First knee for pain and function versus second knee for quality of life.

Aims: The aim of this study was to describe and compare joint-specific and generic health-related quality of life outcomes of the first versus second knee in patients undergoing staged bilateral total knee arthroplasty (BTKA) for osteoarthritis. Methods: This retrospective cohort study used Australian national arthroplasty registry data from January 2013 to January 2021 to identify participants who underwent elective staged BTKA with six to 24 months between procedures. The primary outcome was Oxford Knee Score (OKS) at six months postoperatively for the first TKA compared to the second TKA, adjusted for age and sex. Secondary outcomes compared six-month EuroQol five-dimension five-level (EQ-5D-5L) domain scores, EQ-5D index scores, and the EQ visual analogue scale (EQ-VAS) between knees at six months postoperatively. Results: The cohort included 635 participants (1,270 primary procedures). Preoperative scores were worse in the first knee compared to the second for all instruments; however, comparing the first knee at six months postoperatively with the second knee at six months postoperatively, the mean between-knee difference was minimal for OKS (-0.8 points; 95% confidence interval (CI) -1.4 to -0.2), EQ-VAS (3.3; 95% CI 1.9 to 4.7), and EQ-5D index (0.09 points; 95% CI 0.07 to 0.12). Outcomes for the EQ-5D-5L domains 'mobility', 'usual activities', and 'pain/discomfort' were better following the second TKA. Conclusion: At six months postoperatively, there were no clinically meaningful differences between the first and second TKA in either the joint-specific or overall generic health-related quality of life outcomes. However, individual domain scores assessing mobility, pain, and usual activities were notably higher after the second TKA, likely reflecting the cumulative improvement in quality of life after both knees have been replaced.

Hip-specific and generic patient-reported outcome measure scores after primary hip replacement are associated with early revision surgery: a national registry study.

BACKGROUND: The ability to efficiently identify patients at higher risk of poor outcomes after joint replacement would enable limited resources for post-operative follow-up to be directed to those with the greatest clinical need. This is particularly important as joint replacement rates continue to grow internationally, stretching health system capabilities. Patient-reported outcome measures (PROMs) are routinely administered in many settings and offer an opportunity to detect suboptimal patient outcomes early. This study aimed to determine whether hip-specific and generic PROM scores are associated with early revision hip replacement within six to 24 months after the primary procedure. METHODS: Pre-operative and six-month post-operative PROM scores for patients undergoing primary total hip replacement (THR) were obtained from the Australian Orthopaedic Association National Joint Replacement Registry and Arthroplasty Clinical Outcomes Registry National and linked to revision surgery data. Clinically important improvement was defined using anchor-based thresholds. Associations between PROM scores (hip pain, Oxford Hip Score, HOOS-12, EQ-5D-5L, EQ VAS, patient-perceived change, satisfaction) and revision surgery were evaluated using t-tests, chi-square tests and regression models. RESULTS: Data were analysed for 21,236 primary THR procedures between 2013 and 2022. Eighty-eight revision procedures were performed at six to 24 months. Patients who were revised had more back pain and worse HOOS-12 scores pre-operatively but between-group differences were small. Worse post-operative PROM scores (hip pain, Oxford, HOOS-12, EQ-5D-5L, EQ VAS) were associated with early revision, after adjusting for age and sex (p < 0.001 for all analyses). Patient dissatisfaction (relative risk (RR) 10.18, 95%CI 6.01-17.25) and patient-perceived worsening (RR 19.62, 95%CI 11.33-33.98) were also associated with a higher likelihood of revision. Patients who did not achieve clinically important improvement in hip pain, function, or quality of life had a higher revision risk (RRs 2.54-5.64), compared with those who did (reference). CONCLUSION: Six-month hip-specific and generic PROM scores can identify patients at higher risk of early revision surgery. Our data highlight the utility of routine post-operative PROM assessment for signaling suboptimal surgical outcomes.

Measurement Properties of the Oxford Shoulder Score and Minimal Clinically Important Changes After Primary Total Shoulder Replacement Surgery.

OBJECTIVE: We evaluated the measurement properties of the Oxford Shoulder Score (OSS) and estimated the minimal clinically important change (MCIC) in patients undergoing primary total shoulder replacement in Australia. METHODS: Deidentified data from the Australian Orthopaedic Association National Joint Replacement Registry were used for this analysis. Pre- and 6-month postoperative OSS scores were used, with the 5-level EuroQoL quality of life instrument and shoulder pain scores used as comparators. Floor and ceiling effects, internal consistency reliability, construct validity, and responsiveness to change were evaluated using standard psychometric methods. Mean change and predictive modeling approaches (with and without adjustment for the proportion of improved patients) were used to calculate MCIC thresholds, with patient-perceived improvement after surgery as the anchor. RESULTS: Preoperative OSS data were available for 1,117 patients (59% female; 90% aged ≥60 years) undergoing primary total shoulder replacement. No floor or ceiling effects were observed pre- or postoperatively. The OSS showed high internal consistency reliability (Cronbach alpha >0.89), good construct validity, and high responsiveness to change (effect size 1.88). The MCIC derived from the mean change method was 6.50 points (95% confidence interval [95% CI] 4.41-8.61). The predictive modeling approach produced an MCIC estimate of 8.42 points (95% CI 5.68-12.23) after adjustment. CONCLUSION: The OSS has good measurement properties to capture pain and function outcomes after shoulder replacement procedures and is highly responsive to change. Based on robust methods, an increase in OSS scores of at least eight points can be considered as meaningful improvement after surgery from the patient's perspective.

