Risk of early revision in total hip arthroplasty: the relative contribution of the surgeon versus the hospital.

BACKGROUND: Early revision for total hip arthroplasty is a serious adverse outcome. There are multiple contributing risk factors for early revision. Risk factors can exist at the level of the surgeon and the level of the institution. The primary research question of this study was to determine the relative contribution of surgeon-level and hospital-level variance to rates of early revision (overall and for infection) after primary total hip arthroplasty. METHODS: This is a registry-based study from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Data for the most commonly used stem (Exeter V40) were used to reduce prosthesis variation from the analysis. A mixed effects Cox Model (also known as a frailty model) with crossed random effects for surgeon and hospital was used. Outcomes were early revision (within 2 years) for all causes and for infection. This model allowed for the risk of early revision to be explained by the variability at the surgeon level or hospital level. RESULTS: There were 32 031 procedures performed by 735 surgeons across 250 hospitals between 1 January 2015 and 31 December 2019. Surgeon variability significantly contributed to overall variation in revision for any cause and revision for infection (P < 0.0001). There was no significant contribution of hospital-level variation to overall revision or for infection. CONCLUSIONS: Surgeon-level factors play a more important role than institution-level factors in early revision after primary total hip arthroplasty. If surgeons are identified as having a higher risk of revision, there is potential for surgeon-level practice change to reduce the risk of early revision.

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.

Distal humeral hemiarthroplasty compared to total elbow replacement for distal humeral fractures: a registry analysis of 906 procedures.

BACKGROUND: Total elbow replacement (TER) is an accepted treatment for complex intra-articular distal humerus fractures in elderly patients. Distal humeral hemiarthroplasty (HA) is also a potential surgical option for unreconstructable fractures and avoids the concerns regarding mechanical wear and functional restrictions associated with TER. In the current literature, there are limited data available to compare the revision rates of HA and TER for the treatment of fracture. We used data from a large national arthroplasty registry to compare the outcome of HA and TER undertaken for fracture/dislocation and to assess the impact of demographics and implant choice on revision rates. METHODS: Data obtained from the Australian Orthopaedic Association National Joint Replacement Registry from May 2, 2005, to December 31, 2021, included all procedures for primary elbow replacement with primary diagnosis of fracture or dislocation. The analyses were performed using Kaplan-Meier estimates of survivorship and hazard ratios (HRs) from Cox proportional hazards models. RESULTS: There were 293 primary HA and 631 primary TER procedures included. The cumulative percentage revision (CPR) rate at 9 years was 9.7% for HA (95% confidence interval [CI] 6.0, 15.7), and 11.9% (95% CI 8.5, 16.6) for TER. When adjusted for age and gender, there was a significantly higher risk of revision after 3 months for TER compared to HA (HR 2.47, 95% CI 1.22, 5.03, P = .012). There was no difference in the rate of revision for patients aged <55 years or ≥75 years when HA and TER procedures were compared. In primary TER procedures, loosening was the most common cause of revision (3.6% of primary TER procedures), and the most common type of revision in primary TER involved revision of the humeral component only (2.6% of TER procedures). TER has a higher rate of first revision for loosening compared to HA (HR 4.21, 95% CI 1.29, 13.73; P = .017). In HA procedures, instability (1.7%) was the most common cause for revision. The addition of an ulna component was the most common type of revision (2.4% of all HA procedures). CONCLUSION: For the treatment of distal humerus fractures, HA had a lower revision rate than TER after 3 months when adjusted for age and gender. Age <55 or ≥75 years was not a risk factor for revision when HA was compared to TER. Loosening leading to revision is more prevalent in TER and increases with time. In HA, the most common type of revision involved addition of an ulna component with preservation of the humeral component.

Does hospital setting influence shoulder replacement revision rate? A national comparison of outcomes between private and public settings.

