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.

The KOOS-12 shortform shows no ceiling effect, good responsiveness and construct validity compared to standard outcome measures after total knee arthroplasty.

PURPOSE: To investigate the validity, responsiveness and ceiling effect of the recently introduced KOOS-12 and compare its performance to the KOOS, OKS, WOMAC and UCLA activity scales. METHODS: Patients from an independent multicentre study examining a medially stabilized knee system prospectively completed the KOOS, OKS, WOMAC and UCLA preoperatively and at 1 year postoperatively. KOOS-12 scores were calculated from the full length KOOS data. Construct validity was assessed using Spearman's correlation analysis. The ceiling effect was evaluated by calculating the percentage of patients with a maximum score. If the percentage exceeded 15%, a ceiling effect was considered to be present. Responsiveness was evaluated by performing paired t tests on the changes in measures and calculation of Cohen's d. RESULTS: A ceiling effect was present for the KOOS Pain, ADL and QoL subscales and the KOOS-JR at 1 year postoperatively. No ceiling effect was observed for the KOOS-12. Correlation of the KOOS-12 was low (0.3 < r < 0.5) with the UCLA, moderate (0.5 < r < 0.7) with the KOOS symptoms, sports and WOMAC stiffness subscales and high (r > 0.7) with all other scores and subscales. Effect size of the UCLA activity scale was moderate (Cohen's d 0.2-0.8) whereas effect sizes of all other outcome measures were large (d > 0.8). CONCLUSION: The KOOS-12 does not exhibit a ceiling effect, has good convergent construct validity and is responsive to changes in pain, function, QoL and knee impact between preoperatively and 1 year postoperatively. LEVEL OF EVIDENCE: Diagnostic level III.

A Single Surgeon Series Comparing the Outcomes of a Cruciate Retaining and Medially Stabilized Total Knee Arthroplasty Using Kinematic Alignment Principles.

BACKGROUND: Total knee arthroplasty (TKA) designs are developed to optimize kinematics and improve patient satisfaction. The cruciate retaining (CR) and medially stabilized (MS) TKA designs have reported good mid-term follow-up outcomes. However, reasons for consistently high rates of patient dissatisfaction following a TKA remain poorly understood. To further investigate this, we compared the short-term functional outcomes and quality of life, using patient-reported outcome measures (PROMs) and range of motion (ROM), between a CR and MS TKA. METHODS: A prospective comparison was made between 2 groups (44 CR-TKAs vs 46 MS-TKAs). The Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS-12, KOOS-Short form, KOOS-Joint Replacement, Oxford Knee Score, Western Ontario and McMaster Universities Osteoarthritis Index, UCLA Activity Scale, and EuroQuality of life - 5 Dimension were completed preoperatively and 1 year postoperatively. The Forgotten Joint Score (FJS) and Visual Analogue Scale-Satisfaction were completed at 1 year postoperatively. ROM was collected preoperatively and 1 year postoperatively. RESULTS: Patients who underwent an MS-TKA scored significantly better than the CR-TKA on the FJS (MS = 79.87, CR = 63.8, P = .005), the KOOS-12 Quality of Life subscale (MS = 82.8, CR = 74.4, P = .43), and the KOOS Quality of Life subscale (MS = 82.8, CR = 74.6, P = .44). There was no difference between the groups in all assessed PROMs or ROM, preoperatively and 1 year postoperatively. CONCLUSION: Patients who underwent the MS-TKA scored significantly better on the FJS and the quality of life subscale of the KOOS and KOOS-12 than those who underwent a CR-TKA. All other assessed PROMs and ROM were comparable between the 2 groups and demonstrated that both implants facilitated symptom relief and improved daily function at 1 year postoperatively. These findings suggest that at short-term follow-up, the MS device is more likely to allow a patient to "forget" that a joint has been replaced and restore their quality of life. Long-term assessment of MS-TKA design outcomes in larger cohorts is recommended.

Sagittal Stability and Implant Design Affect Patient Reported Outcomes After Total Knee Arthroplasty.

