Risk of partial school closure for COVID-19 by socio-economic level in the period 2020-22.

BACKGROUND: The objective was to analyse the risk of partial school closure by economic level in Barcelona city. METHODS: In this ecological study, the risk of partial school closure for the academic years 2020-21 and 2021-22 was estimated by dividing the total number of days that each child was in quarantine or isolation by the total number of days that each child was at risk to be in quarantine or isolation in the academic year. The association between partial school closure risk and mean income by district was estimated with the Spearman rho. RESULTS: The lower the mean income, the higher the risk of partial closure (Spearman rho = 0.83; P-value = 0.003) during the academic year 2020-21. Specifically, the children from the district with the lowest income had a six times greater risk of partial school closure compared with those from the highest-income district. This risk did not show a significant socioeconomic gradient in the academic year 2021-22. CONCLUSIONS: The risk of partial school closure presented an inverse socioeconomic gradient in the city of Barcelona according to average income by district in the academic year 2020-21. This distribution was not observed in the academic year 2021-22.

Comparative CT Study on Syndesmosis Mobility after Static or Dynamic Fixation for Ankle Fractures with Syndesmotic Rupture: A Pilot Study.

Background: The objective of this prospective randomized pilot study is to compare, by computed tomography (CT), the mobility of syndesmosis after static fixation (SF) or dynamic fixation (DF) in ankle fractures with syndesmotic rupture (AFSR) in adults, and to compare this mobility with that of healthy ankles. Methods: Forty-two patients with an AFSR were randomized to 2 groups: SF (N=21) or DF (N=21). Seven patients were lost to follow-up. Ultimately, 35 patients (SF, N=20; DF, N=15) were analyzed. The clinical results were assessed with the American Orthopedic Foot and Ankle Society scale. To assess syndesmosis mobility, CT in 30° of plantar flexion (PFlex) and 20° of dorsal flexion (DFlex) was performed on both ankles one year after the fracture. Four parameters were measured: anterior tibiofibular distance, posterior tibiofibular posterior distance, angle of fibular rotation (AFR), and anteroposterior fibular translation. Results: The AFR between DFlex and PFlex was more similar to the non-affected side in the DF group. The other three parameters showed no statistical differences between types of fixation. The mean loss of AFR compared with the non-affected side was 1.2° in the SF group and 0.1° in the DF group. No clinical differences between the SF group and the DF group were found. No correlation between clinical and radiological results was observed. Conclusion: The AFR was more similar to the non-affected side in the DF group. However, this finding did not correlate with a better clinical result.

SARS-CoV-2 outbreak impact on a trauma unit.

BACKGROUND: From February 2020 onwards, our country has been hit by the coronavirus severe acute respiratory syndrome-2 (SARS-CoV-2) infection. At a glance, hospitals became overrun and had to reformulate all the assistance guidelines, focusing on the coronavirus disease 2019. One year after the start of the pandemic, we present the results of a morbimortality study. AIM: To analyze how our department was affected by the outbreak in terms of morbimortality, and to analyze demographic data, admission to hospital-related data, and subgroups analyses for patients with hip fractures and polytrauma. METHODS: We designed a study comparing data from patients who were admitted to our unit due to a lower limb fracture or a high energy trauma during the pandemic (from March to April 2020) to those admitted during the same period in 2019 before the pandemic. during the pandemic situation. Both cohorts completed a minimum of 6 mo of follow-up. RESULTS: The number of patients admitted to hospital in 2020 was nearly half of those in 2019. Hip fractures in the elderly represented 52 out of 73 of the admitted patients. Twenty patients had a positive test result for SARS-CoV-2 infection. Patients with SARS-CoV-2 infection were admitted to the hospital for a longer time than the non-infected (P < 0.001), and had a higher mortality rate during hospitalization and follow-up (P = 0.02). Patients with a hip fracture associated with a severe respiratory syndrome were mostly selected for conservative treatment (P = 0.03). CONCLUSION: Mortality and readmission rates were higher in the 2020 cohort and during follow-up, in comparison with the cohort in 2019.

The use of external fixation in the emergency department: applications, common errors, complications and their treatment.

