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

• Applicant: Professor Dr. Dieter Rixen
• Subject Area: Orthopaedics, Traumatology, Reconstructive Surgery
• Term: from 2007 to 2009
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 34242345

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.

• DFG Programme: Clinical Trials