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.
To conduct a pilot randomised controlled trial to evaluate the
feasibility of conducting a larger trial to evaluate the difference
in Victorian Institute of Sports Assessment-Achilles (VISA-A) scores
at six months between patients with Achilles tendinopathy treated
with a platelet-rich plasma (PRP) injection compared with an eccentric
loading programme. Two groups of patients with mid-substance Achilles tendinopathy
were randomised to receive a PRP injection or an eccentric loading
programme. A total of 20 patients were randomised, with a mean age
of 49 years (35 to 66). All outcome measures were recorded at baseline,
six weeks, three months and six months.Objectives
Methods
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.
The role of heritable thrombophilic risk factors in the pathogenesis of the Perthes’ disease is controversial. The clinical and radiological findings of Perthes’ disease may be indistinguishable from those of Gaucher’s disease, and the most common Jewish N370S Gaucher mutation is threefold greater in patients with Perthes’ disease. Familial osteonecrosis of the femoral head is associated with variant mutations of collagen type II (COL2A1 mutations). We therefore studied the potential role of genetic thrombophilia and the Gaucher and COL2A1 mutations in children with Perthes’ disease. Genomic DNA of 119 children with radiologically-confirmed Perthes’ disease diagnosed between 1986 and 2005 was analysed for the thrombophilic polymorphisms Factor V Leiden, 677T-MTHFR and FIIG20210A. The results were compared with those of a group of 276 children without Perthes’ disease. DNA was also analysed for the Gaucher mutations N370S, G insertion (84GG), L444P, Intron 2 (IVS2+1G>
A) and R496H. Enzymic assays confirmed the Gaucher disease status. Collagen (COL2A1) mutations of the 12q13 gene were also analysed. The prevalence of thrombophilic markers was similar among the 119 patients with Perthes’ disease and the 276 control subjects. The prevalence of the Gaucher mutation was consistent with Israeli population carriership data and did not confirm an earlier-claimed association with Perthes’ disease. All 199 patients were negative for the studied COL2A1 mutations. We found no genetic association between Perthes’ disease and either Gaucher’s disease or COL2A1 mutations or increased genetic thrombophilia among our patients compared with the control group. A systematic review of case-control studies suggested that there was a positive association between Perthes’ disease and Factor V Leiden. The impact of this association upon the disease, although not consistent across the studies, remains unclear.
We investigated the incidence of and risk factors
for venous thromboembolism (VTE) following surgery of the shoulder
and elbow and assessed the role of thromboprophylaxis in upper limb
surgery. All papers describing VTE after shoulder and elbow surgery
published in the English language literature before 31 March 2012
were reviewed. A total of 14 papers were available for analysis,
most of which were retrospective studies and case series. The incidence
of VTE was 0.038% from 92 440 shoulder arthroscopic procedures,
0.52% from 42 261 shoulder replacements, and 0.64% from 4833 procedures
for fractures of the proximal humerus (open reduction and internal fixation
or hemiarthroplasty). The incidence following replacement of the
elbow was 0.26% from 2701 procedures. Diabetes mellitus, rheumatoid
arthritis and ischaemic heart disease were identified as the major
risk factors. The evidence that exists on thromboprophylaxis is based on level
III and IV studies, and we therefore cannot make any recommendations
on prophylaxis based on the current evidence. It seems reasonable
to adopt a multimodal approach that involves all patients receiving
mechanical prophylaxis, with chemical prophylaxis reserved for those
who are at high risk for VTE. Cite this article:
The October 2012 Research Roundup360 looks at: whether you can escape your genes; oral prophylaxis for DVT; non-responders and the internet; metal-on-metal, mice and damaged livers; sleeping on the job; cartilage contact stress in the normal human hip; and a perfect reason to subscribe to
Autologous retransfusion and no-drainage are
both blood-saving measures in total hip replacement (THR). A new combined
intra- and post-operative autotransfusion filter system has been
developed especially for primary THR, and we conducted a randomised
controlled blinded study comparing this with no-drainage. A total of 204 THR patients were randomised to autologous blood
transfusion (ABT)
(n = 102) or no-drainage (n = 102). In the ABT group, a mean of
488 ml ( The use of a new intra- and post-operative autologous blood transfusion
filter system results in less total blood loss and a smaller maximum
decrease in haemoglobin levels than no-drainage following primary
THR. Cite this article:
Thromboprophylaxis remains a controversial subject. A vast amount of epidemiological and trial data about venous thromboembolism has been published over the past 40 years. These data have been distilled and synthesised into guidelines designed to help the practitioner translate this extensive research into ‘evidence-based’ advice. Guidelines should, in theory, benefit patient care by ensuring that every patient routinely receives the best prophylaxis; without guidelines, it is argued, patients may fail to receive treatment or be exposed to protocols which are ineffective, dangerous or expensive. Guidelines, however, have not been welcomed or applied universally. In the United States, orthopaedic surgeons have published their concerns about the thromboprophylaxis guidelines prepared by the American College of Chest Physicians. In Britain, controversy persists with many surgeons unconvinced of the risk/benefit, cost/benefit or practicality of thromboprophylaxis. The extended remit of the recent National Institute of Clinical Excellence thromboprophylaxis guidelines has been challenged. The reasons for this disquiet are addressed in this paper and particular emphasis is placed on how clinically-acceptable guidelines could be developed and applied.
