Abstract 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 utilized by randomized clinical trials, is unknown. Methods Prospective, observational, non-interventional, phase IV study of 3,914 consecutive patients whom underwent total joint arthroplasty from June 2010 to December 2012. Patients were treated with rivaroxaban 10 mg by mouth daily starting post-operative 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 one deep venous thrombosis event occurred within 7 days of surgery. The incidence of symptomatic pulmonary embolism at 3 months was 0.7% (n=28). Thirteen pulmonary embolisms (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. Conclusions This prospective observational phase IV study demonstrates that rivaroxaban appears to protect patients against symptomatic pulmonary embolism and is not associated with major bleeding events when used in a real world setting as described.
Abstract 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.
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.
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.
Data of 100 patients, 70 (70%) females, mean age: 65 ± 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 = 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.
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.
Abstract Rates of post-operative allogenic blood transfusion in primary hip and knee arthroplasty can be as high as 50%. Risks of allogenic blood transfusion include increased risk of orthopaedic and ...non-orthopaedic infection in addition to the general risks of transfusion. Measures have been developed to minimise the requirements for post-operative allogenic blood transfusion in lower limb arthroplasty. These include pre-operative screening of patients, risk stratification, raising pre-operative haemoglobin pharmacologically, pre-operative autologous donation, minimising intra- and post-operative blood loss and suitable post-operative transfusion practices. Pharmacological, haematological and surgical methods of blood management in lower limb arthroplasty are discussed.
Background: This study examines whether technical skills learned on a bench model are transferable to the human cadaver model.
Methods: Twenty-three first-year residents were randomly assigned to ...three groups receiving teaching on six procedures. For each procedure, one group received training on a cadaver model, one received training on a bench model, and one learned independently from a prepared text. Following training, all residents were assessed on their ability to perform the six procedures.
Results: Repeated measures analysis of variance revealed a significant effect of training modality for both checklist scores (F
2,44 = 3.49,
P <0.05) and global scores (F
2,44 = 7.48,
P <0.01). Post-hoc tests indicated that both bench and cadaver training were superior to text learning and that bench and cadaver training were equivalent.
Conclusions: Training on a bench model transfers well to the human model, suggesting strong potential for transfer to the operating room.
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.
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).
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).
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 .).
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.
Abstract 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.
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.
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.
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.
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.
A total of
= 1273 operations (THA
= 534, TKA
= 739) were performed in
= 1264 patients. There was no statistically significant difference in the rate of deep (OR 0.74% (5/675)
NR 0.50% (3/598); fishers exact test
= 0.72), nor superficial SSIs (OR 2.07% (14/675)
NR 1.50% (9/598); chi-squared test
= 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)
= 0.46.
A weight-adjusted regime, with a reduction in number of post-operative doses had no adverse impact on SSI incidence in this population.
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