Efficacy and safety of different antimicrobial DURATions for the treatment of Infections associated with Osteosynthesis Material implanted after long bone fractures (DURATIOM): Protocol for a randomized, pragmatic trial.

BACKGROUND: Infection associated with osteosynthesis material (IOM) is one of the most feared and challenging complications of trauma surgery and can cause significant functional loss, requiring multiple interventions and excessive consumption of antimicrobials. Evidence is needed about the best surgical procedure and the duration of antibiotic treatment according to the age of the implant or onset of infection symptoms, as it considers the biofilm formation and the state of fracture healing. There were not clinical trials evaluating the optimal duration of antibiotic therapy in IOM when implant is retained. Because there are antibiotics that have proven to be effective for the treatment of infection associated to implant, mainly in PJI, these antibiotics could be used in these infections. Investigating whether shorter duration of treatment is a priority in infectious diseases, as a way to reduce the exposure to antibiotics and help in controlling antimicrobial resistance and avoiding unnecessary adverse events and cost. We aim to describe the hypothesis, objectives, design, variables and procedures for a pragmatic randomized controlled trial comparing different durations of antibiotic treatment in IOM after long bone fractures treated with debridement and implant retention. METHODS AND DESIGN: This is a multicenter, open-label, non-inferiority, randomized, controlled, pragmatic phase 3 trial, comparing different durations of antibiotic treatment in IOM after long bone fractures treated with debridement and implant retention. Patients with microbiologically confirmed IOM will be included. Eligible patients are those older than 14 years, with early IOM (up to 2 weeks after the implant surgery) and delayed IOM (between 3 and 10 weeks after the implant surgery) with stabilized fracture and absence of bone exposure who sign the informed consent. Randomization will be 1:1 to receive a short-term antibiotic treatment (8 weeks in early IOM and 12 weeks in delayed IOM) or a long-term antibiotic treatment (12 weeks in early IOM or until fracture healing or implant removal in delayed IOM). The antibiotic treatment will be that used in routine practice by the specialist in infectious diseases. The primary outcome is the composited variable "cure" that includes clinical cure, radiological healing, and definitive soft tissue coverage, which will be evaluated in the test of cure at 12 months after the end of antibiotic therapy. Adverse events, resistance development during therapy and functional status will be collected. A total of 364 patients are needed to show a 10% non-inferiority margin, with 80% power and 5% one-sided significance level. DISCUSSION: If the hypothesis of non-inferiority of short vs. long antibiotic treatments is demonstrated, and the efficacy of antibiotics with less ecological impact in long treatments, the impact on reduction of bacterial resistance, toxicity and health costs will be observed. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov (NCT05294796) on Jan 26th 2022 and at the European Union Drug Regulating Authorities Clinical Trials (EUDRACT) (2021-003914-38) on Jul 16th 2021. The Sponsor Study Code is DURATIOM.

Reconstrucción con aloinjerto tendinoso en rotura crónica de tendón de Aquiles. A propósito de un caso / Reconstruction with allograft tendon in chronic torn of Achilles tendon. A case report

Las rupturas del tendón de Aquiles son cada vez más comunes en los pacientes de edad avanzada que realizan ejercicio físico ocasional. Inicialmente esta lesión puede pasar desapercibida. Tras seis semanas se considera una ruptura crónica y el diagnóstico es complejo pero importante pues este tipo de lesión puede ser invalidante. No existe consenso en el tratamiento de las rupturas crónicas del tendón de Aquiles siendo el tratamiento con aloinjerto tendinoso crioconservado una opción válida en grandes roturas. Presentamos el caso de un paciente con una ruptura crónica del tendón de Aquiles tratada por medio de reconstrucción con aloinjerto crioconservado. Tras tres años de seguimiento el paciente se mantiene asintomático y realizando actividad física. Las puntuaciones de los cuestionarios Mazur y AOFAS mejoraron ostensiblemente

The Achilles tendon ruptures are increasingly common in elderly patients who perform intense physical exercise. Initially this injury may go unnoticed. Once past six weeks is considered a chronic rupture and diagnosis is complex but important because this type of injury is crippling. No consensus exists in the treatment of chronic Achilles tendon ruptures. Treatment with tendon allograft is an option in large tendon ruptures. We report the case of a patient with a chronic Achilles tendon rupture treated with cryopreserved allograft tendon. After three years of follow-up the patient is asymptomatic and doing fitness exercise. The score questionnaires Mazur and AOFAS improved markedly

