Aims

Modular dual-mobility (DM) articulations are increasingly used during total hip arthroplasty (THA). However, concerns remain regarding the metal liner modularity. This study aims to correlate metal artifact reduction sequence (MARS)-MRI abnormalities with serum metal ion levels in patients with DM articulations.

Modular dual mobility (DM) articulations are increasingly utilized during total hip arthroplasty (THA). However, concerns remain regarding the metal liner modularity. This study aims to correlate metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) abnormalities with serum metal ion levels in patients with DM articulations.

All patients with an asymptomatic, primary THA and DM articulation with >2-year follow-up underwent MARS-MRI of the operative hip. Each patient had serum cobalt, chromium, and titanium levels drawn. Patient satisfaction, Oxford Hip Score, and Forgotten Joint Score-12 (FJS-12) were collected. Each MARS-MRI was independently reviewed by fellowship-trained musculoskeletal radiologists blinded to serum ion levels.

Forty-five patients (50 hips) with a modular DM articulation were included with average follow-up of 3.7±1.2 years. Two patients (4.4%) had abnormal periprosthetic fluid collections on MARS-MRI with cobalt levels >3.0 μg/L. Four patients (8.9%) had MARS-MRI findings consistent with greater trochanteric bursitis, all with cobalt levels < 1.0 μg/L. A seventh patient had a periprosthetic fluid collection with normal ion levels. Of the 38 patients without MARS-MRI abnormalities, 37 (97.4%) had cobalt levels <1.0 μg/L, while one (2.6%) had a cobalt level of 1.4 μg/L. One patient (2.2%) had a chromium level >3.0 μg/L and a periprosthetic fluid collection. Of the 41 patients with titanium levels, five (12.2%) had titanium levels >5.0 μg/L without associated MARS-MRI abnormalities.

Periprosthetic fluid collections associated with elevated serum cobalt levels in patients with asymptomatic dual mobility articulations occur infrequently (4.4%), but further assessment of these patients is necessary.

Level of Evidence: Level IV

Aims

The goal of the current systematic review was to assess the impact of implant placement accuracy on outcomes following total knee arthroplasty (TKA).

Aims

Dual mobility (DM) bearings are an attractive treatment option to obtain hip stability during challenging primary and revision total hip arthroplasty (THA) cases. The purpose of this study was to analyze data submitted to the American Joint Replacement Registry (AJRR) to characterize utilization trends of DM bearings in the USA.

Introduction

Patient reported outcome measures (PROMs) are increasingly used as quality benchmarks in total joint arthroplasty (TJA). The objective of this study was to investigate whether PROMs correlate with patient satisfaction, which is arguably the most important and desired outcome.

Background

Dual mobility bearings are an attractive treatment option to obtain hip stability during challenging primary and revision total hip arthroplasty (THA) cases. Despite growing enthusiasm in the United States, long-term results of modern dual mobility implants are lacking. The purpose of this study is to analyze data submitted to the American Joint Replacement Registry (AJRR) to characterize utilization trends of dual mobility bearings in the United States.

The selection of a prophylaxis agent is a balance between efficacy and safety. Total knee arthroplasty patients receive DVT prophylaxis because orthopaedic surgeons are concerned about the morbidity and mortality associated with pulmonary embolism. However, at the same time there is great concern about excessive bleeding. The goal is to provide the appropriate anticoagulation to prevent symptomatic pulmonary embolism (PE) and DVT but at the same time avoid over anticoagulation which can be associated with bleeding and other wound problems. Therefore, risk stratification is necessary.

Although risk stratification is the ideal way to determine the appropriate prophylaxis agent to use for a specific patient, there is no validated risk stratification strategy available today. There is general agreement at this time that patients who have had a prior PE or symptomatic DVT are at higher risk for development of a pulmonary embolism. In addition, there is a general belief that patients who have coagulation abnormalities (i.e. Factor V Leiden, Protein C and S deficiency) have an increased risk of developing a pulmonary embolism. Other factors that have been mentioned as associated with PE after total hip arthroplasty include age, female gender, and higher body mass index. The selection of a prophylaxis regimen should be influenced by the ability to mobilise the patient after surgery.

