Does Kinematic Alignment Increase Polyethylene Wear Compared With Mechanically Aligned Components? A Wear Simulation Study.

BACKGROUND: Kinematic alignment is an alternative approach to mechanical alignment. Kinematic alignment can restore the joint line to its prearthritic condition, and its advocates have suggested it may be associated with other benefits. But this alignment approach often results in tibial components that are placed in varus and femoral components that are placed in valgus alignment, which may result in an increased risk of component loosening because of wear. Like malaligned implant components, kinematically aligned knee implants could increase wear in vivo, but we lack comparative data about wear behavior between these approaches. QUESTIONS/PURPOSES: (1) Do the different alignment approaches (kinematic, mechanical, and purposefully malaligned components) result in different wear rates in a wear simulator? (2) Do the different alignment approaches lead to different worn areas on the polyethylene inserts in a wear simulator? (3) Do the different alignment approaches result in different joint kinematics in a wear simulator? METHODS: Mechanical alignment was simulated in a force-controlled manner with a virtual ligament structure according to the International Organization for Standardization (ISO 14243-1) using a knee wear simulator. To simulate kinematic alignment, flexion-extension motion, internal-external torque, and the joint line were tilted by 4°, using a novel mechanical setup, without changing the force axis. The setup includes bearings with inclinations of 4° so that the joint axis of 4° is determined. To verify the angle of 4°, a digital spirit level was used. To simulate malalignment, we tilted the implant and, therefore, the joint axis by 4° using a wedge with an angle of 4° without tilting the torque axes of the simulator. This leads to a purposefully malaligned tibial varus and femoral valgus of 4°. For each condition, three cruciate-retaining knee implants were tested for 3.0 x 10 6 cycles, and one additional implant was used as soak control. Gravimetric wear analyses were performed every 0.5 x 10 6 cycles to determine the linear wear rate of each group by linear regression. The wear area was measured after 3.0 x 10 6 cycles by outlining the worn areas on the polyethylene inserts, then photographing the inserts and determining the worn areas using imaging software. The joint kinematics (AP translation and internal-external rotation) were recorded by the knee simulator software and analyzed during each of the six simulation intervals. RESULTS: Comparing the wear rates of the different groups, no difference could be found between the mechanical alignment and the kinematic alignment (3.8 ± 0.5 mg/million cycles versus 4.1 ± 0.2 mg/million cycles; p > 0.99). However, there was a lower wear rate in the malaligned group (2.7 ± 0.2 mg/million cycles) than in the other two groups (p < 0.01). When comparing the total wear areas of the polyethylene inserts among the three different alignment groups, the lowest worn area could be found for the malaligned group (716 ± 19 mm 2 ; p ≤ 0.003), but there was no difference between kinematic alignment and mechanical alignment (823 ± 19 mm 2 versus 825 ± 26 mm 2 ; p > 0.99). Comparing the AP translation, no difference was found between the mechanical alignment, the kinematic alignment, and the malalignment group (6.6 ± 0.1 mm versus 6.9 ± 0.2 mm versus 6.8 ± 0.3 mm; p = 0.06). In addition, the internal-external rotation between mechanical alignment, kinematic alignment, and malalignment also revealed no difference (9.9° ± 0.4° versus 10.2° ± 0.1° versus 10.1° ± 0.6°; p = 0.44). CONCLUSION: In the current wear simulation study, the wear rates of mechanical alignment and kinematic alignment of 4° were in a comparable range. CLINICAL RELEVANCE: The results suggest that kinematic alignment with up to 4° of component inclination may give the surgeon confidence that the reconstruction will have good wear-related performance when using a modern cruciate-retaining implant. The malaligned group had the lowest wear rate, which may be a function of the smaller worn area on the inserts compared with the other two alignment groups. This smaller articulation area between the femoral condyles and polyethylene insert could increase the risk of delamination of malaligned components over longer test durations and during high-load activities. For that reason, and because malalignment can cause nonwear-related revisions, malalignment should be avoided. Further in vitro and clinical studies must prove whether the wear simulation of different alignments can predict the wear behavior in vivo.

Duration of antibiotic treatment using procalcitonin-guided treatment algorithms in older patients: a patient-level meta-analysis from randomized controlled trials.

