Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty.

BACKGROUND: Clinical trials and meta-analyses have suggested that aspirin may be effective for the prevention of venous thromboembolism (proximal deep-vein thrombosis or pulmonary embolism) after total hip or total knee arthroplasty, but comparisons with direct oral anticoagulants are lacking for prophylaxis beyond hospital discharge. METHODS: We performed a multicenter, double-blind, randomized, controlled trial involving patients who were undergoing total hip or knee arthroplasty. All the patients received once-daily oral rivaroxaban (10 mg) until postoperative day 5 and then were randomly assigned to continue rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days after total knee arthroplasty or for 30 days after total hip arthroplasty. Patients were followed for 90 days for symptomatic venous thromboembolism (the primary effectiveness outcome) and bleeding complications, including major or clinically relevant nonmajor bleeding (the primary safety outcome). RESULTS: A total of 3424 patients (1804 undergoing total hip arthroplasty and 1620 undergoing total knee arthroplasty) were enrolled in the trial. Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban group (difference, 0.06 percentage points; 95% confidence interval [CI], -0.55 to 0.66; P<0.001 for noninferiority and P=0.84 for superiority). Major bleeding complications occurred in 8 patients (0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group (difference, 0.18 percentage points; 95% CI, -0.65 to 0.29; P=0.42). Clinically important bleeding occurred in 22 patients (1.29%) in the aspirin group and in 17 (0.99%) in the rivaroxaban group (difference, 0.30 percentage points; 95% CI, -1.07 to 0.47; P=0.43). CONCLUSIONS: Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT01720108 .).

A Phase IV Study of Thromboembolic and Bleeding Events Following Hip and Knee Arthroplasty Using Oral Factor Xa Inhibitor.

BACKGROUND: Multiple randomized controlled trials have documented the effectiveness of rivaroxaban in the prevention of venous thromboembolism up to 1-month following total joint arthroplasty. However, the effectiveness and safety of rivaroxaban in the real-world setting, outside of the strict protocols used by randomized clinical trials, are unknown. METHODS: This was a prospective, observational, noninterventional, phase IV study of 3914 consecutive patients who underwent total joint arthroplasty from June 2010 to December 2012. Patients were treated with rivaroxaban 10 mg by mouth daily starting postoperative day 1 and continued for 15 days. Participants were followed up in clinic at 6 weeks and contacted by telephone at 12 weeks. The primary outcome of interest was symptomatic venous thromboembolism; secondary outcomes included bleeding events, transfusion requirements, and death. RESULTS: The incidence of symptomatic deep venous thrombosis at 3 months was 0.5% (n = 18). Only 1 deep venous thrombosis event occurred within 7 days of surgery. The incidence of symptomatic pulmonary embolism (PE) at 3 months was 0.7% (n = 28). Thirteen PEs (46%) occurred within 7 days of surgery. The rate of major bleeding while on prophylaxis was 0.1%. Only 5% of patients received a blood transfusion. No deaths were attributed to thromboembolic events. CONCLUSION: This prospective, observational, phase IV study demonstrates that rivaroxaban appears to protect patients against symptomatic PE and is not associated with major bleeding events when used in a real-world setting as described.

Patient-reported compliance with thromboprophylaxis using an oral factor Xa inhibitor (rivaroxaban) following total hip and total knee arthroplasty.

This prospective study examines patient non-compliance (NC) for an oral factor Xa inhibitor (Rivaroxaban) when used as venous thromboembolic (VTE) prophylaxis following lower limb arthroplasty. A total of 3145 patients underwent surgery from May 2010 to December 2011. At 6 weeks patients completed an anonymous self-administered questionnaire. Postoperatively 2947 (94%, 2947/3145) received Rivaroxaban. 2824 (96%, 2824/2947) completed all in-hospital doses. Seven percent (203/2824) of patients did not attend the 6-week follow-up. Two thousand one hundred sixty-three (83%, 2163/2621) completed all prescribed doses, 98 (4%, 98/2621) were NC and 360 (14%, 360/2621) had incomplete data. Gender, age, body mass index and preoperative hemoglobin all correlated with NC (p < 0.05). Type and side of surgery did not correlate with compliance (p > 0.05). Patient-reported NC for Rivaroxaban is 4% which compares favorably to other VTE prophylaxis modalities.

