Ensayo clínico sobre el efecto del ácido tranexámico en el sangrado y la fibrinólisis durante la artroplastia simple de cadera y rodilla / Clinical trial on the effect of tranexamic acid on bleeding and fibrinolysis in primary hip and knee replacement

Objetivo: La isquemia derivada de la aplicación del torniquete es un factor fibrinolítico que podría potenciar la eficacia del ácido tranexámico (ATx) en artroplastia total de rodilla (ATR) frente a la artroplastia total de cadera (ATC). Nuestro objetivo es comparar el efecto del ATx sobre sangrado y fibrinólisis en estas 2 artroplastias, valorando la incidencia de complicaciones. Método: Ensayo clínico prospectivo, aleatorizado y doble ciego. Los pacientes programados para ATR o ATC recibían ATx (2 infusiones 10mg/kg) o placebo. Se cuantificó sangrado y parámetros de fibrinólisis, y se detectaron complicaciones tromboembólicas con ecografía doppler y tomografía computarizada. Resultados: Fueron incluidos 44 pacientes (11 ATC y 11 ATR tratados con ATx; 11 ATC y 11 ATR fueron controles). El sangrado fue significativamente menor en el grupo tratado con ATx (promedio 921mL vs. 1383mL en ATC y 969mL vs. 1223mL en ATR) y se necesitaron menos transfusiones (ninguna frente a 5 unidades en grupo control). El ATx fue igualmente eficaz en la reducción del sangrado en ambas cirugías (reducción del 33% en ATC y del 21% en ATR). El gran incremento medio de dímero D entre el periodo basal y las 6h (1.004 a 10.284μg /L en ATC y 571 a 6.480μg /L en ATR) es atenuado por el uso de ATx (1.077 a 2.590μg/L en ATC y 655 a 2.535μg/L en ATR). No hubo diferencias significativas en eventos tromboembólicos. Conclusiones: El ATx profiláctico es igualmente efectivo en ATR y ATC para reducir sangrado. Ambas cirugías tienen efecto similar sobre la fibrinólisis

Background: Tourniquet-induced ischaemia could increase fibrinolysis and enhance tranexamic acid (TXA) efficacy in total knee arthroplasty (TKA) compared to total hip arthroplasty (THA). The aims of this study are to compare the effect of TXA on bleeding and fibrinolysis in both types of surgery, and to record thromboembolic complications. Methods: A prospective double-blind study was conducted on patients scheduled for TKA or THA who received TXA (2 bolus of 10mg/kg) or placebo. Bleeding and fibrinolysis were evaluated. Doppler-ultrasound and computed tomography were performed in order to assess any thromboembolic complications. Results: A total of 44 patients were included (11 THA and 11 TKA treated with TXA; 11 THA and 11 TKA as controls). Blood losses were significantly lower in the TXA group (mean 921mL vs 1,383mL in THA and 969mL vs 1,223mL in TKA), and no transfusions were needed with TXA, whereas 5 blood units were transfused in controls. TXA was equally effecting in reducing bleeding in both surgeries (33% in THA and 21% in TKA). The significant mean increase in D-dimers from baseline to 6 hours after surgery (1,004 ug/L to 10,284 ug/L in THA and 571 ug/L to 6,480 ug/L in TKA) was attenuated by TXA (1,077 ug/L to 2,590 ug/L in THA and 655 ug/L to 2,535 ug/L in TKA). There were no differences in thromboembolic episodes. Conclusions: Prophylactic use of tranexamic acid is equally effective in reducing bleeding in TKA and THA. Both surgeries have a similar effect on fibrinolysis

Clinical trial on the effect of tranexamic acid on bleeding and fibrinolysis in primary hip and knee replacement. / Ensayo clínico sobre el efecto del ácido tranexámico en el sangrado y la fibrinólisis durante la artroplastia simple de cadera y rodilla.

