The National Institute for Health and Clinical
Excellence (NICE) has thus far relied on historical data and predominantly
industry-sponsored trials to provide evidence for venous thromboembolic
(VTE) prophylaxis in joint replacement patients. We argue that the
NICE guidelines may be reliant on assumptions that are in need of
revision. Following the publication of large scale, independent
observational studies showing little difference between low-molecular-weight
heparins and aspirin, and recent changes to the guidance provided
by other international bodies, should NICE reconsider their recommendations? Cite this article:
In our department we use an enhanced recovery
protocol for joint replacement of the lower limb. This incorporates the
use of intravenous tranexamic acid (IVTA; 15 mg/kg) at the induction
of anaesthesia. Recently there was a national shortage of IVTA for
18 weeks; during this period all patients received an oral preparation
of tranexamic acid (OTA; 25 mg/kg). This retrospective study compares
the safety (surgical and medical complications) and efficacy (reduction
of transfusion requirements) of OTA and IVTA. During the study period
a total of 2698 patients received IVTA and 302 received OTA. After
adjusting for a range of patient and surgical factors, the odds
ratio (OR) of receiving a blood transfusion was significantly higher
with IVTA than with OTA (OR 0.48 (95% confidence interval 0.26 to
0.89), p = 0.019), whereas the safety profile was similar, based
on length of stay, rate of readmission, return to theatre, deep
infection, stroke, gastrointestinal bleeding, myocardial infarction,
pneumonia, deep-vein thrombosis and pulmonary embolism. The financial
benefit of OTA is £2.04 for a 70 kg patient; this is amplified when
the cost saving associated with significantly fewer blood transfusions
is considered. Although the number of patients in the study is modest, this
work supports the use of OTA, and we recommend that a randomised
trial be undertaken to compare the different methods of administering
tranexamic acid. Cite this article:
The popularity of cementless total hip replacement
(THR) has surpassed cemented THR in England and Wales. This retrospective
cohort study records survival time to revision following primary
cementless THR with the most common combination (accounting for
almost a third of all cementless THRs), and explores risk factors independently
associated with failure, using data from the National Joint Registry
for England and Wales. Patients with osteoarthritis who had a DePuy
Corail/Pinnacle THR implanted between the establishment of the registry
in 2003 and 31 December 2010 were included within analyses. There
were 35 386 procedures. Cox proportional hazard models were used
to analyse the extent to which the risk of revision was related
to patient, surgeon and implant covariates. The overall rate of
revision at five years was 2.4% (99% confidence interval 2.02 to
2.79). In the final adjusted model, we found that the risk of revision
was significantly higher in patients receiving metal-on-metal (MoM:
hazard ratio (HR) 1.93, p <
0.001) and ceramic-on-ceramic bearings
(CoC: HR 1.55, p = 0.003) compared with the best performing bearing
(metal-on-polyethylene). The risk of revision was also greater for
smaller femoral stems (sizes 8 to 10: HR 1.82, p <
0.001) compared
with mid-range sizes. In a secondary analysis of only patients where body
mass index (BMI) data were available (n = 17 166), BMI ≥ 30 kg/m2 significantly
increased the risk of revision (HR 1.55, p = 0.002). The influence
of the bearing on the risk of revision remained significant (MoM:
HR 2.19, p <
0.001; CoC: HR 2.09,
p = 0.001). The risk of revision was independent of age, gender,
head size and offset, shell, liner and stem type, and surgeon characteristics. We found significant differences in failure between bearing surfaces
and femoral stem size after adjustment for a range of covariates
in a large cohort of single-brand cementless THRs. In this study
of procedures performed since 2003, hard bearings had significantly
higher rates of revision, but we found no evidence that head size
had an effect. Patient characteristics, such as BMI and American
Society of Anesthesiologists grade, also influence the survival
of cementless components. Cite this article:
In May 2012, in airports across the globe, seven
orthopaedic surgeons bravely said goodbye to their loved ones, and
slowly turned towards their respective aircraft. Filled with expectation
and mild trepidation they stepped into the unknown… the ABC fellowship
of 2012.