Effect of Aspirin vs Enoxaparin on 90-Day Mortality in Patients Undergoing Hip or Knee Arthroplasty: A Secondary Analysis of the CRISTAL Cluster Randomized Trial.

Importance: Ischemic heart disease remains the leading cause of mortality following hip and knee arthroplasty. Due to its antiplatelet and cardioprotective properties, aspirin has been proposed as an agent that could reduce mortality when used as venous thromboembolism (VTE) prophylaxis following these procedures. Objective: To compare aspirin with enoxaparin in reducing 90-day mortality for patients undergoing hip or knee arthroplasty procedures. Design, Setting, and Participants: This study was a planned secondary analysis of the CRISTAL cluster randomized, crossover, registry-nested trial performed across 31 participating hospitals in Australia between April 20, 2019, and December 18, 2020. The aim of the CRISTAL trial was to determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE following hip or knee arthroplasty. The primary study restricted the analysis to patients undergoing total hip or knee arthroplasty for a diagnosis of osteoarthritis only. This study includes all adult patients (aged ≥18 years) undergoing any hip or knee arthroplasty procedure at participating sites during the course of the trial. Data were analyzed from June 1 to September 6, 2021. Interventions: Hospitals were randomized to administer all patients oral aspirin (100 mg daily) or subcutaneous enoxaparin (40 mg daily) for 35 days after hip arthroplasty and 14 days after knee arthroplasty procedures. Main Outcomes and Measures: The primary outcome was mortality within 90 days. The between-group difference in mortality was estimated using cluster summary methods. Results: A total of 23 458 patients from 31 hospitals were included, with 14 156 patients allocated to aspirin (median [IQR] age, 69 [62-77] years; 7984 [56.4%] female) and 9302 patients allocated to enoxaparin (median [IQR] age, 70 [62-77] years; 5277 [56.7%] female). The mortality rate within 90 days of surgery was 1.67% in the aspirin group and 1.53% in the enoxaparin group (estimated difference, 0.04%; 95% CI, -0.05%-0.42%). For the subgroup of 21 148 patients with a nonfracture diagnosis, the mortality rate was 0.49% in the aspirin group and 0.41% in the enoxaparin group (estimated difference, 0.05%; 95% CI, -0.67% to 0.76%). Conclusions and Relevance: In this secondary analysis of a cluster randomized trial comparing aspirin with enoxaparin following hip or knee arthroplasty, there was no significant between-group difference in mortality within 90 days when either drug was used for VTE prophylaxis. Trial Registration: http://anzctr.org.au Identifier: ACTRN12618001879257.

The association between body mass index and patient-reported outcome measures before and after primary total hip or knee arthroplasty: a registry.

BACKGROUND: The objective is to determine whether body mass index is associated with patient-reported expectations and well-being before primary total hip or total knee arthroplasty, and patient-reported outcomes 6 months after surgery. METHODS: Data were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. Outcome measures included pre-operative expectations for post-operative mobility, joint pain and health, pre- and post-operative EQ-5D-5L, EQ-VAS, Oxford Hip/Knee Scores and joint pain scales, and post-operative perceived change and perceived satisfaction. Associations with BMI were assessed using chi-square tests, analysis of variance and Linear Mixed Models equations. RESULTS: Data were available for 12 816 primary THA patients and 20 253 primary TKA patients. Pre-operatively, patients in higher BMI categories were significantly more likely to expect ongoing problems with mobility, more joint pain and poorer health following surgery (P<0.01 for all analyses). For arthroplasty patients, higher BMI was associated with poorer pre-operative and post-operative scores for all measures. BMI was positively associated with improvements in EQ-5D, OHS/KS and joint pain. While between-group differences were statistically significant, many were small in magnitude. There was no association between BMI and patient-perceived change or satisfaction after arthroplasty. CONCLUSION: Patients undergoing THA/TKA, higher BMI was associated with lower pre-operative expectations, poorer well-being before surgery, and worse scores after surgery. Patients who were obese demonstrated comparable satisfaction with their operated joint, compared with non-obese patients. BMI was associated with greater pre- to post-operative improvements in outcome scores for EQ-5D, VAS knee, OHS/OKS and joint pain but these differences may not be clinically important.

