Protocol for a randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients.
BACKGROUND
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. Although there is a trend towards the concept of "Damage Control Orthopedics" (DCO) in the management of multiple trauma patients with long bone fractures as reflected by a significant increase in primary external fixation of femur fractures, current literature is insufficient. Thus, in the era of "evidence-based medicine", there is the need for a more specific, clarifying trial.


METHODS
The trial is designed as a randomized controlled open-label multicenter study. Multiple trauma patients with femur shaft fractures and a calculated probability of death between 20 and 60% will be randomized to either temporary fracture fixation with fixateur externe and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective is to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score.


CONCLUSIONS
The Damage Control Study is the first to evaluate the risk adapted damage control orthopedic surgery concept of femur shaft fractures in multiple trauma patients in a randomized controlled design. The trial investigates the differences in clinical outcome of two currently accepted different ways of treating multiple trauma patients with femoral shaft fractures. This study will help to answer the question whether the "early total care" or the "damage control" concept is associated with better outcome.


BACKGROUND
Current Controlled Trials ISRCTN10321620.
Rixen
Dieter
D
Department of Trauma and Orthopedic Surgery, University of Witten-Herdecke at the Hospital Cologne-Merheim, Ostmerheimer Str, 200, 51109 Cologne, Germany. RixenD@kliniken-koeln.de
Steinhausen
Eva
E
Sauerland
Stefan
S
Lefering
Rolf
R
Meier
Matthias
M
Maegele
Marc G
MG
Bouillon
Bertil
B
Neugebauer
Edmund A M
EA
D002985:Clinical Protocols; D023381:Endpoint Determination; D005264:Femoral Fractures / Q000601:surgery*; D006801:Humans; D009104:Multiple Trauma / Q000401:mortality / Q000601:surgery*; D019637:Orthopedic Procedures / Q000009:adverse effects; D012107:Research Design; D018401:Sample Size
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