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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 199 - 199
1 Sep 2012
Nancoo T Ho K Young S Waite J
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NICE technology appraisal guidance 157 suggests that the oral anticoagulation medication Dabigatran etexilate (Pradaxa®, Boehringer Ingelheim) can be used for the primary prevention of venous thromboembolic events (VTE's) in adult patients who have undergone elective total hip (THR) or knee replacement (TKR) surgery. The NICE guidance and the Pradaxa® Summary of Product characteristics (SPC) report that 13.8% of patients receiving recommended doses of Dabigatran experience adverse bleeding events. In the manufacturer's pivotal clinical trials, wound secretion accounted for 4.9% of patients treated with Dabigatran as compared to 3.0% treated with Enoxaparin. The aim of this audit was to assess the impact of Dabigatran on wound complications at a UK district general hospital and to quantify the effect on the postoperative discharge home support services provided by the award-winning South Warwickshire Accelerated Transfer Team (SWATT). We report our experience of Dabigatran use at Warwick Hospital from March 2009 to March 2010. Of the 788 lower limb arthroplasties performed, 681 patients (81.0%) were accepted for SWATT follow-up. Fifty-five (8.6%) of patients accepted by SWATT showed increased wound secretion for greater than 5 days. This included 12.7% of THR and 5.5% of TKR patients. Increased wound secretion resulted in 226 extra home visits by SWATT, at an extra cost of £23,104 (7.5% increase in SWATT budget). Twenty-six of the 55 patients had positive microbial growth when wound secretions were swabbed. Five patients were admitted for management of wound infections. Incidentally, there were 2 reported cases of DVT and PE. These were not in the increased wound secretion patients. In summary, Dabigatran at Warwick Hospital was associated with a higher than predicted incidence of surgical site morbidity, increased resource output and increased postoperative discharge costs. As a consequence, Dabigatran use has been reduced and other oral anticoagulants are being trialled


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIV | Pages 32 - 32
1 Jul 2012
Nancoo T Ho K Rai P Waite J Young S
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NICE technology appraisal guidance 157 suggests that the oral anticoagulation medication Dabigatran etexilate can be used for the primary prevention of venous thromboembolic events (VTE's) in adult patients who have undergone elective total hip or knee replacement surgery. The NICE guidance reports that 13.8% of patients receiving recommended doses of Dabigatran experienced adverse bleeding events. In the pivotal hip and knee VTE trial, wound secretion only accounted for 4.9% of patients treated with Dabigatran (cf 3.0% of patients treated with Enoxaparin). We report our wound secretion experience after Dabigatran use at Warwick Hospital from March 2009 to March 2010. Of the 788 lower-limb arthroplasties performed, 55 patients (6.9%) had oozing wounds after discharge (Mean=8 days, Range=1-39 days). This resulted in 226 extra home-visits by discharge nurses, 26 positive microbiology cultures and 5 confirmed wound infections needing antibiotic treatment and/or surgical intervention. Incidentally, there were also 2 known cases each of deep vein thrombosis and pulmonary embolus in this cohort. The number of complications was markedly increased from previous years when LMWH was the VTE prophylaxis used. This data suggests that the use of Dabigatran in Warwick Hospital may significantly increase surgical site morbidity and resource output after lower limb arthroplasty


