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.
Following the publication in 2007 of the guidelines from the National Institute for Health and Clinical Excellence (NICE) for prophylaxis against venous thromboembolism (VTE) for patients undergoing surgery, concerns were raised by British orthopaedic surgeons as to the appropriateness of the recommendations for their clinical practice. In order to address these concerns NICE and the British Orthopaedic Association agreed to engage a representative panel of orthopaedic surgeons in the process of developing expanded VTE guidelines applicable to all patients admitted to hospital. The functions of this panel were to review the evidence and to consider the applicability and implications in orthopaedic practice in order to advise the main Guideline Development Group in framing recommendations. The panel considered both direct and indirect evidence of the safety and efficacy, the cost-effectiveness of prophylaxis and its implication in clinical practice for orthopaedic patients. We describe the process of selection of the orthopaedic panel, the evidence considered and the contribution of the panel to the latest guidelines from NICE on the prophylaxis against VTE, published in January 2010.
The June 2014 Hip &
Pelvis Roundup360 looks at: Modular femoral necks: early signs are not good; is corrosion to blame for modular neck failures; metal-on-metal is not quite a closed book; no excess failures in fixation of displaced femoral neck fractures; noise no problem in hip replacement; heterotopic ossification after hip arthroscopy: are NSAIDs the answer?; thrombotic and bleeding events surprisingly low in total joint replacement; and the elephant in the room: complications and surgical volume.
The June 2015 Trauma Roundup360 looks at: HIV-related implant surgery in trauma; Major transfusion under the spotlight; Surgery and mortality in elderly acetabular fractures; Traction pin safety; Obesity and trauma; Salvage of acetabular fixation in the longer term
This study compared the quality of reduction
and complication rate when using a standard ilioinguinal approach and
the new pararectus approach when treating acetabular fractures surgically.
All acetabular fractures that underwent fixation using either approach
between February 2005 and September 2014 were retrospectively reviewed
and the demographics of the patients, the surgical details and complications
were recorded. A total of 100 patients (69 men, 31 women; mean age 57 years,
18 to 93) who were consecutively treated were included for analysis.
The quality of reduction was assessed using standardised measurement
of the gaps and steps in the articular surface on pre- and post-operative
CT-scans. There were no significant differences in the demographics of
the patients, the surgical details or the complications between
the two approaches. A significantly better reduction of the gap,
however, was achieved with the pararectus approach (axial: p = 0.025,
coronal: p = 0.013, sagittal: p = 0.001). These data suggest that the pararectus approach is at least equal
to, or in the case of reduction of the articular gap, superior to
the ilioinguinal approach. This approach allows direct buttressing of the dome of the acetabulum
and the quadrilateral plate, which is particularly favourable in
geriatric fracture patterns. Cite this article:
The August 2014 Research Roundup360 looks at: Antibiotic loaded ceramic of use in osteomyelitis; fibronectin implicated in cartilage degeneration; Zinc Chloride accelerates fracture healing in rats; advertisements and false claims; Net Promoter Score: substance or rhetoric?; aspirin for venous thromboembolism prophylaxis and dissection, stress and the soul.
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:
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.
Recent recommendations by the National Institute
for Health and Care Excellence (NICE) suggest that all patients undergoing
elective orthopaedic surgery should be assessed for the risk of
venous thromboembolism (VTE). Little is known about the incidence of symptomatic VTE after
elective external fixation. We studied a consecutive series of adult
patients who had undergone elective Ilizarov surgery without routine
pharmacological prophylaxis to establish the incidence of symptomatic
VTE. A review of a prospectively maintained database of consecutive
patients who were treated between October 1998 and February 2011
identified 457 frames in 442 adults whose mean age was 42.6 years
(16.0 to 84.6). There were 425 lower limb and 32 upper limb frames.
