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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 29 - 29
1 Aug 2020
Wong I Oldfield M
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The primary objective of this study was to establish a safety profile for an all-arthroscopic anatomic glenoid reconstruction via iliac crest autograft augmentation for the treatment of shoulder instability with glenoid bone loss. Short-term clinical and radiological outcomes were also evaluated. This study involved a retrospective analysis of prospectively collected data for 14 patients (male 8, female 6) who were treated for shoulder instability with bone loss using autologous iliac crest bone graft between 2014 and 2018. Of 14 patients, 11 were available for follow-up. The safety profile was established by examining intra-operative and post-operative complications such as neurovascular injuries, infections, major bleeding, and subluxations. Assessment of pre-operative and post-operative Western Ontario Shoulder Instability (WOSI) index, radiographs, and CT scans comprised the evaluation of clinical and radiological outcomes. A good safety profile was observed. There was no occurrence of intraoperative complications, neurovascular injuries, adverse events, or major bleeding. One patient did develop an infection in the neurovascular injuries, adverse events, or major bleeding. One patient did develop an infection in the treated shoulder post-surgery. There were no subluxations or positive apprehension tests on clinical examination post-operatively. Short-term clinical outcomes were seen to be favorable WOSI scores at the most recent follow-up were significantly higher than pre-operative scores, with a mean increase of 39.6 ± 10.60 (p = 0.00055). The average follow-up for CT scan was 4.66 (SD± 2.33) months, where all patients showed bone graft union. Arthroscopic treatment of shoulder instability with bone loss via autologous iliac crest bone graft is shown to be a safe operative procedure that results in favorable short-term clinical and radiological outcomes. Further investigations must be done to evaluate the longevity of these positive health outcomes


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 221 - 221
1 Jun 2012
Rose B Sindali K Soueid H Jeer C Saran D
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Introduction. Rivaroxaban is the first licensed oral direct inhibitor of factor Xa. Recent studies from the RECORD trials suggest rivaroxaban has superior efficacy compared to enoxaparin in preventing venous thromboembolism (VTE) with no significant increase in the major bleeding risk. Concerns remain regarding the incidence of minor bleeding, consequent delayed wound healing and subsequent risk of infection. The aim of this observational study was to assess the incidence of post-operative complications in patients receiving either rivaroxaban or enoxaparin thromboprophylaxis following elective hip and knee arthroplasty. Methods. 258 patients undergoing elective total hip or knee arthroplasty within one NHS Trust were included. 202 subjects (mean age 70.7 years ± 10.0, 43% male) received a daily dose of 10mg of oral rivaroxaban and 56 (mean age 70.9 years ± 9.8, 39% male) had a daily subcutaneous injection of 40 mg of enoxaparin as thromboprophylaxis. Endpoints included VTE (deep vein thrombosis and pulmonary embolism), haemorrhagic wound complications, hospital re-admission, requirement for blood transfusion, minor and major bleeding and death. Results. There were no significant differences in the incidence of deep vein thrombosis, requirement for blood transfusion and readmission rate between rivaroxaban and enoxaparin-treated patients. However, the incidence of minor bleeding (2.0% versus 0%) and haemorrhagic wound complications (4.9% versus 1.8%) were non-significantly higher in the rivaroxaban-treated group. There were no cases of pulmonary embolism, major bleeding or death in either group. Conclusion. Our experience with rivaroxaban in elective hip and knee arthroplasty showed no significant difference in the incidence of VTE or major bleeding. There was, however, a tendency to greater risk of minor bleeding and consequent delayed wound healing affecting both morbidity and delaying discharge. These may predispose patients to a higher risk of wound infection, and thus these issues require further large scale evaluation