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_18 | Pages 1 - 1
1 Dec 2014
Luke C Kamalanathan S Doorgakant A Sanger R
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In recent years, many changes have taken place regarding agents used for chemical thromboprophylaxis in elective joint replacement. Enoxaparin, Rivaroxaban, Dabigatran and Apixaban are all now recommended in NICE CG92 and their use varies nationally. Whilst data exists comparing oral anticoagulants to Enoxaparin, there is little data on the comparative efficacy of the individual oral anticoagulants. This study analyses data from Warrington Hospital, where each of the above oral anticoagulants was used trustwide in 3 successive years following hip and knee arthroplasty. We analysed similar 4–5 month periods in 2010(Rivaroxiban), 2011(Dabigatran) and 2012(Apixaban). The study was done prospectively and data was collected contemporaneously. The total sample size was 475 patients. Data was collected through electronic hospital patient records. Patients were excluded if data was incomplete. We defined our primary outcome as any complication requiring the drug to be omitted or stopped. We found that for Rivaroxaban, 7 of 129 patients had the drug omitted or stopped (5.4%, 95% confidence interval 1.0–9.8), for Dabigatran 19 of 150 patients, (12.7%, 95% confidence interval 6.4–19.0) and for Apixaban 10 of 196 patients (5.1%, 95% confidence interval 0.9–9.3). For Rivaroxaban and Apixaban, there were no confirmed thromboembolic events; however, for Dabigatran, there were six VTEs. All three had bleeding complications, which were well below the figures published for Enoxaparin. Apixaban registered the lowest rate in our study (5.1%). This data suggests that Apixaban is a safe oral anticoagulant in elective total knee and hip replacement


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 314 - 314
1 Mar 2013
Rocos B
Full Access

The introduction of direct thrombin inhibitors in arthroplasty surgery has reignited the debate on the risk of wound complications when using chemical thromboprophylaxis. It has been suggested that direct thrombin inhibitors might lead to an increased risk of systemic and operative site bleeding and wound sepsis when compared to low molecular weight heparin. In July 2009, departmental thromboprophylaxis policy for patients undergoing hip and knee replacement surgery (including revision) was changed from subcutaneous enoxaparin for the duration of inpatient stay to dabigatran for 10 days (knees) or 28 days (hips) unless contraindicated. In the 2 years prior to policy change, 1091 patients underwent hip or knee arthroplasty (Group A), with 1150 patients undergoing the same procedures in the 2 years following July 2009 (Group B). A minority of patients were already on warfarin (2% in group 1, 3% in group 2). This study presents a retrospective analysis of all patients who returned to theatre within 30 days of joint replacement surgery to assess whether the change in unit policy caused any discernible increase in bleeding-related complications. In group A, 20 / 1091 patients (1.8%) returned to theatre within 30 days. 9 were for reasons unrelated to thromboprophylaxis (mainly dislocated hips), 4 for gastrointestinal bleeding and 7 for wound complications (haematoma, wound breakdown, or infection). In group B, 22 / 1150 patients (1.9%) returned to theatre within 30 days. 13 were for unrelated reasons, 4 for gastrointestinal bleeding, and 5 for wound complications. One patient with a wound complication was on warfarin and therefore did not receive dabigatran. The lower wound complication rate in group B was not statistically different. This study, in a large heterogeneous group of patients, suggests that a change from enoxaparin to dabigatran does not increase the incidence of early infection, or the risk of bleeding at the operative site or the gastrointestinal tract


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_12 | Pages 32 - 32
1 Mar 2013
Rocos B Lankester B
Full Access

The introduction of direct thrombin inhibitors in arthroplasty surgery has reignited the debate on the risk of wound complications when using chemical thromboprophylaxis. It has been suggested that direct thrombin inhibitors might lead to an increased risk of systemic and operative site bleeding and wound sepsis when compared to low molecular weight heparin. In July 2009, departmental thromboprophylaxis policy for patients undergoing hip and knee replacement surgery (including revision) was changed from subcutaneous enoxaparin for the duration of inpatient stay to dabigatran for 10 days (knees) or 28 days (hips) unless contraindicated. In the 2 years prior to policy change, 1091 patients underwent hip or knee arthroplasty (Group A), with1150 patients undergoing the same procedures in the 2 years following July 2009 (Group B). A minority of patients were already on warfarin (2% in group 1, 3% in group 2). This study presents a retrospective analysis of all patients who returned to theatre within 30 days of joint replacement surgery to assess whether the change in unit policy caused any discernible increase in bleeding-related complications. In group A, 20/1091 patients (1.8%) returned to theatre within 30 days. 9 were for reasons unrelated to thromboprophylaxis (mainly dislocated hips), 4 for gastrointestinal bleeding and 7 for wound complications (haematoma, wound breakdown, or infection). In group B, 22/1150 patients (1.9%) returned to theatre within 30 days. 13 were for unrelated reasons, 4 for gastrointestinal bleeding, and 5 for wound complications. One patient with a wound complication was on warfarin and therefore did not receive dabigatran. The lower wound complication rate in group B was not statistically different. This study, in a large heterogeneous group of patients, suggests that a change from enoxaparin to dabigatran does not increase the incidence of local or systemic complications of sufficient severity to warrant return to theatre


