Randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients

创伤是当今卫生保健系统的一个主要和经济问题，也是45岁以下人群死亡的主要原因。世界卫生组织预测，到2020年，因事故、暴力和战争造成的死亡人数甚至会增加。长骨骨折和股骨骨折在多发创伤患者中尤为常见，但这些患者股骨骨折的最佳治疗方法尚未解决。原则上，治疗这些骨折有五种方法：铸造、伸展、外固定器外固定骨折，以及髓内钉或钢板内固定。本研究探讨两种不同方法治疗多发创伤股骨干骨折患者的临床结局和免疫状态的差异。它是一项多中心、随机、对照试验。第一种治疗方法是“风险适应损伤控制手术”=“实验组”，包括创伤后48小时内用外固定物进行初级稳定，再用扩孔髓内钉进行二次延迟最终治疗。第二组治疗为“对照组”，采用初扩髓内钉治疗。将对这两种手术进行检查，包括器官衰竭的严重程度（SOFA评分为主要终点）、并发症发生率、住院时间、患者的免疫状态、成本效益和生活质量。

Trauma is a major and economical issue of health care systems today and the leading cause of death up to an age of 45 years. The World Health Organization assumes that death caused by accidents, violence, and war will even increase till 2020. Fractures of the long bones and femur fractures in particular are common in multiple trauma patients, but the optimal management of femur fractures in these patients is not yet resolved. In principle, there are five methods for the treatment of these fractures: cast, extension, external fracture fixation by fixateur externe, and internal fixation with either intramedullary nail or plate osteosynthesis. This trail investigates the differences in clinical outcome and immune status of two different ways of treating multiple trauma patients with femoral shaft fractures. It is set up as a multicenter, randomized, controlled trial. The first treatment is “risk adapted damage control surgery” = “experimental group”, which consits of primary stabilization with a fixateur externe within 48 hours after trauma and secondary delayed definitive treatment with reamed intramedullary nailing. The second treatment = “control group” is primary reamed intramedullary nailing. These two procedures will be examined concerning the severity of organ failure (SOFA score as primary endpoint), the rate of complications, length of stay, the immune status of the patients, cost effectiveness, and quality of life.