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_II | Pages 82 - 82
1 Feb 2012
Dunbar M Griffin D Copas J Marsh J Lozada-Can C Kwong H Upadhyay P
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Thromboprophylaxis remains a controversial issue and many disagree about the optimum method or even if it is required at all. We present a new method of performing meta-analysis incorporating studies with both experimental and observational study designs. We have developed a model that compares study cohorts of several different methods of thromboprophylaxis with a simulated matched control group whose variance helps to adjust for bias. This allows meaningful comparisons between studies and treatments that have not been directly compared. We performed a systematic review of the literature from 1981 to October 2004. Studies where more than one method of prophylaxis was used were excluded from analysis. For each individual method of prophylaxis, data was extracted, combined and converted to give estimates of the rates of symptomatic, proximal DVT, fatal PE and major bleeding events. We identified 1242 studies of which 203 met the inclusion criteria for further analysis. This represented the results of over fifty thousand studied patients. We expressed the results for the different prophylactic methods as odds ratios compared to no prophylaxis. All methods showed a beneficial effect in reducing VTEs apart from stockings and aspirin which showed an increase in the number of PE events. These results are particularly interesting when viewed from the standpoint of an individual NHS hospital trust that performs around 500 hip and knee replacements per year. Over a 5 year period, the more effective methods of prophylaxis prevented between 15 and 40 symptomatic DVTs and up to 3 fatal PEs compared to no treatment. However, they cause between 8 and 40 more major bleeding events. We do not know the proportion of these major bleeding events that are fatal


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 60 - 60
1 Dec 2013
Frisch N Charters M Wessell N Sikora-Klak J Dobson C Yu S Silverton C Laker M Les C
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Purpose:. Starting February 2012, our institution changed from enoxaparin (Lovenox) to the Factor Xa inhibitor, rivaroxaban (Xarelto) for venous thromboembolism prophylaxis after primary total hip (THA) and total knee arthroplasty (TKA). The purpose of our study was to compare rates of venous thromboembolism and rates of major bleeding between these two medications when used for venous thromboembolism prophylaxis after primary THA and TKA. Methods:. A retrospective review was performed on 1795 patients who underwent THA or TKA at our institution between January 1, 2011 and December 31, 2012. Patients were excluded if they had a bilateral procedure, partial arthroplasty (hip hemiarthroplasty, unicompartmental knee arthroplasty), revision surgery, and cases designated as complex. Patients were excluded if they were on other anticoagulants (dabigatran, aspirin, clopidogrel, warfarin, heparin, fondaparinux), or if pre-operative creatinine was 1.2 or greater. After excluding these patients, there were 1089 patients included in the study. Chart review recorded demographics (age, gender), comorbidities (BMI, ASA, creatinine), surgery performed (primary THA or TKA), length of stay (LOS), venous thromboembolic events (deep venous thrombosis [DVT], pulmonary embolus [PE]), post-operative infections, and major bleeding events (stroke, post-operative bleeding requiring transfusion). Periprosthetic infection rates are also currently being reviewed. T-tests were used to compare continuous variables between treatment groups, and Chi-square tests were used to compare categorical variables between treatment groups (α = 0.05). Results:. There were 779 patients (71.5%) who received enoxaparin and 310 patients (28.5%) who received rivaroxaban during the study period. Demographics of the patients are presented in Table 1. A comparison of venous thromboembolism rates. Pre-operative creatinine was higher in the enoxaparin group (0.81 ± 0.19 vs. 0.72 ± 0.18, p < 0.001). With the numbers available for study, there were no demonstrable differences in DVT (p = 0.400, power = 0.125), PE (p = 0.679, power = 0.066), cerebrovascular events (p = 0.913, power = 0.049), or transfusion rates (p = 0.412, power = 0.121). Conclusion:. To our knowledge this is one of, if not the largest non-industry funded studies comparing these two medications. There were no statistically demonstrable differences between the enoxaparin and rivaroxaban groups in terms of venous thromboembolism or major bleeding complications