The use of an external fixator (EF) in the emergency department (ED) or the emergency theatre in the ED is reserved for critically ill patients in a life-saving attempt. Hence, usually only fixation/stabilization of the pelvis, tibia, femur and humerus are performed. All other external fixation methods are not indicated in an ED and thus should be performed in the operating room with a sterile environment.Anterior EF is used in unstable pelvic lesions due to anterior-posterior compression, and in stable pelvic fractures in haemodynamically unstable patients.Patients with multiple trauma should be stabilized quickly with EF.The C-clamp has been designed to be used in the ED to stabilize fractures of the sacrum or alterations of the sacroiliac joint in patients with circulatory instability.Choose a modular EF that allows for the free placement of the pins, is radiolucent and is compatible with magnetic resonance imaging (MRI).Planning the type of framework to be used is crucial.Avoid mistakes in the placement of EF. Cite this article: EFORT Open Rev 2020;5:204-214. DOI: 10.1302/2058-5241.5.190029.

Characteristics and Outcomes of Patients With Systemic Sclerosis (Scleroderma) Requiring Renal Replacement Therapy in Europe: Results From the ERA-EDTA Registry.

RATIONALE & OBJECTIVE: Data for outcomes of patients with end-stage renal disease (ESRD) secondary to systemic sclerosis (scleroderma) requiring renal replacement therapy (RRT) are limited. We examined the incidence and prevalence of ESRD due to scleroderma in Europe and the outcomes among these patients following initiation of RRT. STUDY DESIGN: Registry study of incidence and prevalence and a matched cohort study of clinical outcomes. SETTING & PARTICIPANTS: Patients represented in any of 19 renal registries that provided data to the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Registry between 2002 and 2013. PREDICTOR: Scleroderma as the identified cause of ESRD. OUTCOMES: Incidence and prevalence of ESRD from scleroderma. Recovery from RRT dependence, patient survival after ESRD, and graft survival after kidney transplantation. ANALYTICAL APPROACH: Incidence and prevalence were calculated using population data from the European Union and standardized to population characteristics in 2005. Patient and graft survival were compared with 2 age- and sex-matched control groups without scleroderma: (1) diabetes mellitus as the cause of ESRD and (2) conditions other than diabetes mellitus as the cause of ESRD. Survival analyses were performed using Kaplan-Meier analysis and Cox regression. RESULTS: 342 patients with scleroderma (0.14% of all incident RRT patients) were included. Between 2002 and 2013, the range of adjusted annual incidence and prevalence rates of RRT for ESRD due to scleroderma were 0.11 to 0.26 and 0.73 to 0.95 per million population, respectively. Recovery of independent kidney function was greatest in the scleroderma group (7.6% vs 0.7% in diabetes mellitus and 2.0% in other primary kidney diseases control group patients, both P<0.001), though time required to achieve recovery was longer. The 5-year survival probability from day 91 of RRT among patients with scleroderma was 38.9% (95% CI, 32.0%-45.8%), whereas 5-year posttransplantation patient survival and 5-year allograft survival were 88.2% (95% CI, 75.3%-94.6%) and 72.4% (95% CI, 55.0%-84.0%), respectively. Adjusted mortality from day 91 on RRT was higher among patients with scleroderma than observed in both control groups (HRs of 1.25 [95% CI, 1.05-1.48] and 2.00 [95% CI, 1.69-2.39]). In contrast, patient and graft survival after kidney transplantation did not differ between patients with scleroderma and control groups. LIMITATIONS: No data for extrarenal manifestations, treatment, or recurrence. CONCLUSIONS: Survival of patients with scleroderma who receive dialysis for more than 90 days was worse than for those with other causes of ESRD. Patient survival after transplantation was similar to that observed among patients with ESRD due to other conditions. Patients with scleroderma had a higher rate of recovery from RRT dependence than controls.

Factors associating with differences in the incidence of renal replacement therapy among elderly: data from the ERA-EDTA Registry.

