The importance for observing the intention-to-treat approach in clinical studies is explained.

Cite this article: Bone Joint J 2013;95-B:1443–4.

We aimed to determine whether cemented hemiarthroplasty is associated with a higher post-operative mortality and rate of re-operation when compared with uncemented hemiarthroplasty. Data on 19 669 patients, who were treated with a hemiarthroplasty following a fracture of the hip in a nine-year period from 2002 to 2011, were extracted from NHS Scotland’s acute admission database (Scottish Morbidity Record, SMR01). We investigated the rate of mortality at day 0, 1, 7, 30, 120 and one-year post-operatively using 12 case-mix variables to determine the independent effect of the method of fixation. At day 0, those with a cemented hemiarthroplasty had a higher rate of mortality (p < 0.001) compared with those with an uncemented hemiarthroplasty, equivalent to one extra death per 424 procedures. By day one this had become one extra death per 338 procedures. Increasing age and the five-year co-morbidity score were noted as independent risk factors. By day seven, the cumulative rate of mortality was less for cemented hemiarthroplasty though this did not reach significance until day 120. The rate of re-operation was significantly higher for uncemented hemiarthroplasty. Despite adjusting for 12 confounding variables, these only accounted for 15% of the observed variability.

The debate about the choice of the method of fixation for a hemiarthroplasty with respect to the rate of mortality or the risk of re-operation may be largely superfluous. Our results suggest that uncemented hemiarthroplasties may have a role to play in elderly patients with significant co-morbid disease.

Cite this article: Bone Joint J 2014;96-B:1185–91.

We describe the impact of a targeted performance improvement programme and the associated performance improvement interventions, on mortality rates, error rates and process of care for haemodynamically unstable patients with pelvic fractures. Clinical care and performance improvement data for 185 adult patients with exsanguinating pelvic trauma presenting to a United Kingdom Major Trauma Centre between January 2007 and January 2011 were analysed with univariate and multivariate regression and compared with National data. In total 62 patients (34%) died from their injuries and opportunities for improved care were identified in one third of deaths.

Three major interventions were introduced during the study period in response to the findings. These were a massive haemorrhage protocol, a decision-making algorithm and employment of specialist pelvic orthopaedic surgeons. Interventions which improved performance were associated with an annual reduction in mortality (odds ratio 0.64 (95% confidence interval (CI) 0.44 to 0.93), p = 0.02), a reduction in error rates (p = 0.024) and significant improvements in the targeted processes of care. Exsanguinating patients with pelvic trauma are complex to manage and are associated with high mortality rates; implementation of a targeted performance improvement programme achieved sustained improvements in mortality, error rates and trauma care in this group of severely injured patients.

Cite this article: Bone Joint J 2014;96-B:1090–7.

Whether patients with asymptomatic bacteriuria should be investigated and treated before elective hip and knee replacement is controversial, although it is a widespread practice. We conducted a prospective observational cohort study with urine analyses before surgery and three days post-operatively. Patients with symptomatic urinary infections or an indwelling catheter were excluded. Post-discharge surveillance included questionnaires to patients and general practitioners at three months. Among 510 patients (309 women and 201 men), with a median age of 69 years (16 to 97) undergoing lower limb joint replacements (290 hips and 220 knees), 182 (36%) had pre-operative asymptomatic bacteriuria, mostly due to Escherichia coli, and 181 (35%) had white cells in the urine. Most patients (95%) received a single intravenous peri-operative dose (1.5 g) of cefuroxime as prophylaxis. On the third post-operative day urinary analysis identified white cells in 99 samples (19%) and bacteriuria in 208 (41%). Pathogens in the cultures on the third post-operative day were different from those in the pre-operative samples in 260 patients (51%). Only 25 patients (5%) developed a symptomatic urinary infection during their stay or in a subsequent three-month follow-up period, and two thirds of organisms identified were unrelated to those found during the admission. All symptomatic infections were successfully treated with oral antibiotics with no perceived effect on the joint replacement.

We conclude that testing and treating asymptomatic urinary tract colonisation before joint replacement is unnecessary.

Cite this article: Bone Joint J 2014;96-B:390–4.

The aims of this study were to evaluate the incidence of local argyria in patients with silver-coated megaprostheses and to identify a possible association between argyria and elevated levels of silver both locally and in the blood. Between 2004 and 2011, 32 megaprostheses with silver coatings were implanted in 20 female and 12 male patients following revision arthroplasty for infection or resection of a malignant tumour, and the levels of silver locally in drains and seromas and in the blood were determined. The mean age of the patients was 46 years (10 to 81); one patient died in the immediate post-operative period and was excluded.