BACKGROUND: Older patients have a less pronounced immune response to infection, which may also influence infection biomarkers. There is currently insufficient data regarding clinical effects of procalcitonin (PCT) to guide antibiotic treatment in older patients. OBJECTIVE AND DESIGN: We performed an individual patient data meta-analysis to investigate the association of age on effects of PCT-guided antibiotic stewardship regarding antibiotic use and outcome. SUBJECTS AND METHODS: We had access to 9,421 individual infection patients from 28 randomized controlled trials comparing PCT-guided antibiotic therapy (intervention group) or standard care. We stratified patients according to age in four groups (<75 years [n = 7,079], 75-80 years [n = 1,034], 81-85 years [n = 803] and >85 years [n = 505]). The primary endpoint was the duration of antibiotic treatment and the secondary endpoints were 30-day mortality and length of stay. RESULTS: Compared to control patients, mean duration of antibiotic therapy in PCT-guided patients was significantly reduced by 24, 22, 26 and 24% in the four age groups corresponding to adjusted differences in antibiotic days of -1.99 (95% confidence interval [CI] -2.36 to -1.62), -1.98 (95% CI -2.94 to -1.02), -2.20 (95% CI -3.15 to -1.25) and - 2.10 (95% CI -3.29 to -0.91) with no differences among age groups. There was no increase in the risk for mortality in any of the age groups. Effects were similar in subgroups by infection type, blood culture result and clinical setting (P interaction >0.05). CONCLUSIONS: This large individual patient data meta-analysis confirms that, similar to younger patients, PCT-guided antibiotic treatment in older patients is associated with significantly reduced antibiotic exposures and no increase in mortality.

Understanding the use of observational and randomized data in cardiovascular medicine.

The availability of large datasets from multiple sources [e.g. registries, biobanks, electronic health records (EHRs), claims or billing databases, implantable devices, wearable sensors, and mobile apps], coupled with advances in computing and analytic technologies, have provided new opportunities for conducting innovative health research. Equally, improved digital access to health information has facilitated the conduct of efficient randomized controlled trials (RCTs) upon which clinical management decisions can be based, for instance, by permitting the identification of eligible patients for recruitment and/or linkage for follow-up via their EHRs. Given these advances in cardiovascular data science and the complexities they behold, it is important that health professionals have clarity on the appropriate use and interpretation of observational, so-called 'real-world', and randomized data in cardiovascular medicine. The Cardiovascular Roundtable of the European Society of Cardiology (ESC) held a workshop to explore the future of RCTs and the current and emerging opportunities for gathering and exploiting complex observational datasets in cardiovascular research. The aim of this article is to provide a perspective on the appropriate use of randomized and observational data and to outline the ESC plans for supporting the collection and availability of clinical data to monitor and improve the quality of care of patients with cardiovascular disease in Europe and provide an infrastructure for undertaking pragmatic RCTs. Moreover, the ESC continues to campaign for greater engagement amongst regulators, industry, patients, and health professionals in the development and application of a more efficient regulatory framework that is able to take maximal advantage of new opportunities for improving the design and efficiency of observational studies and RCT in patients with cardiovascular disease.

Effect of procalcitonin-guided antibiotic treatment on clinical outcomes in intensive care unit patients with infection and sepsis patients: a patient-level meta-analysis of randomized trials.

BACKGROUND: The clinical utility of serum procalcitonin levels in guiding antibiotic treatment decisions in patients with sepsis remains unclear. This patient-level meta-analysis based on 11 randomized trials investigates the impact of procalcitonin-guided antibiotic therapy on mortality in intensive care unit (ICU) patients with infection, both overall and stratified according to sepsis definition, severity, and type of infection. METHODS: For this meta-analysis focusing on procalcitonin-guided antibiotic management in critically ill patients with sepsis of any type, in February 2018 we updated the database of a previous individual patient data meta-analysis which was limited to patients with respiratory infections only. We used individual patient data from 11 trials that randomly assigned patients to receive antibiotics based on procalcitonin levels (the "procalcitonin-guided" group) or the current standard of care (the "controls"). The primary endpoint was mortality within 30 days. Secondary endpoints were duration of antibiotic treatment and length of stay. RESULTS: Mortality in the 2252 procalcitonin-guided patients was significantly lower compared with the 2230 control group patients (21.1% vs 23.7%; adjusted odds ratio 0.89, 95% confidence interval (CI) 0.8 to 0.99; p = 0.03). These effects on mortality persisted in a subgroup of patients meeting the sepsis 3 definition and based on the severity of sepsis (assessed on the basis of the Sequential Organ Failure Assessment (SOFA) score, occurrence of septic shock or renal failure, and need for vasopressor or ventilatory support) and on the type of infection (respiratory, urinary tract, abdominal, skin, or central nervous system), with interaction for each analysis being > 0.05. Procalcitonin guidance also facilitated earlier discontinuation of antibiotics, with a reduction in treatment duration (9.3 vs 10.4 days; adjusted coefficient -1.19 days, 95% CI -1.73 to -0.66; p <  0.001). CONCLUSION: Procalcitonin-guided antibiotic treatment in ICU patients with infection and sepsis patients results in improved survival and lower antibiotic treatment duration.