Background: The incidence of renal replacement therapy (RRT) in the general population ≥75 years of age varies considerably between countries and regions in Europe. Our aim was to study characteristics and survival of elderly RRT patients and to find explanations for differences in RRT incidence. Methods: Patients ≥75 years of age at the onset of RRT in 2010-2013 from 29 national or regional registries providing data to the European Renal Association-European Dialysis and Transplant Association Registry were included. Chi-square and Mann-Whitney U tests were used to assess variation in patient characteristics and linear regression was used to study the association between RRT incidence and various factors. Kaplan-Meier curves and Cox regression were employed for survival analyses. Results: The mean annual incidence of RRT in the age group ≥75 years of age ranged from 157 to 924 per million age-related population. The median age at the start of RRT was higher and comorbidities were less common in areas with higher RRT incidence, but overall the association between patient characteristics and RRT incidence was weak. The unadjusted survival was lower in high-incidence areas due to an older age at onset of RRT, but the adjusted survival was similar [relative risk 1.00 (95% confidence interval, 0.97-1.03)] in patients from low- and high-incidence areas. Conclusions: Variation in the incidence of RRT among the elderly across European countries and regions is remarkable and could not be explained by the available data. However, the survival of patients in low- and high-incidence areas was remarkably similar.

Access to kidney transplantation in European adults aged 75-84 years and related outcomes: an analysis of the European Renal Association-European Dialysis and Transplant Association Registry.

To what extent access to, and allocation of kidney transplants and survival outcomes in patients aged ≥75 years have changed over time in Europe is unclear. We included patients aged ≥75-84 years (termed older adults) receiving renal replacement therapy in thirteen European countries between 2005 and 2014. Country differences and time trends in access to, and allocation of kidney transplants were examined. Survival outcomes were determined by Cox regression analyses. Between 2005 and 2014, 1392 older adult patients received 1406 transplants. Access to kidney transplantation varied from ~0% (Slovenia, Greece and Denmark) to ~4% (Norway and various Spanish regions) of all older adult dialysis patients, and overall increased from 0.3% (2005) to 0.9% (2014). Allocation of kidney transplants to older adults overall increased from 0.8% (2005) to 3.2% (2014). Seven-year unadjusted patient and graft survival probabilities were 49.1% (95% confidence interval, 95% CI: 43.6; 54.4) and 41.7% (95% CI: 36.5; 46.8), respectively, with a temporal trend towards improved survival outcomes. In conclusion, in the European dialysis population aged ≥75-84 years access to kidney transplantation is low, and allocation of kidney transplants remains a rare event. Though both are increasing with time and vary considerably between countries. The trend towards improved survival outcomes is encouraging. This information can aid informed decision-making regarding treatment options.

Changes in co-morbidity pattern in patients starting renal replacement therapy in Europe-data from the ERA-EDTA Registry.

Background: Patients starting renal replacement therapy (RRT) for end-stage renal disease often present with one or more co-morbidities. This study explored the prevalence of co-morbidities in patients who started RRT in Europe during the period from 2005 to 2014. Methods: Using data from patients aged 20 years or older from all 11 national or regional registries providing co-morbidity data to the European Renal Association - European Dialysis and Transplant Association Registry, we examined the prevalence of the following co-morbidities: diabetes mellitus (DM) (primary renal disease and/or co-morbidity), ischaemic heart disease (IHD), congestive heart failure (CHF), peripheral vascular disease (PVD), cerebrovascular disease (CVD) and malignancy. Results: Overall, 70% of 7578 patients who initiated RRT in 2014 presented with at least one co-morbidity: 39.0% presented with DM, 25.0% with IHD, 22.3% with CHF, 17.7% with PVD, 16.4% with malignancy and 15.5% with CVD. These percentages differed substantially between countries. Co-morbidities were more common in men than in women, in older patients than in younger patients, and in patients on haemodialysis at Day 91 when compared with patients on peritoneal dialysis. Between 2005 and 2014 the prevalence of DM and malignancy increased over time, whereas the prevalence of IHD and PVD declined. Conclusions: More than two-thirds of patients initiating RRT in Europe have at least one co-morbidity. With the rising age at the start of RRT over the last decade, there have been changes in the co-morbidity pattern: the prevalence of cardiovascular co-morbidities decreased, while the prevalence of DM and malignancy increased.

Nocardia farcinica Brain Abscess: Report of 3 Cases.

