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Intramedullary nails vs distal locking plates for fracture of the distal femur: Results from the Trial of Acute Femoral Fracture Fixation (TrAFFix) randomised feasibility study and process evaluation

BMJ Open May 10, 2019

Griffin XL, et al. - This research of fracture fixation with nails vs plates aimed at evaluating the feasibility of a future definitive trial and conducting a process evaluation to understand the generalizability and likely success of a future trial. Seven NHS hospitals in England carried out a multicenter, parallel, two-arm, randomized controlled feasibility study with embedded process evaluation. Patients (18 years of age and older) with distal femur fracture who were thought to benefit from internal fixation by their surgeon were eligible to participate. There were less recruitment and completion of data than expected. The process evaluation showed that variation in treatment pathways across centres, lack of surgeon equipoise and confidence in using both interventions and newly formed research cultures that lacked cohesion were the main barriers to recruitment. The data presented in this work showed a modified trial design, with embedded recruitment support intervention, is feasible to compare functional results in cognitively intact adults who have sustained a distal femur fragility fracture.
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