Aims. NICE recommends oral anticoagulants after lower limb arthroplasty, as they are thought to lead to better outpatient compliance than injected anticoagulants. Having prescribed self-administered Dalteparin for many years, we began using oral Dabigatran in December 2010. The change afforded an opportunity to compare compliance and acceptability of the two treatments. Methods. Patients were recruited at discharge and telephoned at 28 days. Left over doses were counted to assess compliance. Side-effects, complications and patient views were also recorded. Results. 47 patients were discharged on dalteparin, 59 on dabigatran. Total compliance rates were 81% and 56% respectively (p<0.001). However, the mean pain score associated with dalteparin was 2.4 out of 10, and 31% of patients experienced significant bruising. No patient suffered pain or bruising with dabigatran (p<0.001), but two experienced dyspepsia and four suffered wound problems. Two thromboembolic events and one gastrointestinal bleed occurred in the dalteparin group. Conclusions. Our outpatient compliance is higher for injected anticoagulants than for oral anticoagulants. This runs contrary to some of the marketing for oral agents. However, Dabigatran offers better patient acceptability than Dalteparin. While not designed or powered to show statistically significant differences in complication rates, our study has prompted closer investigation of wound problems with both treatments


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_27 | Pages 3 - 3
1 Jul 2013
Kamalanathan S Luke C Doorgakant A Sanger R
Full Access

In recent years, many changes have taken place regarding agents used for chemical thromboprophylaxis in elective joint replacement. Enoxaparin, Rivaroxaban, Dabigatran and Apixaban are all now recommended in NICE CG92 and their use varies nationally. While data exist comparing oral anticoagulants to Enoxaparin, there is little data on the comparative efficacy of the individual oral anticoagulants. This study analyses data from Warrington Hospital, where each of the above oral anticoagulants was used trustwide in 3 successive years following hip and knee arthroplasty. We analysed similar 4–5 month periods in 2010 (Rivaroxiban), 2011 (Dabigatran) and 2012 (Apixaban). The study was done prospectively and data was collected contemporaneously. The total sample size was 475 patients. Data was collected through electronic hospital patient records. Patients were excluded if data was incomplete. We defined our primary outcome as any complication requiring the drug to be omitted or stopped. We found that for Rivaroxaban, 7 of 129 patients had the drug omitted or stopped (5.4%, 95% confidence interval 1.0–9.8), for Dabigatran 19 of 150 patients, (12.7%, 95% confidence interval 6.4–19.0) and for Apixaban 10 of 196 patients (5.1%, 95% confidence interval 0.9–9.3). For Rivaroxaban and Apixaban, there were no confirmed thromboembolic events; however, for Dabigatran, there were six VTEs. All three had bleeding complications, which were well below the figures published for Enoxaparin. Apixaban registered the lowest rate in our study (5.1%). This data suggests that Apixaban is a safe oral anticoagulant in elective total knee and hip replacement


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIV | Pages 4 - 4
1 Jul 2012
Subramanian P Kantharuban S Shilston S Pearce O
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We present the 12 month data on the relatively novel drug Dabigatran Etexilate (Pradaxa), a new oral anticoagulant which was introduced to combat the risk of post operative venous-thromboembolic disease (VTED) in orthopaedic surgery. This drug was introduced at our hospital in March 2010 and we present our modified protocol of: using 5000u subcutaneous Dalteparin whilst in hospital and giving Dabigatran only on discharge, and at a lower dose (150mg compared to 220mg). We carried out a retrospective analysis of the notes and imaging of every patient who underwent elective hip and knee arthroplasty over 12 months since the drug was introduced. We evaluated the rate of VTED complications and the rate of transfusion and bleeding post operatively. The case series of 370 patients showed a 1% risk of deep vein thrombosis with no pulmonary emboli and 1 death due to an unrelated cause. There was a transfusion rate of 11% with 0.5% patients taken back to theatre for evacuation of haematomas. There were no reported adverse effects of Dabigatran. We argue that our modified protocol for this novel drug should be followed as it is both safe and effective for postoperative anticoagulation