Influence of joint kinematics on polyethylene wear in anatomic shoulder joint arthroplasty.

BACKGROUND: Despite the positive results in total shoulder arthroplasties (TSAs), a higher revision rate is documented compared with total hip and knee replacements. Wear is the possible main cause of TSA failure in the long-term. This study investigated the effect of joint kinematics and the influence of the rotator cuff on the polyethylene wear performance in an anatomic TSA. METHODS: Lifting a load of 2 kg with an abduction/adduction of 0° to 90° was simulated for 2 × 106 cycles as a primary motion using a fully kinematic joint simulator. A combined rotation in anteversion-retroversion of ±5° and ±10° was also simulated. The force in the superior-inferior direction and the axial joint compression were applied under force control based on in vivo data of the shoulder. A soft tissue restraint model was used to simulate an intact and an insufficient rotator cuff. RESULTS: The highest wear rate in the intact rotator cuff group was 58.90 ± 1.20 mg/106 cycles with a combined rotation of ±10°. When an insufficient rotator cuff was simulated, the highest polyethylene wear rate determined was 79.67 ± 4.18 mg/106 cycles. CONCLUSIONS: This study confirms a high dependency of the polyethylene wear behavior and dimension on the joint kinematics in total shoulder replacement. This can be explained by an increasing cross-shear stress on the polyethylene component. The results obtained indicate that additional combined kinematics are an indispensable part of wear tests on anatomic shoulder replacements.

Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections.

BACKGROUND: Acute respiratory infections (ARIs) comprise of a large and heterogeneous group of infections including bacterial, viral, and other aetiologies. In recent years, procalcitonin (PCT), a blood marker for bacterial infections, has emerged as a promising tool to improve decisions about antibiotic therapy (PCT-guided antibiotic therapy). Several randomised controlled trials (RCTs) have demonstrated the feasibility of using procalcitonin for starting and stopping antibiotics in different patient populations with ARIs and different settings ranging from primary care settings to emergency departments, hospital wards, and intensive care units. However, the effect of using procalcitonin on clinical outcomes is unclear. This is an update of a Cochrane review and individual participant data meta-analysis first published in 2012 designed to look at the safety of PCT-guided antibiotic stewardship. OBJECTIVES: The aim of this systematic review based on individual participant data was to assess the safety and efficacy of using procalcitonin for starting or stopping antibiotics over a large range of patients with varying severity of ARIs and from different clinical settings. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE, and Embase, in February 2017, to identify suitable trials. We also searched ClinicalTrials.gov to identify ongoing trials in April 2017. SELECTION CRITERIA: We included RCTs of adult participants with ARIs who received an antibiotic treatment either based on a procalcitonin algorithm (PCT-guided antibiotic stewardship algorithm) or usual care. We excluded trials if they focused exclusively on children or used procalcitonin for a purpose other than to guide initiation and duration of antibiotic treatment. DATA COLLECTION AND ANALYSIS: Two teams of review authors independently evaluated the methodology and extracted data from primary studies. The primary endpoints were all-cause mortality and treatment failure at 30 days, for which definitions were harmonised among trials. Secondary endpoints were antibiotic use, antibiotic-related side effects, and length of hospital stay. We calculated odds ratios (ORs) and 95% confidence intervals (CIs) using multivariable hierarchical logistic regression adjusted for age, gender, and clinical diagnosis using a fixed-effect model. The different trials were added as random-effects into the model. We conducted sensitivity analyses stratified by clinical setting and type of ARI. We also performed an aggregate data meta-analysis. MAIN RESULTS: From 32 eligible RCTs including 18 new trials for this 2017 update, we obtained individual participant data from 26 trials including 6708 participants, which we included in the main individual participant data meta-analysis. We did not obtain individual participant data for four trials, and two trials did not include people with confirmed ARIs. According to GRADE, the quality of the evidence was high for the outcomes mortality and antibiotic exposure, and quality was moderate for the outcomes treatment failure and antibiotic-related side effects.Primary endpoints: there were 286 deaths in 3336 procalcitonin-guided participants (8.6%) compared to 336 in 3372 controls (10.0%), resulting in a significantly lower mortality associated with procalcitonin-guided therapy (adjusted OR 0.83, 95% CI 0.70 to 0.99, P = 0.037). We could not estimate mortality in primary care trials because only one death was reported in a control group participant. Treatment failure was not significantly lower in procalcitonin-guided participants (23.0% versus 24.9% in the control group, adjusted OR 0.90, 95% CI 0.80 to 1.01, P = 0.068). Results were similar among subgroups by clinical setting and type of respiratory infection, with no evidence for effect modification (P for interaction > 0.05). Secondary endpoints: procalcitonin guidance was associated with a 2.4-day reduction in antibiotic exposure (5.7 versus 8.1 days, 95% CI -2.71 to -2.15, P < 0.001) and lower risk of antibiotic-related side effects (16.3% versus 22.1%, adjusted OR 0.68, 95% CI 0.57 to 0.82, P < 0.001). Length of hospital stay and intensive care unit stay were similar in both groups. A sensitivity aggregate-data analysis based on all 32 eligible trials showed similar results. AUTHORS' CONCLUSIONS: This updated meta-analysis of individual participant data from 12 countries shows that the use of procalcitonin to guide initiation and duration of antibiotic treatment results in lower risks of mortality, lower antibiotic consumption, and lower risk for antibiotic-related side effects. Results were similar for different clinical settings and types of ARIs, thus supporting the use of procalcitonin in the context of antibiotic stewardship in people with ARIs. Future high-quality research is needed to confirm the results in immunosuppressed patients and patients with non-respiratory infections.