Uso de yeso pelvipédico inmediato en fracturas femorales pediátricas / Inmediate use of spica in pediatric femoral fractures

Objetivo: Evaluar los resultados del tratamiento con yeso pelvipédico inmediato en fracturas diafisarias de fémur en pacientes con edades comprendidas entre los 6 y 24 meses. Material y métodos: Realizamos un estudio observacional analizando pacientes tratados entre 2009 y 2012 por fractura de fémur, mediante yeso pelvipédico inmediato, con edades entre 6 y 24 meses. Se recopilaron 46 pacientes. Registrando tipo de fractura, acortamiento inicial, demora hasta la colocación del yeso, tipo de anestesia, angulaciones y discrepancia de longitud entre miembros inferiores. Resultados: Se observa un predominio de fracturas espiroideas (63%). Un acortamiento inicial de 6 mm de mediana, que guarda relación con la angulación frontal y sagital finales. No se ha constatado relación entre el peso y discrepancia de longitud y/o angulaciones. En el 61% de los pacientes no fue precisa la anestesia general, no existiendo relación entre su uso, y la obtención de mejores resultados radiográficos. La media de la demora en la aplicación del yeso fue de 15 horas. No se han detectado complicaciones graves. Conclusiones: El uso del yeso pelvipédico inmediato en el manejo de la fracturas de fémur en pacientes menores de 24 meses y mayores de 6 ofrece resultados óptimos con escasas complicaciones

Objetive: To evaluate the treatment results with immediate hip spica in diaphyseal femur fractures in patients age between 6 and 24 months. Methods: This was an observational study that retrospectively analyzed patients between 6 and 24 months of age who had suffered a femur fractures and were treated with immediate spica casting in our hospital between 2009 and 2012. Forty six patients were collected. The data recorded were: fracture type, initial shortening, delay until casting, general anesthesia requirement or not, degree of angulation in the frontal and sagittal plane, and leg length discrepancy at follow up. Results: We analyzed the data obtained and observed a predominance of spiral fractures (63%). An initial shortening of 6 mm median that relates with the frontal and sagittal angulation. Five patient's angles were initially out of tolerance range but did not require treatment at the end of follow up. There was no relationship between weight and leg length discrepancy or angulations. Sixty one percent of the patients did not require general anesthesia, with no relationship between its use and better radiographic results. Average in casting delay was 15 hours. No serious complications were detected. Conclusions: The use of immediate hip spica cast in the management of femur fractures in patients younger between 6 and 24 months of age provides optimal results with few complications

Luxación congénita de la cabeza del radio asociado a síndrome uña-rótula. Presentación de 2 casos / Congenital radial head dislocation associated with nail-patella syndrome. Presentation of 2 cases

La luxación de la cabeza del radio aunque poco frecuente, es común en los niños que presentan el síndrome de uña-rótula. Descrito como osteonicodisplasia puede tener además afectación renal, ocular y de otros sistemas. Se describen dos casos de síndrome uña-rótula, con rasgos clínicos signifi cativos de la enfermedad como son luxación de cabeza de radio posterolateral, que causa limitación de la movilidad, rótulas hipoplásicas que desencadenan caídas frecuentes y problemas para la deambulación, y alteraciones ungueales. Existe gran controversia entre el tratamiento quirúrgico, que solicitó uno de los pacientes y el conservador, por el que se inclinó el otro, sabiendo que al ser una patología congénita los niños se adaptan a las limitaciones que padecen (AU)

Radial head dislocation, although infrequent, it is common in those children with nail-patella syndrome. Described as hood syndrome, it can also affect other systems, including kidneys and sight. Two cases of Nail-Patella Syndrome are described, with signifi cant clinical features of the disease, including posterior-lateral radial head dislocation— thus limiting mobility—hypoplastic patella, which can lead to frequent falls and walking problems, and alterations of the nail fold. There is a great deal of controversy about the surgical treatment—requested by one of the patients— and the conservative treatment—preference of other patient—knowing that being a congenital problem, children adapt to their own limitations (AU)