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_9 | Pages 22 - 22
1 Feb 2013
Rocos B Lankester B
Full Access

The introduction of direct thrombin inhibitors in arthroplasty surgery has reignited the debate on the risk of wound complications when using chemical thromboprophylaxis. It has been suggested that direct thrombin inhibitors might lead to an increased risk of systemic and operative site bleeding and wound sepsis when compared to low molecular weight heparin. In July 2009, departmental thromboprophylaxis policy for patients undergoing hip and knee replacement surgery (including revision) was changed from subcutaneous enoxaparin for the duration of inpatient stay to dabigatran for 10 days (knees) or 28 days (hips) unless contraindidated. In the 2 years prior to policy change, 1091 patients underwent hip or knee arthroplasty (Group 1), with1150 patients undergoing the same procedures in the 2 years following July 2009 (Group 2). A minority of patients were already on warfarin (2% in group 1, 3% in group 2). This study presents a retrospective analysis of all patients who returned to theatre within 30 days of joint replacement surgery to assess whether the change in unit policy caused any discernible increase in bleeding-related complications. In group 1, 23/1091 patients (2.1%) returned to theatre within 30 days. 8 were for reasons unrelated to thromboprophylaxis (mainly dislocated hips), 5 for gastrointestinal bleeding (mainly upper GI endoscopy) and 10 for wound complications (haematoma, wound breakdown, or washout of early infection). In group 2, 22 / 1150 patients (1.9%) returned to theatre within 30 days. 12 were for unrelated reasons, 5 for GI bleeding, and 5 for wound complications. The lower return to theatre rate in the second group was not statistically different. This study, in a large heterogeneous group of patients, suggests that a change from enoxaparin to dabigatran does not increase the incidence of early infection, or the risk of bleeding at the operative site or the gastrointestinal tract


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 167 - 167
1 Jan 2013
Morris C Kumar V Sharma S Morris M Raut V Kay P
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Financial impact and patient satisfaction with four different anticoagulants for hip and knee arthroplasty in patients with a previous history of VTE- A prospective randomised trial. Introduction. New generation oral anticoagulants (dabigatran/rivaroxaban) have recently become available for the prevention of venous thromboembolism (VTE) following hip and knee arthroplasty. Traditional therapies (warfarin/low molecular weight heparins) are less costly, but have several limitations. The aim of this study was to evaluate the financial impact of substituting enoxaparin and warfarin with newer therapies dabigatran and rivaroxaban. A secondary objective was to investigate patient satisfaction with these treatments. Methods. A randomised prospective study was conducted over a 12 month period. Patients with a history of VTE undergoing hip or knee replacement were randomised to receive one of four anticoagulants for five weeks post surgery. Information was gathered during the hospital stay and then post discharge, by telephone, for five weeks(35 days)to determine costs. The costs included cost of drug, nursing time, blood monitoring and transport costs. The patients were also asked to complete the Duke Anticoagulation Satisfaction Scale (DASS). The DASS is a 26 item questionnaire which has 7 responses for each question. Results. Although dabigatran and rivaroxaban had higher drug acquisition costs, warfarin and enoxaparin were financially more costly overall. These additional costs were mainly due to increased blood monitoring and time for training and administration which is not required for newer therapies. DASS scores were significantly better with dabigatran (38.5±5.1) and rivaroxaban (38.6±8.3) compared to warfarin (71.8±16.2) and enoxaparin (68.5±14.2) (p< 0.001). This indicates more satisfaction for patients prescribed dabigatran or rivaroxaban compared to traditional therapies. Conclusion. The use of new generation oral anticoagulants has the potential to significantly reduce the financial burden of thromboprophylaxis on the NHS with an additional benefit of better patient satisfaction when compared to traditional therapies