Influence of humeral head material on wear performance in anatomic shoulder joint arthroplasty.

BACKGROUND: The number of total shoulder arthroplasties has increased in the past years, with encouraging results. However, the survival of anatomic total shoulder arthroplasty (aTSA) is lower compared with that of knee and hip replacements. Wear-associated problems like loosening are well-known causes of long-term failure of aTSA. The main purpose of this study was to investigate the wear behavior of ceramic-polyethylene bearings compared with the standard metal-polyethylene bearings. Because there is a lack of valid experimental wear testing methods, the secondary aim was to develop a validated wear simulation. METHODS: The wear assessment was performed using a force-controlled joint simulator for 3 × 106 cycles, and polyethylene wear was assessed gravimetrically and by particle analysis. Kinetic and kinematic data were adopted from in vivo loading measurements and from several clinical studies on shoulder joint kinematics. The reaction of the rotator cuff was simulated on the basis of a virtual soft tissue model. As activity, an abduction-adduction motion of 0°-90° lifting a load of 2 kg superimposed by an anteversion-retroversion has been chosen. RESULTS: The studied aTSA resulted in a polyethylene wear rate of 62.75 ± 1.60 mg/106 cycles in combination with metallic heads. The ceramic heads significantly reduced the wear rate by 26.7% to 45.99 ± 1.31 mg/106. There were no relevant differences in terms of the particle characteristics. CONCLUSION: This is the first study that experimentally studied the wear behavior of aTSA based on patient-related and biomechanical data under load-controlled conditions. Regarding polyethylene wear, the analyzed aTSA could benefit from ceramic humeral heads.

Same Same but Different? 12/14 Stem and Head Tapers in Total Hip Arthroplasty.

BACKGROUND: Taper corrosion has been identified to be a major concern in total hip arthroplasty during the past years. So far, the mechanisms that lead to taper corrosion in modular taper junctions are not fully understood. However, it has been shown that corrosion is also influenced by the geometry and topography of the taper, and these parameters vary among the implant manufacturers. The purpose of this study was to investigate the variations of common stem and head tapers regarding design and surface characteristics. METHODS: An analysis of selected commercially available 12/14 stem and head tapers was performed. As geometric parameters, the taper angle, the opening taper diameter, and the taper length were measured using a coordinate measuring machine. Several topographic parameters were determined using a tactile roughness measurement instrument. RESULTS: Although all investigated tapers are so-called 12/14 tapers, this study showed that the stem and head tapers differ among the manufacturers. The stem tapers were clearly different in both geometry and topography, and the range in variation of the topographic parameter was greater than it was for the geometric parameter. In contrast, the head tapers were different in their geometry, although not in topography. CONCLUSION: Ultimately, this study provides an overview on the characteristics and variations of modular hip taper connections, and in addition, a new classification system regarding the surface finish is presented. These findings could be further considered in experimental corrosion or retrieval studies.

Economic evaluation of procalcitonin-guided antibiotic therapy in acute respiratory infections: a US health system perspective.