BACKGROUND: Central nervous system nocardial infection is a rarely reported disease that usually affects patients with predisposing and debilitating conditions but also the immunocompetent population. The most common variant affecting the brain is Nocardia farcinica. Management of brain nocardiosis is troublesome and requires consideration of the severity of the underlying systemic disease, the difficulties in identifying the bacterium, and the frequent delay in initiating adequate therapy. CASE DESCRIPTION: We present 3 cases of N. farcinica brain abscess (single, multiloculated, and multifocal) diagnosed in 3 patients with predisposing factors that could be successfully cured. The patients underwent craniotomy, evacuation of the purulent collection, and partial resection of the abscesses' walls. Confirmation of N. farcinica species was achieved using specific polymerase chain reaction sequencing of the 16S ribosome RNA gene. Antibiotic therapy was selected on susceptibility tests and was maintained for 10 months (1 case) and 12 months (2 cases). CONCLUSIONS: Brain nocardiosis needs to be suspected primarily (though not exclusively) in immunocompromised patients presenting with neurologic deficit and harboring intracerebral lesions resembling brain tumors. Early identification of the specific species is paramount in order to initiate long-term antibiotic therapy, acknowledging the inherent resistance of N. farcinica to third-generation cefalosporins and its susceptibility to trimethoprim-sulphamethoxazole. According to the literature, surgical excision or aspiration of the brain abscess seems to provide good chances of eradication of the disease. In our experience, successful outcome was achieved with subtotal resection and prolonged and adequate antibiotic therapy.

Prevalence of lower extremity peripheral arterial disease in individuals with chronic immune mediated inflammatory disorders.

OBJECTIVE: To compare the prevalence of lower extremity peripheral artery disease (PAD) and to assess whether age-associated progression in ankle-brachial index (ABI) differs between individuals with chronic immune-mediated inflammatory diseases (CIID) and the general population. METHODS: Pooled analysis with data from individuals aged 50 years and older with ABI measurements, obtained from population-based cross-sectional studies conducted in Catalonia (Spain). Information on three CIID diagnoses (i.e., inflammatory bowel disease, systemic connective tissue disorders, and inflammatory polyarthropathies and spondylopathies, considered as one entity for purposes of analysis) was obtained from electronic medical records. To ascertain the statistical association between PAD and CIID, logistic regression models were fitted and adjusted for age, sex, and cardiovascular risk factors. We tested the interaction between age and CIID diagnosis for ABI values. RESULTS: We included 8799 individuals, 312 (3.6%) with CIID. The age-standardized prevalence of PAD was higher in the CIID group (12% vs. 6% in general population, p = 0.001), and the model adjusted for age, sex, and cardiovascular risk factors also showed higher risk in individuals with CIID [Odds Ratio (95% confidence interval) = 1.65 (1.15-2.38); p = 0.007]. The inflammatory polyarthropathies/spondylopathies diagnosis was significantly associated with PAD in the fully adjusted model [1.80 (1.18-2.75); p = 0.006]. The atherosclerotic process was accelerated in individuals with CIID, compared to the general population (p for interaction<0.001). CONCLUSION: In individuals with CIID, age-standardized prevalence of PAD was significantly higher than in the general population and the atherosclerotic process was accelerated. However, only inflammatory polyarthropathies/spondylopathies was associated with significant risk of PAD.

Culture of human mesenchymal stem cells using a candidate pharmaceutical grade xeno-free cell culture supplement derived from industrial human plasma pools.

INTRODUCTION: Fetal bovine serum (FBS) is an animal product used as a medium supplement. The animal origin of FBS is a concern if cultured stem cells are to be utilized for human cell therapy. Therefore, a substitute for FBS is desirable. In this study, an industrial, xeno-free, pharmaceutical-grade supplement for cell culture (SCC) under development at Grifols was tested for growth of human mesenchymal stem cells (hMSCs), cell characterization, and differentiation capacity. METHODS: SCC is a freeze-dried product obtained through cold-ethanol fractionation of industrial human plasma pools from healthy donors. Bone marrow-derived hMSC cell lines were obtained from two commercial suppliers. Cell growth was evaluated by culturing hMSCs with commercial media or media supplemented with SCC or FBS. Cell viability and cell yield were assessed with an automated cell counter. Cell surface markers were studied by indirect immunofluorescence assay. Cells were cultured then differentiated into adipocytes, chondrocytes, osteoblasts, and neurons, as assessed by specific staining and microscopy observation. RESULTS: SCC supported the growth of commercial hMSCs. Starting from the same number of seeded cells in two consecutive passages of culture with medium supplemented with SCC, hMSC yield and cell population doubling time were equivalent to the values obtained with the commercial medium and was consistent among lots. The viability of hMSCs was higher than 90%, while maintaining the characteristic phenotype of undifferentiated hMSCs (positive for CD29, CD44, CD90, CD105, CD146, CD166 and Stro-1; negative for CD14 and CD19). Cultured hMSCs maintained the potential for differentiation into adipocytes, chondrocytes, osteoblasts, and neurons. CONCLUSIONS: The tested human plasma-derived SCC sustains the adequate growth of hMSCs, while preserving their differentiation capacity. SCC can be a potential candidate for cell culture supplement in advanced cell therapies.

