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Introduction. There is insufficient data on the trends of anticoagulation after total knee arthroplasty (TKA) in the USA, and the efficacy and safety of rivaroxaban, beyond randomized clinical trials and small cohort studies. Patients and Methods. Using the Truven Health MarketScan database, we retrospectively evaluated new anticoagulation prescriptions after elective TKA from 2010 to 2015. The frequency of deep vein thrombosis (DVT), pulmonary embolism (PE), and adverse events, within 90 days, were then evaluated in 24,856 new users of warfarin and 21,398 new users of rivaroxaban in commercially insured patients (COM), and 15,483 new users of warfarin and 8,997 new users of rivaroxaban in Medicare supplement patients (MED). Data was analyzed by odds ratios using logistic regression models with stabilized inverse probability treatment weighting. Results. Warfarin use decreased from approximately 50% to 17% in COM patients and 60% to 25% in MED patients. Rivaroxaban use increased from 0 to 35% in COM patients and from 0 to 39% in MED patients. Older patients, females, a history of DVT, renal impairment, use of antiplatelet agents or surgery performed as an outpatient had lower odds of getting rivaroxaban. Patients in Western region and having surgery in 2015 had higher odds of getting rivaroxaban. COM patients with capitated insurance plans and a history of PE had lower odds of rivaroxaban initiation. MED patients with atrial fibrillation, cardiovascular disease or hyperlipidemia had lower odds of rivaroxaban initiation. Warfarin users had significantly higher odds ratio of DVT (OR 2.06 in COM patients and OR 2.21 in MED patients) and PE (OR 2.03 in COM patients and OR 2.16 in MED patients) than rivaroxaban users. There were no statistically significant differences in the bleeding risk between the two agents, but warfarin users had a significantly higher odds ratio of periprosthetic infection in both COM (1.57) and MED (1.79) patients. Conclusions. There has been an increase in prophylaxis with rivaroxaban, and a decrease in both warfarin and LMWH use after elective TKA over four years. Rivaroxaban had lower odds ratio of both DVT and PE than warfarin, and bleeding risks were similar. For figures, tables, or references, please contact authors directly


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 60 - 60
1 Jul 2012
Colaço H Davidson J Pekicten B Ahmed S Skyrme A Armitage A Rajaratnam S
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Purpose. This study investigates the effect of early tourniquet release on range of flexion following total knee replacement, and the influence of anticoagulation with Rivaroxaban and Clexane (Enoxaparin). Method. 78 patients were included in the study, who underwent unilateral primary total knee replacement (TKR) in our department under the care of two specialist knee surgeons over a 12 month period. 27 patients underwent TKR with early release of the tourniquet and haemostasis, prior to closure of quadriceps layer: 22 were anticoagulated with Rivaroxaban (GROUP ER), 15 with the low molecular weight heparin Clexane (GROUP EC). Over the same time period, 41 patients TKR with late release of the tourniquet, following closure and bandaging: 13 were anticoagulated with Rivaroxaban (GROUP LR), 28 with Clexane (GROUP LC). A standardised operative technique was employed, and all patients received an AGC (Biomet) PCL-retaining prostheses. Outcome was assessed with range of flexion at 12 weeks postoperatively. Results. The mean range of flexion at 12 weeks was 106.8° in Group ER, 96.54° in Group LR, 108.33° in Group EC and 101.11° in LC. The mean difference in flexion at 12 weeks between Group EC and LC was 7.2°, and between ER and LR was 10.2°. Conclusion. Our study supports the theory that early tourniquet release and haemostasis has a beneficial effect on the early range of flexion following TKR. This affect appears to be increased when the oral anticoagulant Rivaroxaban is used, when compared with low molecular weight heparin


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 51 - 51
1 Jul 2012
Donnachie NJ Finley R
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Purpose of the study. To determine the effectiveness, complications and side effects of Rivaroxaban when used for extended thromboprophylaxis in patients undergoing primary and revision knee arthroplasty. Methods. Venous Thromboembolism (VTE) prophylaxis following knee arthroplasty remains controversial. As an Orthopaedic Unit, in July 2009 we developed guidelines to help ensure that our patient management was fully compliant with National Institute for Health and Clinical Excellence (NICE) guidelines regarding risk assessment and extended oral prophylaxis following primary and revision knee arthroplasty. We opted to trial the oral anticoagulant drug Rivaroxaban for an initial period of 12 months. All patients undergoing primary or revision knee arthroplasty between 1. st. July 2009 and 30. th. June 2010 and who had no contraindications to the prescription of Rivaroxaban were included in a prospective audit aimed at determining compliance with the newly developed unit guidelines as well as the effectiveness and possible side effects/complications associated with the drug therapy. All patients were monitored for a period of 90 days post operatively. Results. A total of 415 patients were included in the audit (336 primary knee arthroplasty, 27 revision knee arthroplasty, 6 patello-femoral resurfacing, 46 medial unicompartmental knee arthroplasty). Of this group eight had a confirmed VTE (six deep vein thrombosis, two pulmonary embolism). A further 29 patients had post-operative complications which may be attributed in part to the action of Rivaroxaban. The drug was discontinued prematurely for 22 patients. Conclusions. Our results indicate that Rivaroxaban is effective in providing extended VTE prophylaxis to patients undergoing knee arthroplasty surgery. However, as anticipated, anticoagulation therapy does cause associated wound problems


