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首页> 外文期刊>Trials >Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients
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Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients

机译：多创伤患者股骨干骨折适应风险的损伤控制整形外科手术的随机，对照，两臂，介入性，多中心研究

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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. Trial registration Current Controlled Trials ISRCTN10321620 Date assigned: 9 February 2007.
机译：背景多发伤患者常见长骨骨折，特别是股骨骨折，但尚未确定最佳治疗方法。尽管“损伤控制骨科”（DCO）概念存在趋势，但目前的文献尚无定论。因此，需要更具体的对照临床研究。这项研究的主要目的是阐明与早期确定的治疗策略相比，采用风险适应性的股骨骨折治疗方法是否可以改善预后（发病率和死亡率）。方法/设计研究设计为随机对照多中心研究。多发性股骨干骨折并计算出死亡概率为20％至60％的患者被随机分配到临时性骨折外固定支架内，并进行了明确的二级彻底治疗（DCO）或一级扩髓钉（早期全面护理）。主要目标是减少最大败血症相关器官衰竭评估（SOFA）评分所衡量的器官衰竭程度。结果34例患者随机分为两组，每组17例。两组在性别，年龄，损伤严重程度评分，格拉斯哥昏迷量表，凝血酶原时间，基础过量，死亡的计算概率以及其他生理变量方面具有可比性。两组之间的最高SOFA评分是可比较的（无统计学意义）。关于次要终点，外固定患者需要更长的通气时间（p = 0.049），重症监护时间要长得多（p = 0.037），而住院期间的住院时间是平衡的。两组。不幸的是，由于出乎意料的低患者招募，研究不得不在达到预期的样本量之前终止。结论因此，这项随机研究的结果反映了文献中的矛盾之处。在多发伤患者的股骨骨折治疗中，没有发现损伤控制概念的优势。科学评估此临床相关问题的必要性仍然存在。试验注册当前对照试验ISRCTN10321620分配日期：2007年2月9日。

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