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.

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.

Lumbo-pelvic lordosis and the pelvic radius technique in the assessment of spinal sagittal balance: strengths and caveats.

INTRODUCTION: The two main methodologies described for the assessment of spinal sagittal alignment are the pelvic radius (PR) technique and that based on measures of the Pelvic Incidence (PI) and Spino-Sacral Angle (SSA). Both methods stress the fundamental relationship between the anatomical position and orientation of the sacrum within the pelvis and the spinal curves above. The aim of the current study was to assess the strengths and potential weaknesses of the PR technique. The PR technique uses measures based on a line (the PR), drawn between the hip axis and the posterior corner of the S1 endplate. The angle formed between the PR line and the sacral endplate, PRS1, is a developmental measure of sacropelvic morphology. Geometrically, PI and PRS1 are approximately complementary angles and both reflect reciprocal alterations in pelvic tilt (for PI) or angulation (for PRS1) and the slope of the S1 endplate. The angle formed between PR and T12, the PR-T12, reflects a combined measure of pelvic morphology and lumbar lordosis. It appears to be a useful measure, which provides a simple and rapid assessment of lumbopelvic sagittal balance, but only in the presence of a congruent thoracic curvature. MATERIALS AND METHODS: After reviewing the literature, published measures made using the PR technique were compared to measures taken from a substantial patient population (479 adult patients). CONCLUSIONS: Errors can occur using the PR technique if the PRT12 is viewed in isolation from the thoracic kyphosis. We found the ratio of the thoracic kyphosis to lumbar lordosis (T4-T12/T12-S1) to be a useful predictor of congruent sagittal alignment, which may alert the clinician to situations where use of the PR-T12 in isolation may be misleading.

Early failure of metal-on-metal artificial disc prostheses associated with lymphocytic reaction: diagnosis and treatment experience in four cases.

STUDY DESIGN: Report of four collected cases. OBJECTIVE: The purpose of this report is to describe the presentation, diagnostic workup, treatment, and pathologic findings in four cases of lymphocytic reaction in patients receiving a metal-on-metal total disc replacement (TDR). SUMMARY OF BACKGROUND DATA: Metal-on-metal designs in hip arthroplasty have gained popularity because of decreased volumetric wear rates and theoretically increased implant longevity. Systemic metal ions produced have not been associated with adverse clinical sequelae, although there have been reports of local soft-tissue reactions leading to early prosthetic failure. Histologic evaluation in these cases suggested a cell-mediated delayed-type hypersensitivity reaction. Metal-on-metal bearings have also emerged in lumbar and cervical TDR. METHODS: This report is on four patients, from three centers, who underwent TDR, using a metal-on-metal implant, and later presented with symptoms that were determined to be due to lymphocytic reaction. Details of their symptoms, diagnostic work-up, treatment, and outcomes were compiled. RESULTS: All four patients initially had a good surgical outcome, followed by the onset and worsening of axial pain, and/or radicular symptoms months later. All patients had imaging findings of a mass lesion with neurologic impingement. All three of the lumbar patients underwent a decompressive posterior procedure before the eventual device removal and fusion. Intraoperatively, in all the lumbar cases, a thick, yellowish, avascular soft-tissue mass was found to be responsible for an epidural-mass effect on the thecal sac. In the cervical case, there was a gray-tinged soft-tissue response around the implant, suggestive of metallosis. Independent laboratory analysis confirmed a lymphocytic reaction to the implant. Three of the patients had a good outcome after the explant and revision surgery. The remaining patient continued to have residual symptoms related to the neural compression caused by the mass. CONCLUSIONS: In this group of patients from three centers, a metal-on-metal TDR resulted in a lymphocytic reaction causing subsequent failure of the surgery. This phenomenon has previously been recognized with metal bearings in hip arthroplasty. Surgeons using metal-on-metal TDRs should be aware of this possible occurrence.

Health-related quality of life: a comparison of outcomes after lumbar fusion for degenerative spondylolisthesis with large joint replacement surgery and population norms.

BACKGROUND CONTEXT: Degenerative spine disease will become an increasing health problem, and a significant number of patients will be considered for surgery. Spinal surgeries have evolved since the last decades, and there is a positive impact on the clinical outcomes. Few works in the literature have reviewed the outcome compared with large joint replacement surgery, which is considered a benchmark for operative restoration of patients' quality of life. PURPOSE: The purpose of this study was to investigate if spinal fusion can return patients' health-related quality of life to that of age-matched population norms and yield outcomes comparable with those of total hip and knee joint replacement. STUDY DESIGN: This is a prospective cohort study. PATIENT SAMPLE: The sample consists of 100 consecutive patients who were enrolled between December 1997 and January 2007. OUTCOME MEASURES: The 12-item Short Form Health Survey (SF-12) was chosen for outcome measurement. METHODS: All patients underwent wide decompressive laminectomy and single-level posterior lumbar interbody fusion for spinal stenosis associated with degenerative spondylolisthesis. RESULTS: The preoperative and postoperative physical component summary (PCS)-12 scores of the spinal fusion patients were comparable with those of both the total knee and hip replacement patients. The mean improvement in PCS-12 scores after spine surgery was 11 (95% confidence interval [CI]: 9-14, p<.0001). It was equal to that after total hip replacement surgery, which was 11 (95% CI: 9-13), and higher than that of total knee replacement patients, which had an improvement of 8 (95% CI: 7-9). The postoperative mean and 95% CI of the PCS-12 scores for the three surgical procedures approached the population norm value of 44 (95% CI: 43-46).There was no statistical difference between the postoperative mental component summary-12 score among all the three surgical groups, which approached similar to the population norm value of 54 (95% CI: 53-54). CONCLUSIONS: The current study demonstrated that spinal surgery can return patients' HRQL to that of age-matched population norms and yield outcomes comparable with those of total hip and knee joint replacement patients.

Stress analysis of interbody fusion--finite element modelling of intervertebral implant and vertebral body.

OBJECTIVE: To investigate stresses in cage type interbody fusion systems during compressive loading.Design. The study uses finite element methods to investigate predicted stresses. Previously published experimental material properties are used as inputs to the numerical simulation. BACKGROUND: Interbody spinal fusion procedures using cage style intervertebral implants often cause subsidence failure of the vertebral endplate, resulting in potential pain and mechanical instability of the fusion system. METHODS: Finite element models were developed to simulate compressive load transfer between interbody implants and adjacent vertebral body. The vertebral body was modelled using separate finite element mesh regions for cancellous core and cortical shell, with the meshes tied together at the core/shell interface. Coulomb friction was implemented to model the contact between implants and vertebral endplate.Results. Simulation results predicted endplate stresses of approximately 12 times the nominal contact pressure due to differing deformation stiffnesses of the implant and endplate structures. Reduction of the cancellous core elastic modulus to simulate severely osteoporotic bone resulted in endplate stresses up to three times higher than the values for an intact cancellous core. CONCLUSIONS: In this study, finite element analysis was used to investigate the stresses in interbody fusion systems. Published vertebral loads corresponding to certain activities were shown to generate endplate stresses which approach and exceed the failure stress for cortical bone. Endplate stresses are strongly dependent on the modulus of the underlying cancellous core. RELEVANCE: Endplate subsidence failure can potentially occur at the corners of existing cage-type interbody implants under physiological compressive loads. Matching material properties between cortical endplate and implant does not guarantee optimal contact conditions, and overall bending stiffness should be assessed.