To review the current best surgical practice and detail a multi-disciplinary
approach that could further reduce joint replacement infection. Review of relevant literature indexed in PubMed.Objectives
Methods
Recent guidance recommends the use of a well-proven
cemented femoral stem for hemiarthroplasty in the management of
fractures of the femoral neck, and the Exeter Trauma Stem (ETS)
has been suggested as an example of such an implant. The design
of this stem was based on the well-proven Exeter Total Hip Replacement
stem (ETHRS). This study assessed the surface finish of the ETS
in comparison with the ETHRS. Two ETSs and two ETHRSs were examined
using a profilometer with a precision of 1 nm and compared with
an explanted Exeter Matt stem. The mean roughness average (RA) of
the ETSs was approximately ten times higher than that of the ETHRSs (0.235 μm
(0.095 to 0.452) Cite this article:
Despite excellent results, the use of cemented
total hip replacement (THR) is declining. This retrospective cohort study
records survival time to revision following primary cemented THR
using the most common combination of components that accounted for
almost a quarter of all cemented THRs, exploring risk factors independently associated
with failure. All patients with osteoarthritis who had an Exeter
V40/Contemporary THR (Stryker) implanted before 31 December 2010
and recorded in the National Joint Registry for England and Wales
were included in the analysis. Cox’s proportional hazard models
were used to analyse the extent to which risk of revision was related
to patient, surgeon and implant covariates, with a significance
threshold of p <
0.01. A total of 34 721 THRs were included in
the study. The overall seven-year rate of revision for any reason
was 1.70% (99% confidence interval (CI) 1.28 to 2.12). In the final
adjusted model the risk of revision was significantly higher in
THRs with the Contemporary hooded component (hazard ratio (HR) 1.88,
p <
0.001) than with the flanged version, and in smaller head
sizes (<
28 mm) compared with 28 mm diameter heads (HR 1.50,
p = 0.005). The seven-year revision rate was 1.16% (99% CI 0.69
to 1.63) with a 28 mm diameter head and flanged component. The overall
risk of revision was independent of age, gender, American Society
of Anesthesiologists grade, body mass index, surgeon volume, surgical
approach, brand of cement/presence of antibiotic, femoral head material
(stainless steel/alumina) and stem taper size/offset. However, the
risk of revision for dislocation was significantly higher with a
‘plus’ offset head (HR 2.05, p = 0.003) and a hooded acetabular component
(HR 2.34, p <
0.001). In summary, we found that there were significant differences
in failure between different designs of acetabular component and
sizes of femoral head after adjustment for a range of covariates.
United Kingdom National Institute for Health
and Clinical Excellence guidelines recommend the use of total hip replacement
(THR) for displaced intracapsular fractures of the femoral neck
in cognitively intact patients, who were independently mobile prior
to the injury. This study aimed to analyse the risk factors associated
with revision of the implant and mortality following THR, and to
quantify risk. National Joint Registry data recording a THR performed
for acute fracture of the femoral neck between 2003 and 2010 were
analysed. Cox proportional hazards models were used to investigate
the extent to which risk of revision was related to specific covariates.
Multivariable logistic regression was used to analyse factors affecting
peri-operative mortality (<
90 days). A total of 4323 procedures
were studied. There were 80 patients who had undergone revision
surgery at the time of censoring (five-year revision rate 3.25%, 95%
confidence interval 2.44 to 4.07) and 137 patients (3.2%) patients
died within 90 days. After adjusting for patient and surgeon characteristics,
an increased risk of revision was associated with the use of cementless
prostheses compared with cemented (hazard ratio (HR) 1.33, p = 0.021).
Revision was independent of bearing surface and head size. The risk
of mortality within 90 days was significantly increased with higher
American Society of Anesthesiologists (ASA) grade (grade 3: odds
ratio (OR) 4.04, p <
0.001; grade 4/5: OR 20.26, p <
0.001;
both compared with grades 1/2) and older age (≥ 75 years: OR 1.65,
p = 0.025), but reduced over the study period (9% relative risk reduction
per year). THR is a good option in patients aged <
75 years and with
ASA 1/2. Cementation of the femoral component does not adversely
affect peri-operative mortality but improves survival of the implant
in the mid-term when compared with cementless femoral components.
