The aim of this study was to evaluate the healthcare costs and benefits of enoxaparin compared to aspirin in the prevention of symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) using data from the CRISTAL trial. This trial-based economic analysis reports value for money as incremental cost per quality-adjusted life-year (QALY) gained in 2022 Australian dollars, compared to a single threshold value of AUD$70,000 per QALY. Event costs were estimated based on occurrence of VTEs and bleeds, and on published guidelines for treatment. Unit costs were taken from Australian sources. QALYs were estimated using CRISTAL six-month follow-up data. Sensitivity analyses are presented that vary the cost of VTE treatment, and extend the analyses to two years.Aims
Methods
We investigated the efficacy and safety profile of commonly used venous thromboembolism (VTE) prophylaxis agents following hip and knee arthroplasty. A systematic search of PubMed, Embase, Cochrane Library, Web of Science, and OrthoSearch was performed. Prophylaxis agents investigated were aspirin (< 325 mg and ≥ 325 mg daily), enoxaparin, dalteparin, fondaparinux, unfractionated heparin, warfarin, rivaroxaban, apixaban, and dabigatran. The primary efficacy outcome of interest was the risk of VTE, whereas the primary safety outcomes of interest were the risk of major bleeding events (MBE) and wound complications (WC). VTE was defined as the confirmed diagnosis of any deep vein thrombosis and/or pulmonary embolism. Network meta-analysis combining direct and indirect evidence was performed. Cluster rank analysis using the surface under cumulative ranking (SUCRA) was applied to compare each intervention group, weighing safety and efficacy outcomes.Aims
Methods
We describe three patients with a compartment syndrome of the thigh, two after total hip replacement and one after total knee replacement. Two of the patients were fully anticoagulated. A compartment syndrome of the thigh is a rare, but important complication of joint replacement surgery if patients are receiving
The success rates of two-stage revision arthroplasty for infection have evolved since their early description. The implementation of internationally accepted outcome criteria led to the readjustment of such rates. However, patients who do not undergo reimplantation are usually set aside from these calculations. The aim of this study was to investigate the outcomes of two-stage revision arthroplasty when considering those who do not undergo reimplantation, and to investigate the characteristics of this subgroup. A retrospective cohort study was conducted. Patients with chronic hip or knee periprosthetic joint infection (PJI) treated with two-stage revision between January 2010 and October 2018, with a minimum follow-up of one year, were included. Variables including demography, morbidity, microbiology, and outcome were collected. The primary endpoint was the eradication of infection. Patients who did not undergo reimplantation were analyzed in order to characterize this subgroup better.Aims
Methods
Recent improvements in surgical technique and perioperative blood management after total joint replacement (TJR) have decreased rates of transfusion. However, as many surgeons transition to outpatient TJR, obtaining routine postoperative blood tests becomes more challenging. Therefore, we sought to determine if a preoperative outpatient assessment tool that stratifies patients based on numerous medical comorbidities could predict who required postoperative haemoglobin (Hb) measurement. We performed a prospective study of consecutive unilateral primary total knee arthroplasties (TKAs) and total hip arthroplasties (THAs) performed at a single institution. Prospectively collected data included preoperative and postoperative Hb levels, need for blood transfusion, length of hospital stay, and Outpatient Arthroplasty Risk Assessment (OARA) score.Aims
Methods
Calprotectin (CLP) is produced in neutrophils and monocytes and released into body fluids as a result of inflammation or infection. The aim of this study was to evaluate the utility of blood and synovial CLP in the diagnosis of chronic periprosthetic joint infection (PJI). Blood and synovial fluid samples were collected prospectively from 195 patients undergoing primary or revision hip and knee arthroplasty. Patients were divided into five groups: 1) primary total hip and knee arthroplasty performed due to idiopathic osteoarthritis (OA; n = 60); 2) revision hip and knee arthroplasty performed due to aseptic failure of the implant (AR-TJR; n = 40); 3) patients with a confirmed diagnosis of chronic PJI awaiting surgery (n = 45); 4) patients who have finished the first stage of the PJI treatment with the use of cemented spacer and were qualified for replantation procedure (SR-TJR; n = 25), and 5) patients with rheumatoid arthritis undergoing primary total hip and knee arthroplasty (RA; n = 25). CLP concentrations were measured quantitatively in the blood and synovial fluid using an immunoturbidimetric assay. Additionally, blood and synovial CRP, blood interleukin-6 (IL-6), and ESR were measured, and a leucocyte esterase (LE) strip test was performed.Aims