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 89 - 89
1 Sep 2012
Marlow W Adam R Walker J Musthyala S
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Aims. This phase II safety study aimed to investigate the bleeding side effect profile in patients treated with Rivaroxaban as a new agent for venous thromboembolism (VTE) prophylaxis following hip or knee arthroplasty. Methods. A retrospective study of complications was conducted in 88 consecutive patients undergoing hip and knee arthroplasty at one centre. Patients received chemical and/or mechanical VTE prophylaxis according to local guidelines. Data was collected from notes and evaluated using Fisher's exact test and t-Test. Significance was determined if p< =0.05. The primary end-point was local wound site oozing or bleeding. Secondary end-points were drop in haemoglobin, drain output and infection. Results. 55 patients were treated with Rivaroxaban, 18 with mechanical prophylaxis only, 10 with Enoxaparin and 5 with aspirin, clopidogrel or warfarin. The Rivaroxaban cohort demonstrated a statistically significant amount of increased major bleeding (24% vs. 0% p=0.03) and wound oozing (27% vs. 0% p=0.02) when compared to patients treated with Enoxaparin. Compared to those treated with other methods of VTE prophylaxis, Rivaroxaban also significantly increased major bleeding (24% vs. 6% p=0.01) and wound oozing (27% vs. 12% p=0.03). The Rivaroxaban cohort demonstrated a significantly larger drop in haemoglobin compared to the combined non-Rivaroxaban group (3.0 vs. 2.4 g/dL p=0.04). There was no significant difference in drain volume or rate of infection between groups. Conclusions. Rivaroxaban appears to cause increased wound site bleeding in comparison to Enoxaparin and other methods of thromboembolism prophylaxis. Further use of Rivaroxaban at this centre was therefore discontinued; however, the small group sizes and retrospective non-randomised design of this study introduce bias and limit the reliability of its findings. Prospective randomised controlled trial focused on wound complications is required to eliminate selection and reporter biases


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIV | Pages 6 - 6
1 Jul 2012
Hickey B Tian T Thomas H Godfrey E Johansen A Jones S
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Patients with hip fracture are at high risk of venous thromboembolism (VTE). Chemical thromboprophylaxis with low molecular weight heparin (LMWH) is associated with a risk of major bleeding in certain patient groups, such as those with renal failure. In these patients, unfractionated heparin should be used. Our aim was to determine the practice of VTE risk assessment in patients admitted with hip fracture against the national guidance, which states that all should have VTE risk assessment on admission. We also assessed the impact of introducing the VTE risk assessment form on prescribing practice of chemical thromboprophylaxis in patients with renal failure. Prospective audit of patients of 50 patients admitted with hip fracture from 4/8/10 with re-audit of 50 patients admitted from 17/2/2011 after introducing the VTE risk assessment form into the hip fracture admissions proforma. Retrospective analysis was undertaken to determine chemical thromboprophylaxis prescribing in patients with eGFR <30ml/min/1.73m. 2. . Patient demographics were comparable in both audit loops, with the mean age being equal (84 years) and an equal majority of female patients (76%). There were similar numbers of patients with eGFR <30ml/min/1.73m. 2. in both audit loops with 8% (n=4) in the initial audit, and 10% (n=5) in the re-audit. Frequency of VTE risk assessment significantly increased from 16% to 86% after including the VTE risk assessment form in the hip fracture proforma (p<0.0001). Despite this, there was no significant reduction in prescribing of LMWH in patients with renal failure with eGFR <30ml/min/1.73m. 2. , (P=0.52). Documentation of VTE risk assessment in patients admitted with hip fracture can be improved by simple measures such as inclusion of the VTE risk assessment form in the admissions proforma. However, this did not result in a reduction of LMWH prescribed in patients with significant renal failure and risk of major bleeding


