Aportación del colgajo libre de peroné en la reconstrucción maxilomandibular. Estudio de los sistemas de osteosíntesis del autotrasplante de peroné en reconstrucciones craneo-maxilo-mandibulares

Resumen

1. Introducción o motivación de la tesis La reconstrucción ósea de defectos maxilomandibulares es uno de los problemas más desafiantes en la cirugía maxilofacial y tiene un enorme impacto tanto desde un punto de vista estético como psicosocial. El colgajo libre de peroné es actualmente la primera opción reconstructiva con colgajo óseo vascularizado en reconstrucción craneomaxilofacial. Sin embargo, sorprende que haya pocos estudios que describan y analicen la evolución y el comportamiento del material de osteosíntesis del colgajo libre de peroné utilizado para la reconstrucción craneomandibular y existe un bajo nivel de evidencia en la literatura. Las complicaciones relacionadas con el material de osteosíntesis siguen siendo un desafío significativo y aproximadamente el 15% de los pacientes las padecen. Estas complicaciones pueden requerir uso prolongado de antibióticos, procedimientos quirúrgicos añadidos, y reducen la calidad de vida. Muchos factores como el diagnóstico inicial, la radioterapia previa, tabaquismo, diabetes, tipo de reconstrucción (primaria o secundaria), tipos de osteosíntesis utilizada, planificación quirúrgica convencional vs virtual, la tasa de osteotomías, la localización y clasificación del defecto maxilar o mandibular, el defecto de tejidos blandos asociado, la infección del lecho quirúrgico se han identificado como factores que pueden contribuir al desarrollo de complicaciones relacionadas con el material de osteosíntesis. Los objetivos de este trabajo son evaluar la incidencia y el tipo de complicaciones relacionadas con el material de osteosíntesis en pacientes reconstruidos con colgajo libre de peroné en nuestro servicio de Cirugía Oral y Maxilofacial y determinar e identificar los factores de riesgo asociados con el desarrollo de complicaciones relacionadas con el material de osteosíntesis. 2. Contenido de la investigación El diseño principal del estudio se basa en un estudio descriptivo (serie de casos) y un análisis observacional de 124 colgajos de peroné microvascularizados consecutivos realizados en el Servicio de Cirugía Oral y Maxilofacial del Hospital Universitario Reina Sofía de Córdoba entre mayo de 1997 y agosto de 2018. Las variables clínicas analizadas fueron: edad, sexo, peso, altura, índice de masa corporal (IMC), tabaquismo, diabetes, hipertensión arterial, puntuación ASA, etiología del defecto (tumor benigno, tumor maligno, trauma, osteorradionecrosis , deformidades), tipo de reconstrucción (primaria versus secundaria), estado dental preoperatorio, clasificaciones de Brown y de Jewer de los defectos mandibulares y Brown maxilar, defecto de partes blandas, diseño del colgajo (barra simple o doble), tipo de osteosíntesis utilizada, número de segmentos óseos del peroné, número de uniones óseas, número total de tornillos utilizado, duración de la intervención quirúrgica, estancia hospitalaria, tiempo de seguimiento, radioterapia pre y/o postoperatoria, consolidación ósea, rehabilitación de implantes y complicaciones tardías relacionadas con el material de osteosíntesis (más de 30 días postoperatorio). Hemos realizado un análisis descriptivo, un análisis univariante y un modelo de regresión logística multivariante para explorar posibles factores de riesgo para el desarrollo de complicaciones relacionadas con el material de osteosíntesis. Todos los análisis de datos se realizaron con el software R (versión 3.5.0). Los resultados de los pacientes fueron evaluados con especial atención a las complicaciones relacionadas con el material de osteosíntesis. Estos incluyeron exposición a la placa (extra y/o intraoral), fractura de la placa, aflojamiento de los tornillos, falta de consolidación ósea o no unión, resorción ósea, fístulas oro-cutáneas y exposición ósea. Se encontró una diferencia estadísticamente significativa para la variable "radioterapia preoperatoria" como factor de riesgo para las complicaciones relacionada con el material de osteosíntesis, con una incidencia del 45,45% de los pacientes con radioterapia preoperatoria que desarrollaron complicaciones