ABSTRACT
OBJECTIVE: To examine and compare the clinical efficacy of intraarticular epsilon aminocaproic acid (EACA) and tranexamic acid (TXA) in total knee arthroplasty (TKA). METHODS: This study was a prospective, single-center, double-blinded randomized controlled trial, including sixty patients with osteoarthritis of the knee divided into two groups of 30 patients. In the TXA group, 1 g of TXA (0.05 g/ml) was applied intraarticularly, and in the EACA group, 4 g of EACA (0.2 g/ml) was applied intraarticularly. Serum hemoglobin (Hgb) and hematocrit (Htb) were measured during the preoperatively and 24 and 48 hours postoperatively. The range of motion and pain were evaluated by clinical examination. To evaluate knee function before and 2 months after surgery, the Western Ontario and McMaster Universities Index (WOMAC) questionnaire was used. RESULTS: In total, 56 (93.3%) patients were evaluated up to the second postoperative month. No significant difference between the groups (p > 0.05) was found in the decrease in Hgb or Htb at 24 or 48 hours. Regarding assessment of the pain, WOMAC score and gain in knee flexion, no significant advantages up to 60 days after surgery (p > 0.05) were found. CONCLUSIONS: The decrease in Hgb and Htb during the first 48 hours postoperatively and the risk of transfusion were similar with the intraarticular use of 1 g of TXA and 4 g of EACA in TKA. The possible benefits regarding knee pain, gain in flexion and function were also similar for the two drugs. Level of Evidence II, Randomized, Double-Blinded, Single-Centre, Prospective Clinical Trial.
OBJETIVO: Avaliar e comparar a eficácia clinica do uso intra-articular do ácido épsilon aminocaproico (AEAC) versus o ácido tranexâmico (ATX) na prótese total do joelho. MÉTODOS: Estudo clínico prospectivo, centro-único, duplo-cego e randomizado. Sessenta pacientes com osteoartrose de joelho foram incluídos. Os participantes foram divididos em dois grupos de 30 pacientes. No grupo ATX, foi aplicado 1 g de ATX (0.05 g/ml) intra-articular e, no grupo AEAC, foram aplicados 4 g de AEAC (0.2 g/ml) intra-articular. Valores séricos da hemoglobina (Hb) e hemtatócrito (Ht) foram dosados no pré-operatório e com 24 e 48 horas após a cirurgia. A amplitude de movimento e a dor também foram avaliadas no exame clínico. O índice WOMAC foi utilizado para avaliar a função do joelho antes e após dois meses da cirurgia. RESULTADOS: Foram avaliados 56 (93.3%) pacientes até o segundo mês pós-operatório. Depois da cirurgia, não houve diferenças entre os grupos (p > 0.05) na queda do valor de Hb e Ht com 24 ou 48 horas. Com relação à avaliação da dor, WOMAC e ganho de flexão do joelho, não houve vantagem significativa para nenhum dos grupos até os 60 dias depois da cirurgia(p > 0.05). CONCLUSÃO: A queda do valor da Hb e do Ht durante as primeiras 48 horas pós-operatórias e o risco de transfusão foram similares com o uso intra-articular de 1 g de ATX e 4 g de AEAC na artroplastia total do joelho. Os possíveis benefícios com relação ao controle da dor, ganho de flexão e função foram similares entre as duas drogas. Nível de Evidência II, Ensaio-Clínico Prospectivo, Randomizado, Duplo Cego, Centro-Único.