The mean duration of treatment was 25.7 weeks (1.6 to 85.3). According to NICE guidelines all the patients had at least one
risk factor for VTE, 246 had two, 172 had three and 31 had four
or more. One patient (0.23%) developed a pulmonary embolus after surgery
and was later found to have an inherited thrombophilia. There were
27 deaths, all unrelated to VTE. The cost of providing VTE prophylaxis according to NICE guidelines
in this group of patients would be £89 493.40 (£195.80 per patient)
even if the cheapest recommended medication was used. The rate of symptomatic VTE after Ilizarov surgery was low despite
using no pharmacological prophylaxis. This study leads us to question
whether NICE guidelines are applicable to these patients. Cite this article:
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.
We report an audit of 208 patients with a mean age of 39 years (16 to 65) attending the Orthopaedic Assessment Unit at the Wellington Hospital between January 2006 and December 2007 with an injury of the tendo Achillis requiring immobilisation in a cast. Information on assessment of venous thromboembolism (VTE) risk, prophylactic measures and VTE events for all patients was obtained from the medical records. A VTE risk factor was documented in the records of three (1%) patients. One of the 208 patients received aspirin prophylaxis; none received low molecular weight heparin. In all, 13 patients (6.3%, 95% confidence interval 3.4 to 10.5) developed symptomatic VTE during immobilisation in a cast, including six with a distal deep-vein thrombosis (DVT), four with a proximal DVT, and three with a confirmed pulmonary embolus. This incidence of symptomatic VTE is similar to that reported following elective hip replacement. We propose that consideration is given to VTE prophylaxis during prolonged immobilisation of the lower limbs in a cast, to ensure that the same level of protection is provided as for patients undergoing elective hip replacement.
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
The incidence of deep-vein thrombosis and the need for thromboprophylaxis following isolated trauma below the knee is uncertain. We have investigated this with a prospective randomised double-blind controlled trial using low molecular weight heparin with saline injection as placebo in patients aged between 18 and 75 years who had sustained an isolated fracture below the knee which required operative fixation. All patients had surgery within 48 hours of injury and were randomised to receive either the placebo or low molecular weight heparin for 14 days, after which they underwent bilateral lower limb venography, interpreted by three independent radiologists. Further follow-up was undertaken at two, six, eight and 12 weeks. A total of 238 patients fulfilled all the inclusion criteria, with 127 in the low molecular weight heparin group and 111 in the placebo group, all of whom underwent bilateral venography. There was no statistically significant difference in the incidence of deep-vein thrombosis between those patients treated with low molecular weight heparin or the placebo (p = 0.22). The number of deep-vein thromboses in the two groups was 11 (8.7%) and 14 (12.6%), respectively. Age and the type of fracture were significantly associated with the rate of deep-vein thrombosis (p = 0.001 and p = 0.009, respectively) but gender, comorbidities and the body mass index were not. The overall incidence of deep-vein thrombosis in this series was 11%. There was no clinical or statistical significant reduction in the incidence of deep-vein thrombosis with the use of thromboprophylaxis. However, we accept that owing to a cessation of funding, recruitment to this trial had to be ended prior to establishing the necessary sample size. Our results cannot, therefore, categorically exclude the possibility that low molecular weight heparin treatment could be beneficial. We recommend a further multicentre trial be undertaken to resolve this matter.
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:
Using general practitioner records and hospital
notes and through direct telephone conversation with patients, we investigated
the accuracy of nine patient-reported complications gathered from
a self-completed questionnaire after elective joint replacement
surgery of the hip and knee. A total of 402 post-discharge complications
were reported after 8546 elective operations that were undertaken
within a three-year period. These were reported by 136 men and 240
women with a mean age of 71.8 years (34 to 93). A total of 319 reported
complications (79.4%; 95% confidence interval 75.4 to 83.3) were
confirmed to be correct. High rates of correct reporting were demonstrated
for infection (94.5%) and the need for further surgery (100%), whereas
the rates of reporting deep-vein thrombosis (DVT), pulmonary embolism,
myocardial infarction and stroke were lower (75% to 84.2%). Dislocation,
peri-prosthetic fractures and nerve palsy had modest rates of correct
reporting (36% to 57.1%). More patients who had knee surgery delivered
incorrect reports of dislocation (p = 0.001) and DVT (p = 0.013). Despite these variations, it appears that post-operative complications
may form part of a larger patient-reported outcome programme after
elective joint replacement surgery.