Are large fracture trials really possible? What we have learned from the randomized controlled damage control study?

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.

Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients.

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.

A risk-adapted approach is beneficial in the management of bilateral femoral shaft fractures in multiple trauma patients: an analysis based on the trauma registry of the German Trauma Society.

BACKGROUND: Today, there is a trend toward damage-control orthopedics (DCO) in the management of multiple trauma patients with long bone fractures. However, there is no widely accepted concept. A risk-adapted approach seems to result in low acute morbidity and mortality. Multiple trauma patients with bilateral femoral shaft fractures (FSFs) are considered to be more severely injured. The objective of this study was to validate the risk-adapted approach in the management of multiple trauma patients with bilateral FSF. METHODS: Data analysis is based on the trauma registry of the German Trauma Society (1993-2008, n = 42,248). Multiple trauma patients with bilateral FSF were analyzed in subgroups according to the type of primary operative strategy. Outcome parameters were mortality and major complications as (multiple) organ failure and sepsis. RESULTS: A total of 379 patients with bilateral FSF were divided into four groups as follows: (1) no operation (8.4%), (2) bilateral temporary external fixation (DCO) (50.9%), bilateral primary definitive osteosynthesis (early total care [ETC]) (25.1%), and primary definitive osteosynthesis of one FSF and DCO contralaterally (mixed) (15.6%). Compared with the ETC group, the DCO group was more severely injured. The incidence of (multiple) organ failure and mortality rates were higher in the DCO group but without significance. Adjusted for injury severity, there was no significant difference of mortality rates between DCO and ETC. Injury severity and mortality rates were significantly increased in the no-operation group. The mixed group was similar to the ETC group regarding injury severity and outcome. CONCLUSION: In Germany, both DCO and ETC are practiced in multiple trauma patients with bilateral FSF so far. The unstable or potentially unstable patient is reasonably treated with DCO. The clearly stable patient is reasonably treated with nailing. When in doubt, the patient is probably not totally stable, and the safest precaution may be to use DCO as a risk-adapted approach. LEVEL OF EVIDENCE: Therapeutic study, level IV. Epidemiologic study, level III.

Do parameters used to clear noncritically injured polytrauma patients for extremity surgery predict complications?

BACKGROUND: In multiply injured patients, definitive stabilization of major fractures is performed whenever feasible, depending on the clinical condition. QUESTIONS/PURPOSES: We therefore asked whether (1) any preoperative indicators predict major complications after major extremity surgery; (2) perioperative routine parameters other than those indicative of hemorrhagic shock predict postoperative complications; and (3) any postoperative clinical findings can predict major complications in the further course of the patient. METHODS: We prospectively followed patients with femoral midshaft fracture, Injury Severity Score (ISS) > 16 points, or three fractures and Abbreviated Injury Scale (AIS) ≥ 2 points and another injury (AIS ≥ 2 points), and age 18 to 65 years. We recorded multiple clinical parameters. End points were pneumonia, sepsis, acute respiratory distress syndrome, acute lung injury, and multiple organ failure. RESULTS: Forty-three of 165 patients developed complications. (1) Patients with complications had a decreased initial Glasgow Coma Scale and tended to have a lower ISS. (2) None of the assessed perioperative parameters was able to sufficiently predict postoperative complications. (3) The presence of a lung contusion and ventilation > 48 hours were associated with complications in the further course. CONCLUSIONS: In stable multiply injured patients, none of the individual routine clinical parameters was able to predict complications. Severe head and thoracic injuries seem to be important drivers for the development postoperative complications.

The treatment of patients with severe and multiple traumatic injuries.

