Ensayo clínico aleatorizado, controlado con placebo y doble ciego para evaluar la eficacia y la seguridad del ácido tranexámico tópico en el ahorro de pérdidas sanguíneas en pacientes tratados mediante cirugía protésica de rodilla / Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery

Antecedentes y objetivo: Durante la artroplastia de rodilla se produce una pérdida sanguínea importante. El objetivo de nuestro estudio es valorar la eficacia y la seguridad de la administración tópica de 3 g de ácido tranexámico (TXA) en cuanto a la reducción de pérdidas sanguíneas en artroplastia de rodilla. Material y método: Se ha realizado un ensayo clínico aleatorizado, fase iii, doble ciego, controlado con placebo. Se incluyó a 150 pacientes en 2grupos paralelos de tratamiento (75 por brazo). La solución se administró de forma tópica intraarticular tras la cementación y previo al cierre capsular. Se realizaron determinaciones analíticas antes y después de la cirugía. Resultados: La pérdida total de sangre media para el grupo placebo fue de 831,5ml y 662,3ml para el grupo TXA con una diferencia entre ambos de 169,2ml, lo que supone un ahorro del 20,4%, siendo estadísticamente significativa (p<0,001). No se obtuvieron diferencias en el inicio de la deambulación, días de ingreso o escala visual analógica al mes de la cirugía. Se retiró a 10pacientes por infección del tracto urinario prequirúrgico, alergia a metales, fallo de selección, debilitamiento rotuliano, inestabilidad protésica, fractura tibial intraquirúrgica, cambio de indicación a prótesis unicompartimental y una pérdida de seguimiento. Hubo una única complicación no relacionada con el fármaco (globos vesicales de repetición). Conclusión: La administración de TXA de forma tópica tras la cementación de los componentes protésicos en artroplastia de rodilla en una única dosis demuestra que es segura y eficaz.(AU)

Background and objective: Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3g of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. Material and method: A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in 2parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. Results: Total blood loss for the placebo group was 831.5ml and 662.3ml for the TXA group. The difference between the 2groups was 169.2ml; which means a save of 20.4 per cent; this difference being statistically significant (P<.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). Conclusion: The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.(AU)

[Translated article] Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery / Ensayo clínico aleatorizado, controlado con placebo y doble ciego para evaluar la eficacia y la seguridad del ácido tranexámico tópico en el ahorro de pérdidas sanguíneas en pacientes tratados mediante cirugía protésica de rodilla

Antecedentes y objetivo: Durante la artroplastia de rodilla se produce una pérdida sanguínea importante. El objetivo de nuestro estudio es valorar la eficacia y la seguridad de la administración tópica de 3 g de ácido tranexámico (TXA) en cuanto a la reducción de pérdidas sanguíneas en artroplastia de rodilla. Material y método: Se ha realizado un ensayo clínico aleatorizado, fase iii, doble ciego, controlado con placebo. Se incluyó a 150 pacientes en 2grupos paralelos de tratamiento (75 por brazo). La solución se administró de forma tópica intraarticular tras la cementación y previo al cierre capsular. Se realizaron determinaciones analíticas antes y después de la cirugía. Resultados: La pérdida total de sangre media para el grupo placebo fue de 831,5ml y 662,3ml para el grupo TXA con una diferencia entre ambos de 169,2ml, lo que supone un ahorro del 20,4%, siendo estadísticamente significativa (p<0,001). No se obtuvieron diferencias en el inicio de la deambulación, días de ingreso o escala visual analógica al mes de la cirugía. Se retiró a 10pacientes por infección del tracto urinario prequirúrgico, alergia a metales, fallo de selección, debilitamiento rotuliano, inestabilidad protésica, fractura tibial intraquirúrgica, cambio de indicación a prótesis unicompartimental y una pérdida de seguimiento. Hubo una única complicación no relacionada con el fármaco (globos vesicales de repetición). Conclusión: La administración de TXA de forma tópica tras la cementación de los componentes protésicos en artroplastia de rodilla en una única dosis demuestra que es segura y eficaz.(AU)

Background and objective: Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3g of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. Material and method: A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in 2parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. Results: Total blood loss for the placebo group was 831.5ml and 662.3ml for the TXA group. The difference between the 2groups was 169.2ml; which means a save of 20.4 per cent; this difference being statistically significant (P<.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). Conclusion: The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.(AU)

[Translated article] Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery.

BACKGROUND AND OBJECTIVE: Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3g of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. MATERIAL AND METHOD: A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in 2 parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. RESULTS: Total blood loss for the placebo group was 831.5ml and 662.3ml for the TXA group. The difference between the 2 groups was 169.2ml; which means a save of 20.4%; this difference being statistically significant (p<.001). There were no differences in terms of the onset of ambulation, days of admission or visual analogue scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). CONCLUSION: The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.

Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery. / Ensayo clínico aleatorizado, controlado con placebo y doble ciego para evaluar la eficacia y la seguridad del ácido tranexámico tópico en el ahorro de pérdidas sanguíneas en pacientes tratados mediante cirugía protésica de rodilla.

BACKGROUND AND OBJECTIVE: Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3g of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. MATERIAL AND METHOD: A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in 2parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. RESULTS: Total blood loss for the placebo group was 831.5ml and 662.3ml for the TXA group. The difference between the 2groups was 169.2ml; which means a save of 20.4 per cent; this difference being statistically significant (P<.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). CONCLUSION: The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.

¿Podemos predecir el tamaño de la plastia de los isquiotibiales para la reconstrucción del ligamento cruzado anterior mediante resonancia magnética? / Can we predict the graft diameter for autologous hamstring in anterior cruciate ligament reconstruction?