Discordance between self-report and performance-based outcomes: Contribution of psychosocial factors.

The purpose of this study was to examine the role of psychosocial factors in the discordance between perceived and observed physical disability in patients with osteoarthritis of the hip or knee joint. This was a cross-sectional study of patients seen for consideration of joint arthroplasty surgery. Patients completed a psychosocial outcome measure, a patient self-reported functional scale, and two performance-based tests. Data of 121 patients, mean age, 67 (8), 81 (67%) females were used for analysis. The fear avoidance and positive affect domains had the strongest association with the discordance between the self-report and both performance outcome measures. Age, gender, and severity of osteoarthritis were associated with discordance in relation to walking. Fear avoidance beliefs and positive affect play important roles in perception of pain and function. Age, gender, and severity of arthritis should be taken into consideration for a more holistic approach to arthritis care.

Assessment of the effectiveness of weight-adjusted antibiotic administration, for reduced duration, in surgical prophylaxis of primary hip and knee arthroplasty.

BACKGROUND: Prophylactic antibiotics have significantly led to a reduction in the risk of post-operative surgical site infections (SSI) in orthopaedic surgery. The aim of using antibiotics for this purpose is to achieve serum and tissue drug levels that exceed, for the duration of the operation, the minimum inhibitory concentration of the likely organisms that are encountered. Prophylactic antibiotics reduce the rate of SSIs in lower limb arthroplasty from between 4% and 8% to between 1% and 3%. Controversy, however, still surrounds the optimal frequency and dosing of antibiotic administration. AIM: To evaluate the impact of introduction of a weight-adjusted antibiotic prophylaxis regime, combined with a reduction in the duration of administration of post-operative antibiotics on SSI incidence during the 2 years following primary elective total hip and knee arthroplasty. METHODS: Following ethical approval, patients undergoing primary total hip arthroplasty (THA)/total knee arthroplasty (TKA) with the old regime (OR) of a preoperative dose [cefazolin 2 g intravenously (IV)], and two subsequent doses (2 h and 8 h), were compared to those after a change to a new regime (NR) of a weight-adjusted preoperative dose (cefazolin 2 g IV for patients < 120 kg; cefazolin 3g IV for patients > 120 kg) and a post-operative dose at 2 h. The primary outcome in both groups was SSI rates during the 2 years post-operatively. RESULTS: A total of n = 1273 operations (THA n = 534, TKA n = 739) were performed in n = 1264 patients. There was no statistically significant difference in the rate of deep (OR 0.74% (5/675) vs NR 0.50% (3/598); fishers exact test P = 0.72), nor superficial SSIs (OR 2.07% (14/675) vs NR 1.50% (9/598); chi-squared test P = 0.44) at 2 years post-operatively. With propensity score weighting and an interrupted time series analysis, there was also no difference in SSI rates between both groups [RR 0.88 (95%CI 0.61 to 1.30) P = 0.46]. CONCLUSION: A weight-adjusted regime, with a reduction in number of post-operative doses had no adverse impact on SSI incidence in this population.

Sex-specific differences in 30-day outcomes following primary total hip replacement in 86,684 patients.

INTRODUCTION: Although differential outcomes based on sex are widespread in medicine and surgery, evaluation of sex-specific differences in the field of orthopaedic surgery in general - and arthroplasty in particular - are lacking. We hypothesised that morbidly obese male and female patients would have differing risks of surgical complications following primary total hip replacement. METHODS: We reviewed data contained within the American College of Surgeons National Quality Improvement Program (ACS-NSQIP) database from 2015 through 2018, inclusive. A multivariable binary logistic regression model was used to determine the adjusted odds ratios (OR) of relevant variables on primary and secondary outcomes. RESULTS: A total of 86,684 patients undergoing THR were identified, of whom 9972 patients (4095 male and 5877 female) were morbidly obese. Among morbidly obese patients, odds of surgical site infection were higher in females than males within 30 days of surgery (adjusted OR 1.40; 95% CI, 1.10-1.79; p = 0.007). This comprised the odds of both superficial infection (1.8% vs. 1.1%, adjusted OR 1.67; 95% CI, 1.16-2.40; p = 0.006) and deep infection (1.9% vs. 1.4%, adjusted OR 1.22; 95% CI, 0.88-1.68; p = 0.24). Unexpected return to the operating room (i.e., reoperation) within 30 days of the surgical procedure was also higher among females than males (4.2% vs. 3.1%, adjusted OR 1.38, 95% CI, 1.10-1.71, p = 0.005). There were no differences between male and female patients in the non-obese cohort. CONCLUSIONS: Among patients with morbid obesity, the risk of surgical site infection and reoperation within the first 30 days is greater in women as compared to men. Future research must address whether this early increased risk among morbidly obese women persists in the longer term, and whether it results in compromised function or quality of life.

