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

多发伤患者股骨干骨折风险适应损伤控制骨科手术的随机对照试验

• 批准号: 34242345
• 负责人: Professor Dr. Dieter Rixen
• 金额: --
• 依托单位: Klinik für Unfallchirurgie, Orthopädie und Sportmedizin
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2007
• 资助国家: 德国
• 起止时间: 2006-12-31 至 2008-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/34242345?language=en
• 关键词: Randomized; controlled; trial; risk; adapted

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.

创伤是当今卫生保健系统的一个重大和经济问题，也是导致45岁以下儿童死亡的主要原因。世界卫生组织认为，到2020年，事故、暴力和战争造成的死亡人数甚至会增加。长骨骨折特别是股骨骨折在多发创伤患者中很常见，但这些患者股骨骨折的最佳处理尚未得到解决。原则上，治疗这些骨折的方法有5种：铸型、伸展、外固定器外固定、髓内钉内固定或钢板内固定。本试验研究了两种不同方法治疗多发性创伤合并股骨干骨折患者的临床结局和免疫状态的差异。它被设置为一项多中心、随机、对照试验。第一种治疗为“风险适应损伤控制手术”=“试验组”，包括创伤后48小时内用外固定器进行一期稳定和二次扩髓髓内钉延迟明确治疗。第二组为对照组，一期扩髓髓内钉。这两个程序将检查器官衰竭的严重程度(以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。