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.
For patients undergoing THA or 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.
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.
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.
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/m
2
(SD 7.7) and 32.5 kg/m
2
(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.
The nutrient requirements and metabolic pathways used by the developing embryo transition from predominantly pyruvate during early cleavage stages to glucose at the blastocyst; however, the ...complexities involved in the regulation of metabolism at different developmental stages are not clear. The aims of this study were to examine the role of the malate-aspartate shuttle (MAS) in nutrient metabolism pathways in the developing mouse blastocyst and the consequences of impaired metabolism on embryo viability and fetal and placental growth. Eight-cell-stage mouse embryos were cultured in the presence of the MAS inhibitor amino-oxyacetate, with or without pyruvate as an energy substrate in the media. When the MAS was inhibited, the rate of glycolysis and lactate production was significantly elevated and glucose uptake reduced, relative to control cultured embryos in the presence of pyruvate. Despite these changes in embryo metabolism, this did not influence development to the blastocyst stage, but it did reduce the number of inner cell mass and trophectoderm cells. When these embryos were transferred to psuedopregnant females, inhibition of the MAS significantly reduced the proportion of embryos that implanted and developed into fetuses on Day 18 of pregnancy. Finally, fetal growth was reduced while placental weight was maintained, leading to a decreased fetal:placental weight ratio relative to control embryos. These results suggest that impaired metabolism of glucose in the blastocyst via the MAS alters the ability of the embryos to implant and form a pregnancy and leads to reduced fetal weight, likely via altered placental development and function.
Abstract
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.
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.
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.
Plain English summary
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.
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. Cite this article: Bone Jt Open 2024;5(3):202–209.
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