Universität zu Köln

Rixen, Dieter, Steinhausen, Eva, Sauerland, Stefan ORCID: 0000-0003-1048-796X, Lefering, Rolf, Maegele, Marc G., Bouillon, Bertil, Grass, Guido and Neugebauer, Edmund A. M. (2016). Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients. Trials, 17. LONDON: BIOMED CENTRAL LTD. ISSN 1745-6215

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Abstract

Background: Long bone fractures, particularly of the femur, are common in multiple-trauma patients, but their optimal management has not yet been determined. Although a trend exists toward the concept of damage control orthopedics (DCO), current literature is inconclusive. Thus, a need exists for a more specific controlled clinical study. The primary objective of this study was to clarify whether a risk-adapted procedure for treating femoral fractures, as opposed to an early definitive treatment strategy, leads to an improved outcome (morbidity and mortality). Methods/Design: The study was designed as a randomized controlled multicenter study. Multiple-trauma patients with femur shaft fractures and a calculated probability of death of 20 to 60 % were randomized to either temporary fracture fixation with external fixation and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective was to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score. Results: Thirty-four patients were randomized to two groups of 17 patients each. Both groups were comparable regarding sex, age, injury severity score, Glasgow Coma Scale, prothrombin time, base excess, calculated probability of death, and other physiologic variables. The maximum SOFA score was comparable (nonsignificant) between the groups. Regarding the secondary endpoints, the patients with external fixation required a significantly longer ventilation period (p = 0.049) and stayed on the intensive care significantly longer (p = 0.037), whereas the in-hospital length of stay was balanced for both groups. Unfortunately, the study had to be terminated prior to reaching the anticipated sample size because of unexpected low patient recruitment. Conclusions: Thus, the results of this randomized study reflect the ambivalence in the literature. No advantage of the damage control concept could be detected in the treatment of femur fractures in multiple-trauma patients. The necessity for scientific evaluation of this clinically relevant question remains.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Rixen, Dieter UNSPECIFIED UNSPECIFIED UNSPECIFIED Steinhausen, Eva UNSPECIFIED UNSPECIFIED UNSPECIFIED Sauerland, Stefan UNSPECIFIED orcid.org/0000-0003-1048-796X UNSPECIFIED Lefering, Rolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Maegele, Marc G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bouillon, Bertil UNSPECIFIED UNSPECIFIED UNSPECIFIED Grass, Guido UNSPECIFIED UNSPECIFIED UNSPECIFIED Neugebauer, Edmund A. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-287026
DOI:	10.1186/s13063-016-1162-2
Journal or Publication Title:	Trials
Volume:	17
Date:	2016
Publisher:	BIOMED CENTRAL LTD
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language EPOFF STUDY-GROUP; INJURED PATIENTS; ORGAN DYSFUNCTION/FAILURE; CONSENSUS CONFERENCE; POLYTRAUMA PATIENTS; EXTERNAL FIXATION; LOWER-EXTREMITY; SOFA SCORE; MANAGEMENT; SOCIETY Multiple languages Medicine, Research & Experimental Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28702