ABSTRACT
ABSTRACT Objective: To examine and compare the clinical efficacy of intraarticular epsilon aminocaproic acid (EACA) and tranexamic acid (TXA) in total knee arthroplasty (TKA). Methods: This study was a prospective, single-center, double-blinded randomized controlled trial, including sixty patients with osteoarthritis of the knee divided into two groups of 30 patients. In the TXA group, 1 g of TXA (0.05 g/ml) was applied intraarticularly, and in the EACA group, 4 g of EACA (0.2 g/ml) was applied intraarticularly. Serum hemoglobin (Hgb) and hematocrit (Htb) were measured during the preoperatively and 24 and 48 hours postoperatively. The range of motion and pain were evaluated by clinical examination. To evaluate knee function before and 2 months after surgery, the Western Ontario and McMaster Universities Index (WOMAC) questionnaire was used. Results: In total, 56 (93.3%) patients were evaluated up to the second postoperative month. No significant difference between the groups (p > 0.05) was found in the decrease in Hgb or Htb at 24 or 48 hours. Regarding assessment of the pain, WOMAC score and gain in knee flexion, no significant advantages up to 60 days after surgery (p > 0.05) were found. Conclusions: The decrease in Hgb and Htb during the first 48 hours postoperatively and the risk of transfusion were similar with the intraarticular use of 1 g of TXA and 4 g of EACA in TKA. The possible benefits regarding knee pain, gain in flexion and function were also similar for the two drugs. Level of Evidence II, Randomized, Double-Blinded, Single-Centre, Prospective Clinical Trial.
RESUMO Objetivo: Avaliar e comparar a eficácia clinica do uso intra-articular do ácido épsilon aminocaproico (AEAC) versus o ácido tranexâmico (ATX) na prótese total do joelho. Métodos: Estudo clínico prospectivo, centro-único, duplo-cego e randomizado. Sessenta pacientes com osteoartrose de joelho foram incluídos. Os participantes foram divididos em dois grupos de 30 pacientes. No grupo ATX, foi aplicado 1 g de ATX (0.05 g/ml) intra-articular e, no grupo AEAC, foram aplicados 4 g de AEAC (0.2 g/ml) intra-articular. Valores séricos da hemoglobina (Hb) e hemtatócrito (Ht) foram dosados no pré-operatório e com 24 e 48 horas após a cirurgia. A amplitude de movimento e a dor também foram avaliadas no exame clínico. O índice WOMAC foi utilizado para avaliar a função do joelho antes e após dois meses da cirurgia. Resultados: Foram avaliados 56 (93.3%) pacientes até o segundo mês pós-operatório. Depois da cirurgia, não houve diferenças entre os grupos (p > 0.05) na queda do valor de Hb e Ht com 24 ou 48 horas. Com relação à avaliação da dor, WOMAC e ganho de flexão do joelho, não houve vantagem significativa para nenhum dos grupos até os 60 dias depois da cirurgia(p > 0.05). Conclusão: A queda do valor da Hb e do Ht durante as primeiras 48 horas pós-operatórias e o risco de transfusão foram similares com o uso intra-articular de 1 g de ATX e 4 g de AEAC na artroplastia total do joelho. Os possíveis benefícios com relação ao controle da dor, ganho de flexão e função foram similares entre as duas drogas. Nível de Evidência II, Ensaio-Clínico Prospectivo, Randomizado, Duplo Cego, Centro-Único.
ABSTRACT
BACKGROUND: The use of tranexamic acid (TXA) in total knee arthroplasty (TKA) has shown good results. Bleeding may cause local complications consequently greater pain and reduced function postoperatively. No study has related the use of TXA to these facts. OBJECTIVE: The aim was to evaluate the effects of TXA haemoglobin, Western Ontario and McMaster Universities Index (WOMAC), pain intensity and flexion gain after TKA. METHODS: 43 patients were randomized and then underwent TKA. TXA was applied to 22 of these patients before closure of the joint capsule. Haemoglobin measurements (mg/dL) were taken preoperatively and 24 and 48 hours after surgery. The WOMAC questionnaire and pain visual analogue scale (VAS) were applied, and flexion gain was measured up to the second postoperative month. Statistical analysis compared the results to determine whether there were differences between the groups for each of the evaluated times. RESULTS: There were differences in favour of the drug 48 hours postoperatively for the haemoglobin variable (p = 0.01), in pain evaluation, 24 and 48 hours, postoperatively (p < 0.01) and in flexion gain, 24 hours after surgery (p = 0.03). There were no significant differences between the groups in the haemoglobin evaluation 24 hours postoperatively, in pain assessment 7 days, 21 days and 2 months, postoperatively, in flexion gain 48 hours, 7 days, 21 days and 2 months, postoperatively and in WOMAC after 2 months. CONCLUSION: In addition to reducing bleeding, topical TXA improved pain and increased flexion gain in the first hours after TKA. TRIAL REGISTRATION: RBR-9b4qgq.