Periprosthetic joint infection (PJI) is a devastating
complication which can follow a total joint arthroplasty (TJA).
Although rare, this ongoing threat undermines the success of TJA,
a historically reputable procedure. It has haunted the orthopedic
community for decades and several ongoing studies have provided
insights and new approaches to effectively battle this multilayered
problem.
There is currently limited information available
on the benefits and risks of extended thromboprophylaxis after hip fracture
surgery. SAVE-HIP3 was a randomised, double-blind study conducted
to evaluate the efficacy and safety of extended thromboprophylaxis
with the ultra-low molecular-weight heparin semuloparin compared
with placebo in patients undergoing hip fracture surgery. After
a seven- to ten-day open-label run-in phase with semuloparin (20
mg once daily subcutaneously, initiated post-operatively), patients
were randomised to once-daily semuloparin (20 mg subcutaneously)
or placebo for 19 to 23 additional days. The primary efficacy endpoint
was a composite of any venous thromboembolism (VTE; any deep-vein
thrombosis and non-fatal pulmonary embolism) or all-cause death until
day 24 of the double-blind period. Safety parameters included major
and clinically relevant non-major bleeding, laboratory data, and
treatment-emergent adverse events (TEAEs). Extended thromboprophylaxis
with semuloparin demonstrated a relative risk reduction of 79% in
the rate of any VTE or all-cause death compared with placebo (3.9% Cite this article:
Medium-term survivorship of the Oxford phase
3 unicompartmental knee replacement (UKR) has not yet been established
in an Asian population. We prospectively evaluated the outcome of
400 phase 3 Oxford UKRs in 320 Korean patients with a mean age at
the time of operation of 69 years (48 to 82). The mean follow-up
was 5.2 years (1 to 10). Clinical and radiological assessment was
carried out pre- and post-operatively. At five years, the mean Knee
Society knee and functional scores had increased significantly from
56.2 (30 to 91) pre-operatively to 87.2 (59 to 98) (p = 0.034) and
from 59.2 (30 to 93) to 88.3 (50 to 100) (p = 0.021), respectively.
The Oxford knee score increased from a mean of 25.8 (12 to 39) pre-operatively
to 39.8 (25 to 58) at five years (p = 0.038). The ten-year survival
rate was 94% (95% confidence interval 90.1 to 98.0). A total of
14 UKRs (3.5%) required revision. The most common reason for revision
was dislocation of the bearing in 12 (3%). Conversion to a total
knee replacement was required in two patients who developed osteoarthritis
of the lateral compartment. This is the largest published series of UKR in Korean patients.
It shows that the mid-term results after a minimally invasive Oxford
phase 3 UKR can yield satisfactory clinical and functional results
in this group of patients.
Plasma levels of cobalt and chromium ions and
Metal Artefact Reduction Sequence (MARS)-MRI scans were performed
on patients with 209 consecutive, unilateral, symptomatic metal-on-metal
(MoM) hip arthroplasties. There was wide variation in plasma cobalt
and chromium levels, and MARS-MRI scans were positive for adverse reaction
to metal debris (ARMD) in 84 hips (40%). There was a significant
difference in the median plasma cobalt and chromium levels between
those with positive and negative MARS-MRI scans (p <
0.001).
Compared with MARS-MRI as the potential reference standard for the
diagnosis of ARMD, the sensitivity of metal ion analysis for cobalt
or chromium with a cut-off of >
7 µg/l was 57%. The specificity was
65%, positive predictive value was 52% and the negative predictive
value was 69% in symptomatic patients. A lowered threshold of >
3.5 µg/l for cobalt and chromium ion levels improved the sensitivity
and negative predictive value to 86% and 74% but at the expense
of specificity (27%) and positive predictive value (44%). Metal ion analysis is not recommended as a sole indirect screening
test in the surveillance of symptomatic patients with a MoM arthroplasty.
The investigating clinicians should have a low threshold for obtaining
cross-sectional imaging in these patients, even in the presence
of low plasma metal ion levels.
Our aim was to determine the total blood loss associated with surgery for fracture of the hip and to identify risk factors for increased blood loss. We prospectively studied 546 patients with hip fracture. The total blood loss was calculated on the basis of the haemoglobin difference, the number of transfusions and the estimated blood volume. The hidden blood loss, in excess of that observed during surgery, varied from 547 ml (screws/ pins) to 1473 ml (intramedullary hip nail and screw) and was significantly associated with medical complications and increased hospital stay. The type of surgery, treatment with aspirin, intra-operative hypotension and gastro-intestinal bleeding or ulceration were all independent predictors of blood loss. We conclude that total blood loss after surgery for hip fracture is much greater than that observed intra-operatively. Frequent post-operative measurements of haemoglobin are necessary to avoid anaemia.