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 185 - 185
1 May 2012
W. DF M. RL B. IE S. DB F. M T. JB M. H T. W A. KK A. GGT
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Hypothesis. Pre-specified pooling of data from the four phase III RECORD studies was conducted to determine whether rivaroxaban significantly reduced the less-frequent clinical endpoint of symptomatic venous thromboembolism (VTE) and all-cause mortality after total hip or knee arthroplasty (THA or TKA, respectively), compared with standard North American and European enoxaparin regimens. Methods and analysis. Patients (n=12,729) received rivaroxaban 10 mg once daily or enoxaparin 40 mg once daily (RECORD1-3) or 30 mg 12-hourly (RECORD4). Thromboprophylaxis was administered for 31-39 days (RECORD1; THA) or 10-14 days (RECORD3 and 4; TKA). RECORD2 (THA) compared 31-39 days' rivaroxaban with 10-14 days' enoxaparin followed by placebo. The pre-specified primary efficacy endpoint in the pooled analysis (composite of symptomatic VTE and all-cause mortality) and adjudicated bleeding events were analysed in the day 12±2 active treatment pool, when all patients had received active drug, and total treatment duration pool, where subgroup analyses were performed. Results. In the day 12±2 active treatment pool, the primary efficacy endpoint occurred in 0.5% of patients receiving rivaroxaban versus 1.0% of patients receiving enoxaparin (p=0.001). Major bleeding occurred in 0.3% versus 0.2% patients respectively (p=0.18) and major plus clinically relevant non-major bleeding occurred in 2.9% versus 2.5% patients respectively (p=0.19). In the total treatment duration pool, rivaroxaban significantly reduced the primary efficacy endpoint compared with enoxaparin regimens 0.6% versus 1.3% patients (p< 0.001) with similar rates of major bleeding. Over the total treatment period, rivaroxaban consistently reduced the primary efficacy endpoint across the pre-specified subgroups (age, gender, body weight, creatinine clearance). Conclusion. Rivaroxaban significantly reduced the composite of clinically important symptomatic VTE and all-cause mortality after THA or TKA compared with subcutaneous enoxaparin regimens in the direct comparison day 12±2 active treatment pool, with no significant differences in bleeding events. These results suggest a positive benefit-risk profile for oral, once-daily rivaroxaban


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 291 - 291
1 Mar 2013
Okada Y Abe N Miyazawa S Furumatsu T Fujii M Ozaki T
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Introduction. In Japan, edoxaban has been used for the prevention of venous thromboembolism (VTE) after total knee arthroplasty (TKA) since June 2011. Edoxaban is an oral direct factor Xa inhibitor, expected to be more convenient for the postoperative treatment of TKA. Enoxaparin, a II and Xa inhibitor, was approved in Japan for the prevention of VTE in patients undergoing orthopedics surgery from 2008. In this study, the effect for the prevention of VTE after TKA was compared between these two drugs in Japanese patients. Patients and Methods. We studied 42 Japanese patients who underwent TKA from May 2011 to April 2012. The operations were performed under general anesthesia, continuous femoral nerve block, an air tourniquet, and using cements for implant fixation. These patients were divided in two groups, use of 30 mg edoxaban once daily (ED group), and use of 1000 IU of enoxaparin twice daily (EN group). The initial dose was administered between 12 and 21 hours after surgery. We compared the incidence of VTE, bleeding complications, D dimer levels, and hemoglobin (Hb) loss. The screening of VTE was performed by enhanced CT scan screening from the chest to the foot on postoperative day 5 or 6 in all patients. The bleeding complication was divided into major bleeding and minor bleeding with Japanese guideline for the prevention of VTE. D dimer levels and Hb levels were preoperatively and postoperative day 1, 3, 5, 7, and 14. The loss of Hb was calculated from preoperative Hb level minus lowest postoperative Hb level. Results. The following results is showed in the order as ED group, EN group. The incidence of VTE was 45%, 32%, that was higher in ED group (see figure 1). There were almost no differences between both groups about D dimer levels and Hb loss in follow up period (see figure 2, 3). There were no major bleeding in both groups. The incidence of minor bleeding were 20%, 32%, that was higher in EN group (see figure 4). Discussion. We compared the effect of edoxaban and enoxaparin for the prevention of VTE. These two drugs are different way of administration. Edoxaban is administered orally, on the other enoxaparin requires with hypodermic injection. Therefore edoxaban is expected to be more convenient and less complaints than enoxaparin for the prevention of VTE. However our study showed that the use of 30 mg edoxaban once daily was less efficacy than the use of enoxaparin 1000 IU twice daily. The bleeding complication was lower incidence in the edoxaban, thus consideration should be given to the administration dosage of edoxaban to Japanese patients


