RESUMEN
Noninferiority studies in surgery are, by their very nature, reductionist. They use multiple variables to generate a yes or no answer about the new device being tested. A binary outcome is appropriate for a regulatory agency such as the Food and Drug Administration, but the clinical situation is more nuanced. It is critical to understand the underlying philosophies and choices that go into trial design when a surgeon is recommending a new device. In the case of Cartiva, any of 3 reasonable alternative means of defining surgical success would have altered the final outcome of the MOTION trial. Additionally, using a more rigorous noninferiority margin rather than adding an additional cushion based upon the argument that motion alone had extra inherent value would have also led to failure of the trial to demonstrate noninferiority.
Asunto(s)
Artrodesis , Humanos , Artrodesis/métodos , Estudios de Equivalencia como AsuntoRESUMEN
Background: Ankle fractures are a frequent injury in the adult population and a quarter of all ankle fractures are classified as unstable, requiring surgical intervention. Plate-and-screw construct is the traditionally used fixation method for fibula fractures. The use of an intramedullary nail is an alternative fixation method, with current literature supporting very low complication rates and hardware removal surgeries. The purpose of this study was to evaluate the outcomes, including complication rates and implant removal rates, using a fibula nail with both proximal and distal fixation capabilities by an experienced surgeon. Methods: We retrospectively reviewed 203 consecutive fibula nail cases from a single surgeon using a mini-open technique for anatomic reduction. Demographic, operative, clinical, and radiographic outcome data were analyzed, specifically examining complication rates and need for implant removal. Results: The average follow-up was 18.8 months (6-54 months). All fractures healed. We identified 2 cases of superficial wound infection, 1 superficial peroneal nerve irritation, and 1 case of implant removal. In the first 110 cases, 2 fractures were converted to a plate intraoperatively prior to a technique modification which has prevented this occurrence. No deep infection, delayed union, or nonunion occurred. Conclusion: Our data support that fibula nails with proximal and distal locking capabilities offer an alternative to plating with the potential for lower complication rates and lower need for implant removal. Level of evidence: Level IV, case series.
RESUMEN
Introducción: los síntomas, signos y hallazgos imagenológicos e histológicos del quiste óseo aneurismático (QOA) y el osteosarcoma telangiectásico (OT) son similares, por lo que constituyen uno de los diagnósticos diferenciales más difíciles de establecer.Presentación del caso: mujer de 19 años que asistió al servicio de urgencias de un hospital de cuarto nivel de atención en Bogotá por dolor en la cadera izquierda, donde se identificó lesión lítica en el cuello del fémur y se remitió a consulta externa. Tres días después, la paciente regresó al servicio de urgencias por dolor en la cadera izquierda e incapacidad funcional. Mediante radiografía y resonancia magnética, se identificó fractura transcervical de la cadera en el lugar de la lesión lítica, por lo que se sospechó la presencia de QOA u OT. La paciente fue llevada a cirugía y se realizó biopsia por congelación, confirmando el diagnóstico de QOA; por lo tanto, se realizó curetaje y fresado de la lesión, reducción y fijación de la fractura con sistema DHS (dynamic hip screw), y aplicación de injerto y cemento óseo. Cuatro días después del procedimiento, la paciente fue dada de alta. En el seguimiento a los ocho meses, se evidenció recuperación completa de la funcionalidad de la cadera y ausencia de dolor.Conclusión: en pacientes en los que hay una alta sospecha de este tipo de lesiones óseas, es importante realizar un estudio histopatológico para confirmar el diagnóstico de QOA u OT, e instaurar un tratamiento adecuado y oportuno, que sin duda contribuirá a un mejor pronóstico, particularmente en términos de supervivencia
Introduction: Symptoms, signs, imaging and histological findings of aneurysmal bone cyst (ABC) and telangiectatic osteosarcoma (TO) are similar, which makes them one of the most difficult differential diagnoses. Case presentation: A 19-year-old woman attended the emergency department of a quaternary care hospital in Bogotá, Colombia, due to pain in the left hip. A lytic lesion in the femur was identified and the patient was referred to the outpatient clinic. Three days later, the patient returned to the emergency department with left hip pain and functional disability. By means of X-ray and MRI, a transcervical fracture of the hip was identified at the site of the lytic lesion, so the presence of ABC or TO was suspected. The patient was taken to surgery and a frozen section biopsy was performed, confirming the diagnosis of ABC. Consequently, curettage and reaming of the lesion were undertaken, followed by reduction and fixation of the fracture using the DHS (dynamic hip screw) system, and application of bone grafting and bone cement. Four days after the procedure, the patient was discharged. A follow-up at eight months showed complete recovery of hip functionality and absence of pain.Conclusion: In patients with a high suspicion of this type of bone lesions, it is important to perform a histopathological study to confirm the diagnosis of ABC or TO, and to establish an adequate and timely treatment, which will undoubtedly contribute to a better prognosis, particularly in terms of surviva