Robustness of nanofiltration for increasing the viral safety margin of biological products.

In this study, the virus-removal capacity of nanofiltration was assessed using validated laboratory scale models on a wide range of viruses (pseudorabies virus; human immunodeficiency virus; bovine viral diarrhea virus; West Nile virus; hepatitis A virus; murine encephalomyocarditis virus; and porcine parvovirus) with sizes from 18 nm to 200 nm and applying the different process conditions existing in a number of Grifols' plasma-derived manufacturing processes (thrombin, α1-proteinase inhibitor, Factor IX, antithrombin, plasmin, intravenous immunoglobulin, and fibrinogen). Spiking experiments (n = 133) were performed in process intermediate products, and removal was subsequently determined by infectivity titration. Reduction Factor (RF) was calculated by comparing the virus load before and after nanofiltration under each product purification condition. In all experiments, the RFs were close to or greater than 4 log10 (>99.99% of virus elimination). RF values were not significantly affected by the process conditions within the limits assayed (pH, ionic strength, temperature, filtration ratio, and protein concentration). The virus-removal capacity of nanofiltration correlated only with the size of the removed agent. In conclusion, nanofiltration, as used in the manufacturing of several Grifols' products, is consistent, robust, and not significantly affected by process conditions.

Determinants of the transition from a cardiometabolic normal to abnormal overweight/obese phenotype in a Spanish population.

PURPOSE: There is limited prospective evidence at population scale of the impacts of lifestyle and surrogate measures of general and abdominal adiposity on the transition of a metabolically healthy (absence of a metabolic disorder) overweight/obese (MHOO) phenotype to a metabolically abnormal overweight/obese (MAOO) phenotype. Therefore, we determined the relationship between 10-year body mass index (BMI), waist circumferences (WC), waist to height ratio (WHtR), and lifestyle changes and the transition of the MHOO phenotype. METHODS: We conducted a prospective population-based study of 3,052 male and female Spaniards aged 25-74 years who were followed from 2000 through 2009. Diet and leisure-time physical activity were recorded on validated questionnaires. Weight, height, WC, blood lipids, glycemia, and blood pressure were measured. All variables were obtained at baseline (BL) and follow-up (FL). Participants with a BMI ≥ 25 kg/m(2) and free from hypercholesterolemia, hypertriglyceridemia, diabetes, hypertension, and low HDL and high LDL cholesterol levels were characterized as the MHOO phenotype. A composite healthy lifestyle index (HLI) was constructed by including temporary changes in 3 lifestyle variables (diet, leisure-time physical activity, and smoking). RESULTS: Initially, 20.8% of subjects had the MHOO phenotype; 49.2% of these shifted to MAOO phenotype. In multivariate analysis, changes in BMI, WC, WHtR were positively associated (p = 0.004, p = 0.018, and p = 0.016, respectively) with this transition. One unit increase in the HLI was associated with a 33% lower risk (p = 0.025) to the MAOO phenotype transition after adjusting for age, sex, educational level, and baseline energy intake, BMI, WC, and WHtR. CONCLUSIONS: The presence of metabolic disorders in the MHOO phenotype is predicted by an increase in anthropometric surrogate measures of general and abdominal adiposity. In contrast, a healthy lifestyle protects against a transition to the MAOO phenotype.

Renal replacement therapy in Europe: a summary of the 2011 ERA-EDTA Registry Annual Report.