Conseguir en la reconstrucción de una rotura completa del ligamento cruzado anterior una plastia con fuerza, tensión y poca comorbilidad es fundamental. Un concepto emergente es que plastias menores de 7mm de diámetro tienen mayor riesgo de rerrotura e inestabilidad. Consecuentemente se están buscando distintos métodos que predigan el tamaño intraquirófano de la misma. El objetivo es predecir el tamaño de la plastia de isquiotibiales mediante la medición del área del tendón semitendinoso y grácil con resonancia magnética nuclear (RMN). METODOLOGÍA: Estudio observacional restrospectivo de 56 pacientes, en los que se realiza reconstrucción tetrafascicular del ligamento cruzado anterior mediante plastia de isquiotibiales. Los parámetros evaluados han sido: datos antropométricos, diámetro de la plastia intraquirófano, área del tendón del grácil y semitendinoso en RMN. Las mediciones fueron realizadas por tres evaluadores independientes. RESULTADOS: El diámetro medio intraquirófano de la plastia fue de 8,46mm; la medición mediante RMN del área del grácil fue de 8.875mm y del semitendinoso de 13.068mm. La suma de ellas fue de 22,12 para la medición automática y de 21,53 para la manual. La correlación interobservador fue regular para la medición automática (ICC=0,595) y baja para la forma manual (ICC=0,446). El resultado de la correlación intraobservador fue excelente (ICC=0,917). No obtuvimos una correlación estadística entre la medición de áreas y el aumento del diámetro de la plastia (R=0,069, P=0,63). CONCLUSIÓN: Determinamos con nuestros resultados que la medición de la plastia intraquirófano de isquiotibiales y la medición mediante RMN no es un método adecuado para predecir su tamaño

To achieve in the reconstruction of the anterior cruciate ligament a graft with strength, tension and low comorbidity is fundamental. An emerging concept is that a graft diameter of less than 7mm carries a greater risk of re-rupture and instability. Consequently, different methods are being sought to predict intra-surgical size. The objective is to predict the size of the hamstring graft by measuring the area of the semitendinous and gracilis tendon with magnetic resonance imaging (MRI). METHODOLOGY: We carried out an observational retrospective study of 56 patients. They underwent anterior cruciate ligament reconstruction with 4-GST hamstring graft. The parameters evaluated were anthropometric data, hamstring graft diameter, area of gracilis and semitendinosus tendon in MRI. The measurements were made by three independent evaluators. RESULTS: The mean diameter of the intrasurgical graft was 8.46mm, in the MRI the area of the gracilis was 8,875mm and the semitendinosus area was 13,068mm. Their mean was 22.12 for the automatic measurement and 21.53 for the manual measurement. The interobserver correlation was regular for the automatic measurement (ICC = 0.595) and low for the manual measurement (ICC = 0.446). The result of the intraobserver correlation was excellent (ICC = 0.917). We did not obtain a statistical correlation between the measurement of areas and the increase of the graft diameter (R = 0.069, P = .63). CONCLUSION: We determined with our results that the intrasurgical graft size is not predictable with the measurement of the area of the gracilis and semitendinosus tendon on the MRI

Can we predict the graft diameter for autologous hamstring in anterior cruciate ligament reconstruction? / ¿Podemos predecir el tamaño de la plastia de los isquiotibiales para la reconstrucción del ligamento cruzado anterior mediante resonancia magnética?

To achieve in the reconstruction of the anterior cruciate ligament a graft with strength, tension and low comorbidity is fundamental. An emerging concept is that a graft diameter of less than 7mm carries a greater risk of re-rupture and instability. Consequently, different methods are being sought to predict intra-surgical size. The objective is to predict the size of the hamstring graft by measuring the area of the semitendinous and gracilis tendon with magnetic resonance imaging (MRI). METHODOLOGY: We carried out an observational retrospective study of 56 patients. They underwent anterior cruciate ligament reconstruction with 4-GST hamstring graft. The parameters evaluated were anthropometric data, hamstring graft diameter, area of gracilis and semitendinosus tendon in MRI. The measurements were made by three independent evaluators. RESULTS: The mean diameter of the intrasurgical graft was 8.46mm, in the MRI the area of the gracilis was 8,875mm and the semitendinosus area was 13,068mm. Their mean was 22.12 for the automatic measurement and 21.53 for the manual measurement. The interobserver correlation was regular for the automatic measurement (ICC = 0.595) and low for the manual measurement (ICC = 0.446). The result of the intraobserver correlation was excellent (ICC = 0.917). We did not obtain a statistical correlation between the measurement of areas and the increase of the graft diameter (R = 0.069, P = .63). CONCLUSION: We determined with our results that the intrasurgical graft size is not predictable with the measurement of the area of the gracilis and semitendinosus tendon on the MRI.

¿Qué hay nuevo sobre traumatismos en edad pediátrica? / What’s new in children orthopaedic trauma?

Cada vez son más frecuentes la aparición en la bibliografía de artículos relacionados con problemas en edad pediátrica. Con el objetivo de actualizar información hemos realizado una revisión de la bibliografía publicada en las principales revistas relacionadas con la ortopedia y traumatología infantil durante el año 2015 seleccionando aquellos que trataban sobre traumatismos en edad pediátrica. El artículo ha sido divido en bloques por región anatómica y se resume la información más destacada de las publicaciones

Increasingly frequent occurrence in the literature related problems in childhood items. In order to update information we have conducted a review of the literature published in leading journals related to orthopedics and traumatology child during 2015 selecting those that dealt with trauma age pediatric. The article has been divided into blocks by anatomical region and the most important information is summarized publications