BACKGROUND: The care of severely and multiply injured patients is an interdisciplinary challenge. The only existing German-language guideline up to now has been the S1-guideline issued in 2002 by the German Society for Trauma Surgery (Deutsche Gesellschaft für Unfallchirurgie, DGU). In this article, we present a new, comprehensive, evidence and consensus based S3-guideline for the treatment of severely and multiply injured patients in the pre-hospital and early in-hospital phases which has been developed with the aim of structural and procedural quality optimization. Its implementation should lower these patients' mortality and improve their quality of life. METHODS: The guideline was developed by a panel consisting of 18 delegates from 11 specialty societies under the lead of the DGU, with designated coordinators for each of three phases of treatment: the pre-hospital phase, the emergency-room phase, and the emergency surgery phase. The key questions to be answered were determined by vote, and then the relevant literature (in English and German, 1995-2010) was systematically searched and evaluated. Key recommendations with explanatory texts were formulated and agreed upon in a nominal group process (NGP) with five consensus conferences and three further Delphi rounds. RESULTS: 264 recommendations were issued: 66 for the pre-hospital phase, 102 for the emergency-room phase, and 96 for the emergency surgery phase. The three phases were subcategorized according to organizational and anatomical considerations. Topics of major emphasis were, in the pre-hospital phase, the establishment and implementation of correct priorities for treatment; in the emergency-room phase, the creation of clear structures and processes; and, in the emergency surgery phase, the avoidance of secondary injury (i.e., the principle of damage control). CONCLUSION: This guideline can only improve outcomes if it is implemented in routine practice. Aside from the guideline itself, the DGU trauma network (www.dgu-traumanetzwerk.de) has issued a set of directions as an aid to its implementation.

Do stable multiply injured patients with bilateral femur fractures have higher complication rates? An investigation by the EPOFF study group.

BACKGROUND: Polytrauma patients with bilateral femur shaft fractures are known to have a higher rate of complications when compared with those who have sustained unilateral fractures. The current study tests the hypothesis that the high incidence of posttraumatic complications in patients who do not have a severe head or chest injury is caused by accompanying injuries rather than by the additional femur fracture. METHODS: Inclusion criteria New Injury Severity Score > 16 points; AIS score value of the chest ≤3 points and no severe head injury. Two study groups: a unilateral group (USF group) (n = 146) and a bilateral femur shaft fracture group (BSF group) (n = 19). Endpoints monitored were length of stay in the intensive care unit, duration on a ventilator, and several postsurgical complications (e.g., SEPSIS, acute lung injury). Statistics Fisher's exact test for binary variables, and independent t-tests and regression analyses for continuous indicators of injury severity and clinical outcomes. RESULTS: Patients with bilateral femur fractures had a significantly higher incidence of hemothorax. Moreover, they received blood transfusions more often upon admission, and exhibited a longer ICU stay (p = 0.008). However, this patient group did not exhibit a significantly higher incidence of postsurgical complications (p = 0.1) than those with unilateral fractures. After adjusting for injury severity, no difference in the length of the ICU stay was observed. Bilateral fracture patients who were in an uncertain condition preoperatively had a longer length of stay in the ICU postoperatively (p = 0.002). CONCLUSIONS: In the absence of major head or chest injuries, patients with multiple injuries and bilateral femur shaft fractures have a similar complication rate to polytrauma patients with unilateral fractures. Moreover, an uncertain condition preoperatively was associated with an increased stay in the intensive care unit. The results support the idea that associated injuries rather than the additional femur fracture are responsible for complications during the clinical stay.

Image-guided spine surgery: state of the art and future directions.