Management of symptomatic osteonecrosis of the hip includes either some type of head preservation procedure or a total hip arthroplasty (THA). In general, once there is collapse of the femoral head, femoral head preservation procedures have limited success. There are a number of different femoral head preservation procedures that are presently performed and there is no consensus regarding which one is most effective. These procedures involve a core decompression with some type of vascularised or nonvascularised grafting of the femoral head. Core decompression with bone grafting of the femoral head with stem cells harvested from the iliac crest and vascularised fibula grafts are the two most popular femoral head preservation procedures.

Once the femoral head has collapsed then a THA should be performed when the patient has significant disability. In the past, total hip arthroplasty in osteonecrosis patients was not considered a highly successful procedure because it was performed in younger patients (most patients are younger than fifty years of age) and longevity was limited by wear and osteolysis. The advent of reliable cementless acetabular and femoral fixation and alternative bearing surfaces (i.e. highly crosslinked polyethylene liners) has been associated with improved outcomes and enhanced longevity. THA is considered the procedure of choice even for young patients (less than 30 years old) with collapse of the femoral head and significant pain and disability.

Introduction

The American Joint Replacement Registry (AJRR) was created to capture total hip (THA) and total knee arthroplasty (TKA) procedural data in order to conduct implant-specific survivorship analyses, produce risk-adjusted patient outcome data, and provide hospitals and surgeons with quality benchmarks. The purpose of this study is to compare early reports from the AJRR to other national registries to identify similarities and differences in surgeon practice and potential topics for future analysis.

There are a number of different non-operative management options for patients with a painful knee secondary to osteoarthritis (OA). In 2013 the American Academy of Orthopaedic Surgeons developed an evidence-based clinical practice guideline addressing treatment of osteoarthritis of the knee. Strength of recommendations were designated as strong, moderate and inconclusive. Strong recommendations included: self-management program, NSAIDs or tramadol and no acupuncture, no glucosamine and chondroitin sulfate and no hyaluronic acid. The “No” recommendations for hyaluronic acid and glucosamine and chondroitin sulfate were quite controversial because orthopaedic surgeons argued that some of their patients benefited from these treatments. Moderate strength recommendations included weight loss, lateral wedge insoles and needle lavage. The evidence-based data was inconclusive with respect to valgus force unloading brace, manual physical therapy, acetaminophen, opioids and pain patches. The effectiveness of corticosteroid and platelet rich plasma (PRP) injections were also inconclusive.

Unloader braces are available to decrease pressure on the involved compartment. There is data showing that these braces can be effective for some patients. However, there are concerns with patient compliance because of poor fit and discomfort. These braces seemed to be tolerated best when used for sports activities in patients with medial compartment arthritis.

Oral anti-inflammatory agents are effective in relieving pain and are a good first line agent for patients with OA. There is significant interest in the use of PRP injections for management of patients with knee OA particularly when patients have already received a steroid and/or a hyaluronic acid injection. To date there are no appropriately powered multi-centered randomised trials demonstrating that PRP is effective in decreasing pain and function in knee OA. However, there are some studies that suggest PRP can be helpful for patients with OA. Further studies to determine the indications for PRP injections are necessary. PRP injections are not covered by insurance in the United States.

In summary, the management of patients with painful OA of the knee needs to be individualised based on patient symptoms and expectations. Non-operative management can be effective in limiting pain and enhancing function.

The bearing surface is the critical element in determining the longevity of a total hip arthroplasty. Over the past decade problems associated with bearing surfaces and modular femoral tapers have had an impact on surgeon selection of both acetabular liners and modular femoral heads. The purpose of this study was to analyse THA bearing surface trends from 2007 through 2014 using a large national database.

A retrospective review of the Nationwide Inpatient Sample (NIS) database was conducted from 2007 to 2014. All patients who underwent a primary THA were identified using International Classification of Diseases, 9th edition (ICD-9) procedure codes. Bearing surface data was extracted by identifying patients with ICD-9 procedure modifier codes. Patient and hospital characteristics were recorded for each patient. Descriptive statistics were employed to characterise bearing surface trends for the following bearing surfaces: metal on polyethylene (MoP); ceramic on polyethylene (CoP); ceramic on ceramic (CoC) and metal on metal (MoM). Univariate analysis was performed to identify differences between the bearing surface groups.