BACKGROUND: Whether or not antibiotic stewardship protocols based on procalcitonin levels results in cost savings remains unclear. Herein, our objective was to assess the economic impact of adopting procalcitonin testing among patients with suspected acute respiratory tract infection (ARI) from the perspective of a typical US integrated delivery network (IDN) with a 1,000,000 member catchment area or enrollment. METHODS: To conduct an economic evaluation of procalcitonin testing versus usual care we built a cost-impact model based on patient-level meta-analysis data of randomized trials. The meta-analytic data was adapted to the US setting by applying the meta-analytic results to US lengths of stay, costs, and practice patterns. We estimated the annual ARI visit rate for the one million member cohort, by setting (inpatient, ICU, outpatient) and ARI diagnosis. RESULTS: In the inpatient setting, the costs of procalcitonin-guided compared to usual care for the one million member cohort was $2,083,545, compared to $2,780,322, resulting in net savings of nearly $700,000 to the IDN for 2014. In the ICU and outpatient settings, savings were $73,326 and $5,329,824, respectively, summing up to overall net savings of $6,099,927 for the cohort. RESULTS were robust for all ARI diagnoses. For the whole US insured population, procalcitonin-guided care would result in $1.6 billion in savings annually. CONCLUSIONS: Our results show substantial savings associated with procalcitonin protocols of ARI across common US treatment settings mainly by direct reduction in unnecessary antibiotic utilization. These results are robust to changes in key parameters, and the savings can be achieved without any negative impact on treatment outcomes.

Prognostic value of procalcitonin in respiratory tract infections across clinical settings.

INTRODUCTION: Whether the inflammatory biomarker procalcitonin provides prognostic information across clinical settings and different acute respiratory tract infections (ARIs) is poorly understood. In the present study, we investigated the prognostic value of admission procalcitonin levels to predict adverse clinical outcome in a large ARI population. METHODS: We analysed data from 14 trials and 4,211 ARI patients to study associations of admission procalcitonin levels and setting specific treatment failure and mortality alone at 30 days. We used multivariable hierarchical logistic regression and conducted sensitivity analyses stratified by clinical settings and ARI diagnoses to assess the results' consistency. RESULTS: Overall, 864 patients (20.5%) experienced treatment failure and 252 (6.0%) died. The ability of procalcitonin to differentiate patients with from those without treatment failure was highest in the emergency department setting (treatment failure area under the curve (AUC): 0.64 (95% confidence interval (CI): 0.61, 0.67), adjusted odds ratio (OR): 1.85 (95% CI: 1.61, 2.12), P <0.001; and mortality AUC: 0.67 (95% CI: 0.63, 0.71), adjusted OR: 1.82 (95% CI: 1.45, 2.29), P <0.001). In lower respiratory tract infections, procalcitonin was a good predictor of identifying patients at risk for mortality (AUC: 0.71 (95% CI: 0.68, 0.74), adjusted OR: 2.13 (95% CI: 1.82, 2.49), P <0.001). In primary care and intensive care unit patients, no significant association of initial procalcitonin levels and outcome was found. CONCLUSIONS: Admission procalcitonin levels are associated with setting specific treatment failure and provide the most prognostic information regarding ARI in the emergency department setting.

The continuum of personalized cardiovascular medicine: a position paper of the European Society of Cardiology.

There is strong need to develop the current stratified practice of CVD management into a better personalized cardiovascular medicine, within a broad framework of global patient care. Clinical information obtained from history and physical examination, functional and imaging studies, biochemical biomarkers, genetic/epigenetic data, and pathophysiological insights into disease-driving processes need to be integrated into a new taxonomy of CVDs to allow personalized disease management. This has the potential for major health benefits for the population suffering from cardiovascular diseases.

Procalcitonin-guided algorithm to reduce length of antibiotic therapy in patients with severe sepsis and septic shock.

