title: Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients.
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
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN10321620 Date assigned: 9 February 2007.
authors.affiliation: Department of Orthopedic and Trauma Surgery, Berufsgenossenschaftliche Unfallklinik Duisburg, Großenbaumer Allee 250, 47249, Duisburg, Germany. dieter.rixen@t-online.de.|Witten-Herdecke University, Faculty of Health, Witten, Germany. dieter.rixen@t-online.de.
authors.forename: Dieter
authors.initials: D
authors.lastname: Rixen
authors.affiliation: Department of Orthopedic and Trauma Surgery, Berufsgenossenschaftliche Unfallklinik Duisburg, Großenbaumer Allee 250, 47249, Duisburg, Germany.|Witten-Herdecke University, Faculty of Health, Witten, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Steinhausen
authors.affiliation: Institute for Research in Operative Medicine, University of Witten-Herdecke, Ostmerheimer Str. 200, 51109, Cologne, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Sauerland
authors.affiliation: Institute for Research in Operative Medicine, University of Witten-Herdecke, Ostmerheimer Str. 200, 51109, Cologne, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Lefering
authors.affiliation: Witten-Herdecke University, Faculty of Health, Witten, Germany.|Department of Trauma and Orthopedic Surgery, University of Witten-Herdecke at the Hospital Cologne-Merheim, Ostmerheimer Str. 200, 51109, Cologne, Germany.
authors.forename: Marc G
authors.initials: MG
authors.lastname: Maegele
authors.affiliation: Witten-Herdecke University, Faculty of Health, Witten, Germany.|Department of Trauma and Orthopedic Surgery, University of Witten-Herdecke at the Hospital Cologne-Merheim, Ostmerheimer Str. 200, 51109, Cologne, Germany.
authors.forename: Bertil
authors.initials: B
authors.lastname: Bouillon
authors.affiliation: Office of the Ethics Committee, Medical Faculty of the University of Cologne, Cologne, Germany.
authors.forename: Guido
authors.initials: G
authors.lastname: Grass
authors.affiliation: Institute for Research in Operative Medicine, University of Witten-Herdecke, Ostmerheimer Str. 200, 51109, Cologne, Germany.
authors.forename: Edmund A M
authors.initials: EAM
authors.lastname: Neugebauer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005264:Femoral Fractures / Q000601:surgery*; D006801:Humans; D008875:Middle Aged; D009104:Multiple Trauma / Q000601:surgery*; D063305:Organ Dysfunction Scores; D019637:Orthopedic Procedures; D011446:Prospective Studies
references.citation: J Orthop Trauma. 2000 Jan;14(1):2-9
references.pmid: 10630795
references.citation: Shock. 2001 Feb;15(2):83-9
references.pmid: 11220646
references.citation: Unfallchirurg. 2001 Mar;104(3):230-9
references.pmid: 11284354
references.citation: J Trauma. 2001 May;50(5):958-67
references.pmid: 11379595
references.citation: JAMA. 2001 Oct 10;286(14):1754-8
references.pmid: 11594901
references.citation: J Trauma. 2003 Jul;55(1):7-13
references.pmid: 12855874
references.citation: J Orthop Trauma. 2005 Feb;19(2):140-4
references.pmid: 15677932
references.citation: Unfallchirurg. 2005 Apr;108(4):288-92
references.pmid: 15812668
references.citation: Unfallchirurg. 2005 Oct;108(10):829-38, 840-2
references.pmid: 16180003
references.citation: J Trauma. 2005 Dec;59(6):1375-94; discussion 1394-5
references.pmid: 16394911
references.citation: Acta Orthop Belg. 2006 Jan;72(1):39-43
references.pmid: 16570893
references.citation: Ann Surg. 2007 Sep;246(3):491-9; discussion 499-501
references.pmid: 17717453
references.citation: Vox Sang. 2009 Jul;97(1):39-49
references.pmid: 19392782
references.citation: Trials. 2009 Aug 19;10:72
references.pmid: 19691847
references.citation: Eur J Trauma Emerg Surg. 2012 Apr;38(2):185-90
references.pmid: 26815836
references.citation: Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24
references.pmid: 7509706
references.citation: Intensive Care Med. 1996 Jul;22(7):707-10
references.pmid: 8844239
references.citation: Lancet. 1997 May 24;349(9064):1498-504
references.pmid: 9167458
references.citation: Crit Care Med. 1997 Nov;25(11):1789-95
references.pmid: 9366759
references.citation: Crit Care Med. 1998 Nov;26(11):1793-800
references.pmid: 9824069