relacionadas (p = 0,021). En el análisis univariante, encontramos que las variables "radioterapia preoperatoria" y "defecto extraoral de los tejidos blandos" pueden ser posibles factores de riesgo para el desarrollo de complicaciones relacionadas con el material de osteosíntesis (p <0.05). Interesantemente hemos observado una interacción entre el tipo de reconstrucción (primaria o secundaria) y la clase de Brown de defectos mandibulares. Esta interacción tiene un efecto significativo sobre la probabilidad de tener complicaciones relacionadas con el material de osteosíntesis. Así, los pacientes con ambas clases de “Brown III + IV” y "reconstrucción secundaria" tiene un riesgo 47.30 veces mayor en comparación con aquellos con clase I de Brown y "reconstrucción primaria" (p = 0.026) y deben ser seguidos de cerca durante el período postoperatorio. Es importante destacar que el riesgo de complicaciones no se asoció estadísticamente con la edad, el sexo, el peso, la estatura, el IMC, el historial de tabaquismo, diabetes, hipertensión, puntuación ASA, el diagnóstico inicial, el estado dental preoperatorio, el área anatómica de la cara, las clasificaciones Brown y Jewer, planificación convencional versus planificación virtual, infección del lecho quirúrgico, tipo de osteosíntesis, diseño de colgajo (barra simple o doble), número de segmentos del colgajo, tasa de osteotomía, número de uniones óseas, número de tornillos, duración de la intervención quirúrgica y de la estancia hospitalaria y radioterapia postoperatoria. El tiempo medio de aparición de las complicaciones relacionadas con el material de osteosíntesis fue de 22,14 meses, con una mediana de 12 meses y una moda de 12 meses. Más del 65% ocurrieron dentro del primer año y un 72.4% dentro de los dos primeros años. Curiosamente, el riesgo de complicaciones de la placa disminuye con el tiempo, con un riesgo 80% menor con cada año adicional. Probablemente no haya una sola variable, sino un conjunto de variables con diferente peso o importancia que puedan predecir el desarrollo de complicaciones relacionadas con el material de osteosíntesis. Por otro lado y siguiendo a Brown, se hace evidente la necesidad de homogeneizar los datos para analizar variables en reconstrucciones con colgajos óseos microvascularizados. Nosotros, tras el estudio de nuestros pacientes proponemos 12 variables a tener en cuenta en las publicaciones sobre la reconstrucción con colgajos libres: 1. Características generales del paciente, 2. Diagnóstico principal, 3. Tipo de reconstrucción (primaria vs secundaria), 4. Estado dental preoperatorio, 5. Clasificación del defecto: descriptiva/pictórica, 6. Defecto asociado de tejidos blandos (intraoral, extraoral…), 7. Tipo de colgajo/s utilizado/s, 8. Tipo de material de osteosíntesis utilizado, 9. Número de osteotomías, 10. Complicaciones precoces (≤30 días después de la cirugía) como necesidad de rescate quirúrgico o pérdida del colgajo, 11. Complicaciones tardías (>30 días después de la cirugía) como exposición del material de osteosíntesis, fractura de la placa, fístula orocutánea, no-unión, 12. Evolución/Resultados (función postoperatoria y Calidad de Vida Relacionada con la Salud (CVRS) (HRQOL: Health-Related Quality of Life), habla, dieta y estética. 3. Conclusiones: o Los pacientes con las variables "radioterapia preoperatoria" y "defecto de tejidos blandos extraorales" tienen un mayor riesgo de desarrollar complicaciones relacionadas con el material de osteosíntesis (p <0.05). o Observamos un efecto de interacción entre el tipo de reconstrucción (primaria o secundaria) y la clase de Brown tiene un efecto significativo en la probabilidad de tener complicaciones relacionadas con la osteosíntesis. El grupo de pacientes con ambas clases de Brown III + IV y "reconstrucción secundaria" tenían un mayor riesgo de desarrollar complicaciones relacionadas con el material de osteosíntesis; más de 47.30 veces el riesgo en comparación con aquellos con clase I de Brown y "reconstrucción primaria". o La mayoría de las complicaciones relacionadas con el material de osteosíntesis aparecen en los dos primeros años tras la cirugía, siendo a partir de ese tiempo cada vez menor el riesgo de que aparezcan complicaciones. o Probablemente no haya una sola variable, sino un conjunto de variables con diferente peso o importancia que puedan influir y predecir el desarrollo de complicaciones relacionadas con el material de osteosíntesis. o Proponemos un conjunto básico mínimo de datos que todas las publicaciones sobre la reconstrucción con colgajo libre del esqueleto craneofacial deben incluir, para mejorar la evidencia científica de este tipo de reconstrucción. Title CONTRIBUTION OF THE FIBULA FREE FLAP IN MAXILLOMANDIBULAR RECONSTRUCTION. Study of the osteosynthesis of the fibula free flap in cranio-maxillo-mandibular reconstruction. 