Estudo randomizado comparativo da enxertia autóloga de células da medula óssea para consolidação da pseudoartrose da tíbia em relação aos tratamentos convencionais
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Data
2019-04-26
Autores
Meirelles, Alexandre Vasconcelos de
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Universidade Estadual Paulista (Unesp)
Resumo
Pseudoartrose é definida como a ausência de evidências radiográficas do processo de consolidação de uma fratura. Células-tronco, são células com capacidade de proliferar e originar células de qualquer linhagem, formando qualquer tecido do organismo. Estudos com animais demonstraram que o uso de medula óssea contendo células do estroma melhoram os resultados do tratamento das pseudoartroses, mas os dados ainda são experimentais e necessitam de mais testes, com número relevante de pacientes, para demonstrar sua segurança e eficácia. Desta forma, este trabalho objetiva a comparação do método tradicional de tratamento da pseudoartrose da tíbia, realizado com o uso de fixador externo, haste ou placa e parafuso com o tratamento combinado do uso das técnicas convencionais e infiltração de células-tronco mesenquimais autólogas. Para isso, foram feitos ensaios clínicos randomizados, aberto, com cegamento dos grupos experimentais, com 18 pacientes diagnosticados com pseudoartrose divididos em dois grupos: grupo controle, formado por 9 pacientes e grupo experimental, também com 9 pacientes. A idade média do grupo foi de 38,3 anos e a maioria se autodeclarou pardo ou negro. O nível de escolaridade mostrou-se baixo, com 72 % dos participantes não tendo concluído o Ensino Médio. Cinco pacientes foram tratados com uso de haste metálica e apenas três tiveram a colocação de fixador externo. O tempo de doença (pseudoartrose) e o tempo cirúrgico não mostraram influenciar no desfecho. Em relação ao desfecho clínico, pacientes tratados com a combinação de técnicas convencionais associadas à enxertia autóloga de células tronco mesenquimais foram mais favoráveis e, quando comparados com o grupo controle, mostrou-se estatisticamente significante. Os estudos mostraram que o uso de células tronco mesenquimais associado a técnicas cirúrgicas clássicas para consolidação de pseudoartrose de tíbia mostrou-se capaz de interferir no desfecho clínico e melhorar as condições dos pacientes submetidos a essa nova abordagem terapêutica
Pseudoarhrosis is defined such as no radiographic evidence during consolidation fracture process. Stem cells are undifferentiated cells, multipotent, capable of proliferating and originating cells of any lineage, forming any tissue of the body. Animal studies have shown that using bone marrow containing stromal cells improves the results of pseudoarthrosis treatment, but the results are still experimental and require further testing with a significant number of patients to demonstrate their safety and efficacy. Thus, this study aims to compare the traditional method of treatment of tibial pseudoarthrosis, performed with the use of external fixator, rod or plate and screw with the combined treatment of the use of conventional techniques and infiltration of autologous mesenchymal stem cells. For this, randomized, open-label clinical trials with blinded experimental groups were performed with 18 patients diagnosed with pseudoarthrosis divided into two groups: a control group consisting of 9 patients and an experimental group, also with 9 patients. The mean age of the group was 38.3 years old and the majority self-declared brown or black. The level of schooling was low, with 72% of the participants not having finished high school. Five patients were treated with metal rod and only three had external fixator placement. Disease duration (pseudoarthrosis) and surgical time did not influence the outcome. Regarding the clinical outcome, patients treated with the combination of conventional techniques associated with autologous mesenchymal stem cell grafting were more favorable and, when compared with the control group, were statistically significant. The studies showed that the use of mesenchymal stem cells associated with classical surgical techniques for the consolidation of tibial pseudoarthrosis was able to interfere in the clinical outcome and to improve the conditions of the patients submitted to this new therapeutic approach.
Pseudoarhrosis is defined such as no radiographic evidence during consolidation fracture process. Stem cells are undifferentiated cells, multipotent, capable of proliferating and originating cells of any lineage, forming any tissue of the body. Animal studies have shown that using bone marrow containing stromal cells improves the results of pseudoarthrosis treatment, but the results are still experimental and require further testing with a significant number of patients to demonstrate their safety and efficacy. Thus, this study aims to compare the traditional method of treatment of tibial pseudoarthrosis, performed with the use of external fixator, rod or plate and screw with the combined treatment of the use of conventional techniques and infiltration of autologous mesenchymal stem cells. For this, randomized, open-label clinical trials with blinded experimental groups were performed with 18 patients diagnosed with pseudoarthrosis divided into two groups: a control group consisting of 9 patients and an experimental group, also with 9 patients. The mean age of the group was 38.3 years old and the majority self-declared brown or black. The level of schooling was low, with 72% of the participants not having finished high school. Five patients were treated with metal rod and only three had external fixator placement. Disease duration (pseudoarthrosis) and surgical time did not influence the outcome. Regarding the clinical outcome, patients treated with the combination of conventional techniques associated with autologous mesenchymal stem cell grafting were more favorable and, when compared with the control group, were statistically significant. The studies showed that the use of mesenchymal stem cells associated with classical surgical techniques for the consolidation of tibial pseudoarthrosis was able to interfere in the clinical outcome and to improve the conditions of the patients submitted to this new therapeutic approach.
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Palavras-chave
Pseudoartrose, Fratura de tíbia, Células tronco