BACKGROUND: Tourniquet-induced ischaemia could increase fibrinolysis and enhance tranexamic acid (TXA) efficacy in total knee arthroplasty (TKA) compared to total hip arthroplasty (THA). The aims of this study are to compare the effect of TXA on bleeding and fibrinolysis in both types of surgery, and to record thromboembolic complications. METHODS: A prospective double-blind study was conducted on patients scheduled for TKA or THA who received TXA (2 bolus of 10mg/kg) or placebo. Bleeding and fibrinolysis were evaluated. Doppler-ultrasound and computed tomography were performed in order to assess any thromboembolic complications. RESULTS: A total of 44 patients were included (11 THA and 11 TKA treated with TXA; 11 THA and 11 TKA as controls). Blood losses were significantly lower in the TXA group (mean 921mL vs 1,383mL in THA and 969mL vs 1,223mL in TKA), and no transfusions were needed with TXA, whereas 5 blood units were transfused in controls. TXA was equally effecting in reducing bleeding in both surgeries (33% in THA and 21% in TKA). The significant mean increase in D-dimers from baseline to 6 hours after surgery (1,004 ug/L to 10,284 ug/L in THA and 571 ug/L to 6,480 ug/L in TKA) was attenuated by TXA (1,077 ug/L to 2,590 ug/L in THA and 655 ug/L to 2,535 ug/L in TKA). There were no differences in thromboembolic episodes. CONCLUSIONS: Prophylactic use of tranexamic acid is equally effective in reducing bleeding in TKA and THA. Both surgeries have a similar effect on fibrinolysis.

Una década del Registro de Artroplastias de Cataluña (RACat): exhaustividad, variabilidad y supervivencia de las prótesis entre 2005 y 2014 / A decade of the Catalonian Arthroplasty Register (RACat): variability, exhaustivity, and survival of prostheses between 2005 and 2014

Antecedentes y objetivo. El Registro de Artroplastias de Cataluña (RACat) es un registro poblacional basado en el sistema sanitario público para analizar y evaluar artroplastias de cadera y rodilla en Cataluña. El objetivo de este estudio es presentar los resultados tras 10 años de funcionamiento (de enero de 2005 a diciembre de 2014). Metodología. A partir de la información del RACat y del conjunto mínimo básico de datos al alta hospitalaria, se analizó la calidad y exhaustividad de los datos y se realizaron análisis descriptivos de pacientes, prótesis y proceso asistencial. Además, se analizó la supervivencia calculando la incidencia acumulada de revisión (según causa de intervención en artroplastias de cadera y preservación o sacrificio del ligamento cruzado posterior en artroplastia de rodilla) y la asociación entre riesgo de revisión y técnica de fijación de las prótesis como modelos de riesgos competitivos ajustados por sexo, edad y comorbilidad. Resultados. El principal motivo de intervención en artroplastias primarias de cadera y rodilla fue la artrosis. La incidencia acumulada de revisión a los 10 años fue del 3,9% en artroplastias de cadera causadas por artrosis y del 2,3% en las causadas por fractura. Las artroplastias de rodilla que conservan el ligamento cruzado posterior son el 4,4% y las que no lo conservan, el 5,1%. Discusión. El RACat se consolida como herramienta para la evaluación de las artroplastias con gran potencial en el análisis de la efectividad a medio y largo plazo, el estudio de la variabilidad de la práctica clínica y la vigilancia poscomercialización (AU)

Background and aim. The Catalonian Arthroplasty Register (RACat) is a public health-based population register used to analyse and evaluate hip and knee replacements in Catalonia. The aim of this study is to present the outcomes after 10 years in operation (January 2005-December 2014). Methodology. Using the information from the RACat and the minimum basic data set at hospital discharge, an analysis was made of the quality and exhaustivity of the data, as well as a descriptive analysis of the patients, prostheses, and care process. Survival was also analysed by calculating the accumulated incidence of revisions (according to the cause of intervention in hip replacements and conservation or sacrifice of the posterior cruciate ligament in knee replacement). The relationship between revision risk and the fixation technique of the prosthesis is also analysed, using competitive risk models adjusted for gender, age, and comorbidities. Results. The main reason for the primary hip and knee replacement surgery was arthrosis. The accumulated incidence of revisions at 10 years was 3.9% in hip replacements caused by arthrosis, and 2.3% in those caused by fracture. Conservation of the posterior cruciate ligament was achieved in 4.4% of knee replacements, with sacrifice in 5.1%. Discussion. The RACat is consolidated as a tool for the evaluation of joint replacements, with great potential in the analysis of medium and long-term efficacy, the study of the variability in clinical practice, and post-marketing surveillance (AU)