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 33 - 33
1 Jan 2013
Colegate-Stone T Colaco H Harper-Smith H Skyrme A Armitage A Rajaratnam S
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Study Aim. To assess the impact of two oral thromboprophylaxis agents against Clexane with regard to range of movement (ROM) following TKR with or without haemostasis following tourniquet release. Methods & Results. Thromboprophylaxis choice following total knee replacement (TKR) has become of interest with the introduction of oral anticoagulants and support for these by NICE. Specific concerns with oral agents include a perceived elevated level of anti-coagulation and soft tissue complications. The population (n=264) was subclassified into cohorts regarding thromboprophylaxis cover: Clexane, Rivaroxaban and Dabigatran. Each subgroup was subdivided into whether surgery was performed with or without haemostasis following tourniquet release. This study demonstrates Clexane is associated with a better and earlier return of ROM post-operatively as compared to oral the thromboprophylaxis agents. This effect was more obvious when combined with haemostasis following early tourniquet release (p< 0.05). The oral thromboprophylaxis agents Rivaroxaban and Dabigatran had a relative negative effect on ROM as compared against Clexane. This was independent of whether the surgery was performed with or without haemostasis following tourniquet release. There was no different between the subgroups with repect to change of serum haemoglobin, symptomatic venous thromboembolism or rate of return to theatre. Conclusions. This study demonstrates Clexane to have a beneficial effect over the oral anticoagulants, Rivaroxaban and Dabigatran, on ROM and speed of recovery post TKR. This effect was significant (p< 0.05) when combined with genicular vessel haemostasis following early tourniquet release. We hypothesise independent of intra-operative haemostasis of genicular vessels after torniquet release, elevated small vessel ooze secondary to the oral thromboprophylaxis has a detrimental impact on ROM post TKR


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_13 | Pages 95 - 95
1 Nov 2015
Barrack R
Full Access

Venous thromboembolic events, either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.®; Medical Compression Systems, Inc., Or Akiva, Israel) with or without aspirin compared with current pharmacology protocols for venous thromboembolism prophylaxis in patients undergoing elective primary unilateral lower extremity joint arthroplasty. A multicenter registry was established to capture the rate of symptomatic venous thromboemboli following primary lower extremity joint arthroplasty in 3,060 patients from ten sites including knee arthroplasty (1,551) or hip arthroplasty (1,509). All patients were 18 years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began peri-operatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months post-operatively to document any evidence of deep venous thrombosis or pulmonary embolism. Of 3,060 patients, twenty-eight (0.92%) had venous thromboembolism (20 distal deep venous thromboses, 3 proximal deep venous thromboses, and 5 pulmonary emboli). One death occurred with no autopsy performed. Symptomatic venous thromboembolic rates observed in lower extremity joint arthroplasty patients using the mobile compression device were non-inferior (not worse than) at a margin of 1.0% to rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran except in the knee arthroplasty group where the mobile compression device fell short of rivaroxaban by 0.06%. Use of the mobile compression device with or without aspirin for patients undergoing lower extremity joint arthroplasty provide a non-inferior risk for developing venous thromboembolism compared with current pharmacological protocols reported in the literature


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_1 | Pages 40 - 40
1 Feb 2015
Barrack R
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Venous thromboembolic events, either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.®; Medical Compression Systems, Inc., Or Akiva, Israel) with or without aspirin compared with current pharmacology protocols for venous thromboembolism prophylaxis in patients undergoing elective primary unilateral lower extremity joint arthroplasty. A multicenter registry was established to capture the rate of symptomatic venous thromboemboli following primary lower extremity joint arthroplasty in 3,060 patients from ten sites including knee arthroplasty (1,551) or hip arthroplasty (1,509). All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous thrombosis or pulmonary embolism. Of 3,060 patients, 28 (0.92%) had venous thromboembolism (20 distal deep venous thromboses, 3 proximal deep venous thromboses, and 5 pulmonary emboli). One death occurred with no autopsy performed. Symptomatic venous thromboembolic rates observed in lower extremity joint arthroplasty patients using the mobile compression device were non-inferior (not worse than) at a margin of 1.0% to rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran except in the knee arthroplasty group where the mobile compression device fell short of rivaroxaban by 0.06%. Use of the mobile compression device with or without aspirin for patients undergoing lower extremity joint arthroplasty provide a non-inferior risk for developing venous thromboembolism compared with current pharmacological protocols reported in the literature