Methods
Prosthetic joint infection (PJI) remains a major clinical challenge. Neutrophil CD64 index, Fc-gamma receptor 1 (FcγR1), plays an important role in mediating inflammation of bacterial infections and therefore could be a valuable biomarker for PJI. The aim of this study is to compare the neutrophil CD64 index in synovial and blood diagnostic ability with the standard clinical tests for discrimination PJI and aseptic implant failure. A total of 50 patients undergoing revision hip and knee arthroplasty were enrolled into a prospective study. According to Musculoskeletal Infection Society (MSIS) criteria, 25 patients were classified as infected and 25 as not infected. In all patients, neutrophil CD64 index and percentage of polymorphonuclear neutrophils (PMN%) in synovial fluid, serum CRP, ESR, and serum CD64 index levels were measured preoperatively. Receiver operating characteristic (ROC) curves and the area under the curve (AUC) were analyzed for each biomarker.Aims
Methods
There is uncertainty regarding the optimal means of thromboprophylaxis
following total hip and knee arthroplasty (THA, TKA). This systematic
review presents the evidence for acetylsalicylic acid (aspirin)
as a thromboprophylactic agent in THA and TKA and compares it with
other chemoprophylactic agents. A search of literature published between 2004 and 2014 was performed
in accordance with Preferred Reporting Items for Systematic Reviews
and Meta-Analyses guidelines. A total of 13 studies were eligible
for inclusion.Aims
Materials and Methods
The purpose of this study was to assess early physical function
after total hip or knee arthroplasty (THA/TKA), and the correlation
between patient-reported outcome measures, physical performance
and actual physical activity (measured by actigraphy). A total of 80 patients aged 55 to 80 years undergoing THA or
TKA for osteoarthritis were included in this prospective cohort
study. The main outcome measure was change in patient reported hip
or knee injury and osteoarthritis outcome score (HOOS/KOOS) from
pre-operatively until post-operative day 13 (THA) or 20 (TKA). Secondary measures
were correlations to objectively assessed change in physical performance
(paced-walk, chair-stand, stair-climb tests) at day 14 (THA) or
21 (TKA) and actual physical activity (actigraphy) measured at day
12 and 13 (THA) or 19 and 20 (TKA). Aims
Patients and Methods
The aim of this study was to present data on 11 459 patients
who underwent total hip (THA), total knee (TKA) or unicompartmental
knee arthroplasty (UKA) between November 2002 and April 2014 with
aspirin as the primary agent for pharmacological thromboprophylaxis. We analysed the incidence of deep vein thrombosis (DVT) and pulmonary
embolism (PE) then compared the 90-day all-cause mortality with
the corresponding data in the National Joint Registry for England
and Wales (NJR). Aims
Patients and Methods
Post-operative complications after total hip
or knee replacement can delay recovery, prolong hospitalisation, increase
rates of re-admission and, in the most severe cases, lead to long-term
disability or even death. In this analysis of pooled data from four
large, randomised, phase III clinical trials that compared the oral,
direct Factor Xa inhibitor rivaroxaban with subcutaneous enoxaparin
for the prevention of venous thromboembolism after total hip or
knee replacement (n = 12 729), the incidence of complications, including
bleeding and adverse events related to surgery (such as wound infection,
wound dehiscence and haemarthrosis) are reported. Interventions
and procedures relating to surgery are also compared between the
groups. Bleeding events, including excessive wound haematoma and
surgical-site bleeding, occurred at similar rates in the rivaroxaban
and enoxaparin groups. Over the total study duration, adverse surgical
events occurred at a similar rate in the rivaroxaban group compared
with the enoxaparin group after total knee replacement (2.26% This analysis shows that the incidence of adverse surgical events
with rivaroxaban was similar to enoxaparin.
In order to compare the effect of oral apixaban
(a factor Xa inhibitor) with subcutaneous enoxaparin on major venous
thromboembolism and major and non-major clinically relevant bleeding
after total knee and hip replacement, we conducted a pooled analysis
of two previously reported double-blind randomised studies involving 8464
patients. One group received apixaban 2.5 mg twice daily (plus placebo
injection) starting 12 to 24 hours after operation, and the other
received enoxaparin subcutaneously once daily (and placebo tablets)
starting 12 hours (± 3) pre-operatively. Each regimen was continued
for 12 days ( Apixaban 2.5 mg twice daily is more effective than enoxaparin
40 mg once daily without increased bleeding.