BACKGROUND: Australian healthcare relies on both private and public sectors to meet the demand for surgical care. Rapid growth of shoulder replacement surgery highlights a disparity in service provision, with two-thirds occurring privately. This study aimed to assess the influence of hospital setting on shoulder replacement revision rate at a national level. METHODS: All primary shoulder replacements recorded by the Australian Orthopaedic Association National Joint Replacement Registry from April 2004 to December 2020 were included. Private and public settings were compared for stemmed total shoulder replacement (sTSR) for osteoarthritis (OA), reverse total shoulder replacement (rTSR) for OA/cuff arthropathy (CA), and rTSR for fracture. The primary outcome was cumulative percent revision (CPR), with Kaplan-Meier estimates of survivorship to determine differences between private and public hospitals, recorded as hazard ratios (HR). Secondary analyses investigated differences between hospital settings, targeting hospital outliers for revision and prosthesis selection. RESULTS: Primary sTSR (OA) demonstrated a higher revision rate in private hospitals compared to public hospitals (HR = 1.27; P = 0.001), as did rTSR (OA/CA) after 3 months (HR = 1.33; P = 0.003). However, no significant difference was observed for primary rTSR (fracture) (HR = 1.10; P = 0.484). Restricting rTSR (OA/CA) to the best performing prosthesis combinations eliminated the difference between private and public outcomes (HR 1.10; P = 0.415). No other secondary analysis altered the primary result. CONCLUSIONS: Differences exist between private and public hospitals for revision rate following primary shoulder replacement. Prosthesis selection accounts for some of the variation. Further analysis into patient specific characteristics is necessary to better understand these disparities.

Long-term implant survival following hemiarthroplasty for fractured neck of femur.

Aims: Several different designs of hemiarthroplasty are used to treat intracapsular fractures of the proximal femur, with large variations in costs. No clinical benefit of modular over monoblock designs has been reported in the literature. Long-term data are lacking. The aim of this study was to report the ten-year implant survival of commonly used designs of hemiarthroplasty. Methods: Patients recorded by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) between 1 September 1999 and 31 December 2020 who underwent hemiarthroplasty for the treatment of a hip fracture with the following implants were included: a cemented monoblock Exeter Trauma Stem (ETS), cemented Exeter V40 with a bipolar head, a monoblock Thompsons prosthesis (Cobalt/Chromium or Titanium), and an Exeter V40 with a Unitrax head. Overall and age-defined cumulative revision rates were compared over the ten years following surgery. Results: A total of 41,949 hemiarthroplasties were included. Exeter V40 with a Unitrax head was the most commonly used (n = 20,707, 49.4%). The overall rate of revision was small. A total of 28,201 patients (67.2%) were aged > 80 years. There were no significant differences in revision rates across all designs of hemiarthroplasty in patients of this age at any time. The revision rates for all designs were < 3.5%, three years postoperatively. At subsequent times the ETS and Exeter V40 with a bipolar head performed well in all age groups. The unadjusted ten-year mortality rate for the whole cohort was 82.2%. Conclusion: There was no difference in implant survival between all the designs of hemiarthroplasty in the first three years following surgery, supporting the selection of a cost-effective design of hemiarthroplasty for most patients with an intracapsular fracture of the hip, as determined by local availability and costs. Beyond this, the ETS and Exeter bipolar designs performed well in all age groups.

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.

Obesity is associated with an increased risk of undergoing hip replacement in Australia.

BACKGROUND: Obesity is a known risk factor for the development of hip osteoarthritis. The aim of this study was to investigate whether obesity is associated with the risk of undergoing total hip replacement (THR) in Australia. METHODS: A cohort study was conducted comparing data from the Australian Bureau of Statistics and the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) from 2017 to 2018. Body mass index (BMI) data for patients undergoing primary total hip replacement and resurfacing for osteoarthritis were obtained from the AOANJRR. The distribution of THR patients by BMI category was compared to the general population, in age and sex sub-groups. RESULTS: During the study period, 32 495 primary THR were performed for osteoarthritis in Australia. Compared to the general population, there was a higher prevalence of Class I, II and III obesity in patients undergoing THR in both sexes aged 35-74 years. Class III obese females and males aged 55-64 years were 2.9 and 1.7 times more likely to undergo THR, respectively (P < 0.001). Class III obese females and males underwent THR on average 5.7 and 7.0 years younger than their normal weight counterparts, respectively. CONCLUSION: Obese Australians are at increased risk of undergoing THR, and at a younger age.

Obesity is associated with an increased risk of undergoing shoulder arthroplasty in Australia.

BACKGROUND: The aim of this study was to examine the incidence of overweight and obesity in patients undergoing primary total shoulder arthroplasty (TSA) for osteoarthritis (OA) in Australia compared to the incidence of obesity in the general population. MATERIALS AND METHODS: A 2017/18 cohort consisting of 2997 patients from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) who underwent TSA were compared with matched controls from the Australian Bureau of Statistics (ABS) National Health Survey from the same time period. The 2 groups were analyzed according to body mass index (BMI) category, sex, and age. RESULTS: According to the 2017/18 National Health Survey, 35.6% of Australian adults were overweight and 31.3% were obese. Of the primary TSA cases performed, 34.9% were overweight and 50.1% were obese. The relative risk of requiring TSA for OA increased with increasing BMI category. Class III obese females, aged 55-64, were 8.6 times more likely to receive a TSA compared to their normal weight counterparts. Males in the same age and BMI category were 2.5 times more likely. Class III obese patients underwent TSA 4 years (female) and 6 years (male) younger than their normal weight counterparts. CONCLUSION: Obesity significantly increases the risk of requiring TSA. The association appears to be particularly strong for younger females.