BACKGROUND: This article provides a summary of the 2011 ERA-EDTA Registry Annual Report (available at www.era-edta-reg.org). METHODS: Data on renal replacement therapy (RRT) for end-stage renal disease (ESRD) from national and regional renal registries in 30 countries in Europe and bordering the Mediterranean Sea were used. From 27 registries, individual patient data were received, whereas 17 registries contributed data in aggregated form. We present the incidence and prevalence of RRT, and renal transplant rates in 2011. In addition, survival probabilities and expected remaining lifetimes were calculated for those registries providing individual patient data. RESULTS: The overall unadjusted incidence rate of RRT in 2011 among all registries reporting to the ERA-EDTA Registry was 117 per million population (pmp) (n = 71.631). Incidence rates varied from 24 pmp in Ukraine to 238 pmp in Turkey. The overall unadjusted prevalence of RRT for ESRD on 31 December 2011 was 692 pmp (n = 425 824). The highest prevalence was reported by Portugal (1662 pmp) and the lowest by Ukraine (131 pmp). Among all registries, a total of 22 814 renal transplantations were performed (37 pmp). The highest overall transplant rate was reported from Spain, Cantabria (81 pmp), whereas the highest rate of living donor transplants was reported from Turkey (39 pmp). For patients who started RRT between 2002 and 2006, the unadjusted 5-year patient survival on RRT was 46.8% [95% confidence interval (CI) 46.6-47.0], and on dialysis 39.3% (95% CI 39.2-39.4). The unadjusted 5-year patient survival after the first renal transplantation performed between 2002 and 2006 was 86.7% (95% CI 86.2-87.2) for kidneys from deceased donors and 94.3% (95% CI 93.6-95.0) for kidneys from living donors.

Polypharmacy patterns: unravelling systematic associations between prescribed medications.

OBJECTIVES: The aim of this study was to demonstrate the existence of systematic associations in drug prescription that lead to the establishment of patterns of polypharmacy, and the clinical interpretation of the associations found in each pattern. METHODS: A cross-sectional study was conducted based on information obtained from electronic medical records and the primary care pharmacy database in 2008. An exploratory factor analysis of drug dispensing information regarding 79,089 adult patients was performed to identify the patterns of polypharmacy. The analysis was stratified by age and sex. RESULTS: Seven patterns of polypharmacy were identified, which may be classified depending on the type of disease they are intended to treat: cardiovascular, depression-anxiety, acute respiratory infection (ARI), chronic obstructive pulmonary disease (COPD), rhinitis-asthma, pain, and menopause. Some of these patterns revealed a clear clinical consistency and included drugs that are prescribed together for the same clinical indication (i.e., ARI and COPD patterns). Other patterns were more complex but also clinically consistent: in the cardiovascular pattern, drugs for the treatment of known risk factors-such as hypertension or dyslipidemia-were combined with other medications for the treatment of diabetes or established cardiovascular pathology (e.g., antiplatelet agents). Almost all of the patterns included drugs for preventing or treating potential side effects of other drugs in the same pattern. CONCLUSIONS: The present study demonstrated the existence of non-random associations in drug prescription, resulting in patterns of polypharmacy that are sound from the pharmacological and clinical viewpoints and that exist in a significant proportion of the population. This finding necessitates future longitudinal studies to confirm some of the proposed causal associations. The information discovered would further the development and/or adaptation of clinical patient guidelines to patients with multimorbidity who are taking multiple drugs.

Long-term outcome of one-piece implants. Part II: Prosthetic outcomes. A systematic literature review with meta-analysis.