1. Introduction and objectives Bone reconstruction of maxillomandibular defects is one of the most challenging problems in maxillofacial surgery and has a huge impact from both an aesthetic and psychosocial point of view. The fibula-free flap is currently the first reconstructive option with vascularized bone flap in craniomaxillofacial reconstruction. However, it is surprising that there are few studies that describe and analyze the evolution and behaviour of the osteosynthesis material of the fibula-free flap used for craniomandibular reconstruction and there is a low level of evidence in the literature. Complications related to osteosynthesis material remain a significant challenge and approximately 15% of patients experience them. These complications may require prolonged use of antibiotics, added surgical procedures, and reduce quality of life. Many factors such as initial diagnosis, previous radiotherapy, smoking, diabetes, type of reconstruction (primary or secondary), types of osteosynthesis used, conventional vs. virtual surgical planning, the rate of osteotomies, the location and classification of the maxillary or mandibular defect, the associated soft tissue defect, surgical bed infection have been identified as factors that may contribute to the development of complications related to the material of osteosynthesis. The objectives of this thesis are to evaluate the incidence and type of complications related to osteosynthesis material in reconstructed patients with fibula free flap in our Oral and Maxillofacial Surgery service and to determine and identify the risk factors associated with the development of complications related to osteosynthesis material. 2. Content of the investigation The main design of the study is based on a descriptive study (case series) and an observational analysis of 124 consecutive microvascularized fibula flaps performed at the Oral and Maxillofacial Surgery Service of the Reina Sofía University Hospital in Córdoba from May 1997 to August 2018. The clinical variables analyzed were: age, sex, weight, height, body mass index (BMI), smoking, diabetes, hypertension, ASA score, etiology of the defect (benign tumor, malignant tumor, trauma, osteoradionecrosis, deformities), type of reconstruction (primary versus secondary), preoperative dental status, Brown and Jewer classifications of mandibular and maxillary defects and Brown classification of maxillary defects, soft tissue defect, flap design (single or double bar), type of osteosynthesis used, number of bone segments of the fibula, number of bone joints, total number of screws used, duration of the surgical intervention, hospital stay, follow-up time, pre and/or postoperative radiation therapy, bone consolidation, implant rehabilitation and late complications related to osteosynthesis material ( more than 30 postoperative days). We have performed a descriptive analysis, a univariate analysis and a multivariate logistic regression model to explore possible risk factors for the development of complications related to osteosynthesis material. All data analysis was performed with R software (version 3.5.0). The results of the patients were evaluated with special attention to the complications related to the osteosynthesis material. These included plate exposure (extra and / or intraoral), plate fracture, screw loosening, lack of bone consolidation or non-union, bone resorption, oro-cutaneous fistulas, and bone exposure. A statistically significant difference was found for the variable "preoperative radiotherapy" as a risk factor for complications related to osteosynthesis material, with a 45.45% incidence of patients with