A decade of the Catalonian Arthroplasty Register (RACat): Variability, exhaustivity, and survival of prostheses between 2005 and 2014. / Una década del Registro de Artroplastias de Cataluña (RACat): exhaustividad, variabilidad y supervivencia de las prótesis entre 2005 y 2014.

BACKGROUND AND AIM: The Catalonian Arthroplasty Register (RACat) is a public health-based population register used to analyse and evaluate hip and knee replacements in Catalonia. The aim of this study is to present the outcomes after 10 years in operation (January 2005-December 2014). METHODOLOGY: Using the information from the RACat and the minimum basic data set at hospital discharge, an analysis was made of the quality and exhaustivity of the data, as well as a descriptive analysis of the patients, prostheses, and care process. Survival was also analysed by calculating the accumulated incidence of revisions (according to the cause of intervention in hip replacements and conservation or sacrifice of the posterior cruciate ligament in knee replacement). The relationship between revision risk and the fixation technique of the prosthesis is also analysed, using competitive risk models adjusted for gender, age, and comorbidities. RESULTS: The main reason for the primary hip and knee replacement surgery was arthrosis. The accumulated incidence of revisions at 10 years was 3.9% in hip replacements caused by arthrosis, and 2.3% in those caused by fracture. Conservation of the posterior cruciate ligament was achieved in 4.4% of knee replacements, with sacrifice in 5.1%. DISCUSSION: The RACat is consolidated as a tool for the evaluation of joint replacements, with great potential in the analysis of medium and long-term efficacy, the study of the variability in clinical practice, and post-marketing surveillance.

Topical and intravenous tranexamic acid reduce blood loss compared to routine hemostasis in total knee arthroplasty: a multicenter, randomized, controlled trial.

INTRODUCTION: Tranexamic acid (TXA) is becoming widely used in orthopedic surgery to reduce blood loss and transfusion requirements, but consensus is lacking regarding the optimal route and dose of administration. The aim of this study was to compare the efficacy and safety of topical and intravenous routes of TXA with routine hemostasis in patients undergoing primary total knee arthroplasty (TKA). MATERIALS AND METHODS: We performed a randomized, multicenter, parallel, open-label clinical trial in adult patients undergoing primary TKA. Patients were divided into three groups of 50 patients each: Group 1 received 1 g topical TXA, Group 2 received 2 g intravenous TXA, and Group 3 (control group) had routine hemostasis. The primary outcome was total blood loss. Secondary outcomes were hidden blood loss, blood collected in drains, transfusion rate, number of blood units transfused, adverse events, and mortality. RESULTS: One hundred and fifty patients were included. Total blood loss was 1021.57 (481.09) mL in Group 1, 817.54 (324.82) mL in Group 2 and 1415.72 (595.11) mL in Group 3 (control group). Differences in total blood loss between the TXA groups and the control group were clinically and statistically significant (p < 0.001). In an exploratory analysis differences between the two TXA groups were not statistically significant (p = 0.073) Seventeen patients were transfused. Transfusion requirements were significantly higher in Group 3 (p = 0.005). No significant differences were found between groups regarding adverse events. CONCLUSION: We found that 1 g of topical TXA and 2 g of intravenous TXA were both safe strategies and more effective than routine hemostasis to reduce blood loss and transfusion requirements after primary TKA. LEVEL OF EVIDENCE: I.