Seven patients (23%) developed local argyria after a median of 25.7 months (interquartile range 2 to 44.5). Patients with and without local argyria had comparable levels of silver in the blood and aspiration fluids. The length of the implant did not influence the development of local argyria. Patients with clinical evidence of local argyria had no neurological symptoms and no evidence of renal or hepatic failure. Thus, we conclude that the short-term surveillance of blood silver levels in these patients is not required.

Cite this article: Bone Joint J 2013;95-B:988–92.

The aim of this study was to evaluate whether coating titanium discs with selenium in the form of sodium selenite decreased bacterial adhesion of Staphylococcus aureus and Staph. epidermidis and impeded osteoblastic cell growth.

In order to evaluate bacterial adhesion, sterile titanium discs were coated with increasing concentrations of selenium and incubated with bacterial solutions of Staph. aureus (ATCC 29213) and Staph. epidermidis (DSM 3269) and stained with Safranin-O. The effect of selenium on osteoblastic cell growth was also observed. The adherence of MG-63 cells on the coated discs was detected by staining with Safranin-O. The proportion of covered area was calculated with imaging software.

The tested Staph. aureus strain showed a significantly reduced attachment on titanium discs with 0.5% (p = 0.011) and 0.2% (p = 0.02) selenium coating. Our test strain from Staph. epidermidis showed a highly significant reduction in bacterial adherence on discs coated with 0.5% (p = 0.0099) and 0.2% (p = 0.002) selenium solution. There was no inhibitory effect of the selenium coating on the osteoblastic cell growth.

Selenium coating is a promising method to reduce bacterial attachment on prosthetic material.

Cite this article: Bone Joint J 2013;95-B:678–82.

The use of journal clubs and, more recently, case-based discussions in order to stimulate debate among orthopaedic surgeons lies at the heart of orthopaedic training and education. A virtual learning environment can be used as a platform to host virtual journal clubs and case-based discussions. This has many advantages in the current climate of constrained time and diminishing trainee and consultant participation in such activities. The virtual environment model opens up participation and improves access to journal clubs and case-based discussions, provides reusable educational content, establishes an electronic record of participation for individuals, makes use of multimedia material (including clinical imaging and photographs) for discussion, and finally, allows participants to link case-based discussions with relevant papers in the journal club.

The Leicester experience highlights the many advantages and some of the potential difficulties in setting up such a virtual system and provides useful guidance for those considering such a system in their own training programme. As a result of the virtual learning environment, trainee participation has increased and there is a trend for increased consultant input in the virtual journal club and case-based discussions.

It is likely that the use of virtual environments will expand to encompass newer technological approaches to personal learning and professional development.

In order to assess the efficacy of inspection and accreditation by the Specialist Advisory Committee for higher surgical training in orthopaedic surgery and trauma, seven training regions with 109 hospitals and 433 Specialist Registrars were studied over a period of two years.

There were initial deficiencies in a mean of 14.8% of required standards (10.3% to 19.2%). This improved following completion of the inspection, with a mean residual deficiency in 8.9% (6.5% to 12.7%.) Overall, 84% of standards were checked, 68% of the units improved and training was withdrawn in 4%.

Most units (97%) were deficient on initial assessment. Moderately good rectification was achieved but the process of follow-up and collection of data require improvement. There is an imbalance between the setting of standards and their implementation. Any major revision of the process of accreditation by the new Post-graduate Medical Education and Training Board should recognise the importance of assessment of training by direct inspection on site, of the relationship between service and training, and the advantage of defining mandatory and developmental standards.

With the established success of the National Joint Registry and the emergence of a range of new national initiatives for the capture of electronic data in the National Health Service, orthopaedic surgery in the United Kingdom has found itself thrust to the forefront of an information revolution. In this review we consider the benefits and threats that this revolution poses, and how orthopaedic surgeons should marshal their resources to ensure that this is a force for good.

This prospective randomised controlled double-blind trial compared two types of PFC Sigma total knee replacement (TKR), differing in three design features aimed at improving flexion. The outcome of a standard fixed-bearing posterior cruciate ligament-preserving design (FB-S) was compared with that of a high-flexion rotating-platform posterior-stabilised design (RP-F) at one year after TKR.

The study group of 77 patients with osteoarthritis of the knee comprised 37 men and 40 women, with a mean age of 69 years (44.9 to 84.9). The patients were randomly allocated either to the FB-S or the RP-F group and assessed pre-operatively and at one year post-operatively. The mean post-operative non-weight-bearing flexion was 107° (95% confidence interval (CI) 104° to 110°)) for the FB-S group and 113° (95% CI 109° to 117°) for the RP-F group, and this difference was statistically significant (p = 0.032). However, weight-bearing range of movement during both level walking and ascending a slope as measured during flexible electrogoniometry was a mean of 4° lower in the RP-F group than in the FB-S group, with 58° (95% CI 56° to 60°) versus 54° (95% CI 51° to 57°) for level walking (p = 0.019) and 56° (95% CI 54° to 58°) versus 52° (95% CI 48° to 56°) for ascending a slope (p = 0.044). Further, the mean post-operative pain score of the Western Ontario and McMaster Universities Osteoarthritis Index was significantly higher in the RP-F group (2.5 (95% CI 1.5 to 3.5) versus 4.2 (95% CI 2.9 to 5.5), p = 0.043).