During the study period, 2,460,640 primary THA discharges were identified, of which 1,059,825 (43.1%) had bearing surface data available for further analysis. The breakdown of the bearing surfaces used for these THAs were as follows: MoP − 49.1% (496,713); CoP − 29.1% (307,907); CoC − 4.2% (44,823); and MoM − 19.9% (210,381). MoM utilization peaked in 2008 with 51,033 cases representing 40.1% of THAs implanted that year. The usage steadily declined and by 2014 there were only 6,600 MoM cases representing only 4.0% of the THAs. From 2007 to 2014, the use of CoP bearing surfaces increased from 11,482 discharges (11.1% of cases) in 2007, to 83,300 discharges (50.8% of cases) in 2014. CoP utilization surpassed MoP in 2014. MoP accounted for 54.7% of discharges in 2011 and just 42.1% in 2014.

During the study period, MoM bearing surface usage declined precipitously, while CoP surpassed MoP as the most prevalent bearing surface used in total hip arthroplasty patients. These changes in bearing surface usage over time were clearly influenced by concerns regarding high failure rates associated with MoM articulations and reports of taper corrosion associated with modular metal femoral heads.

Drainage from the knee wound after TKA is an obvious concern for the arthroplasty surgeon. One of the inherent problems with a total knee arthroplasty is there is a focus on obtaining maximum range of motion but at the same time the wound needs to heal in a timely fashion. Consistent knee drainage after a TKA is a source of concern. The quantity and quality of drainage needs to be assessed and there are certain questions that need to be answered including: 1) Is there bloody drainage which suggests fascial dehiscence?; 2) Is the patient too active?; 3) Is the drainage in some way related to DVT prophylaxis?; 4) Is the patient obese and could the drainage be secondary to fat necrosis or seroma? and 5) Is the drainage suggestive of an infection? The work-up can include C-reactive protein and sed rate, and possibly a knee aspiration. In general, C-reactive protein >100mg/L within the first six weeks after surgery suggests the presence of an infection. The sed rate is generally not useful in the early post-operative period. In the first six weeks after surgery if the number of white cells in the aspiration is >10,000 this suggests infection especially if there are 80–90% polymorphonuclear cells.

Each day of prolonged wound drainage is noted to increase the risk of infection by 29%. Morbid obesity has been shown to be an independent risk factor for infection. Some anticoagulants (i.e. low molecular weight heparin) have been associated with increased wound drainage. In a retrospective review of 11,785 total joint arthroplasties, 2.9% of joints developed wound drainage, and of these patients, 28% required further surgery. It was noted that patients that were malnourished had a 35% failure rate with respect to controlling the drainage and preventing infection versus 5% in patients that were healthy.

The International Consensus Conference on Infection concluded that a wound that has been persistently draining for greater than 5–7 days requires surgical intervention. The available literature provides little guidance regarding the specifics of this procedure. In general, if the wound is draining or is red, rest the leg for a day or two. In some instances a bulky Jones dressing can be helpful. If the drainage persists one could consider using a negative pressure dressing (wound vac) but there is little data on efficacy after TKA. If there is persistent drainage or cellulitis, then operative intervention is probably necessary. Evaluation of CRP and a knee joint aspiration can be helpful. The decision to return to the OR should be made within the first 7 days after the surgery. At the time of the procedure one will need to decide to perform either a superficial washout versus a washout and polyethylene exchange.

An outpatient total hip arthroplasty (THA) will be defined as a THA performed at an ambulatory care facility where the patient is discharged the same day as the procedure. Such procedures are being done in the United States and the hypothesis is that a “same day” THA will lead to reduced costs and improved outcomes. However, there are no appropriately powered randomised controlled trials evaluating outcomes in this group of patients to support this hypothesis.

It appears that a “same day” THA is here to stay. Therefore, the selection criteria for patients that undergo the procedure needs to be carefully defined. The safety of this regimen needs to be confirmed.

In an evaluation of the NSQIP database, Otero et al. compared outcomes in patients discharged on POD 0 and POD 1 and noted that THA patients in the POD 0 group had increased rates of complications. Risk factors for complications included age >70, smoking, COPD, CAD and hematocrit less than 36. In addition, the patients discharged on POD 0 had higher rates of diabetes, steroid use and lower hematocrit. Clearly, the selection criteria for this procedure needs to be defined.

In two separate studies, Goyal et al. and Dorr et al. noted that approximately 25% of patients were unable to leave the hospital on POD 0 usually because of nausea and/or hypertension.

Issues to consider before developing a same day discharge program include: 1) Is the patient healthy enough to go home the same day as the surgery?; 2) Does the patient live close enough to the hospital to be discharged the same day?; 3) Can the family provide the appropriate care for the patient at home?; 4) Is it really better for the patient or just better for the surgeon?

