateral and posterior approach. MATERIALS AND METHODS: This observational cohort study based on the Swedish Arthroplasty Register (SAR) compared 2242 patients with dual mobility cups (DMC) and 6726 with conventional total hip arthroplasty (cTHA), all due to acute fracture 2005-2019. This was after propensity score matching of 1:3 (age, gender, ASA). Kaplan-Meier survival analysis was used to investigate the 5-year revision rate after DMC and cTHA in the posterior and lateral approach groups. RESULTS: The rates of revision in general, and due to dislocation or infection, were similar for DMC and cTHA in the different approach groups during the follow-up. The cumulative revision rate after posterior approach was 4.7% (95% CI 3.1-6.2) for DMC and 4.8% (3.8-5.7) for cTHA at 5 years. For lateral approach, the result was 2.3% (CI 1.3-3.3) for DMC and 3.7% (CI 3.0-4.4) for cTHA. The 5-year results for cumulative revision rate due to dislocation after posterior approach were 1.3% (0.4-2.2) for DMC and 2.2% (1.5-2.8) for cTHA. Corresponding results for lateral approach was 0.4% (0-0.8) for DMC and 0.7% (0.4-1) for cTHA. DISCUSSION: With implant revision surgery as outcome, we could not detect any differences between DMC and cTHA. Further studies with high external validity are needed regarding total dislocation rate, patient-reported outcome, cost-effectiveness and learning curve, to make a definitive recommendation on the use of DMC for fracture cases. CONCLUSIONS: As treatment of acute femoral neck fractures, total hip arthroplasty with a dual mobility cup have similar outcome in terms of revisions in general, and due to dislocation or infections specifically, as one with conventional bearing. The similar outcome is regardless of surgical approach.

Variations in Patients' Overall Assessment of Their Health Across and Within Disease Groups Using the EQ-5D Questionnaire: Protocol for a Longitudinal Study in the Swedish National Quality Registers.

BACKGROUND: EQ-5D is one of the most commonly used questionnaires to measure health-related quality of life. It is included in many of the Swedish National Quality Registers (NQRs). EQ-5D health states are usually summarized using "values" obtained from members of the general public, a majority of whom are healthy. However, an alternative, which remains to be studied in detail, is the potential to use patients' self-reported overall health on the visual analog scale (VAS) as a means of capturing experience-based perspective. OBJECTIVE: The aim of this study is to assess EQ VAS as a valuation method with an experience-based perspective through comparison of its performance across and within patient groups, and with that of the general population in Sweden. METHODS: Data on nearly 700,000 patients from 12 NQRs covering a variety of diseases/conditions and nearly 50,000 individuals from the general population will be analyzed. The EQ-5D-3L data from the 12 registers and EQ-5D-5L data from 2 registers will be used in the analyses. Longitudinal studies of patient-reported outcomes among different patient groups will be conducted in the period from baseline to 1-year follow-up. Descriptive statistics and analyses comparing EQ-5D dimensions and observed self-assessed EQ VAS values across and within patient groups will be performed. Comparisons of the change in health state and observed EQ VAS values at 1-year follow-up will also be undertaken. Regression models will be used to assess whether EQ-5D dimensions predict observed EQ VAS values to investigate patient value sets in each patient group. These will be compared across the patient groups and with the existing Swedish experience-based VAS and time trade-off value sets obtained from the general population. RESULTS: Data retrieval started in May 2019 and data of patients in the 12 NQRs and from the survey conducted among the general population have been retrieved. Data analysis is ongoing on the retrieved data. CONCLUSIONS: This research project will provide information on the differences across and within patient groups in terms of self-reported health status through EQ VAS and comparison with the general population. The findings of the study will contribute to the literature by exploring the potential of self-assessed EQ VAS values to develop value sets using an experience-based perspective. TRIAL REGISTRATION: ClinicalTrials.gov NCT04359628; https://clinicaltrials.gov/ct2/show/NCT04359628. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27669.

Fast-Track Programs in Total Hip and Knee Replacement at Swedish Hospitals-Influence on 2-Year Risk of Revision and Mortality.