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 5 - 5
1 Feb 2017
Habashy A Sumarriva G Chimento G
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Background. Intravenous and topical tranexamic acid (TXA) has become increasingly popular in total joint arthroplasty to decrease perioperative blood loss. In direct comparison, the outcomes and risks of either modality have been found to be equivalent. In addition, current literature has also demonstrated that topical TXA is safe and effective in the healthy population. To our knowledge, there is a scarcity of studies demonstrating the safety of topical TXA in high risk patient populations undergoing total joint arthroplasty or revision joint arthroplasty. The purpose of this study is to determine the safety of topical TXA in patients undergoing total or revision arthroplasty that are also on chronic anticoagulant or anti-platelet therapy. Methods. We performeded a retrospective review of patients undergoing primary and revision total hip or knee arthroplasties that received topical TXA (3g/100mL NS) from November 2012 to March 2015. All patients, regardless of co-morbidities, were included in the study population. Patients were divided into 3 groups:. Group 1: Patients without any antiplatelet or anticoagulant therapy within 90 days of surgery. Group 2: Patients receiving antiplatelet therapy (Aspirin and/or Plavix) within 90 days of surgery. Group 3: Patients receiving anti-coagulant therapy within 90 days of surgery (low molecular weight heparin, unfractionated heparin, warfarin, dabigatran, rivaroxaban, apixaban). Chart review analyzing ICD-9 and ICD-10 coding was then utilized to establish any peri-operative complications within the 30 day post-operative period in all groups. Complications amongst the groups were evaluated via chi-squared testing as well as multivariate linear regression. Review of current literature and CMS protocols were used to establish reportable peri-operative complications. Wound infections, thromboembolic events and vascular complications such as myocardial infarction, pulmonary embolism, deep venous thrombosis, stroke, aortic dissection were included. Results. During the study period, a total 1471 total joint arthroplasties were performed on 1324 patients (88.7% knee arthroplasty, 11.3% hip arthroplasty). Group 1 included 1033 patients who were not on any prior anti-platelet or anticoagulant therapy. Group 2 included 254 patients receiving chronic antiplatelet therapy 90 days prior to surgery. Group 3 included 184 patients receiving chronic anticoagulant therapy 90 days prior to surgery. No statistically significant differences were found between the groups for any of the included peri-operative complications. The most common complication occurring amongst all the groups was superficial wound infection, which occurred in a total of 60 (4.1%) patients in contrast to 18 (1.2%) patients who sustained an acute deep peri-prosthetic infection. Twenty (1.4%) patients sustained an ultrasound proven deep vein thrombosis, with the highest prevalence occurring in those patients receiving no anticoagulation prior to surgery (15/20, 75%), however this was not statistically significant following linear regression analysis. Conclusions. To our knowledge, this is the first study that demonstrates that topical tranexamic acid is safe to use in so-called high risk patients who are being treated prior to surgery with anti-platelet or anti-coagulation therapy


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_12 | Pages 36 - 36
1 Jul 2014
Barrack R
Full Access

Venous thromboembolic events, either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.®; Medical Compression Systems, Inc., Or Akiva, Israel) with or without aspirin compared with current pharmacology protocols for venous thromboembolism prophylaxis in patients undergoing elective primary unilateral lower extremity joint arthroplasty. A multicenter registry was established to capture the rate of symptomatic venous thromboemboli following primary lower extremity joint arthroplasty in 3,060 patients from ten sites including knee arthroplasty (1,551) or hip arthroplasty (1,509). All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began peri-operatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months post-operatively to document any evidence of deep venous thrombosis or pulmonary embolism. Of 3,060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thromboses, three proximal deep venous thromboses, and five pulmonary emboli). One death occurred with no autopsy performed. Symptomatic venous thromboembolic rates observed in lower extremity joint arthroplasty patients using the mobile compression device were non-inferior (not worse than) at a margin of 1.0% to rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran except in the knee arthroplasty group where the mobile compression device fell short of rivaroxaban by 0.06%. Use of the mobile compression device with or without aspirin for patients undergoing lower extremity joint arthroplasty provide a non-inferior risk for developing venous thromboembolism compared with current pharmacological protocols reported in the literature