If a surgeon embarks on a same day discharge program, rigorous selection criteria must be instituted and followed. In addition, the patient must have free choice with respect to a same day discharge versus a 24-hour stay.

Drainage from the knee wound after TKA is an obvious concern for the arthroplasty surgeon. One of the inherent problems with a total knee arthroplasty is there is a focus on obtaining maximum range of motion but at the same time the wound needs to heal in a timely fashion. Consistent knee drainage after a TKA is a source of concern. The quantity and quality of drainage needs to be assessed and there are certain questions that need to be answered including: 1) Is there bloody drainage which suggests fascial dehiscence?; 2) Is the patient too active?; 3) Is the drainage in some way related to DVT prophylaxis?; 4) Is the patient obese and could the drainage be secondary to fat necrosis or seroma? and 5) Is the drainage suggestive of an infection? The work up can include C-reactive protein and sed rate, and possibly a knee aspiration. In general, C-reactive protein >100 mg/L within the first six weeks after surgery suggests the presence of an infection. The sed rate is generally not useful in the early post-operative period. In the first six weeks after surgery if the number of white cells in the aspiration is >10,000 this suggests infection especially if there are 80–90% polymorphonuclear cells.

Each day of prolonged wound drainage is noted to increase the risk of infection by 29%. Morbid obesity has been shown to be an independent risk factor for infection. Some anticoagulants (i.e. low molecular weight heparin) have been associated with increased wound drainage. In a retrospective review of 11,785 total joint arthroplasties, 2.9% of joints developed wound drainage, and of these patients, 28% required further surgery. It was noted that patients that were malnourished had a 35% failure rate with respect to controlling the drainage and preventing infection versus 5% in patients that were healthy.

The International Consensus Conference on Infection concluded that a wound that has been persistently draining for greater than 5–7 days requires surgical intervention. The available literature provides little guidance regarding the specifics of this procedure. In general, if the wound is draining or is red, rest the leg for a day or two. In some instances a bulky Jones dressing can be helpful. If there is persistent drainage or cellulitis, then operative intervention is probably necessary. Evaluation of CRP and a knee joint aspiration can be helpful. The decision to return to the OR should be made within the first 7 days after the surgery. At the time of the procedure one will need to decide to perform either a superficial washout versus a washout and polyethylene exchange.

Wear and osteolysis are the major problems limiting the longevity of total hip arthroplasty. There is general agreement that if left untreated osteolysis will eventually lead to loosening of the acetabular component. In many cases polyethylene liner exchange may be preferable to revision of a well-fixed acetabular component. If there is osteolysis present the question is when should the polyethylene liner exchange be performed? The answer to that question has not been definitively defined at the present time.

There are few studies available that evaluate the timing of surgical intervention when acetabular osteolysis is present. Indications for surgical intervention include prevention of complete wear of the head through the polyethylene liner (liner thickness < 1.5 mm) and when the osteolysis involves 50% or more of the shell circumference on AP or lateral x-rays. Of course persistent pain with wear or osteolysis is another indication for surgery. Contraindications to cup retention and liner exchange include: 1) Malpositioned component; 2) Non-modular component; 3) Unable to obtain hip stability; 4) Thin polyethylene liner (relative); 5) Severe damage to acetabular shell; and 6) Poor track record of the acetabular component.

If one decides to retain the component the following steps are generally involved in operative management. Remove the liner and assess component stability. Assess the locking mechanism for the polyethylene. If the locking mechanism is not intact one can consider cementing the liner in place. In general, it is recommended to debride and bone graft the osteolytic lesion. The author prefers to use an access hole at the periphery of the component or at times a trapdoor can be made in the ilium. It is essential not to de-stabilise the acetabular component. At the present time there is no optimal graft material to use. Potential graft options include demineralised bone matrix or cancellous bone chips. Since dislocation is the number one complication after polyethylene liner exchange, it is a good idea to use a larger femoral head whenever possible. In some cases it is also worthwhile to consider bracing the patient after the surgery.

It is essential to be ready to perform a complete revision. Therefore, when planning to perform a polyethylene liner exchange one needs to have the appropriate components available to completely revise the acetabular component.