BACKGROUND: Joint stability is one of the goals of any joint replacement. The contribution of prosthesis design to sagittal stability in total knee arthroplasty (TKA) has emerged as an area of interest. The purpose of this study was to evaluate the sagittal stability of four prosthesis types and determine the effect on patient reported outcome measures (PROMs). METHODS: A matched-cohort cross-sectional study was performed on 60 patients after TKA at 1-year follow-up. Three surgeons performed 10 medially stabilized (MS) TKA and 10 non-MS TKA. Sagittal stability was assessed by a blinded observer using a KT-1000 arthrometer, Lachman's test, and the anterior drawer test. PROMs (Oxford, Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, Forgotten joint score) and visual analog scale assessed function and satisfaction. RESULTS: MS TKA had significantly decreased translation on KT-1000 and improved stability compared with non-MS TKA (P < .05). Increased PROMs were demonstrated in the MS TKA group compared with the non-MS TKA group (P < .05). When divided based on objective stability, regardless of the prosthesis type, patients with a stable knee had superior PROMs (P < .05), particularly in sport-related questions. CONCLUSION: The MS TKA had significantly greater sagittal stability, improved PROMs, and satisfaction compared with non-MS TKA. Independent of prosthesis design, patients with greater sagittal stability demonstrated improved PROMs.

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 ceiling effects of patient reported outcome measures for total knee arthroplasty.

BACKGROUND: Patient reported outcome measurements (PROMs) that exhibit a substantial ceiling effect show clustering of participant's scores towards the upper limit of a scale and consequently have low discriminatory power among high end scores. This study aimed to compare ceiling effects at 1 and 2 years postoperatively across commonly usedPROMs for TKA. HYPOTHESIS: We hypothesized, that the analyzed PROMs differ substantially in regards to their ceiling effect. PATIENTS AND METHODS: Patients that underwent a primary unilateral TKA and completed pre-operative and post-operative questionnaires were included in the analysis. Participants completed the KOOS, KOOS-12, KOOS-JR, KOOS-PS, WOMAC and OKS preoperatively, and completed the KOOS, KOOS-12, KOOS-JR, KOOS-PS, WOMAC,OKS and FJS postoperatively at 1 and 2 years. RESULTS: 1-year and 2-year follow-up data was available for 380 and 193 patients, respectively. The preoperative mean age was 68.0 (8.5) and mean BMI was 31.4kg/m2 (6.6), with a male to female ratio of 49.6% to 50.4%. At 1 year postoperatively, a ceiling effect was seen for the Pain and ADL subscales of the KOOS and the KOOS JR. The KOOS Pain, Symptoms, ADL and QoL subscales, the WOMAC Total and KOOS JR exhibited a ceiling effect at 2 years postoperatively. We found 9.0% and 14.8% of patients achieving a maximum score in the FJS at 1 and 2 years, respectively, indicating the absence of a substantial ceiling effect. CONCLUSION: The PROMs studied differ substantially with regards to their ceiling effect and consequently their ability to detect differences between well performing groups. The KOOS Pain, Symptoms, ADL and QoL subscales, the WOMAC Total and KOOS JR exhibited a substantial ceiling effect at 2 years postoperatively. We recommend using PROMs like the FJS and KOOS-12 with a more evenly distribution of scores across the scale when studying well performing cohorts. LEVEL OF EVIDENCE: III.

Minimal important change and minimum clinically important difference values of the KOOS-12 after total knee arthroplasty.