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 104 - 104
1 Jul 2012
Hoare C Harper-Smith H Ashman O Skyrme A Rajaratnam S Armitage A
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Introduction. This study investigates the effect of Rivaroxaban (Bayer HealthCare) on early post-operative stiffness in primary total knee replacement. Methods. The anticoagulant of choice for total knee arthroplasty in our Department was changed from Enoxaparin to Rivaroxaban in September 2009. We reviewed a consecutive, multi-surgeon, multi-implant series of primary total knee replacements for a 6 month period prior to (group A) and after (group B) the treatment change. All patients were reviewed by an independent Clinical Specialist Physiotherapist at 6 weeks post-surgery, where the range of movement was recorded prospectively using a goniometer. A stiff knee replacement was defined as one with 15 degrees of extension deficit or flexion to less than 75 degrees at 6 week follow up. All data was analysed on an intention to treat basis. Results. There were 76 patients in group A and 58 in group B. There were 9 stiff knees in group A (11.8%) of which 4 had an extension deficit and 5 had limited flexion. There were 11 stiff knees in group B (19.0%) of which 7 had an extension deficit and 4 had limited flexion. No patient in either group had both an extension deficit and limited flexion as defined by our criteria. 1 patient in group A and 2 in group B underwent manipulation in theatre for stiffness. Conclusion. We conclude that Rivaroxaban appears to increase stiffness at 6 weeks following total knee replacement. We postulate that this may be due to increased soft tissue tension from haematoma or serous discharge


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 47 - 47
1 Jul 2012
Jameson S James P Serrano-Pedraza I Muller S Hui A Reed M
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Introduction. The National Institute for Health and Clinical Effectiveness recommends both low molecular weight heparin (LMWH) and Rivaroxaban for venous thromboembolic (VTE) prophylaxis following lower limb arthroplasty. Despite evidence in the literature that suggests Rivaroxaban reduces VTE events, there are emerging concerns from the orthopaedic community regarding an increase in wound complications following its use. Methods. Through the orthopaedic clinical directors forum, Trusts replacing LMWH with Rivaroxaban for lower limb arthroplasty thromboprophylaxis during 2009 were identified. Prospectively collected Hospital episode statistics (HES) data was then analysed for these units so as to determine rates of 90-day symptomatic deep venous thrombosis (DVT), pulmonary thromboembolism (PTE), major bleed (cerebrovascular accident or gastrointestinal haemorrhage), all-cause mortality, and 30-day wound infection and readmission rates before and after the change to Rivaroxaban. 2752 patients prescribed Rivaroxaban following TKR or THR were compared to 10358 patients prescribed LMWH. Data was analysed using odds ratios (OR). Results. There were significantly more wound infections in the Rivaroxaban group (3.85% vs. 2.81%, OR=0.72; 95% CI 0.58-0.90). There were no significant differences between the two groups for PTE (OR=1.52; 0.77-2.97), major bleed (OR=0.73; 0.48-1.12), all-cause mortality (OR=0.93; 0.46-1.87) and re-admission rate (OR=1.21; 0.88-1.67). There were significantly fewer symptomatic DVTs in the Rivaroxaban group (0.91% vs. 0.36%, OR=2.51; 1.30-4.82). Conclusion. This study is the first to describe the real impact of the use of Rivaroxaban in the NHS. When compared with LMWH in lower limb arthroplasty patients, wound infection rates were significantly higher following Rivaroxaban use whilst providing no reduction in symptomatic PTE or all-cause mortality


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1571 - 1577
1 Oct 2021
Schelde AB Petersen J Jensen TB Gromov K Overgaard S Olesen JB Jimenez-Solem E