Metal-on-metal bearing surfaces were used frequently until recently because of the potential for decreased wear and the ability to use large femoral heads which can reduce instability. However, data reported in the Australian registry over the past 5 years demonstrated an increase in failure rates compared to metal-on-polyethylene bearings. In addition, adverse local tissue reactions (ALTR) associated with pseudotumors and destruction of the soft tissue around the joint have led to revision of these implants. Unfortunately, at the present time there is no optimal management strategy that has been delineated for metal-on-metal implants because of a lack of evidence. The biologic response to metal-on-metal implants is usually local but may be systemic. The management of these patients is complex because patients may have pseudotumors and/or elevated metal ion levels and be asymptomatic. In addition, there are a number of intrinsic causes (loosening, infection, iliopsoas tendinitis) and extrinsic causes (spinal disease, trochanteric bursitis) that can be a source of pain.

There is no evidenced based approach to manage these patients and no single test should be used to determine treatment. A thorough clinical evaluation is essential and blood tests are necessary to rule out infection. Imaging studies including plain radiographs and a MARS MRI are needed to evaluate either the stability of the prosthesis and to assess for the presence of pseudotumors and soft tissue destruction around the implant. Patients with symptomatic hips and evidence of muscle involvement on MRI require revision. Finally, the clinician must always be aware of the potential for systemic effects which require early and aggressive intervention to limit the adverse response to the metal and the metal bearing.

Metal on metal bearing surfaces were used frequently until recently because of the potential for decreased wear and the ability to use large femoral heads which can reduce instability. However, data reported in the Australian registry over the past 5 years demonstrated an increase in failure rates compared to metal on polyethylene bearings. In addition, adverse local tissue reactions (ALTR) associated with pseudotumors and destruction of the soft tissue around the joint have led to revision of these implants.

Unfortunately, at the present time there is no optimal management strategy that has been delineated for metal on metal implants because of a lack of evidence. The biologic response to metal on metal implants is usually local but may be systemic. The management of these patients is complex because patients may have pseudotumors and/or elevated metal ion levels and be asymptomatic. In addition, there are a number of intrinsic causes (loosening, infection, iliopsoas tendinitis) and extrinsic causes (spinal disease, trochanteric bursitis) that can be a source of pain.

There is no evidence based approach to manage these patients and no single test should be used to determine treatment. A thorough clinical evaluation is essential and blood tests are necessary to rule out infection. Imaging studies including plain radiographs and a MARs MRI are needed to evaluate either the stability of the prosthesis and to assess for the presence of pseudotumors and soft tissue destruction around the implant. Patients with symptomatic hips and evidence of muscle involvement on MRI require revision. Finally, the clinician must always be aware of the potential for systemic effects which require early and aggressive intervention to limit the adverse response to the metal and the metal bearing.

RECORD3 was a multicentre, phase III study designed to investigate the efficacy and safety of rivaroxaban – a novel, oral, once-daily, direct Factor Xa inhibitor – compared with subcutaneous enoxaparin for thromboprophylaxis in patients undergoing total knee arthroplasty (TKA).

Patients scheduled to undergo TKA (N=2,531) were randomized to receive either rivaroxaban 10 mg once daily (initiated 6–8 hours after surgery) or enoxaparin 40 mg once daily (initiated the evening before surgery, then given 6–8 hours after surgery), and daily thereafter for 10–14 days.

The primary efficacy outcome was the composite of any deep vein thrombosis (DVT; symptomatic or asymptomatic detected by mandatory, bilateral venography), non-fatal pulmonary embolism (PE) and all-cause mortality within 13–17 days after surgery.

Rivaroxaban significantly reduced the incidence of the primary efficacy outcome compared with enoxaparin (9.6% vs 18.9%, respectively; p< 0.001; relative risk reduction [RRR] 49%). Rivaroxaban significantly reduced the incidence of major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) compared with enoxaparin (1.0% vs 2.6%, p=0.01; RRR 62%), and the incidence of symptomatic VTE (0.7% vs 2.0%, p=0.005; RRR 66%). The incidence of bleeding events was similar in both groups (major bleeding: 0.6% and 0.5% in the rivaroxaban and enoxaparin groups, respectively; any on-treatment bleeding: 4.9% and 4.8%, respectively; haemorrhagic wound complications [the composite of excessive wound haematoma and surgical-site bleeding]: 2.0% and 1.9%, respectively). There were no deaths or PEs in the rivaroxaban group during the treatment period, and two deaths and four PEs in the enoxaparin group.