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 39 - 39
1 Jun 2018
Jacobs J
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Thromboembolic disease (TED) remains as a major concern for orthopaedic surgeons and is a well-known complication of lower extremity joint replacement procedures. While there is voluminous literature on the topic, it is difficult for the average orthopaedic surgeon to keep up with all the advancements in this area as well as the newer pharmacological options for prophylaxis. To address this, the American Academy of Orthopaedic Surgeons (AAOS) has developed a clinical practice guideline (CPG) in this area to provide treatment recommendations based on the best available evidence. Historically, guidelines for TED prophylaxis have been based largely on randomised controlled trials whose outcome measure was venographically documented deep vein thrombosis (DVT). However, many venographically documented DVTs, particularly those distal to the popliteal vein, are of no clinical consequence. Therefore, in the AAOS CPG the systematic review of the literature was focused on those outcomes that have the most clinical relevance: all-cause mortality, symptomatic or fatal pulmonary embolism (PE), proximal DVT, major bleeding and symptomatic DVT rates. Using these as the clinically important endpoints, it is evident that the extant literature is insufficient to provide definitive guidance in this area and to make specific recommendations about optimal pharmacological prophylaxis. Nonetheless, one strong recommendation has emerged from this systematic review: the guideline recommended against routine post-operative duplex ultrasonography screening of patients who undergo elective hip or knee arthroplasty. Only one risk factor – previous history of TED – had evidence demonstrating a higher risk beyond the risk from elective hip or knee arthroplasty itself (weak recommendation). There was not sufficient evidence that other potential risk factors increase the risk of TED, likely because of the relatively high background risk of elective hip or knee arthroplasty. In addition, there is very little evidence defining populations at increased risk for bleeding and bleeding-associated complications associated with pharmacological prophylaxis. However, the panel did come to a consensus that patients with known bleeding disorders or active liver disease are at an increased risk for post-operative bleeding. In these circumstances, it is recommended that mechanical compressive devices be the primary modality of prophylaxis as pharmacologic prophylaxis may increase the risk of bleeding. There was a moderate strength recommendation for the superiority of neuraxial anesthesia to limit blood loss even though there is no demonstrable effect on the incidence of TED. Finally, there was a moderate grade recommendation that pharmacologic agents (including aspirin) and/or mechanical compression devices be utilised for the prevention of VTE in patients that are undergoing elective hip or knee arthroplasty who are not at elevated risk beyond that of the surgery itself for VTE or bleeding. Clearly there is great need for better evidence with appropriately powered studies that examine the most clinically relevant outcomes in TED prophylaxis