There are no benefits of using head sizes >
28 mm or bearings other
than metal-on-polyethylene. More research is required to determine
the benefits of THR over hemiarthroplasty in older patients and
those with ASA grades >
2.
Patient-reported outcome measures (PROMs) are
increasingly being used to assess functional outcome and patient satisfaction.
They provide a framework for comparisons between surgical units,
and individual surgeons for benchmarking and financial remuneration.
Better performance may bring the reward of more customers as patients and
commissioners seek out high performers for their elective procedures.
Using National Joint Registry (NJR) data linked to PROMs we identified
22 691 primary total knee replacements (TKRs) undertaken for osteoarthritis
in England and Wales between August 2008 and February 2011, and
identified the surgical factors that influenced the improvements
in the Oxford knee score (OKS) and EuroQol-5D (EQ-5D) assessment
using multiple regression analysis. After correction for patient
factors the only surgical factors that influenced PROMs were implant
brand and hospital type (both p <
0.001). However, the effects
of surgical factors upon the PROMs were modest compared with patient
factors. For both the OKS and the EQ-5D the most important factors
influencing the improvement in PROMs were the corresponding pre-operative
score and the patient’s general health status. Despite having only
a small effect on PROMs, this study has shown that both implant
brand and hospital type do influence reported subjective functional
scores following TKR. In the current climate of financial austerity,
proposed performance-based remuneration and wider patient choice,
it would seem unwise to ignore these effects and the influence of
a range of additional patient factors.
Following arthroplasty of the knee, the patient’s
perception of improvement in symptoms is fundamental to the assessment
of outcome. Better clinical outcome may offset the inferior survival
observed for some types of implant. By examining linked National
Joint Registry (NJR) and patient-reported outcome measures (PROMs)
data, we aimed to compare PROMs collected at a minimum of six months
post-operatively for total (TKR: n = 23 393) and unicondylar knee
replacements (UKR: n = 505). Improvements in knee-specific (Oxford
knee score, OKS) and generic (EuroQol, EQ-5D) scores were compared
and adjusted for case-mix differences using multiple regression.
Whereas the improvements in the OKS and EQ-5D were significantly
greater for TKR than for UKR, once adjustments were made for case-mix
differences and pre-operative score, the improvements in the two
scores were not significantly different. The adjusted mean differences
in the improvement of OKS and EQ-5D were 0.0 (95% confidence interval (CI)
-0.9 to 0.9; p = 0.96) and 0.009 (95% CI -0.034 to 0.015; p = 0.37),
respectively. We found no difference in the improvement of either knee-specific
or general health outcomes between TKR and UKR in a large cohort
of registry patients. With concerns about significantly higher revision
rates for UKR observed in worldwide registries, we question the
widespread use of an arthroplasty that does not confer a significant
benefit in clinical outcome.
We compared thromboembolic events, major haemorrhage
and death after knee replacement in patients receiving either aspirin
or low-molecular-weight heparin (LMWH). Data from the National Joint
Registry for England and Wales were linked to an administrative
database of hospital admissions in the English National Health Service.
A total of 156 798 patients between April 2003 and September 2008
were included and followed for 90 days. Multivariable risk modelling
was used to estimate odds ratios adjusted for baseline risk factors
(AOR). An AOR <
1 indicates that risk rates are lower with LMWH
than with aspirin. In all, 36 159 patients (23.1%) were prescribed aspirin
and 120 639 patients (76.9%) were prescribed LMWH. We found no statistically
significant differences between the aspirin and LMWH groups in the
rate of pulmonary embolism (0.49% These results should be considered when the existing guidelines
for thromboprophylaxis after knee replacement are reviewed.
Modern metal-on-metal hip resurfacing has been
widely performed in the United Kingdom for over a decade. However,
the literature reports conflicting views of the benefits: excellent
medium- to long-term results with some brands in specific subgroups,
but high failure rates and local soft-tissue reactions in others.
