[Randomized clinical trials in trauma surgery: decision-making in an area of conflict between eminence and evidence]

Abstract

Well-designed, prospective, multicenter, randomized clinical trials (RCTs) define the gold standard of evidence-based medicine. The results of such trials represent the most solid rationale for therapeutic recommendations in the S3 guideline of medical societies (http://www.leitlinie.de). The performance of studies according to good clinical practice (GCP) guidelines (Guidelines of the International Conference on Harmonization on Good Clinical Practice) is extremely demanding. The findings can shake long established principles and practices to the core. For more than 20 years now, the management of femoral shaft fractures in critically injured patients has been controversially discussed. There are two different concepts competing against each other: Early total care (ETC) aiming at definitive care by immediate femoral nailing and damage control orthopedics (DCO), where nailing is performed at a later time point after initial retention by the use of external fixation. In order to answer this still unresolved question, the Damage Control Study is currently under way involving 25 trauma centers throughout Germany. This study is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Association), it is endorsed by the board of Deutschen Gesellschaft für Unfallchirurgie (DGU, German Society for Casualty Surgery) and it is embedded in a joint program of the DFG and the Federal Ministry of Education and Research (BMBF) to support clinical studies in Germany. Moreover, the study is supported by the ChirNet Site at Witten/Herdecke-Köln (http://www.chir-net.de). Without a doubt, this RCT is one of the most important studies carried out in the field of care for the critically injured patient, because the results will have a profound influence on the future management of femoral shaft fractures in multiple trauma patients and because successful completion of this study will underline the high scientific competence and skills claimed by German trauma surgeons. At the same time, ironically, the success of this study is endangered by the dilemma of an as yet insufficient recruitment of suitable patients to be enrolled into the trial. In this article possible explanations for this problem will be discussed based on a case report and the specific challenges in performing RCTs that scrutinize questions in the field of surgery will be analyzed.