Aims. The aim of this study is to compare the effectiveness and safety of thromboprophylactic treatments in patients undergoing primary total knee arthroplasty (TKA). Methods. Using nationwide medical registries, we identified patients with a primary TKA performed in Denmark between 1 January 2013 and 31 December 2018 who received thromboprophylactic treatment. We examined the 90-day risk of venous thromboembolism (VTE), major bleeding, and all-cause mortality following surgery. We used a Cox regression model to compute hazard ratios (HRs) with 95% confidence intervals (CIs) for each outcome, pairwise comparing treatment with dalteparin or dabigatran with rivaroxaban as the reference. The HRs were both computed using a multivariable and a propensity score matched analysis. Results. We identified 27,736 primary TKA patients who received thromboprophylactic treatment (rivaroxaban (n = 18,846); dalteparin (n = 5,767); dabigatran (n = 1,443); tinzaparin (n = 1,372); and enoxaparin (n = 308)). In the adjusted multivariable analysis and compared with rivaroxaban, treatment with dalteparin (HR 0.68 (95% CI 0.49 to 0.92)) or dabigatran (HR 0.31 (95% CI 0.13 to 0.70)) was associated with a decreased risk of VTE. No statistically significant differences were observed for major bleeding or all-cause mortality. The propensity score matched analysis yielded similar results. Conclusion. Treatment with dalteparin or dabigatran was associated with a decreased 90-day risk of VTE following primary TKA surgery compared with treatment with rivaroxaban. Cite this article: Bone Joint J 2021;103-B(10):1571–1577


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 49 - 49
1 Jul 2012
Goodson MW Rath NK White SP John A Forster MC
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NICE guidelines state patients undergoing elective TKR receive post-operative chemical prophylaxis unless contraindicated, following guideline implementation our aim was to determine VTE incidence and wound complication outcomes related to administration of Rivaroxaban or Enoxaparin. From April to October 2010 we prospectively studied 294 patients having primary or revision TKR. Each received either Rivaroxoban (n=219), Enoxaparin (n=68), UHF 5000 units (n=4) or no thromboprohylaxis (n=3) post-operatively. Primary outcome was identification of symptomatic post-operative VTE incidence and compared incidence over the same period in 2009 when aspirin was the standard chemical prophylaxis for VTE. Secondary outcomes were prolonged wound oozing rates and wound washout. VTE occurred in 3 of 219 patients (2 PE, 1 DVT) receiving Rivaroxaban, and 1 PE in a patient who did not receive any thromboprophylaxis. No patients prescribed Enoxaparin developed VTE. In the same period 2009 there were 21 confirmed PEs in 512 patients undergoing TKR. This was statistically significant (Chi squared test p=0.02). Prolonged oozing was noted in 3 patients receiving Enoxaparin, and 17 patients receiving Rivaroxaban. 6 patients treated with Rivaroxaban returned to theatre, 3 for continuous ooze, 2 for wound dehiscence and 1 for infection. During the same period in 2009, there was only 1 return to theatre for haematoma washout. (Chi squared test; p=0.02). Following the NICE guidelines, there is a reduction in the PE rate following TKR but there is an increase in the overall return to theatre rate


Aims

The tibial component of total knee arthroplasty can either be an all-polyethylene (AP) implant or a metal-backed (MB) implant. This study aims to compare the five-year functional outcomes of AP tibial components to MB components in patients aged over 70 years. Secondary aims are to compare quality of life, implant survivorship, and cost-effectiveness.

Methods

A group of 130 patients who had received an AP tibial component were matched for demographic factors of age, BMI, American Society of Anesthesiologists (ASA) grade, sex, and preoperative Knee Society Score (KSS) to create a comparison group of 130 patients who received a MB tibial component. Functional outcome was assessed prospectively by KSS, quality of life by 12-Item Short-Form Health Survey questionnaire (SF-12), and range of motion (ROM), and implant survivorships were compared. The SF six-dimension (6D) was used to calculate the incremental cost effectiveness ratio (ICER) for AP compared to MB tibial components using quality-adjusted life year methodology.


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 191 - 195
1 Jun 2021
Gausden EB Shirley MB Abdel MP Sierra RJ

Aims

To describe the risk of periprosthetic joint infection (PJI) and reoperation in patients who have an acute, traumatic wound dehiscence following total knee arthroplasty (TKA).

Methods

From January 2002 to December 2018, 16,134 primary TKAs were performed at a single institution. A total of 26 patients (0.1%) had a traumatic wound dehiscence within the first 30 days. Mean age was 68 years (44 to 87), 38% (n = 10) were female, and mean BMI was 34 kg/m2 (23 to 48). Median time to dehiscence was 13 days (interquartile range (IQR) 4 to 15). The dehiscence resulted from a fall in 22 patients and sudden flexion after staple removal in four. The arthrotomy was also disrupted in 58% (n = 15), including a complete extensor mechanism disruption in four knees. An irrigation and debridement with component retention (IDCR) was performed within 48 hours in 19 of 26 knees and two-thirds were discharged on antibiotic therapy. The mean follow-up was six years (2 to 15). The association of wound dehiscence and the risk of developing a PJI was analyzed.