BACKGROUND: Procalcitonin (PCT)-protocols to guide antibiotic treatment in severe infections are known to be effective. But less is known about the long-term effects of such protocols on antibiotic consumption under real life conditions. This retrospective study analyses the effects on antibiotic use in patients with severe sepsis and septic shock after implementation of a PCT-protocol. METHODS: We conducted a retrospective ICU-database search for adult patients between 2005 and 2009 with sepsis and organ dysfunction who where treated accordingly to a PCT-guided algorithm as follows: Daily measurements of PCT (BRAHMS PCT LIA(®); BRAHMS Aktiengesellschaft, Hennigsdorf, Germany). Antibiotic therapy was discontinued if 1) clinical signs and symptoms of infection improved and PCT decreased to ≤1 ng/ml, or 2) if the PCT value was >1 ng/ml, but had dropped to 25-35% of the initial value within three days. The primary outcome parameters were: antibiotic days on ICU, ICU re-infection rate, 28-day mortality rate, length of stay (LOS) in ICU, mean antibiotic costs (per patient) and ventilation hours. Data from 141 patients were included in our study. Primary outcome parameters were analysed using covariance analyses (ANCOVA) to control for effects by gender, age, SAPS II, APACHE II and effective cost weight. RESULTS: From baseline data of 2005, duration of antibiotic therapy was reduced by an average of 1.0 day per year from 14.3 ±1.2 to 9.0 ±1.7 days in 2009 (p=0.02). ICU re-infection rate was decreased by yearly 35.1% (95% CI -53 to -8.5; p=0.014) just as ventilation hours by 42 hours per year (95% CI -72.6 to -11.4; p=0.008). ICU-LOS was reduced by 2.7 days per year (p<0.001). Trends towards an average yearly reduction of 28-day mortality by -22.4% (95% CI -44.3 to 8.1; p=0.133) and mean cost for antibiotic therapy/ patient by -14.3 Euro (95% CI -55.7 to 27.1) did not reach statistical significance. CONCLUSIONS: In a real-life clinical setting, implementation of a PCT-protocol was associated with a reduced duration of antibiotic therapy in septic ICU patients without compromising clinical or economical outcomes. GERMAN CLINICAL TRIALS REGISTER: DRKS00003490.

Proteome efficiency of metabolic pathways in Escherichia coli increases along the nutrient flow.

IMPORTANCE: Protein translation is the most expensive cellular process in fast-growing bacteria, and efficient proteome usage should thus be under strong natural selection. However, recent studies show that a considerable part of the proteome is unneeded for instantaneous cell growth in Escherichia coli. We still lack a systematic understanding of how this excess proteome is distributed across different pathways as a function of the growth conditions. We estimated the minimal required proteome across growth conditions in E. coli and compared the predictions with experimental data. We found that the proteome allocated to the most expensive internal pathways, including translation and the synthesis of amino acids and cofactors, is near the minimally required levels. In contrast, transporters and central carbon metabolism show much higher proteome levels than the predicted minimal abundance. Our analyses show that the proteome fraction unneeded for instantaneous cell growth decreases along the nutrient flow in E. coli.

Pulsatile Lavage Improves Tibial Cement Penetration and Implant Stability in Medial Unicompartmental Arthroplasty: A Cadaveric Study.

Cemented unicompartmental knee arthroplasty (UKA) shows good survivorship and function. However, implant failure, causing the need for revision, can occur. Aseptic loosening is still among the most common reasons for revision. The purpose of this study was to assess the influence of preimplantation lavage technique on tibial cement penetration depth, tibial cement volume, and load to fracture in the tibial component of mobile-bearing UKA. In 10 pairs of fresh frozen human tibiae, cemented UKA was implanted by an experienced surgeon. Tibial components were then implanted, left and right tibiae were randomly allocated to group A or B. Prior to implantation, irrigation was performed with either syringe lavage or pulsatile jet lavage in a standardized manner. Cement surface was 4170.2 mm2 (3271.6-5497.8 mm2) in the syringe lavage group, whereas the jet lavage group showed 4499.3 mm2 (3354.3-5809.1 mm2); cement volume was significantly higher as well (4143.4 mm3 (2956.6-6198.6 mm3) compared with 5936.9 mm3 (3077.5-8183.1 mm3)). Cement penetration depth was 2.5 mm (1.7-3.2 mm) for the jet lavage, and 1.8 mm (1.2-2.4 mm) for the syringe lavage. The mean fracture load was 4680 N in the jet lavage group and 3800 N in the syringe lavage group (p = 0.001). Subsidence was significantly higher for syringe lavage. This study suggests a correlation of cement penetration depth and cement volume to implant failure in the tibial component of a UKA using a cadaveric model. The type of bone lavage most likely influences these two key parameters.

Procalcitonin to guide initiation and duration of antibiotic treatment in acute respiratory infections: an individual patient data meta-analysis.