Hip Arthroplasty Outcomes in the Presence of Kidney Failure: A National Data Linkage Study.

BACKGROUND: Patients who have kidney failure are at higher risk of requiring total hip arthroplasty (THA) and are at higher risk of complications. This study compared the rate of revision surgery and mortality following THA between patients who have kidney failure receiving long term dialysis or who had a kidney transplant and those who did not have kidney failure. METHODS: A data linkage study was performed using data from 2 national registries: a registry of dialysis and kidney transplant patients and a registry of THA procedures. Both registries had coverage of almost all procedures or treatments in Australia. Data from September 1999 to December 2016 were used. Mortality and revision surgery were compared between patients receiving dialysis, those who had a functioning kidney transplant, and patients who did not have kidney failure using Cox and Fine-Gray (competing risk) regression models. A total of 383,478 primary THA procedures were identified as people receiving dialysis (n = 490), who had a functioning kidney transplant (n = 459), or who did not have kidney failure (n = 382,529). RESULTS: There was no significant difference in the overall rate of revision surgery between the groups (dialysis versus no kidney failure HR = 1.20; 95% CI 0.76, 1.88, transplant versus no kidney failure (hazard ratio) HR = 1.01; 95% (confidence interval) CI 0.66, 1.53). The risk for death after surgery was significantly higher in the dialysis group compared to both the functioning transplant group (HR = 3.44; 95%CI 1.58, 7.5), and in those without kidney failure (HR = 4.13; 95%CI 3.25, 5.25). CONCLUSION: The rate of mortality after THA in patients on dialysis is higher than in patients who have a functioning transplant or those who do not have kidney failure, but there is no early excess mortality to suggest a difference in this metric due to the surgery.

Dual mobility versus conventional total hip arthroplasty in femoral neck fractures (DISTINCT): protocol for a registry-nested, open-label, cluster-randomised crossover trial.

INTRODUCTION: Hip fractures treated with total hip arthroplasty (THA) are at high risk of prosthesis instability, and dislocation is the most common indication for revision surgery. This study aims to determine whether dual mobility THA implants reduce the risk of dislocation compared with conventional THA in patients with hip fracture suitable to be treated with THA. METHODS AND ANALYSIS: This is a cluster-randomised, crossover, open-label trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will comprise hospitals that perform at least 12 THAs for hip fracture per annum. All adults age ≥50 years who meet the Australian and New Zealand Hip Fracture Registry guidelines for THA will be included. The intervention will be dual mobility THA and the comparator will be conventional THA. Each hospital will be allocated to two consecutive periods, one of dual mobility THA and the other of conventional THA in random order, aiming for an average of 16 patients eligible for the primary analysis per group (32 total per site), allowing different recruitment totals between sites. Data will be collected through the AOANJRR and linked with patient-level discharge data acquired through government agencies. The primary outcome is dislocation within 1 year. Secondary outcomes include revision surgery for dislocation and all-cause, complications and mortality at 1, 2 and 5 years. If dual mobility THA is found to be superior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 1536 patients from at least 48 hospitals over 3 years. ETHICS AND DISSEMINATION: Ethics approval has been granted (Sydney Local Health District - Royal Prince Alfred Hospital Zone (approval X20-0162 and 2020/ETH00680) and site-specific approvals). Participant recruitment is via an opt-out consent process as both treatments are considered accepted, standard practice. The trial is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network. TRIAL REGISTRATION NUMBER: ACTRN12621000069853.

What Is the Outcome of the First Revision Procedure of Primary THA for Osteoarthritis? A Study From the Australian Orthopaedic Association National Joint Replacement Registry.

