Eva Steinhausen1,2, Bertil Bouillon3,4, Dieter Rixen3. 1. Department of Orthopedic and Trauma Surgery, BG Klinikum Duisburg, Großenbaumer Allee 250, 47249, Duisburg, Germany. EvaSimone.Steinhausen@bg-klinikum-duisburg.de. 2. Faculty of Health, University of Witten/Herdecke, Witten, Germany. EvaSimone.Steinhausen@bg-klinikum-duisburg.de. 3. Faculty of Health, University of Witten/Herdecke, Witten, Germany. 4. Department of Trauma, Orthopaedic Surgery and Sports Traumatology, Cologne Merheim Medical Center, University of Witten/ Herdecke, Ostmerheimer Str. 200, 51109, Cologne, Germany.
Abstract
PURPOSE: Although they are considered the 'gold standard' of evidence-based medicine, randomized controlled trials are still a rarity in orthopedic surgery. In the management of patients with multiple trauma, there is a current trend toward 'damage control orthopedics', but to date, there is no proof of the superiority of this concept in terms of evidence-based medicine. The purpose of this article is to present unexpected difficulties we encountered in successfully completing our randomized controlled trial and to discuss the problematic differences between theoretically planning a trial and real-life practical experience of implementing the plan, with attention to published strategies. METHODS: The multicenter randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients (DCO study) was designed to determine whether 'risk adapted damage control orthopedics' of femoral shaft fractures is advantageous when treating multiple trauma patients. We compared our methods of study planning and realization point by point with published methods for conducting such trials. RESULTS: The study was methodically planned. We met the most prerequisites for successfully completing a large fracture trial, but experienced unexpected difficulties. After 2.5 years, the Deutsche Forschungsgemeinschaft suspended the financing because of low recruitment. The reasons were multifactorial. CONCLUSIONS: We believe it is much more difficult to perform a large fracture trial in reality than to plan it in theory. Even the theoretically best designed trial can prove unsuccessful in its implementation. The question remains: are large fracture trials even possible? Hopefully YES! TRIAL REGISTRATION: Current Controlled Trials ISRCTN10321620. Date assigned: 09/02/2007. LEVEL OF EVIDENCE: Level I.
RCT Entities:
PURPOSE: Although they are considered the 'gold standard' of evidence-based medicine, randomized controlled trials are still a rarity in orthopedic surgery. In the management of patients with multiple trauma, there is a current trend toward 'damage control orthopedics', but to date, there is no proof of the superiority of this concept in terms of evidence-based medicine. The purpose of this article is to present unexpected difficulties we encountered in successfully completing our randomized controlled trial and to discuss the problematic differences between theoretically planning a trial and real-life practical experience of implementing the plan, with attention to published strategies. METHODS: The multicenter randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple traumapatients (DCO study) was designed to determine whether 'risk adapted damage control orthopedics' of femoral shaft fractures is advantageous when treating multiple traumapatients. We compared our methods of study planning and realization point by point with published methods for conducting such trials. RESULTS: The study was methodically planned. We met the most prerequisites for successfully completing a large fracture trial, but experienced unexpected difficulties. After 2.5 years, the Deutsche Forschungsgemeinschaft suspended the financing because of low recruitment. The reasons were multifactorial. CONCLUSIONS: We believe it is much more difficult to perform a large fracture trial in reality than to plan it in theory. Even the theoretically best designed trial can prove unsuccessful in its implementation. The question remains: are large fracture trials even possible? Hopefully YES! TRIAL REGISTRATION: Current Controlled Trials ISRCTN10321620. Date assigned: 09/02/2007. LEVEL OF EVIDENCE: Level I.
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