Navigation technology is a widely available tool in spine surgery and has become a part of clinical routine in many centers. The issue of where and when navigation technology should be used is still an issue of debate. It is the aim of this study to give an overview on the current knowledge concerning the technical capabilities of image-guided approaches and to discuss possible future directions of research and implementation of this technique. Based on a Medline search total of 1,462 publications published until October 2008 were retrieved. The abstracts were scanned manually for relevance to the topics of navigated spine surgery in the cervical spine, the thoracic spine, the lumbar spine, as well as ventral spine surgery, radiation exposure, tumor surgery and cost-effectivity in navigated spine surgery. Papers not contributing to these subjects were deleted resulting in 276 papers that were included in the analysis. Image-guided approaches have been investigated and partially implemented into clinical routine in virtually any field of spine surgery. However, the data available is mostly limited to small clinical series, case reports or retrospective studies. Only two RCTs and one metaanalysis have been retrieved. Concerning the most popular application of image-guided approaches, pedicle screw insertion, the evidence of clinical benefit in the most critical areas, e.g. the thoracic spine, is still lacking. In many other areas of spine surgery, e.g. ventral spine surgery or tumor surgery, image-guided approaches are still in an experimental stage. The technical development of image-guided techniques has reached a high level as the accuracies that can be achieved technically meet the anatomical demands. However, there is evidence that the interaction between the surgeon ('human factor') and the navigation system is a source of inaccuracy. It is concluded that more effort needs to be spend to understand this interaction.

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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10321620.

Emergency trauma score: an instrument for early estimation of trauma severity.

OBJECTIVES: Early estimation of the mortality risk of severely injured patients is mandatory. To estimate the seriousness of the condition of patients with trauma, we developed the emergency trauma score (EMTRAS) for ease of use, with simple parameters that are available within 30 minutes. DESIGN: Prospective analysis of the German Trauma Registry of multitrauma patients. SETTING: EMTRAS was derived from data from 1993 through 2003. Potential parameters that were prognostic for mortality in univariate analysis were evaluated by multivariate binary logistic regression. Selected parameters were then assigned a subscore that varied from 0 to 3. The EMTRAS score was a simple addition of these subscores. EMTRAS was compared with other scores' receiver operating characteristic curves. After completion, EMTRAS was validated in patients from 2004 and 2005. PATIENTS: A total of 11,533 patients were to be used for developing the score and 3314 patients for validating it. MAIN RESULTS: The strongest predictors of mortality were age, prehospital Glasgow Coma Scale, base excess (mmol/L), and prothrombin time (% of reference). These parameters were categorized in subscores of 0 through 3. Age: <40, 40 through 60, 61 through 75, and >75 scored 0, 1, 2, and 3, respectively. Glasgow Coma Scale: 13 through 15, 10 through 12, 6 through 9, and 3 through 5 scored 0, 1, 2, and 3, respectively. Base excess: >-1, -5 through -1, -10 through -5.1, and <-10 scored 0, 1, 2, and 3, respectively. Prothrombin time: <80%, 80% through 50%, 49% through 20%, and >20% received a score of 0, 1, 2, and 3, respectively. In the validation dataset, the area under the receiver operating characteristic curve for EMTRAS was 0.828. CONCLUSIONS: EMTRAS combines four early parameters from the emergency room and accurately predicts mortality. Knowledge of the anatomical injuries is not necessary. The determination of the EMTRAS will inform caregivers of the seriousness of patients with trauma at an early stage.

Computer assisted percutaneous placement of augmented iliosacral screws: a reasonable alternative to sacroplasty.

STUDY DESIGN: A technical report of fluoroscopy guided placement of augmented iliosacral screws in osteoporotic insufficiency fractures of the sacrum. OBJECTIVE: To describe a combined approach of navigated iliosacral screw placement and screw augmentation as an option for osteosynthesis of sacral insufficiency fractures in the elderly. SUMMARY OF BACKGROUND DATA: The incidence of sacral insufficiency fractures is increasing. Outcome of conservative treatment is inconsistent. Recently sacroplasty is propagated as an interventional therapy but the long-term outcome is still unknown. Evidence from finite element models suggests that stabilization of the sacrum achieved by sacroplasty is insufficient to restore the weight bearing capacity of the sacrum permanently. METHODS: We suggest a minimally invasive fluoroscopically navigated iliosacral screw osteosynthesis with cement augmentation of the screws for treatment of insufficiency fractures of the sacrum. RESULTS: The procedure, especially fluoroscopic visualization and navigation of the osteoporotic sacrum is technically feasible. A total radiograph time of 7,4 minutes, including image acquisition for navigation and fluoroscopic control of cement injection, is acceptable and can be expected to be significantly reduced with repeated applications of the procedure. The patient presented in the report was discharged to rehabilitation soon after the operation. An assistive device (delta wheel) is only needed for longer walking distances. Pain was reduced drastically immediately after surgery. CONCLUSION: In general, fractures are treated by reduction and fixation to restore the biomechanical function of the injured bone. These principles should be applied to elderly patients with osteoporotic fractures as well. The technique reported here is adapted to the special demands of the elderly patient, i.e., minimally invasive, support of the weakened bone by cement augmentation, bone protective screw positioning and safety due to navigation support.