PURPOSE: We aimed to study the influence of fast-track care programs in total hip and total knee replacements (THR and TKR) at Swedish hospitals on the risk of revision and mortality within 2 years after the operation. METHODS: Data were collected from the Swedish Hip and Knee Arthroplasty Registers (SHAR and SKAR), including 67,913 THR and 59,268 TKR operations from 2011 to 2015 on patients with osteoarthritis. Operations from 2011 to 2015 Revision and mortality in the fast-track group were compared with non-fast-track using Kaplan-Meier survival analysis and Cox regression analysis with adjustments. RESULTS: The hazard ratio (HR) for revision within 2 years after THR with fast-track was 1.19 (CI: 1.03-1.39), indicating increased risk, whereas no increased risk was found in TKR (HR 0.91; CI: 0.79-1.06). The risk of death within 2 years was estimated with a HR of 0.85 (CI: 0.74-0.97) for TKR and 0.96 (CI: 0.85-1.09) for THR in fast-track hospitals compared to non-fast-track. CONCLUSIONS: Fast-track programs at Swedish hospitals were associated with an increased risk of revision in THR but not in TKR, while we found the mortality to be lower (TKR) or similar (THR) as compared to non-fast track.

Exchange of Modular Components Improves Success of Debridement, Antibiotics, and Implant Retention: An Observational Study of 575 Patients with Infection After Primary Total Hip Arthroplasty.

Debridement, antibiotics, and implant retention (DAIR) is a surgical treatment for periprosthetic joint infection (PJI). DAIR is a desirable treatment option from an economic and patient perspective, if successful. The aim of this observational study was to compare the rates of success, defined as no additional reoperations due to PJI, between DAIR with exchange of modular components and DAIR without exchange in patients who had first-time PJI after primary total hip arthroplasty (THA). METHODS: Patients with PJI at the site of a primary THA who were treated with DAIR in Sweden between January 1, 2009, and December 31, 2016, were identified in the Swedish Hip Arthroplasty Register. Supplementary questionnaires were sent to orthopaedic departments for additional variables of interest related to PJI. The primary end point was another reoperation due to PJI within 2 years after the first-time DAIR. DAIR with exchange was compared with DAIR without exchange using Kaplan-Meier survival analysis and Cox regression analysis. RESULTS: A total of 575 patients treated with DAIR for a first-time PJI at the site of a primary THA were analyzed; 364 underwent component exchange and 211 did not. The exchange of components was associated with a lower rate of reoperations due to PJI after DAIR (28.0%) compared with non-exchange (44.1%). The Kaplan-Meier implant survival estimate for exchange was 71.4% (95% confidence interval [CI] = 66.9% to 76.3%) compared with 55.5% (95% CI = 49.1% to 62.7%) for non-exchange. With the analysis adjusted for confounders, DAIR with exchange was associated with a significantly decreased risk of another reoperation due to PJI compared with non-exchange (hazard ratio [HR] = 0.51 [95% CI = 0.38 to 0.68]). CONCLUSIONS: In patients with a first-time PJI at the site of a primary THA, DAIR with exchange of modular components was superior to non-exchange DAIR. Surgeons should strive to exchange components when they perform DAIR, but there is a need to further identify how DAIR best should be practiced and which patients benefit from it. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

A small number of surgeons outside the control-limit: an observational study based on 9,482 cases and 208 surgeons performing primary total hip arthroplasties in western Sweden.

Background and purpose - Feedback programs relating to surgeon levels have been introduced in some orthopedic quality registers around the globe. The aim of an established surgeon feedback program is to help surgeons understand their practice and enable an analysis of their own results. There is no surgeon feedback program in Sweden in the orthopedic quality registers and there is a fear that a feedback system might pinpoint surgeons as poor performers, partly due to patient case mix. As a step prior to the introduction of a future possible feedback program in Sweden, we assessed the variation in the occurrence of adverse events (AE) within 90 days and reoperations within 2 years between surgeons in western Sweden and explored the number of surgeons outside the control-limit following primary total hip arthroplasties (THAs).Patients and methods - Patient data, surgical data, and information on the surgeons, relating to surgeries performed in 2011-2016, were retrieved from 9 publicly funded hospitals in western Sweden. Data from medical hospital records, the Swedish Hip Arthroplasty Register (SHAR) and a regional patient register located in western Sweden were linked to a database. Funnel plots with control-limits based on upper 95% and 99.8% confidence intervals (CI) were used to illustrate the variation between surgeons in terms of the outcome and to explore the number of surgeons outside the control-limit. Both observed and standardized proportions are explored. The definition of surgeons outside the control-limit in the study is a surgeon above the upper 95% CI.Results - The study comprised 9,482 primary THAs due to osteoarthritis performed by 208 surgeons, where 91% of the included primary THAs were performed by orthopedic specialists and 9% by trainees. The mean overall annual volume for all surgeons was 27. The observed overall mean rate for AEs within 90 days for all surgeons was 6.2% (5.8-6.7) and for reoperations within 2 years 1.8% (1.7-2.2). The proportion of surgeons outside the 95% CI was low for both AEs (0-5%) and reoperations within 2 years (0-1%) in 2011-2016. The corresponding numbers were even lower for AEs (0-3%) but similar for reoperations (0-1%) after standardization for differences in case mix. In a sub-analysis when the number of surgeries performed was restricted to more than 10 primary THAs annually to being evaluated, almost half or more of all the surgeons were excluded from the annual analysis. The result of this restriction was that all surgeons outside the control-limit disappeared after standardization for both AEs and reoperations for all the years investigated. Considering the complete period of 6 years, less than 1% (1 high-volume surgeon for AEs and 2 high-volume surgeons for reoperations) after risk adjustments were outside the 95% CI, and no surgeons were outside the 99.8% CI.Interpretation - In a Swedish setting, the variation in surgeon performance, as measured by AEs within 90 days and reoperations within 2 years following primary THA, was small and 3% or less of the surgeons were outside the 95% CI for the investigated years after adjustments for case mix. The risk for an individual surgeon to be regarded as having poor performance when creating surgeon-specific feedback in the SHAR is very low when volume and patient risk factors are considered.