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 48 - 48
1 Apr 2018
Elbuluk A Kim K Chen K Anoushiravani A Iorio R
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Background. Venous thromboembolism (VTE) is a common, costly, and morbid complication following TJA. Consequently, the current standard of care recommends that all TJA candidates receive some form of thromboprophylaxis postoperatively. Chemoprophylaxis, however, is not without its own risks and has been associated with greater risk of perioperative complications such as major bleeding, infection, stroke, and increased wound drainage. Mechanical compression devices serve as an alternative to chemoprophylaxis. Compression devices are thought to function by decreasing venous stasis and activating fibrinolysis. Intermittent pneumatic compression devices (IPCD) function by providing pressure at a constant cycle; whereas continuous enhanced circulation therapy (CECT) devices such as ActiveCare portable system (Medical Compression Systems, Or Akiva, Israel) function in a synchronized manner with the patient's own respiratory cycles. While both of these systems are widely utilized, there is scarce data comparing their effectiveness as thromboprophylatic agents following TJA. The purpose of this meta-analysis is to comparatively evaluate the efficacy of ActiveCare to IPCDs in the prevention of thromboembolic events following TJA. Methods. A literature search using PubMed, Cochrane, and EMBASE databases were used to identify all articles published between January 2000 and August 2016. Key words used to conduct the search were venous foot pump, intermittent pneumatic compression, total hip arthroplasty/replacement, total knee arthroplasty/replacement, deep vein thrombosis, thromboembolic disease and pulmonary emboli. Two independent investigators carried out the literature review using the PRISMA guidelines (Figure 1). Analysis of risk ratio was performed by evaluation of studies which compared IPCD with any control chemoprophylaxis regiment or ActiveCare with any control chemoprophlaxis regiment. Assessment of heterogeneity and analysis of data were operated by Review Manager 5.3. Results. Our primary search protocol yielded 968 individual studies by both reviewers of which 525 were duplicates. After screening the remaining 443 abstracts for relevancy 357 were excluded, leaving 86 for full text examination. After a thorough evaluation, 60 were further excluded, and a total of 24 studies, published between 2000 and 2014, were included for analysis, representing 9,134 patients. Of these, 13 were randomized controlled trials and 11 were retrospective studies. When compared to control chemoprophylactic groups, the risk ratio (RR) of DVT development was 0.51 (95% CI: 0.39 – 0.67; I. 2. =69%) with NSIPCDs and 0.47 (95% CI: 0.27 – 0.80; I. 2. =0%) with RSCDs. The RR for development of PE in these groups respectively were 0.24 (95% CI: 0.04 – 0.15) versus 0.55 (95% CI: 0.35 – 0.88) (Figure 3). Conclusion. When compared to chemoprophylaxis alone, compression devices appear to reduce the incidence of VTEs following TJA. The addition of mechanical prophylaxis to any chemoprophylactic regimen increased VTED prevention Following a comparative analysis of IPCDs and ActiveCare our study suggests that ActiveCare may be more effective at preventing VTE events, albeit not statistically significant. Thus, our results demonstrate that while both devices are effective thromboprophylactic modalities, more research is warranted to better elucidate the strengths and limitations of compression devices as thromboprophylatic agents. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_14 | Pages 10 - 10
1 Mar 2013
Saragas N Ferrao P
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Background. This retrospective analysis was prompted by the authors' observation of the relatively high incidence of venous thromboembolism (VTE) in the surgical repair of acute Achilles tendon ruptures. Method. 88 patients were treated surgically for an acute Achilles tendon rupture. No prophylactic anticoagulation was given to any patients. The incidence of VTE was then reviewed retrospectively. Results. Five patients developed symptomatic deep vein thrombosis (5.7%) and one a near-fatal pulmonary embolus (1.1%). There were no major bleeding or cardiovascular adverse events. One patient developed a thrombus of the the lesser saphenous vein (1.1%) and there was one superficial sepsis (1.1%). A temporary peroneal nerve palsy occurred in one patient (1.1%). There were two re-ruptures (2.3%). Conclusion. There is no doubt that thromboprophylaxis must be given to the high risk patient and is also recommended for major orthopaedic surgery. Limited data is available for the use of thromboprophylaxis in foot and ankle surgery. In light of the unacceptably high incidence of venous thromboembolism in this study, the authors suggest that routine venous thromboembolism prophylaxis should be considered for these patients. MULTIPLE DISCLOSURES


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 15 - 15
1 Sep 2012
Hoffman R Naylor J Adie S Dave J
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Rivaroxaban is an oral anticoagulant which has the potential to replace subcutaneous Clexane in post operative prophylaxis of venous thromboembolism following knee replacement. Rivaroxaban has been shown to be at least equivalent to Enoxaparin in the prevention of deep venous thrombosis and pulmonary embolism with a similar rate of major bleeding. However, the morbidity associated with the new product has yet to be fully examined. Our own anecdotal evidence suggests that Rivaroxaban may be associated with poorer knee range of motion, and greater bruising and haemarthrosis. This pilot study aimed to compare these outcomes as well as knee pain and length of hospital stay in patients receiving Rivaroxaban and Enoxaparin following total knee replacement. A controlled before and after study with single blinding was performed. Patients in the ‘Before’ group were given Rivaroxaban (our current protocol). Patients treated in the “After’ group were subjected to our previous protocol (Enoxaparin). Patients were followed up to 6-weeks post surgery. Blinded assessors reviewed range of motion and wound outcomes using a photographic method. Swelling was measured using a standardized technique. Bleeding, pain and length of stay were prospectively recorded. Data analysis is due to be completed in April 2011. Complete results will be available after this time. Discussion: Rivaroxaban was introduced to lessen patient burden as oral administration is presumed to be more acceptable than self-injection of Enoxaparin. It is yet to be determined comprehensively whether the benefits of oral administration outweigh any associated risks. Surgeons must carefully consider the risks and benefits of their choice of venous thrombosis prophylaxis following total knee replacement