The National Joint Registry for England and Wales (NJR) has collected
data on all hip resurfacings performed since 2003. This retrospective
cohort study recorded survival time to revision from a resurfacing
procedure, exploring risk factors independently associated with
failure. All patients with a primary diagnosis of osteoarthritis
who underwent resurfacing between 2003 and 2010 were included in
the analyses. Cox’s proportional hazard models were used to analyse
the extent to which the risk of revision was related to patient,
surgeon and implant covariates. A total of 27 971 hip resurfacings were performed during the
study period, of which 1003 (3.59%) underwent revision surgery.
In the final adjusted model, we found that women were at greater
risk of revision than men (hazard ratio (HR) = 1.30, p = 0.007),
but the risk of revision was independent of age. Of the implant-specific
predictors, five brands had a significantly greater risk of revision
than the Birmingham Hip Resurfacing (BHR) (ASR: HR = 2.82, p <
0.001,
Conserve: HR = 2.03, p <
0.001, Cormet: HR = 1.43, p = 0.001,
Durom: HR = 1.67, p <
0.001, Recap: HR = 1.58, p = 0.007). Smaller
femoral head components were also significantly more likely to require
revision (≤ 44 mm: HR = 2.14, p <
0.001, 45 to 47 mm: HR = 1.48,
p = 0.001) than medium or large heads, as were operations performed
by low-volume surgeons (HR = 1.36, p <
0.001). Once these influences
had been removed, in 4873 male patients <
60 years old undergoing
resurfacing with a BHR, the five-year estimated risk of revision
was 1.59%. In summary, after adjustment for a range of covariates we found
that there were significant differences in the rate of failure between
brands and component sizes. Younger male patients had good five-year
implant survival when the BHR was used.
We investigated the capacity of patient warming
devices to disrupt the ultra-clean airflow system. We compared the effects
of two patient warming technologies, forced-air and conductive fabric,
on operating theatre ventilation during simulated hip replacement
and lumbar spinal procedures using a mannequin as a patient. Infection
data were reviewed to determine whether joint infection rates were
associated with the type of patient warming device that was used. Neutral-buoyancy detergent bubbles were released adjacent to
the mannequin’s head and at floor level to assess the movement of
non-sterile air into the clean airflow over the surgical site. During
simulated hip replacement, bubble counts over the surgical site
were greater for forced-air than for conductive fabric warming when
the anaesthesia/surgery drape was laid down (p = 0.010) and at half-height
(p <
0.001). For lumbar surgery, forced-air warming generated
convection currents that mobilised floor air into the surgical site
area. Conductive fabric warming had no such effect. A significant increase in deep joint infection, as demonstrated
by an elevated infection odds ratio (3.8, p = 0.024), was identified
during a period when forced-air warming was used compared to a period
when conductive fabric warming was used. Air-free warming is, therefore,
recommended over forced-air warming for orthopaedic procedures.
We compared thromboembolic events, major haemorrhage
and death after total hip replacement in patients receiving either
aspirin or low-molecular-weight heparin (LMWH). We analysed data from
the National Joint Registry for England and Wales linked to an administrative
database of hospital admissions in the English National Health Service.
A total of 108 584 patients operated on between April 2003 and September 2008
were included and followed up for 90 days. Multivariable risk modelling
and propensity score matching were used to estimate odds ratios
(OR) adjusted for baseline risk factors. An OR <
1 indicates
that rates are lower with LMWH than with aspirin. In all, 21.1%
of patients were prescribed aspirin and 78.9% LMWH. Without adjustment, we
found no statistically significant differences. The rate of pulmonary
embolism was 0.68% in both groups and 90-day mortality was 0.65%
with aspirin and 0.61% with LMWH (OR 0.93; 95% CI 0.77 to 1.11).
With risk adjustment, the difference in mortality increased (OR
0.84; 95% CI 0.69 to 1.01). With propensity score matching the mortality difference
increased even further to 0.65% with aspirin and 0.51% with LMWH
(OR 0.77; 95% CI 0.61 to 0.98). These results should be considered
when the conflicting recommendations of existing guidelines for
thromboprophylaxis after hip replacement are being addressed.