BACKGROUND: Joint arthroplasty registries traditionally report survivorship outcomes mainly on primary joint arthroplasty. The outcome of first revision procedures is less commonly reported, because large numbers of primary procedures are required to analyze a sufficient number of first revision procedures. Additionally, adequate linkage of primary procedures to revisions and mortality is required. When undertaking revision hip surgery, it is important for surgeons to understand the outcomes of these procedures to better inform patients. QUESTIONS/PURPOSES: Using data from a large national joint registry, we asked: (1) What is the overall rate of revision of the first aseptic revision procedure for a primary THA? (2) Does the rate of revision of the first revision vary by the diagnosis for the first revision? (3) What is the mortality after the first revision, and does it vary by the reason for first revision? METHODS: The Australian Orthopaedic Association National Joint Replacement Registry longitudinally maintains data on all primary and revision joint arthroplasties, with nearly 100% capture. The analyses for this study were performed on primary THA procedures in patients with a diagnosis of osteoarthritis up to December 31, 2020, who had undergone subsequent revision. We excluded all primary THAs involving metal-on-metal and ceramic-on-metal bearing surfaces and prostheses with exchangeable necks because these designs may have particular issues associated with revisions, such as extensive soft tissue destruction, that are not seen with conventional bearings, making a comparative analysis of the first revision involving these bearing surfaces more complicated. Metal-on-metal bearing surfaces have not been used in Australia since 2017. We identified 17,046 first revision procedures from the above study population and after exclusions, included 13,713 first revision procedures in the analyses. The mean age at the first revision was 71 ± 11 years, and 55% (7496 of 13,713) of the patients were women. The median (IQR) time from the primary procedure to the first revision was 3 years (0.3 to 7.3), ranging from 0.8 years for the diagnosis of dislocation and instability to 10 years for osteolysis. There was some variation depending on the reason for the first revision. For example, patients undergoing revision for fracture were slightly older (mean age 76 ± 11 years) and patients undergoing revision for dislocation were more likely to be women (61% [2213 of 3620]). The registry has endeavored to standardize the sequence of revisions and uses a numerical approach to describe revision procedures. The first revision is the revision of a primary procedure, the second revision is the revision of the first revision, and so on. We therefore described the outcome of the first revision as the cumulative percent second revision. The outcome measure was the cumulative percent revision, which was defined using Kaplan-Meier estimates of survivorship to describe the time to the second revision. Hazard ratios from Cox proportional hazards models, adjusting for age and gender, were performed to compare the revision rates among groups. When possible, the cumulative percent second revision at the longest follow-up timepoint was determined with the available data, and when there were insufficient numbers, we used appropriate earlier time periods. RESULTS: The cumulative percent second revision at 18 years was 26% (95% confidence interval [CI] 24% to 28%). When comparing the outcome of the first revision by reason, prosthesis dislocation or instability had the highest rate of second revision compared with the other reasons for first revision. Dual-mobility prostheses had a lower rate of second revision for dislocation or instability than head sizes 32 mm or smaller and when compared to constrained prostheses after 3 months. There was no difference between dual-mobility prostheses and head sizes larger than 32 mm. There were no differences in the rate of second revision when first revisions for loosening, periprosthetic fracture, and osteolysis were compared. If cemented femoral fixation was performed at the time of the first revision, there was a higher cumulative percent second revision for loosening than cementless fixation from 6 months to 6 years, and after this time, there was no difference. The overall mortality after a first revision of primary conventional THA was 1% at 30 days, 2% at 90 days, 5% at 1 year, and 40% at 10 years. A first revision for periprosthetic fracture had the highest mortality at all timepoints compared with other reasons for the first revision. CONCLUSION: Larger head sizes and dual-mobility cups may help reduce further revisions for dislocation, and the use of cementless stems for a first revision for loosening seems advantageous. Surgeons may counsel patients about the higher risk of death after first revision procedures, particularly if the first revision is performed for periprosthetic fracture.Level of Evidence Level III, therapeutic study.

Is the Revision Rate for Femoral Neck Fracture Lower for Total Hip Arthroplasty Than for Hemiarthroplasty?: A Comparison of Registry Data for Contemporary Surgical Options.

