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1.
Rev. esp. cir. ortop. traumatol. (Ed. impr.) ; 66(6): 485-490, Nov-Dic. 2022. tab
Artículo en Español | IBECS | ID: ibc-210660

RESUMEN

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)


Asunto(s)
Humanos , Placebos , Efecto Placebo , Ácido Tranexámico , Eficacia , Artroplastia de Reemplazo de Rodilla , Rodilla/cirugía , Traumatismos de la Rodilla , Prótesis de la Rodilla , Heridas y Lesiones , Traumatología , Ortopedia , Cirugía General
2.
Rev. esp. cir. ortop. traumatol. (Ed. impr.) ; 66(6): T67-T72, Nov-Dic. 2022. tab
Artículo en Inglés | IBECS | ID: ibc-210674

RESUMEN

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)


Asunto(s)
Humanos , Placebos , Efecto Placebo , Ácido Tranexámico , Eficacia , Artroplastia de Reemplazo de Rodilla , Rodilla/cirugía , Traumatismos de la Rodilla , Prótesis de la Rodilla , Heridas y Lesiones , Traumatología , Ortopedia , Cirugía General
3.
Rev Esp Cir Ortop Traumatol ; 66(6): T67-T72, 2022.
Artículo en Inglés, Español | MEDLINE | ID: mdl-35940560

RESUMEN

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.

4.
Rev Esp Cir Ortop Traumatol ; 66(6): 485-490, 2022.
Artículo en Inglés, Español | MEDLINE | ID: mdl-35452861

RESUMEN

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.

5.
Artículo en Inglés, Español | MEDLINE | ID: mdl-32197954

RESUMEN

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.


Asunto(s)
Reconstrucción del Ligamento Cruzado Anterior/métodos , Tendones Isquiotibiales/diagnóstico por imagen , Tendones/diagnóstico por imagen , Adolescente , Adulto , Femenino , Fémur/diagnóstico por imagen , Músculo Grácil , Tendones Isquiotibiales/anatomía & histología , Tendones Isquiotibiales/trasplante , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Tamaño de los Órganos , Estudios Retrospectivos , Tendones/anatomía & histología , Tendones/trasplante , Adulto Joven
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