Influence of fast-track programs on patient-reported outcomes in total hip and knee replacement (THR/TKR) at Swedish hospitals 2011-2015: an observational study including 51,169 THR and 8,393 TKR operations.

Background and purpose - Fast-track care programs have been broadly introduced at Swedish hospitals in elective total hip and knee replacement (THR/TKR). We studied the influence of fast-track programs on patient-reported outcomes (PROs) 1 year after surgery, by exploring outcome measures registered in the Swedish arthroplasty registers.Patients and methods - Data were obtained from the Swedish Knee and Hip Arthroplasty Registers and included TKR and THR operations 2011-2015 on patients with osteoarthritis. Based on questionnaires concerning the clinical pathway and care programs at Swedish hospitals, the patients were divided in 2 groups depending on whether they had been operated in a fast-track program or not. PROs of the fast-track group were compared with not fast-track using regression analysis. EQ-5D, EQ VAS, Pain VAS, and Satisfaction VAS were analyzed for both THR and TKR operations. The PROMs for TKR also included KOOS.Results - The differences of EQ-5D, EQ VAS, Pain VAS, and Satisfaction VAS 1 year after surgery were small but all in favor of fast-track for both THR and TKR, also in subscales of KOOS for TKR except KOOS QoL. However, the effect sizes as measured by Cohens' d formula were < 0.2 for all PROs, in both THR and TKR.Interpretation - Our results indicate that the fast-track programs may be at least as good as conventional care from the perspective of PROs 1-year postoperatively.

Understanding the role of diabetes in the osteoarthritis disease and treatment process: a study protocol for the Swedish Osteoarthritis and Diabetes (SOAD) cohort.

INTRODUCTION: Osteoarthritis (OA) is the most common form of arthritis and a leading cause of disability worldwide. Metabolic comorbidities such as type II diabetes occur with a higher rate in people with OA than in the general population. Several factors including obesity, hyperglycaemia toxicity and physical inactivity have been suggested as potential links between diabetes and OA, and have been shown to negatively impact patients' health and quality of life. However, little is known on the role of diabetes in determining the outcome of non-surgical and surgical management of OA, and at the same time, how different OA interventions may affect diabetes control. Thus, the overall aim of this project is to explore (1) the impact of diabetes on the outcome of non-surgical and surgical OA treatments and (2) the impact of non-surgical and surgical OA treatments on diabetes control. METHODS AND ANALYSIS: The study cohort is based on prospectively ascertained register data on a national level in Sweden. Data from OA patients who received a first-line non-surgical intervention and are registered in the National Quality Register for Better Management of Patients with Osteoarthritis will be merged with data from the Swedish Knee and Hip Arthroplasty Registers and the National Diabetes Register. Additional variables regarding patients' use of prescribed drugs, comorbidities, socioeconomic status and cause of death will be obtained through other national health and population data registers. The linkage will be performed on an individual level using unique personal identity numbers. ETHICS AND DISSEMINATION: This study received ethical approval (2019-02570) from the Swedish Ethical Review Authority. Results from this cohort will be submitted to peer-reviewed scientific journals and reported at the leading national and international meetings in the field.