PURPOSE: The minimal important change (minimal amount of change vs. baseline that a patient recognizes as a clinical change) and minimum clinically important difference (smallest difference between two measurements that are deemed important by patients) are important values to evaluate the clinical relevance of changes over time and differences between groups. This study aims to establish these values for the KOOS-12 at 1 year postoperatively. METHODS: KOOS-12 scores were calculated from the full-length KOOS completed by patients undergoing primary TKA preoperatively and at 1 year follow up. Minimal important change (MIC) values were estimated using the anchor-based predictive modeling approach and adjustment for the large proportion of improved patients in the study cohort was performed. The MCID was defined as the difference in the mean change in the KOOS-12 between the 'no improvement' and 'little improvement' groups. RESULTS: A total of 352 patients (161 male:191 female) with an overall mean age of 67.9 years (standard deviation (SD) 8.2) and a mean body mass index of 31.4 kg/m2 (SD 6.3) were included: 97.1% of patients reported an important improvement, 1.1% reported being about the same and 1.7% reported being importantly worse. The MIC improvement values were 11.5 for Pain, 13.7 for Function, 5.5 for Quality of Life (QoL) and 14.9 for the total KOOS-12 score. MCID values were 13.5 for Pain, 15.2 for Function, 8.0 for QoL and 11.1 for the total KOOS-12 score. CONCLUSION: MIC of 14.9 and MCID of 11.1 established in this study can assist clinicians and researchers in the interpretation of within-group changes (MIC) and differences between groups (MCID) at 1 year after TKA.

Results of unicompartmental knee arthroplasty with cemented, fixed-bearing prosthesis using minimally invasive surgery.

The aim of this study was to evaluate the intermediate-term survivorship of cemented fixed-bearing unicompartmental knee arthroplasty (UKA). One hundred twenty-eight consecutive UKAs in 98 patients were performed by a single surgeon with "Allegretto" UKA prostheses. Six patients died and 5 were lost to follow-up, leaving 87 patients (116 knees) with an average follow-up of 5.7 years (range, 3-8 years). At the latest follow-up, the survival rate was 92.2%; average clinical and functional knee society scores improved from 50 and 64 points preoperatively to 89 and 88 points, respectively; and average total knee score was 171 (range, 94-200). Radiographic follow-up demonstrated average alignment of 3 degrees valgus (range, 6 degrees varus to 7 degrees valgus). Ninety-two percent of the patients indicated satisfaction with the procedure. Nine knees failed requiring revision at an average of 40.4 months. We are encouraged with the satisfactory results, considering the broader spectrum of selected patients.

Computerized management of oral anticoagulant therapy: experience in major joint arthroplasty.

OBJECTIVE: Evaluation of the safety and potential cost savings of a computerized, laboratory-based program to manage inpatient warfarin thromboprophylaxis after major joint arthroplasty. DESIGN: A consecutive-case study of adults. SETTING: A tertiary care orthopedic institution. PATIENTS: Patients requiring joint arthroplasty who had no recent episodes of thromboembolic disease, no mechanical heart valve, atrial fibrillation, severe liver disease or baseline international normalized ratio [INR] greater than 1.3 admitted over a 54-month period (July 1994-December 1998). All patients received a standard regimen of warfarin beginning on the evening after the operation. Four hundred and thirty randomly selected patients managed by the program were followed up by telephone survey 3 months after discharge. Patients exhibiting erratic responses to warfarin were withdrawn from the program and managed individually thereafter. INTERVENTION: Major joint arthroplasty with warfarin therapy administered through the computerized program. MAIN OUTCOME MEASURES: Test results maintained within the desired therapeutic range (INR 2.0-3.0), clinically severe bleeding episodes, readmission rates, clinically symptomatic and venographically proven episodes of venous thrombosis or pulmonary embolism. RESULTS: Over the study period 5629 patients underwent joint arthroplasty; 5,372 patients were considered for the program; 332 patients were ineligible and were managed individually; 311 entered patients did not complete the program. This left 4,729 patients who completed the program. In 2932 (62%) patients test results were maintained in the desired therapeutic range. The major bleeding rate was less than 0.5%, the readmission rate was 3.8%, the deep venous thrombosis rate was 3.7% and the pulmonary embolism rate was 0.2% with no thromboembolic related deaths in the small sample cohort. CONCLUSIONS: The majority of patients requiring warfarin thromboprophylaxis can be safely and effectively managed by this laboratory-based computerized program while in hospital. Significant potential cost savings in nursing time could be achieved.