Effect of Aspirin vs Enoxaparin on Symptomatic Venous Thromboembolism in Patients Undergoing Hip or Knee Arthroplasty: The CRISTAL Randomized Trial.

Importance: There remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA). Objective: To determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA. Design, Setting, and Participants: Cluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021. Interventions: Hospitals were randomized to administer aspirin (100 mg/d) or enoxaparin (40 mg/d) for 35 days after THA and for 14 days after TKA. Crossover occurred after the patient enrollment target had been met for the first group. All 31 hospitals were initially randomized and 16 crossed over prior to trial cessation. Main Outcomes and Measures: The primary outcome was symptomatic VTE within 90 days, including pulmonary embolism and deep venous thrombosis (DVT) (above or below the knee). The noninferiority margin was 1%. Six secondary outcomes are reported, including death and major bleeding within 90 days. Analyses were performed by randomization group. Results: Enrollment was stopped after an interim analysis determined the stopping rule was met, with 9711 patients (median age, 68 years; 56.8% female) of the prespecified 15 562 enrolled (62%). Of these, 9203 (95%) completed the trial. Within 90 days of surgery, symptomatic VTE occurred in 256 patients, including pulmonary embolism (79 cases), above-knee DVT (18 cases), and below-knee DVT (174 cases). The symptomatic VTE rate in the aspirin group was 3.45% and in the enoxaparin group was 1.82% (estimated difference, 1.97%; 95% CI, 0.54%-3.41%). This failed to meet the criterion for noninferiority for aspirin and was significantly superior for enoxaparin (P = .007). Of 6 secondary outcomes, none were significantly better in the enoxaparin group compared with the aspirin group. Conclusions and Relevance: Among patients undergoing hip or knee arthroplasty for osteoarthritis, aspirin compared with enoxaparin resulted in a significantly higher rate of symptomatic VTE within 90 days, defined as below- or above-knee DVT or pulmonary embolism. These findings may be informed by a cost-effectiveness analysis. Trial Registration: ANZCTR Identifier: ACTRN12618001879257.

Poor Knee-specific and Generic Patient-reported Outcome Measure Scores at 6 Months Are Associated With Early Revision Knee Arthroplasty: A Study From the Australian Orthopaedic Association National Joint Replacement Registry.

BACKGROUND: The ability to identify which patients are at a greater risk of early revision knee arthroplasty has important practical and resource implications. Many international arthroplasty registries administer patient-reported outcome measures (PROMs) to provide a holistic assessment of pain, function, and quality of life. However, few PROM scores have been evaluated as potential indicators of early revision knee arthroplasty, and earlier studies have largely focused on knee-specific measures. QUESTIONS/PURPOSES: This national registry-based study asked: (1) Which 6-month postoperative knee-specific and generic PROM scores are associated with early revision knee arthroplasty (defined as revision surgery performed 6 to 24 months after the primary procedure)? (2) Is a clinically important improvement in PROM scores (based on thresholds for the minimal important change) after primary knee arthroplasty associated with a lower risk of early revision? METHODS: Preoperative and 6-month postoperative PROM scores for patients undergoing primary knee arthroplasty were sourced from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and Arthroplasty Clinical Outcomes Registry National. Between January 2013 and December 2020, PROM data were available for 19,402 primary total knee arthroplasties; these data were linked to AOANJRR data on revision knee arthroplasty. Of these, 3448 procedures were excluded because they did not have 6-month PROM data, they had not reached the 6-month postoperative point, they had died before 24 months, or they had received revision knee arthroplasty before the 6-month PROMs assessment. After these exclusions, data were analyzed for 15,954 primary knee arthroplasties. Associations between knee-specific (knee pain, Oxford Knee Score, and 12-item Knee injury and Osteoarthritis Outcome Score [KOOS-12]) or generic PROM scores (5-level EuroQol quality of life instrument [EQ-5D], EQ VAS, perceived change, and satisfaction) and revision surgery were explored using t-tests, chi-square tests, and regression models. Ninety-four revision procedures were performed at 6 to 24 months, most commonly for infection (39% [37 procedures]). The early revision group was younger than the unrevised group (mean age 64 years versus 68 years) and a between-group difference in American Society of Anesthesiologists (ASA) grade was noted. Apart from a small difference in preoperative low back pain for the early revision group (mean low back pain VAS 4.2 points for the early revision group versus 3.3 points for the unrevised group), there were no between-group differences in preoperative knee-specific or generic PROM scores on univariate analysis. As the inclusion of ASA grade or low back pain score did not alter the model results, the final multivariable model included only the most clinically plausible confounders (age and gender) as covariates. Multivariable models (adjusting for age and gender) were also used to examine the association between a clinically important improvement in PROM scores (based on published thresholds for minimal important change) and the likelihood of early revision. RESULTS: After adjusting for age and gender, poor postoperative knee pain, Oxford, KOOS-12, EQ-5D, and EQ VAS scores were all associated with early revision. A one-unit increase (worsening) in knee pain at 6 months was associated with a 31% increase in the likelihood of revision (RR 1.31 [95% confidence interval (CI) 1.19 to 1.43]; p < 0.001). Reflecting the reversed scoring direction, a one-unit increase (improvement) in Oxford or KOOS-12 score was associated with a 9% and 5% reduction in revision risk, respectively (RR for Oxford: 0.91 [95% CI 0.90 to 0.93]; p < 0.001; RR for KOOS-12 summary: 0.95 [95% CI 0.94 to 0.97]; p < 0.001). Patient dissatisfaction (RR 6.8 [95% CI 3.7 to 12.3]) and patient-perceived worsening (RR 11.7 [95% CI 7.4 to 18.5]) at 6 months were also associated with an increased likelihood of early revision. After adjusting for age and gender, patients who did not achieve a clinically important improvement in PROM scores had a higher risk of early revision (RR 2.9 for the knee pain VAS, RR 4.2 for the Oxford Knee Score, RR 6.3 to 8.6 for KOOS-12, and RR 2.3 for EQ-5D) compared with those who did (reference group). CONCLUSION: Knee-specific and generic PROM scores offer an efficient approach to identifying patients at greater risk of early revision surgery, using either the 6-month score or the magnitude of improvement. These data indicate that surgeons can use single- and multi-item measures to detect a patient-perceived unsuccessful surgical outcome at 6 months after primary knee arthroplasty. Surgeons should be alert to poor PROM scores at 6 months or small improvements in scores (for example, less than 2 points for knee pain VAS or less than 10.5 points for Oxford Knee Score), which signal a need for direct patient follow-up or expedited clinical review. LEVEL OF EVIDENCE: Level III, therapeutic study.