Bone & Joint Research
Vol. 6, Issue 9 | Pages 535 - 541
1 Sep 2017
Zan P Mol MO Yao JJ Fan L Yang D Liu K Li G

Objectives

The length of the tourniquet time during total knee arthroplasty (TKA) is related to the incidence of post-operative deep vein thrombosis (DVT). Our aim in this study was to investigate the effect of the early release of the tourniquet on the incidence of DVT in patients undergoing TKA.

Methods

A total of 200 patients who underwent TKA between November 2015 and November 2016 were prospectively enrolled. The tourniquet was inflated before surgery and released immediately after the introduction of the components (early release group). This group was compared with a retrospective cohort of 200 primary TKAs, in which the tourniquet was released after the dressings had been applied (late release group). The presence of a DVT was detected using bilateral lower limb ultrasonography. Peri-operative clinical and follow-up data were collected for analysis.


Bone & Joint Research
Vol. 9, Issue 6 | Pages 322 - 332
1 Jun 2020
Zhao H Yeersheng R Kang X Xia Y Kang P Wang W

Aims

The aim of this study was to examine whether tourniquet use can improve perioperative blood loss, early function recovery, and pain after primary total knee arthroplasty (TKA) in the setting of multiple-dose intravenous tranexamic acid.

Methods

This was a prospective, randomized clinical trial including 180 patients undergoing TKA with multiple doses of intravenous tranexamic acid. One group was treated with a tourniquet during the entire procedure, the second group received a tourniquet during cementing, and the third group did not receive a tourniquet. All patients received the same protocol of intravenous tranexamic acid (20 mg/kg) before skin incision, and three and six hours later (10 mg/kg). The primary outcome measure was perioperative blood loss. Secondary outcome measures were creatine kinase (CK), CRP, interleukin-6 (IL-6), visual analogue scale (VAS) pain score, limb swelling ratio, quadriceps strength, straight leg raising, range of motion (ROM), American Knee Society Score (KSS), and adverse events.


The Bone & Joint Journal
Vol. 100-B, Issue 8 | Pages 1025 - 1032
1 Aug 2018
Wang D Wang H Luo Z Meng W Pei F Li Q Zhou Z Zeng W

Aims

The aim of this study was to identify the most effective regimen of multiple doses of oral tranexamic acid (TXA) in achieving maximum reduction of blood loss in total knee arthroplasty (TKA).

Patients and Methods

In this randomized controlled trial, 200 patients were randomized to receive a single dose of 2.0 g of TXA orally two hours preoperatively (group A), a single dose of TXA followed by 1.0 g orally three hours postoperatively (group B), a single dose of TXA followed by 1.0 g three and nine hours postoperatively (group C), or a single dose of TXA followed by 1.0 g orally three, nine, and 15 hours postoperatively (group D). All patients followed a routine enhanced-recovery protocol. The primary outcome measure was the total blood loss. Secondary outcome measures were hidden blood loss (HBL), reduction in the level of haemoglobin, the rate of transfusion and adverse events.


The Bone & Joint Journal
Vol. 100-B, Issue 1_Supple_A | Pages 68 - 75
1 Jan 2018
Goel R Fleischman AN Tan T Sterbis E Huang R Higuera C Parvizi J Rothman RH

Aims

The aims of this study were to compare the efficacy of two agents, aspirin and warfarin, for the prevention of venous thromboembolism (VTE) after simultaneous bilateral total knee arthroplasty (SBTKA), and to elucidate the risk of VTE conferred by this procedure compared with unilateral TKA (UTKA).

Patients and Methods

A retrospective, multi-institutional study was conducted on 18 951 patients, 3685 who underwent SBTKA and 15 266 who underwent UTKA, using aspirin or warfarin as VTE prophylaxis. Each patient was assigned an individualised baseline VTE risk score based on a system using the Nationwide Inpatient Sample. Symptomatic VTE, including pulmonary embolism (PE) and deep vein thrombosis (DVT), were identified in the first 90 days post-operatively. Statistical analyses were performed with logistic regression accounting for baseline VTE risk.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 3 | Pages 351 - 356
1 Mar 2011
Husted H Troelsen A Otte KS Kristensen BB Holm G Kehlet H

Bilateral simultaneous total knee replacement (TKR) has been considered by some to be associated with increased morbidity and mortality. Our study analysed the outcome of 150 consecutive, but selected, bilateral simultaneous TKRs and compared them with that of 271 unilateral TKRs in a standardised fast-track setting. The procedures were performed between 2003 and 2009.

Apart from staying longer in hospital (mean 4.7 days (2 to 16) versus 3.3 days (1 to 25)) and requiring more blood transfusions, the outcome at three months and two years was similar or better in the bilateral simultaneous TKR group in regard to morbidity, mortality, satisfaction, the range of movement, pain, the use of a walking aid and the ability to return to work and to perform activities of daily living. Bilateral simultaneous TKR can therefore be performed as a fast-track procedure with excellent results.