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 16 - 16
1 Sep 2012
Smith R Wood A Keenan A Sabnis B Walmsley P Brenkel I
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The risk of venous thrombo-embolism (VTE) is high in orthopedics. Oral direct factor Xa inhibitors have been introduced to help reduce the incidence of VTE. To reduce post-operative bleeding antifibrinolytics are used. We aimed to ascertain the effect of two drugs on post operative bleeding and transfusion requirements. We prospectively recorded patient demographics, operative details, complications, transfusion incidence and VTE incidence in TKR patients. We also sent out questionnaires to patients asking about wound bleeding and VTE. All patients were given 10mg Rivaroxaban 8 hours post operatively and then OD for 14 or 35 days. Patients given tranexamic acid were given 500mg IV, 5 minutes prior to wound closure at the discretion of the surgeon. VTE was Deep Vein Thrombus or Pulmonary Embolism confirmed by Doppler or CTPA. Minor bleed was categorized as dressing soakage or reported wound leakage, major bleed as hematoma requiring revision within 30 days. 509 patients underwent TKR: 200 (39%) received Rivaroxaban only (Group 1), 296 (58%) also received tranexamic acid (Group 2). 13 (3%) patients had no data available. Five patients had a VTE: 4 (2%) in Group 1, 1 (0.3%) in Group 2 [P<0.05]. 39 patients had a minor bleed: 17 (8.5%) in Group 1, 22 (7.4%) in Group 2 [P=0.5]. 2 patients had major bleeds: 1(0.5%) in Group 1 and 1(0.33%) in Group 2 [P=0.69]. There were 30 blood transfusions: 21 (10.5%) in Group 1, 9 (3%) in Group 2 [P<0.0001]. We have demonstrated a reduced requirement for blood transfusions in the tranexamic acid group. However our results, whilst they show a trend towards decreased minor and major bleeding rates, are not significant and require larger studies looking at wound bleeding and leakage


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 166 - 166
1 Jan 2013
Buddhdev P Basu D Davies N Waters T
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Introduction. Rivaroxiban is a direct inhibitor of factor Xa, a licensed oral thromboprophylactic agent that is increasingly being adopted for lower limb arthroplasty. Rivaroxiban has been NICE-approved for use in primary hip and knee arthroplasty following the RECORD 4 trials; proving it more effective in preventing venous thrombo-embolic (VTE) events compared to enoxaparin. Enhanced Recovery Programmes (ERP) are designed to enable patients to recover quickly and return home safely within a few days. Methods. We prospectively studied 1223 patients (age- and sex-matched) who underwent lower-limb arthroplasty enrolled in our ERP between March 2010 and December 2011; 454 patients (Group 1) received enoxaparin, 769 patients (Group 2) received rivaroxiban. Patients wore thrombo-embolic stockings for six weeks post surgery. Patients were monitored for thrombo-embolic events and wound-related complications for 42 days post-operatively. Results. 1223 patients underwent lower-limb arthroplasty during our study period. There were similar numbers of THRs and TKRs in each group 230:224 and 370:399. Average length of stay was 4.9 days (range 1–19) in group 1 and 4.5 days (range 2–23) in group 2. The rate of VTE events was the same in both groups (< 1%). In group 1 (enoxaparin), 21(4.6%) of the 454 patients experienced oozing/infected wounds that required further surgical attention. In group 2 (rivaroxiban), 46 (6%) of the 769 patients had wound-related complications, of which 70% were in primary THR patients. Conclusion. Rivaroxabans use in clinical practice has been questioned concerning its wound-related complications. The RECORD 4 trial focused on major bleeding as the primary safety outcome, however we postulate slow post-operative oozing can lead to haematoma formation, increasing the risk of superficial wound and deep infections potentially requiring revision surgery. This study shows an increased wound complication rate in the Rivaroxiban group, highlighting the need for further clinical trials to assess its safety and efficacy