Minimal Clinically Important Changes in HOOS-12 and KOOS-12 Scores Following Joint Replacement.

BACKGROUND: For patient-reported outcome measures (PROMs) to provide meaningful information to support clinical care, we need to understand the magnitude of change that matters to patients. The aim of this study was to estimate minimal clinically important changes (MCICs) for the 12-item Hip disability and Osteoarthritis Outcome Score (HOOS-12) and Knee injury and Osteoarthritis Outcome Score (KOOS-12) among people undergoing joint replacement for osteoarthritis. METHODS: Individual-level data from the Australian Orthopaedic Association National Joint Replacement Registry's pilot PROMs program were used for this analysis. Preoperative and 6-month postoperative HOOS-12 and KOOS-12 domain and summary impact scores plus a rating of patient-perceived change after surgery (on a 5-point scale ranging from "much worse" to "much better") were available. Three anchor-based approaches-mean change, receiver operating characteristics (ROC) based on Youden's J statistic, and predictive modeling using a binary logistic regression model-were used to calculate MCICs based on patient-perceived change. RESULTS: Data were available for 1,490 patients treated with total hip replacement (THR) (mean age, 66 years; 54% female) and 1,931 patients treated with total knee replacement (TKR) (mean age, 66 years; 55% female). Using the mean change method, the MCIC ranged from 24.0 to 27.5 points for the HOOS-12 and 17.5 to 21.8 points for the KOOS-12. The ROC analyses generated comparable MCIC values (28.1 for HOOS-12 and a range of 15.6 to 21.9 for KOOS-12) with high sensitivity and specificity. Lower estimates were derived from predictive modeling following adjustment for the proportion of improved patients (range, 15.7 to 19.2 for HOOS-12 and 14.2 to 16.5 for KOOS-12). CONCLUSIONS: We report MCIC values for the HOOS-12 and KOOS-12 instruments that we derived using 3 different methods. As estimates obtained using predictive modeling can be adjusted for the proportion of improved patients, these may be the most clinically applicable. These MCIC values can be used to interpret important changes in pain, function, and quality of life from the patient's perspective. LEVELS OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Association between patient factors and hospital completeness of a patient-reported outcome measures program in joint arthroplasty, a cohort study.