Virtual performance measure in osteoarthritis: An innovative transformation of patient care.

Objectives: The purpose of this study was to develop and establish reliability and validity of a virtual performance measure (VPM) score that encompassed 10 videos in patients with osteoarthritis of the knee joint. Patients' experience and satisfaction were documented. Design: Forty videos were chosen for 10 functional tasks, with four videos showing increasing difficulty for each task. Patients were requested to choose the video that best reflected their own situation. Clinical and radiological findings and self-report and performance measures were completed. Results: Data of 100 patients, 70 (70%) females, mean age: 65 â€‹± â€‹9 were examined. The Cronbach's alpha coefficient that examined internal consistency of the VPM score was 0.92. The intraclass correlation value of 0.82 was obtained for test-retest reliability. Factor analysis showed three distinct domains. There was moderate correlations between the VPM score and the self-report and actual performance measures ranging from r â€‹= â€‹0.46 to 0.66. The VPM summated score of 10 activities was able to differentiate between candidates and non-candidates for knee arthroplasty, with the area under the curve value of 0.90 indicating excellent predictive validity. The overall patient experience and satisfaction was positive with 67% of participants feeling that virtual care could have an impact on minimizing physical presence in the clinic or hospital. Conclusions: The VPM is a reliable and valid outcome measure in patients with osteoarthritis of the knee joint. This digital tool has the potential to transform osteoarthritis care by providing a valid remote measurement of real-life functional limitations and reduce the burden of time consuming in-person tests.

Association between Neuropathic Pain and Reported Disability after Total Knee Arthroplasty.

PURPOSE: To determine whether reporting neuropathic pain (NP) at an average of 5 years after total knee arthroplasty (TKA) was related to patient age, sex, preoperative comorbidity, arthritis self-efficacy, or disability before surgery and at 1 year after surgery. The estimate of NP prevalence and cross-sectional group differences were explored at 5 years after surgery. METHODS: A subsample of participants in a formal research study was contacted via mail approximately 5 years after undergoing surgery and were sent four questionnaires: the Western Ontario and McMaster Universities Osteoarthritis Index, the Patient Health Questionnaire, the Self-Administered Leeds Assessment of Neuropathic Signs and Symptoms (S-LANSS), and a satisfaction questionnaire. NP was defined as an S-LANSS score of 12 or more. RESULTS: Of 89 patients who met the inclusion criteria, data for 63 (71%) patients (47 women; mean age 67 [SD 8] y) were used for analysis. Of these 63, 9 (14%) were identified as having NP. None had a report of failure of prosthesis or other surgical complications according to most recent medical records. There was no relationship between preoperative patient characteristics and development of NP. However, the NP group on average had a higher report of stiffness (p=0.020), physical dysfunction (p=0.019), and pain (p=0.050) at 1 year after surgery. Cross-sectional comparisons showed higher levels of pain (p=0.001), stiffness (p=0.008), physical dysfunction (p=0.003), and depression (p=0.005) and lower satisfaction (p=0.018) at the time of the survey than the patients without NP. CONCLUSION: The estimated prevalence of NP was 14%. Patients with NP reported higher levels of disability as early as 1 year after surgery. They remained more disabled, with a higher level of depression and less satisfaction, at an average of 5 years after surgery.