Impact of the method of initial stabilization for femoral shaft fractures in patients with multiple injuries at risk for complications (borderline patients).

OBJECTIVES: The timing of definitive fixation for major fractures in patients with multiple injuries is controversial. To address this gap, we randomized patients with blunt multiple injuries to either initial definitive stabilization of the femur shaft with an intramedullary nail or an external fixateur with later conversion to an intermedullary nail and documented the postoperative clinical condition. METHODS: Multiply injured patients with femoral shaft fractures were randomized to either initial (<24 hours) intramedullary femoral nailing or external fixation and later conversion to an intramedullary nail. Inclusion: New Injury Severity Score >16 points, or 3 fractures and Abbreviated Injury Scale score > or =2 points and another injury (Abbreviated Injury Scale score > or =2 points), and age 18 to 65 years. Exclusion: patients in unstable or critical condition. Patients were graded as stable or borderline (increased risk of systemic complications). OUTCOMES: : Incidence of acute lung injuries. RESULTS: Ten European Centers, 165 patients, mean age 32.7 +/- 11.7 years. Group intramedullary nailing, n = 94; group external fixation, n = 71. Preoperatively, 121 patients were stable and 44 patients were in borderline condition. After adjusting for differences in initial injury severity between the 2 treatment groups, the odds of developing acute lung injury were 6.69 times greater in borderline patients who underwent intramedullary nailing in comparison with those who underwent external fixation, P < 0.05. CONCLUSION: Intramedullary stabilization of the femur fracture can affect the outcome in patients with multiple injuries. In stable patients, primary femoral nailing is associated with shorter ventilation time. In borderline patients, it is associated with a higher incidence of lung dysfunctions when compared with those who underwent external fixation and later conversion to intermedullary nail. Therefore, the preoperative condition should be when deciding on the type of initial fixation to perform in patients with multiple blunt injuries.

Early coagulopathy in multiple injury: an analysis from the German Trauma Registry on 8724 patients.

BACKGROUND: There is increasing evidence for acute traumatic coagulopathy occurring prior to emergency room (ER) admission but detailed information is lacking. PATIENTS AND METHODS: A retrospective analysis using the German Trauma Registry database including 17,200 multiple injured patients was conducted to determine (a) to what extent clinically relevant coagulopathy has already been established upon ER admission, and whether its presence was associated (b) with the amount of intravenous fluids (i.v.) administered pre-clinically, (c) with the magnitude of injury, and (d) with impaired outcome and mortality. Eight thousand seven hundred and twenty-four patients with complete data sets were screened. RESULTS: Coagulopathy upon ER admission as defined by prothrombin time test (Quick's value) <70% and/or platelets <100,000 microl(-1), was present in 34.2% of all patients. There was an increasing incidence for coagulopathy with increasing amounts of i.v. fluids administered pre-clinically. Coagulopathy was observed in >40% of patients with >2000 ml, in >50% with >3000 ml, and in >70% with >4000 ml administered. Ten percentage of patients presented with clotting disorders although pre-clinical resuscitation was limited to 500 ml of i.v. fluids maximum. The mean ISS score in the coagulopathy group was 30 (S.D. 15) versus 21 (S.D. 12) (p<0.001). Twenty-nine percentage of patients with coagulopathy developed multi organ failure (p<0.001). Early in-hospital mortality (<24h) was 13% in patients with coagulopathy (p<0.001) and overall in-hospital mortality totalled 28% (p<0.001). CONCLUSION: There is a high frequency of established coagulopathy in multiple injury upon ER admission. The presence of early traumatic coagulopathy was associated with the amount of intravenous fluids administered pre-clinically, magnitude of injury, and impaired outcome.