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_8 | Pages 44 - 44
1 May 2014
Barrack R
Full Access

Venous thromboembolic events, either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.®; Medical Compression Systems, Inc., Or Akiva, Israel) with or without aspirin compared with current pharmacology protocols for venous thromboembolism prophylaxis in patients undergoing elective primary unilateral lower extremity joint arthroplasty. A multicenter registry was established to capture the rate of symptomatic venous thromboemboli following primary lower extremity joint arthroplasty in 3,060 patients from ten sites including knee arthroplasty (1,551) or hip arthroplasty (1,509). All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous thrombosis or pulmonary embolism. Of 3,060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thromboses, three proximal deep venous thromboses, and five pulmonary emboli). One death occurred with no autopsy performed. Symptomatic venous thromboembolic rates observed in lower extremity joint arthroplasty patients using the mobile compression device were non-inferior (not worse than) at a margin of 1.0% to rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran except in the knee arthroplasty group where the mobile compression device fell short of rivaroxaban by 0.06%. Use of the mobile compression device with or without aspirin for patients undergoing lower extremity joint arthroplasty provides a non-inferior risk for developing venous thromboembolism compared with current pharmacological protocols reported in the literature


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 195 - 195
1 Sep 2012
Edwards H Yeoh D Dawson-Bowling S Ellens N East D Miles K Butler-Manuel A Apthorp H
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Introduction. Deep vein thrombosis(DVT) and pulmonary embolism(PE) are well-recognised complications following lower limb arthroplasty (Cohen et al, 2001). The National Institute for Clinical Excellence and British Orthopaedic Association recommend the use of both mechanical and chemical prophylaxis. At our institute regimens have changed reflecting new developments in the use of thombo-prophylaxis. Our aim was to assess the efficacy of these methods in preventing complications. Methods. Since moving from Aspirin and compression stockings (TEDS) only, three different treatment methods were prospectively audited. Regimen 1 consisted of Aspirin (150 mg OD) and TEDS for 6 weeks (n=660). Regimen 2 used Clexane 40mg OD (n=448). Regimen 3 used Rivaroxaban (n=100) as licensed and Regimen 4 Dabigatran (n=185) as licensed. We looked at rates of venous thromboembolism (VTE), rates of post op bleeding/haematoma and wound complications. Patients were reviewed prior to discharge, and at a six-week follow-up. Any casualty attendances were also recorded up to 12 weeks post-operatively. Results. Symptomatic VTE rates were as follows 3.78% for Regimen 1, 1.9% for Regimen 2, 0% for Regimen 3 and 1.6% for regimen 4. Haematoma/bleeding rates were as follows 1.06% Regimen 2, 5% Regimen 3, and 2.7% Regimen 4. Rates of serosanguineous exudate were as follows 0.2% Regimen 2, 8% Regimen 3 and 5.4% Regimen 4. Conclusion. Our move from Aspirin was based on local audit, which highlighted a higher than national average PE rate. A change towards oral based prophylaxis was based on ease of administration and potential reduction in costs. Although DVT/PE rates were lower with the oral thrombo-prophylaxis, bleeding and wound complications appear higher. This study highlights the need to monitor both VTE and bleeding rates when adopting any changes in protocol, with a view on individualised treatment on balance of risks