BACKGROUND: The collection of patient-reported outcome measures (PROMs) following arthroplasty is common. PROMs data collection programs seek to maximise completeness in order to minimise selection bias and optimise representativeness of the sample attained. We aimed to determine if patient factors influence variation in PROMs program completeness between-hospitals. METHODS: Using data from a national arthroplasty registry PROMs program, we tested for associations between patient characteristics (age, sex, body mass index [BMI] and American Society of Anaesthesiologists [ASA] class) and both potential completeness (registration completeness: the proportion of arthroplasty patients that were registered in the PROMs electronic system) and actual completeness (response completeness: the proportion of arthroplasty patients who provided PROMs data) using linear regression. RESULTS: When using all elective primary total hip, knee or shoulder arthroplasty procedures (N = 31,801) from 43 hospitals as the denominator, overall registration completeness was 52%, varying from 5 to 87% between hospitals. Overall pre-operative response completeness was 46%, varying from 5 to 82% between hospitals. There were no significant associations between hospital-level registration completeness or response completeness and age, sex, BMI or ASA score. CONCLUSION: Completeness rates of a PROMs program in arthroplasty varied widely between hospitals but in the absence of a relationship between measured patient factors and completeness rates, the observed variation likely relates to local site factors such as access to patients, local resources and clinician engagement with the program. Efforts to improve the rates of completeness of arthroplasty PROMs programs at individual hospitals may not improve the representativeness of the sample.

Hospitals vary in how completely they include and follow up patients when measuring patient-reported health. It is important to know if the completeness of inclusion and follow up by hospitals is affected by patient characteristics. This study addresses that problem by using data from a national patient outcome survey involving over 30,000 patients from 43 hospitals to look at the correlation between certain patient characteristics (like age, sex, obesity and general health) and the rates of inclusion and follow up for each hospital.Rates of inclusion (registering patients in the program) and follow up rates varied widely between hospitals (from 5 to 87%). The rates of inclusion and follow up were not correlated with patient age, sex, body mass index or their general health. These findings suggest that the variation between hospitals in the rates of inclusion of joint replacement patients in health surveys are not due to differences in patient characteristics. The differences may be due to local hospital factors, such as resources and clinician engagement.

CRISTAL (a cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study): statistical analysis plan.

BACKGROUND: This a priori statistical analysis plan describes the analysis for CRISTAL. METHODS: CRISTAL (cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study) aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic venous thromboembolism (VTE) following hip arthroplasty (HA) or knee arthroplasty (KA). The study is nested within the Australian Orthopaedic Association National Joint Replacement Registry. The trial was commenced in April 2019 and after an unplanned interim analysis, recruitment was stopped (December 2020), as the stopping rule was met for the primary outcome. The clusters comprised hospitals performing > 250 HA and/or KA procedures per annum, whereby all adults (> 18 years) undergoing HA or KA were recruited. Each hospital was randomised to commence with aspirin, orally, 85-150 mg daily or LMWH (enoxaparin), 40 mg, subcutaneously, daily within 24 h postoperatively, for 35 days after HA and 14 days after KA. Crossover was planned once the registration target was met for the first arm. The primary end point is symptomatic VTE within 90 days. Secondary outcomes include readmission, reoperation, major bleeding and death within 90 days, and reoperation and patient-reported pain, function and health status at 6 months. The main analyses will focus on the primary and secondary outcomes for patients undergoing elective primary total HA and KA for osteoarthritis. The analysis will use an intention-to-treat approach with cluster summary methods to compare treatment arms. As the trial stopped early, analyses will account for incomplete cluster crossover and unequal cluster sizes. CONCLUSIONS: This paper provides a detailed statistical analysis plan for CRISTAL. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12618001879257 . Registered on 19/11/2018.

Are responders to patient health surveys representative of those invited to participate? An analysis of the Patient-Reported Outcome Measures Pilot from the Australian Orthopaedic Association National Joint Replacement Registry.

BACKGROUND: Patient-reported outcome measures (PROMs) are commonly used to evaluate surgical outcome in patients undergoing joint replacement surgery, however routine collection from the target population is often incomplete. Representative samples are required to allow inference from the sample to the population. Although higher capture rates are desired, the extent to which this improves the representativeness of the sample is not known. We aimed to measure the representativeness of data collected using an electronic PROMs capture system with or without telephone call follow up, and any differences in PROMS reporting between electronic and telephone call follow up. METHODS: Data from a pilot PROMs program within a large national joint replacement registry were examined. Telephone call follow up was used for people that failed to respond electronically. Data were collected pre-operatively and at 6 months post-operatively. Responding groups (either electronic only or electronic plus telephone call follow up) were compared to non-responders based on patient characteristics (joint replaced, bilaterality, age, sex, American Society of Anesthesiologist (ASA) score and Body Mass Index (BMI)) using chi squared test or ANOVA, and PROMs for the two responder groups were compared using generalised linear models adjusted for age and sex. The analysis was restricted to those undergoing primary elective hip, knee or shoulder replacement for osteoarthritis. RESULTS: Pre-operatively, 73.2% of patients responded electronically and telephone follow-up of non-responders increased this to 91.4%. Pre-operatively, patients responding electronically, compared to all others, were on average younger, more likely to be female, and healthier (lower ASA score). Similar differences were found when telephone follow up was included in the responding group. There were little (if any) differences in the post-operative comparisons, where electronic responders were on average one year younger and were more likely to have a lower ASA score compared to those not responding electronically, but there was no significant difference in sex or BMI. PROMs were similar between those reporting electronically and those reporting by telephone. CONCLUSION: Patients undergoing total joint replacement who provide direct electronic PROMs data are younger, healthier and more likely to be female than non-responders, but these differences are small, particularly for post-operative data collection. The addition of telephone call follow up to electronic contact does not provide a more representative sample. Electronic-only follow up of patients undergoing joint replacement provides a satisfactory representation of the population invited to participate.