Although the RP-F group achieved higher non-weight-bearing knee flexion, patients in this group did not use this during activities of daily living and reported more pain one year after surgery.

The poor reporting and use of statistical methods in orthopaedic papers has been widely discussed by both clinicians and statisticians. A detailed review of research published in general orthopaedic journals was undertaken to assess the quality of experimental design, statistical analysis and reporting. A representative sample of 100 papers was assessed for compliance to CONSORT and STROBE guidelines and the quality of the statistical reporting was assessed using a validated questionnaire. Overall compliance with CONSORT and STROBE guidelines in our study was 59% and 58% respectively, with very few papers fulfilling all criteria. In 37% of papers patient numbers were inadequately reported; 20% of papers introduced new statistical methods in the ‘results’ section not previously reported in the ‘methods’ section, and 23% of papers reported no measurement of error with the main outcome measure. Taken together, these issues indicate a general lack of statistical rigour and are consistent with similar reviews undertaken in a number of other scientific and clinical research disciplines. It is imperative that the orthopaedic research community strives to improve the quality of reporting; a failure to do so could seriously limit the development of future research.

Coloured bone cements have been introduced to make the removal of cement debris easier at the time of primary and revision joint replacement. We evaluated the physical, mechanical and pharmacological effects of adding methylene blue to bone cement with or without antibiotics (gentamicin, vancomycin or both). The addition of methylene blue to plain cement significantly decreased its mean setting time (570 seconds (sd 4) vs 775 seconds (sd 11), p = 0.01), mean compression strength (95.4 MPa (sd 3) vs 100.1 MPa (sd 6), p = 0.03), and mean bending strength (65.2 MPa (sd 5) vs 76.6 MPa (sd 4), p < 0.001) as well as its mean elastic modulus (2744 MPa (sd 97) vs 3281 MPa (sd 110), p < 0.001). The supplementation of the coloured cement with vancomycin and gentamicin decreased its mean bending resistance (55.7 MPa (sd 4) vs 65.2 MPa (sd 5), p < 0.001).The methylene blue significantly decreased the mean release of gentamicin alone (228.2 µg (sd 24) vs 385.5 µg (sd 26), p < 0.001) or in combination with vancomycin (498.5 µg (sd 70) vs 613 µg (sd 25), p = 0.018) from the bone cement. This study demonstrates several theoretical disadvantages of the antibiotic-loaded bone cement coloured with methylene blue.

Objectives

The accuracy and precision of two new methods of model-based radiostereometric analysis (RSA) were hypothesised to be superior to a plain radiograph method in the assessment of polyethylene (PE) wear.

We investigated the antibiotic concentration in fresh-frozen femoral head allografts harvested from two groups of living donors. Ten samples were collected from patients with osteoarthritis of the hip and ten from those with a fracture of the neck of the femur scheduled for primary arthroplasty. Cefazolin (1 g) was administered as a pre-operative prophylactic antibiotic. After storage at −80°C for two weeks the pattern of release of cefazolin from morsellised femoral heads was evaluated by an in vitro broth elution assay using high-performance liquid chromatography. The bioactivity of the bone was further determined with an agar disc diffusion and standardised tube dilution bioassay. The results indicated that the fresh-frozen femoral heads contained cefazolin. The morsellised bone released cefazolin for up to four days. The concentration of cefazolin was significantly higher in the heads from patients with osteoarthritis of the hip than in those with a fracture. Also, in bioassays the bone showed inhibitory effects against bacteria.

We concluded that allografts of morsellised bone from the femoral head harvested from patients undergoing arthroplasty of the hip contained cefazolin, which had been administered pre-operatively and they exhibited inhibitory effects against bacteria in vitro.

We investigated the role of ion release in the assessment of fixation of the implant after total knee replacement and hypothesised that ion monitoring could be a useful parameter in the diagnosis of prosthetic loosening. We enrolled 59 patients with unilateral procedures and measured their serum aluminium, titanium, chromium and cobalt ion levels, blinded to the clinical and radiological outcome which was considered to be the reference standard. The cut-off levels for detection of the ions were obtained by measuring the levels in 41 healthy blood donors who had no implants. Based on the clinical and radiological evaluation the patients were divided into two groups with either stable (n = 24) or loosened (n = 35) implants.