Implant survival and patient-reported outcome following total hip arthroplasty in patients 30 years or younger: a matched cohort study of 1,008 patients in the Swedish Hip Arthroplasty Register.

Background and purpose - The outcome of total hip arthroplasty (THA) in younger patients is suggested to be inferior compared with the general THA population. There is a lack of studies with long-term follow up for very young patients. We report on implant survival and patient-reported outcome in patients aged 30 years or younger. Patients and methods - Data on THAs performed in Sweden between the years 2000 and 2016 were included. There were 504 patients 30 years or younger with complete demographic and surgical data (study group). A matched comparison group older than 30 years was identified. Implant survival was analyzed using the Kaplan-Meier method. Patient-reported outcome was analyzed in a subgroup of patients. Results - The 10-year and 15-year implant survivorship for the study group was 90% and 78%, respectively. The corresponding figures for the patients older than 30 years were 94% and 89%. The median preoperative EQ-5D index was lower in the study group; the improvement in EQ-5D index was similar between the study and the comparison groups. The preoperative EQ-VAS was lower and the improvement in EQ-VAS at 1 year was larger in the study group. Interpretation - The promising 10-year implant survival and 1-year improvement in patient-reported outcome suggests that THA is a feasible option in the patients 30 years or younger.

Pharmacokinetics and Acid-suppressive Effects of Esomeprazole in Infants 1-24 Months Old With Symptoms of Gastroesophageal Reflux Disease.

OBJECTIVES: To evaluate the pharmacokinetics and acid-suppressive effects of esomeprazole in infants with gastroesophageal reflux disease (GERD). PATIENTS AND METHODS: In this single-blind, randomized, parallel-group study, 50 infants 1 to 24 months old with symptoms of GERD, and ≥ 5% of time with intraesophageal pH <4 during 24-hour dual pH monitoring, received oral esomeprazole 0.25 mg/kg (n = 26) or 1 mg/kg (n = 24) once daily for 1 week. Intraesophageal and intragastric pH were recorded at 1 week, and blood samples were taken for pharmacokinetic analysis. RESULTS: At baseline, mean percentages of time with intragastric pH >4 and intraesophageal pH <4 were 30.5% and 11.6%, respectively, in the esomeprazole 0.25 mg/kg group and 28.6% and 12.5% in the esomeprazole 1 mg/kg group. After 1 week of treatment, times with intragastric pH >4 were 47.9% and 69.3% in the esomeprazole 0.25 mg/kg and 1 mg/kg groups, respectively (P < 0.001 vs baseline), and times with intraesophageal pH <4 were 8.4% (P < 0.05 vs baseline) and 5.5% (P < 0.001 vs. baseline), respectively. The mean number of acid reflux episodes of >5 minutes duration decreased from 6 at baseline to 3 and 2 with esomeprazole 0.25 mg/kg and 1 mg/kg, respectively. The geometric mean AUC0-t of esomeprazole were 0.24 and 1.79 µmol · h/L for the 0.25 mg/kg and 1 mg/kg dosages of esomeprazole, respectively. Both esomeprazole dosages were well tolerated. CONCLUSIONS: Oral treatment with esomeprazole 0.25 mg/kg and 1 mg/kg was well tolerated and provided dose-related acid suppression, dose-related exposure to esomeprazole, and decreased esophageal acid exposure in infants 1-24 months old with GERD.

Pharmacokinetics and Acid-suppressive Effects of Esomeprazole in Infants 1-24 Months Old With Symptoms of Gastroesophageal Reflux Disease.