Patient-reported outcomes after hip and knee arthroplasty : results from a large national registry.

AIMS: This study aims to describe the pre- and postoperative self-reported health and quality of life from a national cohort of patients undergoing elective total conventional hip arthroplasty (THA) and total knee arthroplasty (TKA) in Australia. For context, these data will be compared with patient-reported outcome measures (PROMs) data from other international nation-wide registries. METHODS: Between 2018 to 2020, and nested within a nationwide arthroplasty registry, preoperative and six-month postoperative PROMs were electronically collected from patients before and after elective THA and TKA. There were 5,228 THA and 8,299 TKA preoperative procedures as well as 3,215 THA and 4,982 TKA postoperative procedures available for analysis. Validated PROMs included the EuroQol five-dimension five-level questionnaire (EQ-5D-5L; range 0 to 100; scored worst-best health), Oxford Hip/Knee Scores (OHS/OKS; range 0 to 48; scored worst-best hip/knee function) and the 12-item Hip/Knee disability and Osteoarthritis Outcome Score (HOOS-12/KOOS-12; range 0 to 100; scored best-worst hip/knee health). Additional items included preoperative expectations, patient-perceived improvement, and postoperative satisfaction. Descriptive analyses were undertaken. RESULTS: For THA and TKA patients respectively, the patient profile was 2,850 (54.5%) and 4,684 (56.4%) female, mean age 66.8 years (SD 10.6) and 67.5 (SD 8.8), and mean BMI 29.9 kg/m2 (SD 7.7) and 32.5 kg/m2 (SD 7.0). The proportion of THA and TKA patients who reported their joint as 'much better' was 2,946 (92.6%) and 4,020 (81.6%) respectively, and the majority of patients were 'satisfied' or 'very satisfied' with their procedure (2,754 (86.5%) and 3,981 (80.8%)). There were 311 (9.7%) of THA patients and 516 (10.5%) of TKA patients who reported 'dissatisfied' or 'very dissatisfied' with their surgery. CONCLUSION: Large improvements in pain, function, and overall health were evident following primary THA and TKA. Approximately 10% of patients reported dissatisfaction with their surgery. Future analyses will focus on factors contributing to dissatisfaction after arthroplasty. Cite this article: Bone Jt Open 2021;2(6):422-432.

A Randomized Trial of Prenatal n-3 Fatty Acid Supplementation and Preterm Delivery.

BACKGROUND: Previous studies have suggested that maternal supplementation with n-3 long-chain polyunsaturated fatty acids may reduce the incidence of preterm delivery but may also prolong gestation beyond term; however, more data are needed regarding the role of n-3 long-chain polyunsaturated fatty acids in pregnancy. METHODS: We performed a multicenter, double-blind, randomized trial in which women who were pregnant with single or multiple fetuses were assigned to receive either fish-oil capsules that contained 900 mg of n-3 long-chain polyunsaturated fatty acids (n-3 group) or vegetable-oil capsules that contained trace n-3 long-chain polyunsaturated fatty acids (control group) daily, beginning before 20 weeks of gestation and continuing to 34 weeks of gestation or delivery, whichever occurred first. The primary outcome was early preterm delivery, defined as delivery before 34 completed weeks of gestation. Other pregnancy and neonatal outcomes were also assessed. RESULTS: A total of 5544 pregnancies in 5517 women were randomly assigned at six centers in Australia; 5486 pregnancies were included in the primary analysis. Early preterm delivery occurred in the case of 61 of 2734 pregnancies (2.2%) in the n-3 group and 55 of 2752 pregnancies (2.0%) in the control group; the between-group difference was not significant (adjusted relative risk, 1.13; 95% confidence interval [CI], 0.79 to 1.63; P = 0.50). There were no significant differences between the groups in the incidence of interventions in post-term (>41 weeks of gestation) deliveries, in adverse events, or in other pregnancy or neonatal outcomes, except that a higher percentage of infants born to women in the n-3 group than in the control group were very large for gestational age at birth (adjusted relative risk, 1.30; 95% CI, 1.02 to 1.65). Percentages of serious adverse events did not differ between the groups. Minor gastrointestinal disturbances were more commonly reported in the n-3 group than in the control group. CONCLUSIONS: Supplementation with n-3 long-chain polyunsaturated fatty acids from early pregnancy (<20 weeks of gestation) until 34 weeks of gestation did not result in a lower incidence of early preterm delivery or a higher incidence of interventions in post-term deliveries than control. (Funded by the Australian National Health and Medical Research Council and the Thyne Reid Foundation; ORIP Australian New Zealand Clinical Trials Registry number, ACTRN12613001142729.).