BACKGROUND: When arthroplasty is indicated for a femoral neck fracture (FNF), it is unclear whether total hip arthroplasty (THA) or hemiarthroplasty (HA) is best. This study compares data from the Australian Orthopaedic Association National Joint Replacement Registry using contemporary surgical options. METHODS: Patients from 60 to 85 years old who were treated with arthroplasty for FNF, between September 1999 and December 2019, were included if the femoral stems were cemented. Only THAs with femoral heads of ≥36 mm or dual-mobility articulations were included. Patients who had monoblock HA were excluded. Rates of revision for all aseptic failures and dislocation were compared. Competing risks of revision and death were considered using the cumulative incidence function. Subdistribution hazard ratios (HRs) for revision or death from a Fine-Gray regression model were used to compare THA and HA. Interactions of procedure with age group and sex were considered. Secondary analysis adjusting for body mass index (BMI) and American Society of Anesthesiologists (ASA) classification was also considered. RESULTS: There were 4,551 THA and 29,714 HA procedures included. The rate of revision for THA was lower for women from 60 to 69 years old (HR = 0.58 [95% confidence interval (CI), 0.39 to 0.85]) and from 70 to 74 years old (HR = 0.65 [95% CI, 0.43 to 0.98]) compared with HA. However, women from 80 to 85 years old (HR = 1.56 [95% CI, 1.03 to 2.35]) and men from 75 to 79 years old (HR = 1.61 [95% CI, 1.05 to 2.46]) and 80 to 85 years old (HR = 2.73 [95% CI, 1.89 to 3.95]) had an increased rate of revision when THA was undertaken compared with HA. There was no difference in the rate of revision for dislocation between THA and HA for either sex or age categories. CONCLUSIONS: When contemporary surgical options for FNF are used, there is a benefit with respect to revision outcomes for THA in women who are <75 years old and a benefit for HA in women who are ≥80 years old and men who are ≥75 years old. There is no difference in dislocation rates. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

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.

Reduced Revision Rates in Total Shoulder Arthroplasty With Crosslinked Polyethylene: Results From the Australian Orthopaedic Association National Joint Replacement Registry.

BACKGROUND: Loss of glenoid fixation is a key factor affecting the survivorship of primary total shoulder arthroplasty (TSA). It is not known whether the lower revision rates associated with crosslinked polyethylene (XLPE) compared with those of non-XLPE identified in hip and knee arthroplasty apply to shoulder arthroplasty. QUESTIONS/PURPOSES: We used data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) to compare the revision rates of primary stemmed anatomic TSA using XLPE to procedures using non-XLPE. In patients receiving a primary stemmed anatomic TSA for osteoarthritis, we asked: (1) Does the rate of revision or reason for revision vary between XLPE and non-XLPE all-polyethylene glenoid components? (2) Is there any difference in the revision rate when XLPE is compared with non-XLPE across varying head sizes? (3) Is there any difference in survival among prosthesis combinations with all-polyethylene glenoid components when they are used with XLPE compared with non-XLPE? METHODS: Data were extracted from the AOANJRR from April 16, 2004, to December 31, 2020. The AOANJRR collects data on more than 97% of joint replacements performed in Australia. The study population included all primary, stemmed, anatomic TSA procedures performed for osteoarthritis using all-polyethylene glenoid components. Procedures were grouped into XLPE and non-XLPE bearing surfaces for comparison. Of the 10,102 primary stemmed anatomic TSAs in the analysis, 39% (3942 of 10,102) used XLPE and 61% (6160 of 10,102) used non-XLPE. There were no differences in age, gender, or follow-up between groups. Revision rates were determined using Kaplan-Meier estimates of survivorship to describe the time to the first revision, with censoring at the time of death or closure of the database at the time of analysis. Revision was defined as removal, replacement, or addition of any component of a joint replacement. The unadjusted cumulative percent revision after the primary arthroplasty (with 95% confidence intervals [CIs]) was calculated and compared using Cox proportional hazard models adjusted for age, gender, fixation, and surgeon volume. Further analyses were performed stratifying according to humeral head size, and a prosthesis-specific analysis adjusted for age and gender was also performed. This analysis was restricted to prosthesis combinations that were used at least 150 times, accounted for at least four revisions, had XLPE and non-XLPE options available, and had a minimum of 3 years of follow-up. RESULTS: Non - XLPE had a higher risk of revision than XLPE after 1.5 years (HR 2.3 [95% CI 1.6 to 3.1]; p < 0.001). The cumulative percent revision at 12 years was 5% (95% CI 4% to 6%) for XLPE and 9% (95% CI 8% to 10%) for non-XLPE. There was no difference in the rate of revision for head sizes smaller than 44 mm. Non-XLPE had a higher rate of revision than XLPE for head sizes 44 to 50 mm after 2 years (HR 2.3 [95% CI 1.5 to 3.6]; p < 0.001) and for heads larger than 50 mm for the entire period (HR 2.2 [95% CI 1.4 to 3.6]; p < 0.001). Two prosthesis combinations fulfilled the inclusion criteria for the prosthesis-specific analysis. One had a higher risk of revision when used with non-XLPE compared with XLPE after 1.5 years (HR 3.7 [95% CI 2.2 to 6.3]; p < 0.001). For the second prosthesis combination, no difference was found in the rate of revision between the two groups. CONCLUSION: These AOANJRR data demonstrate that noncrosslinked, all-polyethylene glenoid components have a higher revision rate compared with crosslinked, all-polyethylene glenoid components when used in stemmed anatomic TSA for osteoarthritis. As polyethylene type is likely an important determinant of revision risk, crosslinked polyethylene should be used when available, particularly for head sizes larger than 44 mm. Further studies will need to be undertaken after larger numbers of shoulder arthroplasties have been performed to determine whether this reduction in revision risk associated with XLPE bears true for all TSA designs. LEVEL OF EVIDENCE: Level III, therapeutic study.

Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes.

INTRODUCTION: Robot-assisted surgery (RAS) and kinematic alignment (KA) are being increasingly adopted to improve patient outcomes in total knee arthroplasty (TKA). There is uncertainty around the individual or combined effect of these concepts compared with computer-assisted surgery (CAS) and mechanical alignment (MA), respectively. This study aims to assess the effectiveness of RAS, KA or both to improve clinical outcomes, functional measures, radiographic precision and prosthetic survivorship when compared with current gold standards of surgical care. METHODS AND ANALYSIS: A national registry-nested, multicentre, double-blinded, 2×2 factorial, randomised trial will be undertaken with 300 patients undergoing primary unilateral TKA performed by 15 surgeons. The primary outcome will be the between-group differences in postoperative change over 2 years in the mean Knee injury and Osteoarthritis Outcome Score (KOOS-12), comparing first, RAS to CAS as its control, and second, KA to MA as its control. Secondary outcomes will include other knee-specific and general health patient-reported outcome measures (PROMs), intraoperative pressure loads as a measure of soft tissue balance, 6-month postoperative functional outcomes, radiological precision using CT imaging, complications and long-term prosthetic survivorship. The contribution of each patient's unique coronal plane alignment of the knee phenotype to primary and secondary PROMs will be investigated. OMERACT-OARSI criteria and Patient Acceptable Symptom State outcome score thresholds for the KOOS-12 and Oxford Knee Score will be used in secondary analyses. Primary intention-to-treat and secondary per-protocol analyses will be performed. Statistical analysis will include a generalised linear mixed model for repeated measures for continuous KOOS-12 scores. Kaplan-Meier estimates with adjusted HRs of implant survivorship will be calculated. ETHICS AND DISSEMINATION: Ethics approval was obtained from Sydney Local Health District-Royal Prince Alfred Hospital (Approval X20-0494 and 2020/ETH02896 10.24/DEC20). Results will be submitted for publication in a peer-reviewed journal and presented in national, state and international meetings. TRIAL REGISTRATION NUMBER: ACTRN12621000205831.

Between-hospital and between-surgeon variation in thresholds for hip and knee replacement.

BACKGROUND: Total hip replacement (THR) and total knee replacement (TKR) are cost-effective interventions to reduce pain and disability associated with osteoarthritis, however there is no clear guidelines available to determine appropriate patient selection and the timing of surgery. This prospective cohort study aimed to evaluate the hospital- and surgeon-level variation in the severity of patient-reported symptoms prior to THR and TKR. METHODS: Patients undergoing primary THR (n = 4330) or TKR (n = 7054) for osteoarthritis who participated in a national registry-led Patient Reported Outcome Measures (PROMs) pilot program were included in the analysis. Pre-operative Oxford Hip Score (OHS) and Oxford Knee Score (OKS) (range 0-48; representing worst to best hip/knee pain and function) data were examined for variation between private and public hospitals and between surgeons using linear mixed models. RESULTS: Pre-operative mean OHS was significantly higher (better) in patients whose surgery was performed in a private hospital compared to public hospitals; 21.39 versus 18.11 (mean difference 3.27, 95% CI 1.75, 4.79). For OKS, the difference between private hospital and public hospital scores was dependent on BMI and gender. Most of the variation in pre-operative OHS and OKS was not at the individual hospital- or surgeon-level, which explained only a negligible proportion of the model variance (⟨5%) for THR and TKR. CONCLUSION: Apart from a difference between private and public hospitals, there was little between-hospital or between-surgeon symptom variation in joint-specific pain and function prior to THR or TKR. The findings suggest consistency in the surgical thresholds for patients being offered hip and knee joint replacement procedures.

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.