preoperative radiotherapy who developed related complications (p = 0.021) . In the univariate analysis, we found that the variables "preoperative radiotherapy" and "extraoral soft tissue defect" may be possible risk factors for the development of complications related to osteosynthesis material (p <0.05). Interestingly, we have observed an interaction between the type of reconstruction (primary or secondary) and Brown's class of mandibular defects. This interaction has a significant effect on the probability of having complications related to the osteosynthesis material. Thus, patients with both classes of "Brown III + IV" and "secondary reconstruction" have a 47.30 times higher risk compared to those with Brown class I and "primary reconstruction" (p = 0.026) and should be closely followed during postoperative period. Importantly, the risk of complications is not statistically associated with age, sex, weight, height, BMI, smoking, diabetes, hypertension, ASA score, initial diagnosis, preoperative dental status, anatomic area, Brown´s and Jewer´s classifications, conventional vs virtual planning, surgical site infection, type of osteosynthesis, flap design (single or double barrel), number of flap segments, osteotomy rate, number of bone joints, number of screws, length of surgical time and hospital stay, and postoperative radiotherapy. Mean time for the occurrence of osteosynthesis related complications was 22.14 months with a median of 12 months and a mode of 12 months. Over 65% appeared within the first postoperative year, and 72.4% within the first two years. Curiously, complications rate diminishes with time, an 80% per additional year. There is probably not a single variable but a set of them with different weight to predict the occurrence of osteosynthesis related complications. On the other hand, and following Brown, the need to homogenize the data to analyze variables in reconstructions with microvascularized bone flaps becomes evident. After studying our patients, we propose 12 variables to be taken into account in the publications on free flap reconstruction: 1. General characteristics of the patient, 2. Main diagnosis, 3. Type of reconstruction (primary vs. secondary), 4. Preoperative dental status, 5. Classification of the defect: descriptive / pictorial, 6. Associated soft tissue defect (intraoral, extraoral ...), 7. Type of flap/s used, 8. Type of osteosynthesis material used, 9. Number of osteotomies, 10. Early complications (≤30 days after surgery) such as a need for surgical rescue or loss of the flap, 11. Late complications (> 30 days after surgery) such as exposure of the osteosynthesis material, fracture of the plate, oro-cutaneous fistula, non-union, 12. Evolution/Results (postoperative function and Health-Related Quality of Life (HRQOL), speech, diet and aesthetics. 3. Conclusions: o Patients with the variables "preoperative radiotherapy" and "extraoral soft tissue defect" have a higher risk of developing complications related to the material of osteosynthesis (p <0.05). o We observed that the interaction between the type of reconstruction (primary or secondary) and the Brown class has a significant effect on the probability of having complications related to osteosynthesis. The group of patients with both Brown´s III+IV classes and "secondary reconstruction" had an increased risk of developing complications related to the material of osteosynthesis; more than 47.30 times the risk compared to those with Brown´s class I and "primary reconstruction". o Most of the complications related to the osteosynthesis material appear in the first two years after surgery, from that time on, the risk of complications decreases rapidly. o There is probably not a single variable, but a set of variables with different weight or importance that can influence and predict the development of complications related to osteosynthesis hardware. o We propose a minimum basic set of data that all publications on free flap reconstruction of the craniofacial skeleton should include, to improve the scientific evidence of this type of reconstruction. 4. Bibliografía 1. Acero Sanz J, Fernández García A, De Paz Hermoso V, Cuesta Gil M, Navarro Vila C. 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