Arthroscopy of the knee is one of the most commonly
performed orthopaedic procedures worldwide. Large-volume outcome
data have not previously been available for English NHS patients.
Prospectively collected admissions data, routinely collected on
every English NHS patient, were analysed to determine the rates
of complications within 30 days (including re-operation and re-admission),
90-day symptomatic venous thromboembolism and all-cause mortality.
There were 301 701 operations performed between 2005 and 2010 –
an annual incidence of 9.9 per 10 000 English population. Of these,
16 552 (6%) underwent ligament reconstruction and 106 793 (35%)
underwent meniscal surgery. The 30-day re-admission rate was 0.64%
(1662) and 30-day wound complication rate was 0.26% (677). The overall
30-day re-operation rate was 0.40% (1033) and the 90-day pulmonary embolism
rate was 0.08% (230), of which six patients died. 90-day mortality
was 0.02% (47). Age <
40 years, male gender and ligament reconstruction
were significantly associated with an increased rate of 30-day re-admission
and unplanned re-operation. In addition, a significant increase
in 30-day admission rates were seen with Charlson comorbidity scores
of 1 (p = 0.037) and ≥ 2 (p <
0.001) compared with scores of
0, and medium volume units compared with high volume units (p <
0.001). Complications following arthroscopy of the knee are rare. It
is a safe procedure, which in the majority of cases is performed
as day case surgery. These data can be used for quality benchmarking,
in terms of consent, consultant re-validation and individual unit
performance.
Increased femoral head size may reduce dislocation rates following total hip replacement. The National Joint Registry for England and Wales has highlighted a statistically significant increase in the use of femoral heads ≥ 36 mm in diameter from 5% in 2005 to 26% in 2009, together with an increase in the use of the posterior approach. The aim of this study was to determine whether rates of dislocation have fallen over the same period. National data for England for 247 546 procedures were analysed in order to determine trends in the rate of dislocation at three, six, 12 and 18 months after operation during this time. The 18-month revision rates were also examined. Between 2005 and 2009 there were significant decreases in cumulative dislocations at three months (1.12% to 0.86%), six months (1.25% to 0.96%) and 12 months (1.42% to 1.11%) (all p <
0.001), and at 18 months (1.56% to 1.31%) for the period 2005 to 2008 (p <
0.001). The 18-month revision rates did not significantly change during the study period (1.26% to 1.39%, odds ratio 1.10 (95% confidence interval 0.98 to 1.24), p = 0.118). There was no evidence of changes in the coding of dislocations during this time. These data have revealed a significant reduction in dislocations associated with the use of large femoral head sizes, with no change in the 18-month revision rate.
Diagnostic and operative codes are routinely collected for every patient admitted to hospital in the English NHS. Data on post-operative complications following foot and ankle surgery have not previously been available in large numbers. Data on symptomatic venous thromboembolism events and mortality within 90 days were extracted for patients undergoing fixation of an ankle fracture, first metatarsal osteotomy, hindfoot fusions and total ankle replacement over a period of 42 months. For ankle fracture surgery (45 949 patients), the rates of deep-vein thrombosis (DVT), pulmonary embolism and mortality were 0.12%, 0.17% and 0.37%, respectively. For first metatarsal osteotomy (33 626 patients), DVT, pulmonary embolism and mortality rates were 0.01%, 0.02% and 0.04%, and for hindfoot fusions (7033 patients) the rates were 0.03%, 0.11% and 0.11%, respectively. The rate of pulmonary embolism in 1633 total ankle replacement patients was 0.06%, and there were no recorded DVTs and no deaths. Statistical analysis could only identify risk factors for venous thromboembolic events of increasing age and multiple comorbidities following fracture surgery. Venous thromboembolism following foot and ankle surgery is extremely rare, but this subset of fracture patients is at a higher risk. However, there is no evidence that thromboprophylaxis reduces this risk, and these national data suggest that prophylaxis is not required in most of these patients.
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.
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.
This paper considers the new financial infrastructure of the National Health Service and provides a resource for orthopaedic surgeons. We describe the importance of accurate documentation and data collection for National Health Service hospital Trust finances and league tables, and support our discussion with examples drawn from our local audit work.