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 88 - 88
1 Sep 2012
Highcock A Craghill E Simmons D
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Introduction. Oral factor Xa inhibitors have recently been licensed for use as thromboprophylaxis in arthroplasty surgery. Phase IV trials have proven there efficacy in DVT/PE prevention with comparable rates in major adverse events, including major bleeding. We examined whether the introduction of rivaroxoban, an oral factor Xa inhibitor, increased total blood loss in patients undergoing primary arthroplasty surgery. Methods. Two groups were studied. The intervention group were prescribed rivaroxoban thrombophrophylaxis 6–10 hours post-surgery, and the control group were prescribed low molecular weight heparin (daltaparin 5,000u) 6–10 hours post-surgery. All other factors were kept constant. Pre- and post-operative haemoglobin levels (post-operative day 2) were recorded. Any requirement for transfusion was also documented. Actual drop in haemoglobin levels was compared between the two groups. Results. 91 patients were prescribed rivaroxoban (48 THR and 43 TKR), and 71 were included in the control group (34 THR and 37 TKR). Baseline pre-operative haemoglobin were comparable (p=0.43; 13.0 vs 13.2g/dL), however, post-operative blood loss was significantly increased in the rivaroxoban group (p=< 0.0001; 3.6 vs 2.8g/dL). Total knee replacements had a significant increase in post-operative blood loss in the rivaroxoban group (p=< 0.0001; 3.4 vs 2.6g/dL). Total hip replacement surgery had an increase in total blood loss in the rivaroxoban group, but this did not reach statistical significance (p=0.33; 3.8 vs 3.3g/dL). More patients undergoing TKR required transfusion in the rivaroxoban group (0.07% vs 0.03%). Conclusions. Oral factor Xa inhibitors significantly increase post-operative blood loss in total knee arthroplasty surgery when compared with LMWH. There is a subsequent increased requirement for blood transfusion and the potential complications related to bleeding and transfusion. These factors must be considered and balanced with the ease of oral anticoagulation when introducing these newer agents in arthroplasty patients


The Bone & Joint Journal
Vol. 96-B, Issue 3 | Pages 426 - 430
1 Mar 2014
Ferguson JY Sutherland M Pandit HG McNally M

Recent recommendations by the National Institute for Health and Care Excellence (NICE) suggest that all patients undergoing elective orthopaedic surgery should be assessed for the risk of venous thromboembolism (VTE).

Little is known about the incidence of symptomatic VTE after elective external fixation. We studied a consecutive series of adult patients who had undergone elective Ilizarov surgery without routine pharmacological prophylaxis to establish the incidence of symptomatic VTE.

A review of a prospectively maintained database of consecutive patients who were treated between October 1998 and February 2011 identified 457 frames in 442 adults whose mean age was 42.6 years (16.0 to 84.6). There were 425 lower limb and 32 upper limb frames. The mean duration of treatment was 25.7 weeks (1.6 to 85.3).

According to NICE guidelines all the patients had at least one risk factor for VTE, 246 had two, 172 had three and 31 had four or more.

One patient (0.23%) developed a pulmonary embolus after surgery and was later found to have an inherited thrombophilia. There were 27 deaths, all unrelated to VTE.

The cost of providing VTE prophylaxis according to NICE guidelines in this group of patients would be £89 493.40 (£195.80 per patient) even if the cheapest recommended medication was used.

The rate of symptomatic VTE after Ilizarov surgery was low despite using no pharmacological prophylaxis. This study leads us to question whether NICE guidelines are applicable to these patients.

Cite this article: Bone Joint J 2014;96-B:426–30.


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 11 | Pages 1549 - 1552
1 Nov 2005
Malhotra R Bhan S Kiran EK

We present seven patients with recurrent haemarthroses after total knee arthroplasty, caused by an inherent platelet function defect. These patients developed painful knee swelling, persistent bleeding and/or wound breakdown, a platelet factor 3 availability defect being identified in all cases. Surgical exploration, with joint debridement, lavage and synovectomy, was performed in four patients who did not improve with conservative therapy. Histopathological examination of synovium revealed a focal synovial reaction with histiocytic infiltration, and occasional foreign-body giant cells. One patient required an early revision because of aseptic loosening of their tibial component. The condition was treated by single-donor platelet transfusions with good results. The diagnosis, management, and relevance of this disorder are discussed.