Trauma Associated Severe Hemorrhage (TASH)-Score: probability of mass transfusion as surrogate for life threatening hemorrhage after multiple trauma.

BACKGROUND: To develop a simple scoring system that allows an early and reliable estimation for the probability of mass transfusion (MT) as a surrogate for life threatening hemorrhage following multiple trauma. METHODS: Potential clinical and laboratory variables documented in the Trauma Registry of the German Trauma Society (DGU) (1993-2003; n=17,200) were subjected to univariate and multivariate logistic regression analysis to predict the probability for MT. RESULTS: Clinical and laboratory variables available from data sets were screened for their association with mass transfusion. MT was defined by transfusion requirement of >or=10 units of packed red blood cells from emergency room (ER) to intensive care unit admission. Seven independent variables were identified to be significantly correlated with an increased probability for MT: systolic blood pressure (<100 mm Hg=4 pts, <120 mm Hg=1 pt), hemoglobin (<7 g/dL=8 pts, <9 g/dL=6 pts, <10 g/dL=4 pts, <11 g/dL=3 pts, and <12 g/dL=2 pts), intra-abdominal fluid (3 pts), complex long bone and/or pelvic fractures (AIS 3/4=3 pts and AIS 5=6 pts), heart rate (>120=2 pts), base excess (<-10 mmol/L=4 pts, <-6 mmol/L=3 pts, and <-2 mmol/L=1 pt), and gender (male=1 pt). These variables were incorporated into a risk score, the Trauma Associated Severe Hemorrhage Score (TASH-Score, 0-28 points). Performance of the score was tested with respect to discrimination, precision, and calibration. Increasing TASH-Score points were associated with an increasing probability for MT. CONCLUSION: The TASH-Score is an easy-to-use scoring system that reliably predicts the probability for MT after multiple trauma. Taken as a surrogate for life threatening bleeding calculation may focus attention on relevant variables indicative for risk and impact strategies to stop bleeding and stabilize coagulation in acute trauma care.

One year ago not business as usual: wound management, infection and psychoemotional control during tertiary medical care following the 2004 Tsunami disaster in southeast Asia.

INTRODUCTION: Following the 2004 tsunami disaster in southeast Asia severely injured tourists were repatriated via airlift to Germany. One cohort was triaged to the Cologne-Merheim Medical Center (Germany) for further medical care. We report on the tertiary medical care provided to this cohort of patients. METHODS: This study is an observational report on complex wound management, infection and psychoemotional control associated with the 2004 Tsunami disaster. The setting was an adult intensive care unit (ICU) of a level I trauma center and subjects included severely injured tsunami victims repatriated from the disaster area (19 to 68 years old; 10 females and 7 males with unknown co-morbidities). RESULTS: Multiple large flap lacerations (2 x 3 to 60 x 60 cm) at various body sites were characteristic. Lower extremities were mostly affected (88%), followed by upper extremities (29%), and head (18%). Two-thirds of patients presented with combined injuries to the thorax or fractures. Near-drowning involved the aspiration of immersion fluids, marine and soil debris into the respiratory tract and all patients displayed signs of pneumonitis and pneumonia upon arrival. Three patients presented with severe sinusitis. Microbiology identified a variety of common but also uncommon isolates that were often multi-resistant. Wound management included aggressive debridement together with vacuum-assisted closure in the interim between initial wound surgery and secondary closure. All patients received empiric anti-infective therapy using quinolones and clindamycin, later adapted to incoming results from microbiology and resistance patterns. This approach was effective in all but one patient who died due to severe fungal sepsis. All patients displayed severe signs of post-traumatic stress response. CONCLUSION: Individuals evacuated to our facility sustained traumatic injuries to head, chest, and limbs that were often contaminated with highly resistant bacteria. Transferred patients from disaster areas should be isolated until their microbial flora is identified as they may introduce new pathogens into an ICU. Successful wound management, including aggressive debridement combined with vacuum-assisted closure was effective. Initial anti-infective therapy using quinolones combined with clindamycin was a good first-line choice. Psychoemotional intervention alleviated severe post-traumatic stress response. For optimum treatment and care a multidisciplinary approach is mandatory.