PURPOSE: To evaluate the long-term clinical performance of prosthetic reconstructions on one-piece implants, with a focus on technical and biological complications. MATERIALS AND METHODS: An electronic MEDLINE search complemented by a manual search was conducted to identify randomized and prospective controlled clinical trials on one-piece implants. Additional inclusion criteria were a mean follow-up period of at least 5 years and an inception cohort where more than 80% of the enrolled patients remained in the study at the 5- or 10-year observation point. RESULTS: Sixty-six studies from an initial yield of 597 titles were selected, and the data were extracted. Of the full-text articles examined, 46 were excluded and a total of 20 articles were finally selected. All studies were published between 1995 and 2011. Two different study designs were identified: 4 randomized controlled trials and 16 prospective cohort studies. The studies were analyzed and classified according to study type, patient characteristics, prosthetic characteristics, and biologic and technical complications after 5 and 10 years. The meta-analysis of the included studies showed a prosthetic survival rate for one-piece, one-part implants of 82.81% after 5 years and 97.85% and 98.24% in two-part implants after 5 and 10 years, respectively. Although the prosthetic survival rates were high, complications were frequent: complications of the suprastructure (18.44% to 18.75%), screw loosening/fracture (7.64%), soft-tissue complications (4.69% to 8.25%), sensory disturbances (0.36% to 6.25%), implant loss before loading (0% to 0.23%) and during function (1.10% to 3.21%), and implant fracture (0.0004%). CONCLUSION: Within the limits of this systematic review, it can be concluded that despite high long-term prosthetic survival rates, technical and biologic complications are frequent in one-piece implants, both in one-part and two-part designs. Further randomized clinical trials are needed to provide more information about the outcome of different variables associated with this type of implant design.

Platelet-rich fibrin in arthroscopic repair of massive rotator cuff tears: a prospective randomized pilot clinical trial.

The objective of this study was to prospectively evaluate the feasibility of a large- scale project on the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff. A prospective, randomized pilot clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range: 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. After the repair was completed, 6 ml PRF (Vivostat) was locally applied to the repair site in 14 patients; no similar action was done in the other 14 patients. All patients underwent a clinical examination and an arthro-MRI to evaluate the integrity of the repair, one year after the operation. They were followed clinically for a minimum of 2 years. Functional outcome was evaluated with the Constant and DASH scores. There were no reported complications in either group. None of the patients was lost to follow-up. Globally, the Constant score improved from 45 preoperatively (range: 25 to 65) to 64 at one year (range: 20 to 79) (p < 0.001), with no significant change at two years (mean 63, range: 20 to 77). The VAS for pain improved from 5.6/10 preoperatively to 1.7/10 at the most recent examination (p < 0.001). All but two patients were satisfied. With the numbers of patients available, we could not detect a significant difference in the preoperative (46 vs. 43; p = 037) or postoperative Constant score (61 vs. 68; p = 0.125) between the control group and the PRF group. On arthro-MRI, 19 of the 28 patients (68%) were found to have a large re-tear : 10/14 in the PRF group and 9/14 in the control group. Local application of autologous PRF to the repair site of massive rotator cuffs fully reconstructed arthroscopically failed to improve the clinical outcome and the healing rate, compared with a standard repair. However, a large-scale study would be necessary to confirm these results.

Long-term outcome of one-piece implants. Part I: implant characteristics and loading protocols. A systematic literature review with meta-analysis.

PURPOSE: The aim of this systematic review was to evaluate the long-term clinical performance of one-piece implants. MATERIALS AND METHODS: An electronic MEDLINE search complemented by a manual search was conducted to identify randomized and prospective cohort studies on one-piece implants. Additional inclusion criteria were: a mean follow-up period of at least 5 years and an inception cohort where more than 80% of the enrolled patients remained in the study at the 5- or 10-year observation point. RESULTS: Sixty-six studies from an initial yield of 597 titles were selected, and the data were extracted. Of the full-text articles examined, 46 were excluded from the final analysis. A total of 20 articles were finally selected. All studies were published between 1995 and 2011. Two different study designs were included: 4 randomized controlled trials and 16 prospective cohort studies. The studies were analyzed and classified according to the follow-up period, the type of implant surface, the type of edentulism, the type of loading protocol, and the type of setting. The meta-analysis of the included studies showed an implant survival rate for one-piece, one-part implants of 96.79% (95% CI: 94.04% to 98.71%) after 5 years. In one-piece, two-part implants, the survival rate was slightly higher: 98.16% (95% CI: 96.48% to 99.31%) after 5 years and 96.83% (95% CI: 93.12% to 99.24%) after 10 years. CONCLUSION: Within the limits of this systematic review, it can be concluded that high long-term survival rates can be observed with one-piece implants. Further randomized clinical trials are needed to provide more information about the outcome of different variables associated with one-piece implants.

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

BACKGROUND: Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. METHODS/DESIGN: An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). DISCUSSION: If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. TRIAL REGISTRATION: The study is registered as NCT01291953 (ClinicalTrials.gob).