Rivaroxaban was significantly more effective than enoxaparin for the prevention of VTE after TKA, with a similar rate of bleeding. The oral, direct Factor Xa inhibitor rivaroxaban, given once daily as a fixed, unmonitored dose of 10 mg, has the potential to change clinical practice for thromboprophylaxis after TKA.

Introduction: Rivaroxaban is a novel, oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. In this phase III trial, the efficacy and safety of thromboprophylaxis with rivaroxaban was compared with enoxaparin in patients undergoing total knee replacement (TKR).

Methods: In RECORD3 – a randomized, double-blind trial – patients received rivaroxaban 10 mg 6–8 hours after surgery and once daily (od) thereafter, or enoxaparin 40 mg od beginning the evening before surgery; both were continued for 10–14 days. The primary efficacy outcome was the composite of any deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all-cause mortality. Secondary efficacy outcomes included major venous thromboembolism (VTE; the composite of proximal DVT, PE and VTE -related death) and symptomatic VTE. The primary safety outcome was major bleeding, and other safety outcomes included any on-treatment bleeding and haemorrhagic wound complications (the composite of excessive wound haematoma and surgical-site bleeding).

Results: A total of 2531 patients were randomized; 2459 were eligible for inclusion in the safety population and 1702 for the modified intention-to-treat population. The primary efficacy outcome was reported in 9.6% of patients receiving rivaroxaban and 18.9% of patients receiving enoxaparin. This equated to a relative risk reduction of 49% (p< 0.001) with rivaroxaban compared with enoxaparin. The incidence of major VTE was also significantly reduced with rivaroxaban compared with enoxaparin (relative risk reduction 62%, p=0.016). The incidence of symptomatic VTE was significantly lower in the rivaroxaban group than in the enoxaparin group (p=0.005). Major bleeding rates were 0.6% and 0.5% in the rivaroxaban and enoxaparin groups, respectively, and rates of any on-treatment bleeding were 4.9% and 4.8%, respectively. The incidence of haemorrhagic wound complications was 2.1% in the rivaroxaban group and 1.9% in the enoxaparin group.

Conclusions: Rivaroxaban was significantly more effective than enoxaparin for the prevention of VTE after TKR, with a similar safety profile. The oral, direct Factor Xa inhibitor rivaroxaban, given as a fixed, unmonitored dose, may have the potential to change clinical practice for thromboprophylaxis after TKR.

Purpose: Rivaroxaban is a novel, oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. RECORD3 was a phase III trial conducted to compare the efficacy and safety of oral rivaroxaban with subcutaneous enoxaparin for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement (TKR).

Method: In this randomized, double-blind trial, patients received rivaroxaban 10 mg once daily (od), or enoxaparin 40 mg od. Enoxaparin was initiated the evening before surgery, and rivaroxaban 6–8 hours after surgery; therapy continued for 10–14 days. The primary efficacy outcome was the composite of any deep vein thrombosis (DVT), pulmonary embolism (PE), and all-cause mortality. Secondary efficacy outcomes included major VTE (the composite of proximal DVT, PE, and VTE-related death) and symptomatic VTE. Major bleeding was the primary safety outcome. Other safety outcomes included any on-treatment bleeding and hemorrhagic wound complications (the composite of excessive wound hematoma and surgical-site bleeding).

Results: A total of 2531 patients were randomized; 2459 were eligible for inclusion in the safety population and 1702 for the modified intention-to-treat population. The incidence of the primary efficacy outcome was significantly reduced with rivaroxaban compared with enoxaparin (relative risk reduction 49%, p< 0.001). Major VTE occurred in 1.0% and 2.6% of patients receiving rivaroxaban and enoxaparin, respectively (relative risk reduction 62%, p=0.016). The incidence of symptomatic VTE was significantly lower in the rivaroxaban group than in the enoxaparin group (p=0.005). Major bleeding rates were 0.6% and 0.5% in the rivaroxaban and enoxaparin groups, respectively, and rates of any on-treatment bleeding were 4.9% and 4.8%, respectively. The incidence of hemorrhagic wound complications was 2.1% in the rivaroxaban group and 1.9% in the enoxaparin group.

Conclusion: Rivaroxaban was significantly more effective than enoxaparin for thromboprophylaxis after TKR. Importantly, the incidence of bleeding was low and similar in both groups. This is the first trial to demonstrate the efficacy and safety of a fixed, unmonitored regimen of an oral, direct Factor Xa inhibitor – rivaroxaban – for thromboprophylaxis after TKR.