We performed a meta-analysis of modern total
joint replacement (TJR) to determine the post-operative mortality and
the cause of death using different thromboprophylactic regimens
as follows: 1) no routine chemothromboprophylaxis (NRC); 2) Potent
anticoagulation (PA) (unfractionated or low-molecular-weight heparin, ximelagatran,
fondaparinux or rivaroxaban); 3) Potent anticoagulation combined
(PAC) with regional anaesthesia and/or pneumatic compression devices
(PCDs); 4) Warfarin (W); 5) Warfarin combined (WAC) with regional anaesthesia
and/or PCD; and 6) Multimodal (MM) prophylaxis, including regional
anaesthesia, PCDs and aspirin in low-risk patients. Cause of death
was classified as autopsy proven, clinically certain or unknown.
Deaths were grouped into cardiopulmonary excluding pulmonary embolism
(PE), PE, bleeding-related, gastrointestinal, central nervous system,
and others (miscellaneous). Meta-analysis based on fixed effects
or random effects models was used for pooling incidence data. In all, 70 studies were included (99 441 patients; 373 deaths).
The mortality was lowest in the MM (0.2%) and WC (0.2%) groups.
The most frequent cause of death was cardiopulmonary (47.9%), followed
by PE (25.4%) and bleeding (8.9%). The proportion of deaths due
to PE was not significantly affected by the thromboprophylaxis regimen (PA, 35.5%;
PAC, 28%; MM, 23.2%; and NRC, 16.3%). Fatal bleeding was higher
in groups relying on the use of anticoagulation (W, 33.8%; PA, 9.4%;
PAC, 10.8%) but the differences were not statistically significant. Our study demonstrated that the routine use of PA does not reduce
the overall mortality or the proportion of deaths due to PE.
We performed a meta-analysis to evaluate the relative efficacy of regional and general anaesthesia in patients undergoing total hip or knee replacement. A comprehensive search for relevant studies was performed in PubMed (1966 to April 2008), EMBASE (1969 to April 2008) and the Cochrane Library. Only randomised studies comparing regional and general anaesthesia for total hip or knee replacement were included. We identified 21 independent, randomised clinical trials. A random-effects model was used to calculate all effect sizes. Pooled results from these trials showed that regional anaesthesia reduces the operating time (odds ratio (OR) −0.19; 95% confidence interval (CI) −0.33 to −0.05), the need for transfusion (OR 0.45; 95% CI 0.22 to 0.94) and the incidence of thromboembolic disease (deep-vein thrombosis OR 0.45, 95% CI 0.24 to 0.84; pulmonary embolism OR 0.46, 95% CI 0.29 to 0.80). Regional anaesthesia therefore seems to improve the outcome of patients undergoing total hip or knee replacement.
The aim of this study was to define return to
theatre (RTT) rates for elective hip and knee replacement (HR and
KR), to describe the predictors and to show the variations in risk-adjusted
rates by surgical team and hospital using national English hospital
administrative data. We examined information on 260 206 HRs and 315 249 KRs undertaken
between April 2007 and March 2012. The 90-day RTT rates were 2.1%
for HR and 1.8% for KR. Male gender, obesity, diabetes and several
other comorbidities were associated with higher odds for both index
procedures. For HR, hip resurfacing had half the odds of cement fixation
(OR = 0.58, 95% confidence intervals (CI) 0.47 to 0.71). For KR,
unicondylar KR had half the odds of total replacement (OR = 0.49,
95% CI 0.42 to 0.56), and younger ages had higher odds (OR = 2.23,
95% CI 1.65 to 3.01) for ages <
40 years compared with ages 60
to 69 years). There were more funnel plot outliers at three standard deviations
than would be expected if variation occurred on a random basis. Hierarchical modelling showed that three-quarters of the variation
between surgeons for HR and over half the variation between surgeons
for KR are not explained by the hospital they operated at or by
available patient factors. We conclude that 90-day RTT rate may
be a useful quality indicator for orthopaedics. Cite this article:
A once-daily dose of rivaroxaban 10 mg, an oral, direct Factor Xa inhibitor, was compared with enoxaparin 40 mg subcutaneously once daily for prevention of venous thromboembolism in three studies of patients undergoing elective hip and knee replacement (RECORD programme). A pooled analysis of data from these studies (n = 9581) showed that rivaroxaban was more effective than enoxaparin in reducing the incidence of the composite of symptomatic venous thromboembolism and all-cause mortality at two weeks (0.4% vs 0.8%, respectively, odds ratio 0.44; 95% confidence interval 0.23 to 0.79; p = 0.005), and at the end of the planned medication period (0.5% vs 1.3%, respectively; odds ratio 0.38; 95% confidence interval 0.22 to 0.62; p <
0.001). The rate of major bleeding was similar at two weeks (0.2% for both) and at the end of the planned medication period (0.3% vs 0.2%). Rivaroxaban started six to eight hours after surgery was more effective than enoxaparin started the previous evening in preventing symptomatic venous thromboembolism and all-cause mortality, without increasing major bleeding.