OBJECTIVES: To evaluate the pharmacokinetics and acid-suppressive effects of esomeprazole in infants with gastroesophageal reflux disease (GERD). PATIENTS AND METHODS: In this single-blind, randomized, parallel-group study, 50 infants 1 to 24 months old with symptoms of GERD, and ≥ 5% of time with intraesophageal pH <4 during 24-hour dual pH monitoring, received oral esomeprazole 0.25 mg/kg (n = 26) or 1 mg/kg (n = 24) once daily for 1 week. Intraesophageal and intragastric pH were recorded at 1 week, and blood samples were taken for pharmacokinetic analysis. RESULTS: At baseline, mean percentages of time with intragastric pH > 4 and intraesophageal pH < 4 were 30.5% and 11.6%, respectively, in the esomeprazole 0.25 mg/kg group and 28.6% and 12.5% in the esomeprazole 1 mg/kg group. After 1 week of treatment, times with intragastric pH >4 were 47.9% and 69.3% in the esomeprazole 0.25 mg/kg and 1 mg/kg groups, respectively (P < 0.001 vs baseline), and times with intraesophageal pH < 4 were 8.4% (P < 0.05 vs baseline) and 5.5% (P < 0.001 vs. baseline), respectively. The mean number of acid reflux episodes of > 5 minutes duration decreased from 6 at baseline to 3 and 2 with esomeprazole 0.25 mg/kg and 1 mg/kg, respectively. The geometric mean AUC0-t of esomeprazole were 0.24 and 1.79 µmol · h/L for the 0.25 mg/kg and 1 mg/kg dosages of esomeprazole, respectively. Both esomeprazole dosages were well tolerated. CONCLUSIONS: Oral treatment with esomeprazole 0.25 mg/kg and 1 mg/kg was well tolerated and provided dose-related acid suppression, dose-related exposure to esomeprazole, and decreased esophageal acid exposure in infants 1-24 months old with GERD.

Esomeprazole for prevention and resolution of upper gastrointestinal symptoms in patients treated with low-dose acetylsalicylic acid for cardiovascular protection: the OBERON trial.

Although low-dose acetylsalicylic acid (ASA) is recommended for prevention of cardiovascular events in at-risk patients, its long-term use can be associated with the risk of peptic ulcer and upper gastrointestinal (GI) symptoms that may impact treatment compliance. This prespecified secondary analysis of the OBERON study (NCT00441727) determined the efficacy of esomeprazole for prevention/resolution of low-dose ASA-associated upper GI symptoms. A post hoc analysis of predictors of symptom prevention/resolution was also conducted. Helicobacter pylori-negative patients taking low-dose ASA (75-325 mg) for cardiovascular protection who had ≥1 upper GI risk factor were eligible. The patients were randomized to once-daily esomeprazole 40 mg, 20 mg, or placebo, for 26 weeks; 2303 patients (mean age 67.6 years; 36% aged >70 years) were evaluable for upper GI symptoms. The proportion of patients with dyspeptic or reflux symptoms (self-reported Reflux Disease Questionnaire) was significantly lower (P < 0.0001) in those treated with esomeprazole versus in those treated with placebo. Treatment with esomeprazole (P < 0.0001), age >70 years (P < 0.01), and the absence of upper GI symptoms at baseline (P < 0.0001) were all factors associated with prevention/resolution of upper GI symptoms. Together, these analyses demonstrate that esomeprazole is effective in preventing and resolving patient-reported upper GI symptoms in low-dose ASA users at increased GI risk.

Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON).

OBJECTIVE: To determine whether once-daily esomeprazole 40 mg or 20 mg compared with placebo reduces the incidence of peptic ulcers over 26 weeks of treatment in patients taking low-dose acetylsalicylic acid (ASA) and who are at risk for ulcer development. DESIGN: Multinational, randomised, blinded, parallel-group, placebo-controlled trial. SETTING: Cardiology, primary care and gastroenterology centres (n=240). PATIENTS: Helicobacter pylori-negative patients taking daily low-dose ASA (75-325 mg), who fulfilled one or more of the following criteria: age ≥18 years with history of uncomplicated peptic ulcer; age ≥60 years with either stable coronary artery disease, upper gastrointestinal symptoms and five or more gastric/duodenal erosions, or low-dose ASA treatment initiated within 1 month of randomisation; or age ≥65 years. All patients were ulcer-free at study entry. INTERVENTIONS: Once-daily, blinded treatment with esomeprazole 40 mg, 20 mg or placebo for 26 weeks. MAIN OUTCOME MEASURES: The primary end point was the occurrence of endoscopy-confirmed peptic ulcer over 26 weeks. RESULTS: A total of 2426 patients (52% men; mean age 68 years) were randomised. After 26 weeks, esomeprazole 40 mg and 20 mg significantly reduced the cumulative proportion of patients developing peptic ulcers; 1.5% of esomeprazole 40 mg and 1.1% of esomeprazole 20 mg recipients, compared with 7.4% of placebo recipients, developed peptic ulcers (both p<0.0001 vs placebo). Esomeprazole was generally well tolerated. Conclusions Acid-suppressive treatment with once-daily esomeprazole 40 mg or 20 mg reduces the occurrence of peptic ulcers in patients at risk for ulcer development who are taking low-dose ASA. Clinical trial registration number ClinicalTrials.gov identifier: NCT00441727.