A significant increase in the mean level of Cr ions was seen in the group with failed implants (p = 0.001). The diagnostic accuracy was 71% providing strong evidence of failure when the level of Cr ions exceeded the cut-off value. The possibility of distinguishing loosening from other causes of failure was demonstrated by the higher diagnostic accuracy of 83%, when considering only patients with failure attributable to loosening.

Measurement of the serum level of Cr ions may be of value for detecting failure due to loosening when the diagnosis is in doubt. The other metal ions studies did not have any diagnostic value.

We reviewed systematically the published evidence on the effectiveness of antibiotic prophylaxis for the reduction of wound infection in patients undergoing total hip and total knee replacement. Publications were identified using the Cochrane Library, MEDLINE, EMBASE and CINAHL databases. We also contacted authors to identify unpublished trials. We included randomised controlled trials which compared any prophylaxis with none, the administration of systemic antibiotics with that of those in cement, cephalosporins with glycopeptides, cephalosporins with penicillin-derivatives, and second-generation with first-generation cephalosporins.

A total of 26 studies (11 343 participants) met the inclusion criteria. Methodological quality was variable. In a meta-analysis of seven studies (3065 participants) antibiotic prophylaxis reduced the absolute risk of wound infection by 8% and the relative risk by 81% compared with no prophylaxis (p < 0.00001). No other comparison showed a significant difference in clinical effect.

Antibiotic prophylaxis should be routine in joint replacement but the choice of agent should be made on the basis of cost and local availability.

This study was undertaken to evaluate the safety and efficacy of retrievable inferior vena cava filters in high-risk orthopaedic patients. A total of 58 patients had a retrievable inferior vena cava filter placed as an adjunct to chemical and mechanical prophylaxis, most commonly for a history of previous deep-vein thrombosis or pulmonary embolism, polytrauma, or expected prolonged immobilisation. In total 56 patients (96.6%) had an uncomplicated post-operative course. Two patients (3.4%) died in the peri-operative period for unrelated reasons.

Of the 56 surviving patients, 50 (89%) were available for follow-up. A total of 32 filters (64%) were removed without complication at a mean of 37.8 days (4 to 238) after placement. There were four filters (8%) which were retained because of thrombosis at the filter site, and four (8%) were retained because of incorporation of the filter into the wall of the inferior vena cava. In ten cases (20%) the retrievable filter was left in place to continue as primary prophylaxis. No patient had post-removal thromboembolic complications.

A retrievable inferior vena cava filter, as an adjunct to chemical and mechanical prophylaxis, was a safe and effective means of reducing the acute risk of pulmonary embolism in this high-risk group of patients. Although most filters were removed without complications, thereby avoiding the long-term complications that have plagued permanent indwelling filters, a relatively high percentage of filters had to be left in situ.

Metal-on-metal bearings are being increasingly used in young patients. The potential adverse effects of systemic metal ion elevation are the subject of ongoing investigation. The purpose of this study was to investigate whether cobalt and chromium ions cross the placenta of pregnant women with a metal-on-metal hip resurfacing and reach the developing fetus. Whole blood levels were estimated using high-resolution inductively-coupled plasma mass spectrometry.

Our findings showed that cobalt and chromium are able to cross the placenta in the study patients with metal-on-metal hip resurfacings and in control subjects without any metal implants. In the study group the mean concentrations of cobalt and chromium in the maternal blood were 1.39 μg/l (0.55 to 2.55) and 1.28 μg/l (0.52 to 2.39), respectively. The mean umbilical cord blood concentrations of cobalt and chromium were comparatively lower, at 0.839 μg/l (0.42 to 1.75) and 0.378 μg/l (0.14 to 1.03), respectively, and this difference was significant with respect to chromium (p < 0.05).

In the control group, the mean concentrations of cobalt and chromium in the maternal blood were 0.341 μg/l (0.18 to 0.54) and 0.199 μg/l (0.12 to 0.33), and in the umbilical cord blood they were 0.336 μg/l (0.17 to 0.5) and 0.194 μg/l (0.11 to 0.56), respectively. The differences between the maternal and umbilical cord blood levels in the controls were marginal, and not statistically significant (p > 0.05). The mean cord blood level of cobalt in the study patients was significantly greater than that in the control group (p < 0.01). Although the mean umbilical cord blood chromium level was nearly twice as high in the study patients (0.378 μg/l) as in the controls (0.1934 μg/l), this difference was not statistically significant. (p > 0.05)

The transplacental transfer rate was in excess of 95% in the controls for both metals, but only 29% for chromium and 60% for cobalt in study patients, suggesting that the placenta exerts a modulatory effect on the rate of metal ion transfer.