BACKGROUND: Procalcitonin algorithms may reduce antibiotic use for acute respiratory tract infections (ARIs). We undertook an individual patient data meta-analysis to assess safety of this approach in different ARI diagnoses and different clinical settings. METHODS: We identified clinical trials in which patients with ARI were assigned to receive antibiotics based on a procalcitonin algorithm or usual care by searching the Cochrane Register, MEDLINE, and EMBASE. Individual patient data from 4221 adults with ARIs in 14 trials were verified and reanalyzed to assess risk of mortality and treatment failure-overall and within different clinical settings and types of ARIs. RESULTS: Overall, there were 118 deaths in 2085 patients (5.7%) assigned to procalcitonin groups compared with 134 deaths in 2126 control patients (6.3%; adjusted odds ratio, 0.94; 95% confidence interval CI, .71-1.23)]. Treatment failure occurred in 398 procalcitonin group patients (19.1%) and in 466 control patients (21.9%; adjusted odds ratio, 0.82; 95% CI, .71-.97). Procalcitonin guidance was not associated with increased mortality or treatment failure in any clinical setting or ARI diagnosis. Total antibiotic exposure per patient was significantly reduced overall (median [interquartile range], from 8 [5-12] to 4 [0-8] days; adjusted difference in days, -3.47 [95% CI, -3.78 to -3.17]) and across all clinical settings and ARI diagnoses. CONCLUSIONS: Use of procalcitonin to guide initiation and duration of antibiotic treatment in patients with ARIs was effective in reducing antibiotic exposure across settings without an increase in the risk of mortality or treatment failure. Further high-quality trials are needed in critical-care patients.

Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections.

BACKGROUND: Acute respiratory infections (ARIs) comprise a large and heterogeneous group of infections including bacterial, viral and other aetiologies. In recent years, procalcitonin - the prohormone of calcitonin - has emerged as a promising marker for the diagnosis of bacterial infections and for improving decisions about antibiotic therapy. Several randomised controlled trials (RCTs) have demonstrated the feasibility of using procalcitonin for starting and stopping antibiotics in different patient populations with acute respiratory infections and different settings ranging from primary care to emergency departments (EDs), hospital wards and intensive care units (ICUs). OBJECTIVES: The aim of this systematic review based on individual patient data was to assess the safety and efficacy of using procalcitonin for starting or stopping antibiotics over a large range of patients with varying severity of ARIs and from different clinical settings. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2011, Issue 2) which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE (1966 to May 2011) and EMBASE (1974 to May 2011) to identify suitable trials. SELECTION CRITERIA: We included RCTs of adult participants with ARIs who received an antibiotic treatment either based on a procalcitonin algorithm or usual care/guidelines. Trials were excluded if they exclusively focused on paediatric patients or if they used procalcitonin for another purpose than to guide initiation and duration of antibiotic treatment. DATA COLLECTION AND ANALYSIS: Two teams of review authors independently evaluated the methodology and extracted data from primary studies. The primary endpoints were all-cause mortality and treatment failure at 30 days. For the primary care setting, treatment failure was defined as death, hospitalisation, ARI-specific complications, recurrent or worsening infection, and patients reporting any symptoms of an ongoing respiratory infection at follow-up. For the ED setting, treatment failure was defined as death, ICU admission, re-hospitalisation after index hospital discharge, ARI-associated complications, and recurrent or worsening infection within 30 days of follow-up. For the ICU setting, treatment failure was defined as death within 30 days of follow-up. Secondary endpoints were antibiotic use (initiation of antibiotics, duration of antibiotics and total exposure to antibiotics (total amount of antibiotic days divided by total number of patients)), length of hospital stay for hospitalised patients, length of ICU stay for critically ill patients, and number of days with restricted activities within 14 days after randomisation for primary care patients.For the two co-primary endpoints of all-cause mortality and treatment failure, we calculated odds ratios (ORs) and 95% confidence intervals (CIs) using multivariable hierarchical logistic regression. The hierarchical regression model was adjusted for age and clinical diagnosis as fixed-effect. The different trials were added as random-effects into the model. We fitted corresponding linear regression models for antibiotic use. We conducted sensitivity analyses stratified by clinical setting and ARI diagnosis to assess the consistency of our results. MAIN RESULTS: We included 14 trials with 4221 participants. There were 118 deaths in 2085 patients (5.7%) assigned to procalcitonin groups compared to 134 deaths in 2126 control patients (6.3%) (adjusted OR 0.94, 95% CI 0.71 to 1.23). Treatment failure occurred in 398 procalcitonin group patients (19.1%) and in 466 control patients (21.9%). Procalcitonin guidance was not associated with increased mortality or treatment failure in any clinical setting, or ARI diagnosis. These results proved robust in various sensitivity analyses. Total antibiotic exposure was significantly reduced overall (median (interquartile range) from 8 (5 to 12) to 4 (0 to 8) days; adjusted difference in days, -3.47, 95% CI -3.78 to -3.17, and across all the different clinical settings and diagnoses. AUTHORS' CONCLUSIONS: Use of procalcitonin to guide initiation and duration of antibiotic treatment in patients with ARI was not associated with higher mortality rates or treatment failure. Antibiotic consumption was significantly reduced across different clinical settings and ARI diagnoses. Further high-quality research is needed to confirm the safety of this approach for non-European countries and patients in intensive care. Moreover, future studies should also establish cost-effectiveness by considering country-specific costs of procalcitonin measurement and potential savings in consumption of antibiotics and other healthcare resources, as well as secondary cost savings due to lower risk of side effects and reduced antimicrobial resistance.