Since the introduction of the National Institute
for Health and Care Excellence (NICE) guidelines on thromboprophylaxis
and the use of extended thromboprophylaxis with new oral agents,
there have been reports of complications arising as a result of
their use. We have looked at the incidence of wound complications
after the introduction of dabigatran for thromboprophylaxis in our
unit. We investigated the rate of venous thromboembolism and wound
leakage in 1728 patients undergoing primary joint replacement, both
before and after the introduction of dabigatran, and following its
subsequent withdrawal from our unit. We found that the use of dabigatran led to a significant increase
in post-operative wound leakage (20% with dabigatran, 5% with a
multimodal regimen; p <
0.001), which also resulted in an increased
duration of hospital stay. The rate of thromboembolism in patients
receiving dabigatran was higher (1.3%) than in those receiving the multimodal
thromboprophylaxis regimen, including low molecular weight heparin
as an inpatient and the extended use of aspirin (0.3%, p = 0.047).
We have ceased the use of dabigatran for thromboprophylaxis in these
patients. Cite this article:
We studied 4253 patients undergoing primary joint replacement between November 2002 and November 2007, of whom 4060 received aspirin only as chemical prophylaxis; 46 were mistakenly given low molecular weight heparin initially, which was stopped and changed to aspirin; 136 received no chemoprophylaxis and 11 patients received warfarin because of a previous history of pulmonary embolism. We identified the rate of clinical thromboembolism before and after discharge, and the mortality from pulmonary embolism at 90 days. The overall death rate was 0.31% (13 of 4253) and the rate of fatal pulmonary embolism was 0.07% (3 of 4253). Our data suggest that fatal pulmonary embolism is not common following elective primary joint replacement, and with modern surgical practice elective hip and knee replacement should no longer be considered high-risk procedures.
The National Institute for Clinical Excellence (NICE) produces recommendations on appropriate treatment within the National Health Service (NHS) in England and Wales. The NICE guidelines on prophylaxis for venous thromboembolism in orthopaedic surgery recommend that all patients be offered a low molecular weight heparin (LMWH). The linked hospital episode statistics of 219 602 patients were examined to determine the rates of complications following lower limb arthroplasty for the 12-month periods prior to and following the publication of these guidelines. These were compared with data from the National Joint Registry (England and Wales) regarding the use of LMWH during the same periods. There was a significant increase in the reported use of LMWH (59.5% to 67.6%, p <
0.001) following the publication of the guidelines. However, the 90-day venous thromboembolism events actually increased slightly following total hip replacement (THR, 1.69% to 1.84%, p = 0.06) and remained unchanged following total knee replacement (TKR, 1.99% to 2.04%). Return to theatre in the first 30 days for infection did not show significant changes. There was an increase in the number of patients diagnosed with thrombocytopenia, which was significant following THR (0.11% to 0.16%, p = 0.04). The recommendations from NICE are based on predicted reductions in venous thromboembolism events, reducing morbidity, mortality and costs to the NHS. The early results in orthopaedic patients do not support these predictions, but do show an increase in complications.
Rivaroxaban has been recommended for routine use as a thromboprophylactic agent in patients undergoing lower-limb arthroplasty. However, trials supporting its use have not fully evaluated the risks of wound complications. This study of 1048 total hip/knee replacements records the rates of return to theatre and infection before and after the change from a low molecular weight heparin (tinzaparin) to rivaroxaban as the agent of chemical thromboprophylaxis in patients undergoing lower-limb arthroplasty. During a period of 13 months, 489 consecutive patients undergoing lower-limb arthroplasty received tinzaparin and the next 559 consecutive patients received rivaroxaban as thromboprophylaxis. Nine patients in the control (tinzaparin) group (1.8%, 95% confidence interval 0.9 to 3.5) returned to theatre with wound complications within 30 days, compared with 22 patients in the rivaroxaban group (3.94%, 95% confidence interval 2.6 to 5.9). This increase was statistically significant (p = 0.046). The proportion of patients who returned to theatre and became infected remained similar (p = 0.10). Our study demonstrates the need for further randomised controlled clinical trials to be conducted to assess the safety and efficacy of rivaroxaban in clinical practice, focusing on the surgical complications as well as the potential prevention of venous thromboembolism.