Objet : Déterminer si la déclaration de douleurs neuropathiques cinq ans en moyenne après une arthroplastie totale du genou (ATG) est liée à l'âge, au sexe ou à la comorbidité préopératoire, l'auto-efficacité concernant l'arthrite ou l'invalidité du patient avant la chirurgie et un an après celle-ci. L'estimation de la prévalence de douleurs neuropathiques et les différences transversales entre les groupes ont été examinées cinq ans après l'opération. Méthodes  : Un sous-échantillon de participants à une étude officielle ont été joints par courriel environ cinq ans après avoir subi leur opération, et quatre questionnaires leur ont été envoyés: le Western Ontario et McMaster sur l'arthrose (WOMAC), le Questionnaire sur la santé du patient (QSP-9), l'auto-évaluation de Leeds des signes et des symptômes neuropathiques (A-ELSSN) et un questionnaire sur la satisfaction. Les douleurs neuropathiques étaient définies comme étant un résultat de ≥12 à l'A-ELSSN. Résultats : Parmi les 89 patients qui répondaient aux critères d'inclusion, les données de 63 (71 %) d'entre eux (47 femmes; âge moyen de 67 ans [ET 8]) ont été utilisées aux fins d'analyse. Parmi ces 63 personnes, 9 (14 %) avaient déclaré souffrir de douleurs neuropathiques. D'après la plupart des récents dossiers médicaux, personne n'avait signalé une défaillance de la prothèse ou d'autres complications chirurgicales. Il n'y avait aucun lien entre les caractéristiques préopératoires des patients et le développement de douleurs neuropathiques. Toutefois, le groupe souffrant de douleurs neuropathiques avait en moyenne signalé dans une proportion plus forte des raideurs (p=0,020), une dysfonction physique (p=0,019) et des douleurs (p=0,050) un an après la chirurgie. Au moment de l'enquête, les comparaisons transversales ont fait état de degrés élevés de douleurs (p=0,001), de raideurs (p=0,008), de dysfonction physique (p=0,003) et de dépression (p=0,005), ainsi que d'un degré inférieur de satisfaction (p=0,018) par rapport aux patients ne souffrant pas de douleurs neuropathiques. Conclusion : La prévalence estimée de douleurs neuropathiques était de 14 %. Les patients souffrant de douleurs neuropathiques ont signalé des niveaux supérieurs d'invalidité dès la première année suivant la chirurgie. Leur invalidité s'était accrue; ils souffraient davantage de dépression et étaient moins satisfaits, cinq ans en moyenne après la chirurgie.

Evaluating the effectiveness of a 2-year curriculum in a surgical skills center.

BACKGROUND: This study was a formative evaluation of a 2-year Surgical Skills Center Curriculum (SSCC) using objective measures of surgical performance and self-reported process-oriented evaluations. METHODS: Fifty postgraduate third-year (PGY-3) residents participated in an Objective Structured Assessment of Technical Skills (OSATS) examination. Nineteen residents underwent the SSCC and 31 residents did not. During the SSCC, self-reported student and faculty evaluations were completed after each session. RESULTS: For the OSATS examination, scores were not significantly different between treatment and control groups, on either the checklist (66.4 +/- 6.1 versus 64.1 +/- 10.8) or global rating scale scores (66.9 +/- 6.9 versus 68.0 +/- 9.6). Further comparisons between groups on individual OSATS stations revealed no significant differences between groups. The majority of student and faculty evaluation remarks were highly positive. CONCLUSIONS: The OSATS results failed to support our hypothesis that training on a core procedure in a single session during a SSCC would have an appreciable and sustained effect after 2 years. Self-reported process-oriented evaluations support the utility of our SSCC.

Bilateral rotational osteotomies of the proximal tibiae and tibial tuberosity distal transfers for the treatment of congenital lateral dislocations of patellae: a case report and literature review.

Congenital dislocation of patella (CDP) causes varying degree of disability. Patients may present as late walkers with asymmetric gait, habitual or recurrent dislocators or even non-walkers if the condition is bilateral. Patellar instability is often associated with soft tissue or bony pathology. Soft tissue anomalies include lateral soft tissue contractures, shortened quadriceps as well as vastus medialis dysplasia (abnormal origin and insertion). Bony anomalies include shallow trochlear groove and hypoplastic patella or lateral femoral condyle. Soft tissue etiologies result in an imbalance of the dynamic forces acting on the patella while in bony etiologies the static stabilizers to resist lateral dislocation are compromised. External tibial torsion is an additional etiology, often under diagnosed due to the difficulty in measuring the Q angle of dislocated patella. We report a case of bilateral congenital lateral dislocations of the patellae treated with bilateral tibial rotational osteotomies with an 8 year and a 4 year follow up.