RESUMEN
PURPOSE: The aim of this study was to identify factors associated with the need for open reduction in subtrochanteric femoral fractures and investigate the effect of cerclage wiring compared to open reduction alone, on the development of complications, especially infection and non-union. METHODS: All consecutive patients with a fracture involving the subtrochanteric region were retrospectively identified, over an 8-year period. Data documented and analysed included patient demographics, fracture characteristics, patient comorbidities, time to fracture union and development of complications. RESULTS: A total of 512 patients met the inclusion criteria (523 fractures). Open reduction was performed in 48% (247) of the fractures. Following matching and regression analysis, we identified diaphyseal extension of the fracture to be associated with an open reduction (OR: 2.30; 95% CI 1.45-3.65; p < 0.001). Open reduction was also associated with an increased risk of superficial infection (OR: 7.88; 95% CI 1.63-38.16; p = 0.010), transfusion within 48 h following surgery (OR: 2.44; 95% CI 1.96-4.87; p < 0.001) and a prolonged surgical time (OR: 3.09; 95% CI 1.96-4.87; p < 0.001). The risk of non-union, deep infection and overall mortality was not increased with open reduction. The use of cerclage wires [50 out of 201 fractures (24.9%) treated with an open reduction] to achieve anatomical reduction as compared to open reduction alone significantly reduced the risk of non-union (OR: 0.20; 95% CI 0.06-0.74; p = 0.015). CONCLUSION: Open reduction of subtrochanteric fractures is not associated with an increased risk of deep infection and non-union, even though it is associated with an increased risk of superficial infection, prolonged surgical time and transfusion. The use of cerclage wire is associated with reduced risk of non-union with little evidence of an increase in complications. LEVEL OF EVIDENCE: III.
Asunto(s)
Fijación Intramedular de Fracturas , Fracturas de Cadera , Clavos Ortopédicos , Fémur , Fijación Intramedular de Fracturas/efectos adversos , Fracturas de Cadera/cirugía , Humanos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: To identify the incidence, risk factors, and treatment course of patients who developed deep infection following fixation of pelvic fractures. METHODS: Over a period of 8 years patients who underwent pelvic reconstruction in our institution and developed postoperative infection were included. Exclusion criteria were pathological fractures and infections that were not secondary to post-traumatic reconstruction. The mean time of follow-up was 43.6 months (33-144). For comparison purposes, we randomly selected patients that underwent pelvic fracture fixation from our database (control group). A logistic regression was fitted to patient characteristics including age, sex, ISS, and diabetic status. RESULTS: Out of 858 patients, 18 (2.1%) (12 males), with a mean age of 41 (18-73) met the inclusion criteria. The control group consisted of 82 patients with a mean age of 41 years (18-72). The mean ISS was 27.7 and 17.6 in the infection and control group, respectively. The mean time from pelvic reconstruction to the diagnosis of infection was 20 days (7-80). The median number of trips to theatre was 3 (1-16). Methicillin-resistant Staphylococcus aureus (MRSA) was the most frequently isolated organism in the years prior to 2012. Eradication was achieved in 93% of the patients. The most important risk factors for deep infection were ISS (OR 1.08, 1.03-1.13), posterior sacral approach (OR 17.03, 1.49-194.40), and diabetes (OR 36.85, 3.54-383.70). CONCLUSION: In this retrospective case-control study, deep infection following pelvic trauma was rare. A number of patient-, injury- and surgery-related factors have shown strong correlation with this serious complication.
Asunto(s)
Fracturas Óseas , Staphylococcus aureus Resistente a Meticilina , Huesos Pélvicos , Adulto , Estudios de Casos y Controles , Fijación Interna de Fracturas/efectos adversos , Fracturas Óseas/epidemiología , Fracturas Óseas/etiología , Fracturas Óseas/cirugía , Humanos , Masculino , Huesos Pélvicos/lesiones , Huesos Pélvicos/cirugía , Prevalencia , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Target Product Profiles (TPPs) outline the characteristics that new health technologies require to address an unmet clinical need. To date, published TPPs for medical tests have focused on infectious diseases, mostly in the context of low- and middle-income countries. Recently, there have been calls for a broader use of TPPs as a mechanism to ensure that diagnostic innovation is aligned with clinical needs, yet the methodology underpinning TPP development remains suboptimal. Here, we propose that early economic evaluation (EEE) should be integrated within the TPP methodology to create a more rigorous framework for the development of "fit-for-purpose" tests. We discuss the potential benefits that EEE could bring to the core activities underpinning TPP development-scoping, drafting, consensus building, and updating-and argue that using EEE to help inform TPPs provides a more objective, evidence-based, and transparent approach to defining test specifications.
Asunto(s)
Renta , Consenso , Análisis Costo-BeneficioRESUMEN
BACKGROUND: A Target Product Profile (TPP) outlines the necessary characteristics of an innovative product to address an unmet clinical need. TPPs could be used to better guide manufacturers in the development of 'fit for purpose' tests, thus increasing the likelihood that novel tests will progress from bench to bedside. However, there is currently no guidance on how to produce a TPP specifically for medical tests. METHODS: A systematic review was conducted to summarise the methods currently used to develop TPPs for medical tests, the sources used to inform these recommendations and the test characteristics for which targets are made. Database and website searches were conducted in November 2018. TPPs written in English for any medical test were included. Based on an existing framework, test characteristics were clustered into commonly recognised themes. RESULTS: Forty-four TPPs were identified, all of which focused on diagnostic tests for infectious diseases. Three core decision-making phases for developing TPPs were identified: scoping, drafting and consensus-building. Consultations with experts and the literature mostly informed the scoping and drafting of TPPs. All TPPs provided information on unmet clinical need and desirable analytical performance, and the majority specified clinical validity characteristics. Few TPPs described specifications for clinical utility, and none included cost-effectiveness. CONCLUSIONS: We have identified a commonly used framework that could be beneficial for anyone interested in drafting a TPP for a medical test. Currently, key outcomes such as utility and cost-effectiveness are largely overlooked within TPPs though and we foresee this as an area for further improvement.