Applying evidence-based surgery in daily clinical routine: a feasibility study.

BACKGROUND: Although the word evidence-based medicine (EBM) has gained wide popularity, only a few studies have evaluated how EBM works in clinical practice. METHODS: We have prospectively evaluated the feasibility of evidence-based trauma surgery. Orthopaedic trauma surgeons were asked to produce clinical questions related to the treatment of current patients. An informaticist searched the literature (Medline, Cochrane Library, practice guidelines and textbooks) and reported the findings on every following day. The study's main endpoints were the rate of questions for which relevant evidence (>level V) was available and the time necessary to find and critically appraise medical evidence. RESULTS: In total, 44 EBM questions were formulated, mainly concerning treatment options. PubMed was searched for 39 questions, textbooks for 14, the Cochrane Library for 11, online guidelines for 9 and other sources were used for 4 questions. On average, 157 text items (three per questions) were identified as potentially relevant. Journal articles predominated (83%) over textbooks (10%). Sixty-eight percent of the questions (30 of 44) were answered, either on the basis level 1 (n=13 questions), level 2 (n=6), or level 4 evidence (n=14). Trying to answer a question required 53 min on average, split up between 39 min of database searches and 25 min of obtaining full text articles. In four cases, the evidence suggested a change in clinical management. The physicians were very appreciative of our project and found the provided evidence very helpful for their clinical decisions. CONCLUSIONS: Time will be the main barrier against the introduction of clinical EBM. It is likely that clinicians reduce EBM to those situations where evidence is likely to be found. Although the impact of EBM on patient-care was limited, the concept of EBM was successfully implemented.

Bench-to-bedside review: oxygen debt and its metabolic correlates as quantifiers of the severity of hemorrhagic and post-traumatic shock.

Evidence is increasing that oxygen debt and its metabolic correlates are important quantifiers of the severity of hemorrhagic and post-traumatic shock and and may serve as useful guides in the treatment of these conditions. The aim of this review is to demonstrate the similarity between experimental oxygen debt in animals and human hemorrhage/post-traumatic conditions, and to examine metabolic oxygen debt correlates, namely base deficit and lactate, as indices of shock severity and adequacy of volume resuscitation. Relevant studies in the medical literature were identified using Medline and Cochrane Library searches. Findings in both experimental animals (dog/pig) and humans suggest that oxygen debt or its metabolic correlates may be more useful quantifiers of hemorrhagic shock than estimates of blood loss, volume replacement, blood pressure, or heart rate. This is evidenced by the oxygen debt/probability of death curves for the animals, and by the consistency of lethal dose (LD)25,50 points for base deficit across all three species. Quantifying human post-traumatic shock based on base deficit and adjusting for Glasgow Coma Scale score, prothrombin time, Injury Severity Score and age is demonstrated to be superior to anatomic injury severity alone or in combination with Trauma and Injury Severity Score. The data examined in this review indicate that estimates of oxygen debt and its metabolic correlates should be included in studies of experimental shock and in the management of patients suffering from hemorrhagic shock.

The long-distance tertiary air transfer and care of tsunami victims: injury pattern and microbiological and psychological aspects.