La geometría de la quilla condiciona el comportamiento de la bandeja tibial frente a fuerzas de torsión en prótesis totales de rodilla / The geometry of the keel determines the behaviour of the tibial tray against torsional forces in total knee replacement

El diseño de la quilla de una bandeja tibial es fundamental para la transmisión de la mayor parte de las cargas a las estructuras óseas periféricas, las cuales tienen mejores propiedades mecánicas reduciendo, de este modo, el riesgo de aflojamiento. El objetivo de este estudio es comparar el comportamiento de diferentes diseños de bandeja tibial ante cargas de torsión. Se modelizaron 4 componentes tibiales diferentes. La reconstrucción 3 D se llevó a cabo con el programa MIMICS. Los sólidos se generaron en SolidWorks. Se realizó el estudio por elementos finitos mediante Unigraphics. Se simuló una torsión de 6 Nm aplicada sobre los laterales de cada bandeja tibial. La bandeja tibial GENUTECH® con apoyo en el hueso trabecular periférico mostró un menor desplazamiento y menores tensiones transmitidos bajo fuerzas de torsión. Los resultados indican que la bandeja tibial con apoyo más periférico tienen un mejor comportamiento mecánico mejor frente a los otros diseños estudiados (AU)

The keel design of the tibial tray is essential for the transmission of the majority of the forces to the peripheral bone structures, which have better mechanical proprieties, thus reducing the risk of loosening. The aim of the present study was to compare the behaviour of different tibial tray designs submitted to torsional forces. Four different tibial components were modelled. The 3-D reconstruction was made using the Mimics software. The solid elements were generated by SolidWorks. The finite elements study was done by Unigraphics. A torsional force of 6 Nm. applied to the lateral aspects of each tibial tray was simulated. The GENUTECH® tibial tray, with peripheral trabecular bone support, showed a lower displacement and less transmitted tensions under torsional forces. The results suggest that a tibial tray with more peripheral support behaves mechanically better than the other studied designs (AU)

[The geometry of the keel determines the behaviour of the tibial tray against torsional forces in total knee replacement]. / La geometría de la quilla condiciona el comportamiento de la bandeja tibial frente a fuerzas de torsión en prótesis totales de rodilla.

The keel design of the tibial tray is essential for the transmission of the majority of the forces to the peripheral bone structures, which have better mechanical proprieties, thus reducing the risk of loosening. The aim of the present study was to compare the behaviour of different tibial tray designs submitted to torsional forces. Four different tibial components were modelled. The 3-D reconstruction was made using the Mimics software. The solid elements were generated by SolidWorks. The finite elements study was done by Unigraphics. A torsional force of 6 Nm. applied to the lateral aspects of each tibial tray was simulated. The GENUTECH® tibial tray, with peripheral trabecular bone support, showed a lower displacement and less transmitted tensions under torsional forces. The results suggest that a tibial tray with more peripheral support behaves mechanically better than the other studied designs.

Implant sonication increases the diagnostic accuracy of infection in patients with delayed, but not early, orthopaedic implant failure.

The purpose of this study was to compare the diagnostic accuracy for the detection of infection between the culture of fluid obtained by sonication (SFC) and the culture of peri-implant tissues (PITC) in patients with early and delayed implant failure, and those with unsuspected and suspected septic failure. It was hypothesised that SFC increases the diagnostic accuracy for infection in delayed, but not early, implant failure, and in unsuspected septic failure. The diagnostic accuracy for infection of all consecutive implants (hardware or prostheses) that were removed for failure was compared between SFC and PITC. This prospective study included 317 patients with a mean age of 62.7 years (9 to 97). The sensitivity for detection of infection using SFC was higher than using PITC in an overall comparison (89.9% versus 67%, respectively; p < 0.001), in unsuspected septic failure (100% versus 48.5%, respectively; p < 0.001), and in delayed implant failure (88% versus 58%, respectively; p < 0.001). PITC sensitivity dropped significantly in unsuspected compared with suspected septic failure (p = 0.007), and in delayed compared with early failure (p = 0.013). There were no differences in specificity. Sonication is mainly recommended when there is implant failure with no clear signs of infection and in patients with delayed implant failure. In early failure, SFC is not superior to PITC for the diagnosis of infection and, therefore, is not recommended as a routine diagnostic test in these patients.