Wear investigation based on a novel, anatomic shoulder prosthesis with bearing materials inversion.

INTRODUCTION: In shoulder arthroplasty, ultra-high-molecular-weight polyethylene is used as standard material for glenoid components. The emergence of wear particles and their influence on the aseptic loosening of joint replacements are well known. The aim of the present study is to investigate the wear behaviour of the implant combinations as well as the size and morphology of the released wear particles from novel anatomic shoulder prosthesis. Here, the main interest lies on the influence of material inversion and different conformities on wear behaviour. METHODS: Wear simulation was performed using a force-controlled joint simulator. The Modular-Shoulder-System from Permedica S.p.A. Orthopaedics was studied. Polyethylene wear was determined gravimetrically and was characterised by particle analysis. An abduction-adduction motion of 0°-90° lifting a load of 2 kg superimposed by an ante-/retroversion was chosen as the activity. In addition, an extreme test was performed to simulate subluxation of the joint. RESULTS: The results showed a wear reduction of approximately 70% and a significant decrease in the total number of wear particles due to the material inversion on the bearing materials. No reduction of wear could be determined by varying the conformity of the bearing partners. In the simulated subluxation, the material inversion shows an increase in wear. CONCLUSION: Compared to similarly investigated systems, the Modular-Shoulder-System shows a reduction in wear. This reduction shows that material inversion may lead to a wear reduction. However, if subluxation of the humeral head occurs more frequently, increased material wear can be expected with the Modular-Shoulder-System. An influence of the conformity on the wear behaviour could not be determined.

Taper corrosion in total hip arthroplasty - How to assess and which design features are crucial?

BACKGROUND: In total hip replacement, wear and corrosion arising from modular taper connections have increasingly become a serious clinical concern. Previous studies led to confounding results regarding the role of specific taper design features, likely due to the application of different analytical approaches. Accordingly, this study has two major objectives: first, to evaluate different analytical approaches to evaluate the fretting-corrosion behavior; and secondly to determine the effect of four specific design variables: the taper engagement situation, the stem taper length and surface topography in terms of roughness and contact ratio. METHODS: An in vitro fretting-corrosion test setup was used including an aggressive solution. Cyclic loading was applied, varying from 300 N to 2500 N at a frequency of 3 Hz. Taper dummies covering different implant designs were tested in seven different test groups. Different quantitative and qualitative analytical test methods such as electrochemical characterization, ion analysis, gravimetry and corrosion scoring were applied in order to quantify the material degradation. RESULTS: A stepwise linear regression analysis showed that the taper engagement situation is the predominant factor that predicts the metal ion release from the taper connection, followed by the contact ratio of the taper surface and subsequently the taper length. A distal taper engagement situation, as well as a high contact ratio and a short taper length are the relevant parameters that decrease the metal ion release. Hereby, metal ion analysis turned out to be the most precise and reliable method for determining corrosive driven material loss, followed by gravimetry. CONCLUSION: It was found that the taper engagement length is the major design parameter that influences the total ion release. It further turned out, that the selection of an appropriate analytical approach is essential for the evaluation of the corrosion behavior of taper connections in an experimental setting.

Accuracy measurement of different marker based motion analysis systems for biomechanical applications: A round robin study.

INTRODUCTION: Multiple camera systems are widely used for 3D-motion analysis. Due to increasing accuracies these camera systems gained interest in biomechanical research areas, where high precision measurements are desirable. In the current study different measurement systems were compared regarding their measurement accuracy. MATERIALS AND METHODS: Translational and rotational accuracy measurements as well as the zero offset measurements of seven different measurement systems were performed using two reference devices and two different evaluation algorithms. All measurements were performed in the same room with constant temperature at the same laboratory. Equal positions were measured with the systems according to a standardized protocol. Measurement errors were determined and compared. RESULTS: The highest measurement errors were seen for a measurement system using active ultrasonic markers, followed by another active marker measurement system (infrared) having measurement errors up to several hundred micrometers. The highest accuracies were achieved by three stereo camera systems, using passive 2D marker points having errors typically below 20 µm. CONCLUSIONS: This study can help to better assess the results obtained with different measurement systems. With the focus on the measurement accuracy, only one aspect in the selection of a system was considered. Depending on the requirements of the user, other factors like measurement frequency, the maximum analyzable volume, the marker type or the costs are important factors as well.