Associations between socioeconomic status and primary total knee joint replacements performed for osteoarthritis across Australia 2003-10: data from the Australian Orthopaedic Association National Joint Replacement Registry.

BACKGROUND: Relatively little is known about the social distribution of total knee joint replacement (TKR) uptake in Australia. We examine associations between socioeconomic status (SES) and TKR performed for diagnosed osteoarthritis 2003-10 for all Australian males and females aged ≥ 30 yr. METHODS: Data of primary TKR (n=213,018, 57.4% female) were ascertained from a comprehensive national joint replacement registry. Residential addresses were matched to Australian Census data to identify area-level social disadvantage, and categorised into deciles. Estimated TKR rates were calculated. Poisson regression was used to model the relative risk (RR) of age-adjusted TKR per 1,000py, stratified by sex and SES. RESULTS: A negative relationship was observed between TKR rates and SES deciles. Females had a greater rate of TKR than males. Surgery utilisation was greatest for all adults aged 70-79 yr. In that age group differences in estimated TKR per 1,000py between deciles were greater for 2010 than 2003 (females: 2010 RR 4.32 and 2003 RR 3.67; males: 2010 RR 2.04 and 2003 RR 1.78). CONCLUSIONS: Identifying factors associated with TKR utilisation and SES may enhance resource planning and promote surgery utilisation for end-stage osteoarthritis.

Patellofemoral crepitus in high flexion rotating platform knee arthroplasty.

INTRODUCTION: Recently, implant manufacturers have made modifications to currently available implants in an attempt to improve postoperative flexion. The Low Contact Stress (LCS) RPS (DePuy Orthopaedics Inc., Warsaw, IN, USA) is one such prosthesis which is a modification of the established LCS RP design. Satisfactory results have been obtained without patella resurfacing in the original LCS RP design. METHODS: We report on a single surgeon series showing an alarmingly high incidence of patellofemoral crepitus when this new prosthesis, LCS RPS, is used without patella resurfacing. In addition, the outcomes for this prosthesis from the Australian National Joint Replacement registry will be reported. These results show a high revision rate with most revisions being patella resurfacing for patellofemoral pain. RESULTS: Affected patients who elected to have a revision procedure underwent either an arthroscopic patellaplasty procedure or revision to resurface the patella. Both of these procedures resulted in satisfactory resolution of symptoms in the majority of patients. DISCUSSION: Potential causes for this complication are discussed. It is the recommendation of the authors that when using this prosthesis the patella is resurfaced.

Exeter short stems compared with standard length Exeter stems: experience from the Australian Orthopaedic Association National Joint Replacement Registry.

The standard Exeter stem has a length of 150 mm with offsets 37.5 to 56 mm. Shorter stems of lengths 95, 115 and 125 mm with offsets 35.5 mm or less are available for patients with smaller femurs. Concern has been raised regarding the behavior of the smaller implants. This paper analyzed data from the Australian Orthopaedic Association National Joint Replacement Registry comparing survivorship of stems of offset 35.5 mm or less with the standard stems of 37.5 mm offset or greater. At 7 years, there was no significant difference in the cumulative percent revision rate in the short stems (3.4%, 95% CI 2.4-4.8%) compared with the standard length stems (3.5%, 95% CI 3.3-3.8%) despite its use in a greater proportion of potentially more difficult developmental dysplasia of the hip cases.

Large diameter metal on metal articulations. Comparison of total hip arthroplasty and hip resurfacing arthroplasty.

The use of large diameter metal bearing total hip arthroplasty (THA) and hip resurfacing arthroplasty (HRA) increased in popularity in the last decade. More recent literature has highlighted the effect of head size in patient outcomes. Data was obtained from the Australian Orthopaedic Association National Joint Replacement Registry (AOA-NJRR) to evaluate the Birmingham (MoM) bearing surface when used with THA and HRA. There is no difference in the overall rate of revision between the THA and HRA but head size has a significant effect on revision rate. The data show that small diameter metal bearings in HRA (below 50mm) have a higher rate of revision than large diameter metal bearings in HRA (equal to and above 50mm) (P<.001). Conversely the large diameter metal bearings in THA have a higher rate of revision than the small diameter metal bearings in THA (P=.027). The revision rate for large diameter HRA compared to small diameter THA is not significantly different P=.670. We recommend caution when choosing either a large diameter (≥50mm) metal on metal THA or small diameter (<50mm) HRA.

Is sudden death random or is it in the weather?