Symptomatic and asymptomatic deep-vein thrombosis
(DVT) is a common complication of knee replacement, with an incidence
of up to 85% in the absence of prophylaxis. National guidelines
for thromboprophylaxis in knee replacement are derived from total
knee replacement (TKR) data. No guidelines exist specific to unicompartmental knee
replacement (UKR). We investigated whether the type of knee arthroplasty
(TKR or UKR) was related to the incidence of DVT and discuss the
applicability of existing national guidelines for prophylaxis following
UKR. Data were collected prospectively on 3449 knee replacements,
including procedure type, tourniquet time, surgeon, patient age,
use of drains and gender. These variables were related to the incidence
of symptomatic DVT. The overall DVT rate was 1.6%. The only variable that had an
association with DVT was operation type, with TKR having a higher
incidence than UKR (2.2% TKR and UKR patients have different risk profiles for symptomatic
DVT. The risk-benefit ratio for TKR that has been used to produce
national guidelines may not be applicable to UKR. Further research
is required to establish the most appropriate form of prophylaxis
for UKR.
The incidence of deep-vein thrombosis (DVT) and
pulmonary embolism (PE) is thought to be low following foot and ankle
surgery, but the routine use of chemoprophylaxis remains controversial.
This retrospective study assessed the incidence of symptomatic venous
thromboembolic (VTE) complications following a consecutive series
of 2654 patients undergoing elective foot and ankle surgery. A total
of 1078 patients received 75 mg aspirin as routine thromboprophylaxis
between 2003 and 2006 and 1576 patients received no form of chemical
thromboprophylaxis between 2007 and 2010. The overall incidence
of VTE was 0.42% (DVT, 0.27%; PE, 0.15%) with 27 patients lost to follow-up.
If these were included to create a worst case scenario, the overall
VTE rate was 1.43%. There was no apparent protective effect against
VTE by using aspirin. We conclude that the incidence of VTE following foot and ankle
surgery is very low and routine use of chemoprophylaxis does not
appear necessary for patients who are not in the high risk group
for VTE.
A total of 159 patients (84 women and 75 men,
mean age of 53 (20 to 87)) with subacromial impingement were randomised
to treatment with subacromial injections using lidocaine with one
of hyaluronic acid (51 patients), corticosteroid (53 patients) or
placebo (55 patients). Patients were followed up for 26 weeks. The
primary outcome was pain on a visual analogue score (VAS), and secondary
outcomes included the Constant Murley score, shoulder pain score,
functional mobility score, shoulder disability questionnaire and
pain-specific disability score. The different outcome measures showed
similar results. After three, six and 12 weeks corticosteroid injections
were superior to hyaluronic acid injections and only at six weeks
significantly better than placebo injections. The mean short-term
reduction in pain on the VAS score at 12 weeks was 7% ( We were not able to show a convincing benefit from hyaluronic
acid injections compared with corticosteroid or placebo injections.
Corticosteroid injections produced a significant reduction in pain
in the short term (three to 12 weeks), but in the long term the
placebo injection produced the best results.
The aims of this piece of work were to: 1) record the background
concentrations of blood chromium (Cr) and cobalt (Co) concentrations
in a large group of subjects; 2) to compare blood/serum Cr and Co
concentrations with retrieved metal-on-metal (MoM) hip resurfacings;
3) to examine the distribution of Co and Cr in the serum and whole
blood of patients with MoM hip arthroplasties; and 4) to further
understand the partitioning of metal ions between the serum and
whole blood fractions. A total of 3042 blood samples donated to the local transfusion
centre were analysed to record Co and Cr concentrations. Also, 91
hip resurfacing devices from patients who had given pre-revision
blood/serum samples for metal ion analysis underwent volumetric
wear assessment using a coordinate measuring machine. Linear regression analysis
was carried out and receiver operating characteristic curves were
constructed to assess the reliability of metal ions to identify
abnormally wearing implants. The relationship between serum and
whole blood concentrations of Cr and Co in 1048 patients was analysed
using Bland-Altman charts. This relationship was further investigated
in an Objectives
Methods
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.
Antiplatelet agents are widely prescribed for the primary and secondary prevention of cardiovascular events. A common clinical problem facing orthopaedic and trauma surgeons is how to manage patients receiving these agents who require surgery, either electively or following trauma. The dilemma is to balance the risk of increased blood loss if the antiplatelet agents are continued peri-operatively against the risk of coronary artery/stent thrombosis and/or other vascular event if the drugs are stopped. The traditional approach of stopping these medications up to two weeks before surgery appears to pose significant danger to patients and may require review. This paper covers the important aspects regarding the two most commonly prescribed antiplatelet agents, aspirin and clopidogrel.