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 186 - 186
1 May 2012
A. P J. H J. B G. S N. T N. R
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Background. Current UK NICE guidelines on the prevention of thromboembolism state that all patients undergoing elective Hip or Knee Replacement surgery should be offered combined mechanical and pharmacological VTE prophylaxis. Methods. The original audit was performed between October 1999 and January 2009, totaling 7,532 patients. Updated to the full 10 years, a total of 8,140 patients underwent hip or knee replacement surgery (revision and primary) in our unit. Using a targeted thromboprophylaxis policy 83% of patients received mechanical A-V foot pumps only until mobile. High risk patients (12%) received in addition LMWH or fondaparinux, with only very high risk patients continuing on chemical prophylaxis post-discharge. All data are collected and stored on our own joint registry database with patients being assessed pre-operatively to determine their level of VTE risk. Results. Overall DVT rate was 1%, PE rate 0.5% and fatal PE rate 0.06%. The rates were slightly higher in the targeted Chemical thromboprophylaxis group (DVT 1.6%, PE 0.95%, fatal PE 0.1%) as expected as these patients were identified as being high risk. 5% of patients failed to receive any prophylaxis and in these patients the rates were the lowest of all (DVT 0.8%, PE 0.3% and fatal PE 0%). All p-values were >0.05. These rates are similar to those published in recent trials involving the oral anticoagulants Dabigatran and Rivaroxaban, given to all patients, (RE-NOVATE, RECORD 1,2,3,4, RE-MOBILISE Trials) with all p values again > 0.05. Complications however were ten times less using a targeted approach. Conclusion. We recommend the use of a targeted approach, only chemically treating those patients who are at high risk for thromboembolism, along with a rapid recovery programme. This has not only been shown to be safe but cuts costs and has ten times fewer complications than treating all patients with both chemical and mechanical prophylaxis as suggested by NICE


The Bone & Joint Journal
Vol. 97-B, Issue 4 | Pages 434 - 441
1 Apr 2015
Shabani F Farrier AJ Krishnaiyan R Hunt C Uzoigwe CE Venkatesan M

Drug therapy forms an integral part of the management of many orthopaedic conditions. However, many medicines can produce serious adverse reactions if prescribed inappropriately, either alone or in combination with other drugs. Often these hazards are not appreciated. In response to this, the European Union recently issued legislation regarding safety measures which member states must adopt to minimise the risk of errors of medication.

In March 2014 the Medicines and Healthcare products Regulatory Agency and NHS England released a Patient Safety Alert initiative focussed on errors of medication. There have been similar initiatives in the United States under the auspices of The National Coordinating Council for Medication Error and The Joint Commission on the Accreditation of Healthcare Organizations. These initiatives have highlighted the importance of informing and educating clinicians.

Here, we discuss common drug interactions and contra-indications in orthopaedic practice. This is germane to safe and effective clinical care.

Cite this article: Bone Joint J 2015;97-B:434–41.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 6 | Pages 729 - 734
1 Jun 2012
Kakkos SK Warwick D Nicolaides AN Stansby GP Tsolakis IA

We performed a systematic review and meta-analysis to compare the efficacy of intermittent mechanical compression combined with pharmacological thromboprophylaxis, against either mechanical compression or pharmacological prophylaxis in preventing deep-vein thrombosis (DVT) and pulmonary embolism in patients undergoing hip or knee replacement. A total of six randomised controlled trials, evaluating a total of 1399 patients, were identified. In knee arthroplasty, the rate of DVT was reduced from 18.7% with anticoagulation alone to 3.7% with combined modalities (risk ratio (RR) 0.27, p = 0.03; number needed to treat: seven). There was moderate, albeit non-significant, heterogeneity (I2 = 42%). In hip replacement, there was a non-significant reduction in DVT from 8.7% with mechanical compression alone to 7.2% with additional pharmacological prophylaxis (RR 0.84) and a significant reduction in DVT from 9.7% with anticoagulation alone to 0.9% with additional mechanical compression (RR 0.17, p < 0.001; number needed to treat: 12), with no heterogeneity (I2 = 0%). The included studies had insufficient power to demonstrate an effect on pulmonary embolism.

We conclude that the addition of intermittent mechanical leg compression augments the efficacy of anticoagulation in preventing DVT in patients undergoing both knee and hip replacement. Further research on the role of combined modalities in thromboprophylaxis in joint replacement and in other high-risk situations, such as fracture of the hip, is warranted.