It has been suggested that the weather may promote some types of death; this study sought to determine if types of death in the region around Adelaide, South Australia, occur in non-random clusters and in relationship to the weather. A Poisson model was used to determine if the occurrence of types of death were random. An exploratory analysis was performed for each death type to see if there was a relationship to weather variables using data supplied by the Bureau of Meteorology. Cases examined at Forensic Science South Australia from 1 January 2008 to 31 December 2009 were reviewed. It was ascertained that cardiovascular deaths were distributed non-randomly; there was statistical evidence to suggest that deaths from ischemic heart disease, pulmonary embolus and drug toxicity had non-random occurrence. Maximum temperatures and increases in temperatures correlated with deaths from natural causes, cardiovascular disease, ischemic heart disease and pulmonary thromboembolus; lower hours of sunlight were statistically significant for deaths due to pulmonary thromboembolus. The distribution pattern of deaths resulting from motor vehicle collision did not fit the Poisson (random) model with variation through the week also being present. Non-random clusters of deaths do occur and weather events, such as increase in temperature, are associated with some types of death. However, analysis indicates that the weather is not responsible for all clustering. With regards to motor vehicle collision deaths temporal variation may be related to social factors, such as holiday periods. Further investigation may assist with health resource planning.

The presence of 1 mM glycine in vitrification solutions protects oocyte mitochondrial homeostasis and improves blastocyst development.

PURPOSE: Embryos generated from oocytes which have been vitrified have lower blastocyst development rates than embryos generated from fresh oocytes. This is indicative of a level of irreversible damage to the oocyte possibly due to exposure to high cryoprotectant levels and osmotic stress. This study aimed to assess the effects of vitrification on the mitochondria of mature mouse oocytes while also examining the ability of the osmolyte glycine, to maintain cell function after vitrification. METHODS: Oocytes were cryopreserved via vitrification with or without 1 mM Glycine and compared to fresh oocyte controls. Oocytes were assessed for mitochondrial distribution and membrane potential as well as their ability to fertilise. Blastocyst development and gene expression was also examined. RESULTS: Vitrification altered mitochondrial distribution and membrane potential, which did not recover after 2 h of culture. Addition of 1 mM glycine to the vitrification media prevented these perturbations. Furthermore, blastocyst development from oocytes that were vitrified with glycine was significantly higher compared to those vitrified without glycine (83.9 % vs. 76.5 % respectively; p<0.05) and blastocysts derived from oocytes that were vitrified without glycine had significantly decreased levels of IGF2 and Glut3 compared to control blastocysts however those derived from oocytes vitrified with glycine had comparable levels of these genes compared to fresh controls. CONCLUSION: Addition of 1 mM glycine to the vitrification solutions improved the ability of the oocyte to maintain its mitochondrial physiology and subsequent development and therefore could be considered for routine inclusion in cryopreservation solutions.

Common mental disorders associated with 2-year diabetes incidence: the Netherlands Study of Depression and Anxiety (NESDA).

BACKGROUND: Few prospective cohort studies describe the risk of type 2 diabetes mellitus associated with depression or anxiety. The aim of this study was to determine the 2-year diabetes incidence and pattern of explanatory factors associated with depressive and/or anxiety disorders. METHODS: A prospective cohort of 2981 participants (aged 18-65 years, 66% women) recruited in the Netherlands Study of Depression and Anxiety (NESDA) from community, primary care and outpatient psychiatric clinics were followed-up for two years. Complete data were analyzed from 2460 participants without baseline diabetes. Lifetime or current (past 6-month) depressive and/or anxiety disorders at baseline were assessed using the Composite Interview Diagnostic Instrument (CIDI) and classified by the DSM-IV. Diabetes was classified by either self-report, medications, or fasting plasma glucose ≥ 7.0 mmol/L. Baseline covariates included age, gender, lifestyle factors, and medical conditions. Odds ratios (OR [95% confidence intervals]) for diabetes were determined using exact logistic regression. RESULTS: The unadjusted 2-year diabetes incidence was 0.2% (1/571), 1.1% (6/548), and 1.8% (24/1340) for no, remitted, and current depressive and/or anxiety disorders, respectively. In comparison to those without psychopathology, current depressive and/or anxiety disorders was associated with diabetes incidence in unadjusted (OR 10.4 [1.7, 429.0]) and age-adjusted (OR 11.9 (1.9, 423.0]) analyses. The strength of this association (beta coefficient) was slightly changed after further adjustments for impaired fasting glucose (11.4%), high triglycerides (-7.8%), and lifestyle cumulative risk score (-5.0%), in contrast to other covariates when assessed in separate models. LIMITATIONS: The low incidence of diabetes resulted in considerable uncertainty for the odds ratios and low statistical power that limited covariate adjustments. CONCLUSIONS: The relative odds of developing diabetes within two years was increased for persons with current depressive and/or anxiety disorders, which was partially explained by, but remained independent of, lifestyle cumulative risk factors.