OBJECTIVE: On December 26, 2004, a giant earthquake shocked Southeast Asia, triggering deadly flood waves (tsunami) across the Indian Ocean. More than 310,000 people have been reported dead and millions left destitute. Shortly thereafter, European governments organized airborne home transfer of most severely injured tourists using MedEvac aircraft. On arrival, patients were distributed to various medical centers. One cohort of the severely injured was admitted to the Cologne-Merheim Medical Center (Germany) for further surgical and intensive care treatment. The objective of this report was to characterize typical injury patterns along with microbiological findings and psychoemotional aspects unique to the tsunami disaster. DESIGN: Observational study. SETTING: Adult intensive care unit of a university hospital. PATIENTS: Seventeen severely injured tsunami victims were screened on arrival for characteristic injury patterns. In parallel, multifocal microbiological assessment was performed to identify pathogens responsible for high-level wound contamination. INTERVENTIONS: Standard clinical management. MEASUREMENTS AND MAIN RESULTS: The predominant pattern of injury comprised multiple large-scale soft-tissue wounds (range, 2 x 3 to 60 x 60 cm) of lower extremities (88%), upper extremities (29%), and head (18%). Additional injuries included thoracic trauma with hemopneumothorax and serial rib fractures (41%) and peripheral bone fractures (47%). A major problem associated with wound management was significant contamination. Microbiological assessment identified a variety of common (Pseudomonas 54%, Enterobacteriae 36%, Aeromonas spp. 27%) but also uncommon isolates that were often multiply resistant (multiply resistant Acinetobacter and extended-spectrum beta-lactamase-positive Escherichia coli, 18% each). Upper respiratory tract specimens contained a high rate of multiply resistant Acinetobacter species but also methicillin-resistant Staphylococcus aureus, Aeromonas hydrophilia, Pseudomonas species, and Candida albicans. Apart from these findings, all patients displayed severe signs of posttraumatic stress response. CONCLUSIONS: Individuals who survived their initial injuries and who were evacuated to Europe had traumatic injuries to head, chest, and limbs that were often contaminated with highly resistant bacteria.

Evaluation of criteria for temporary external fixation in risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients: "evidence-based medicine" versus "reality" in the trauma registry of the German Trauma Society.

BACKGROUND: Femur-shaft fracture treatment (FSFT) follows controversial management concepts after multiple trauma: primary-definitive osteosynthesis, secondary-definitive osteosynthesis after temporary external fixation (EF) in all patients, or individualized primary- or secondary-definitive osteosynthesis ("risk-adapted damage control orthopedics"). This study compares the concepts by analyzing literature evidence and a prospective multicenter database. METHODS: A systematic literature analysis was performed. The German Trauma Society trauma registry was used to assess variables predictive of treatment concept. RESULTS: Contradictory results in 63 controlled trials failed to support a "generalized management strategy." In all, 1,465 FSFTs in 8,057 trauma registry patients (age 39 +/- 19.5 years; Injury Severity Score [ISS] 23.5 +/- 14.9; 17.3% mortality) were treated initially (<24 hour) by EF, nail, or plate in 47.0%, 41.1%, and 11.9%, respectively. Despite large interhospital variability, EF was more likely with increasing severity of ISS, Glasgow Coma Score, thorax trauma, base excess, coagulation abnormalities, and initial probability of death. CONCLUSIONS: Clinical "reality" reflects the controversies of "scientific evidence" for FSFT after multiple trauma in Germany. Although decision making is currently based on unvalidated criteria, anatomic and physiologic injury severity appears to influence the choice of management concept.

The reliability of clinical examination in detecting pelvic fractures in blunt trauma patients: a meta-analysis.

INTRODUCTION: Several studies have recently questioned whether routine radiographic screening for pelvic fractures is necessary in the initial evaluation of blunt trauma patients. Therefore, we assessed how sensitive and specific the clinical examination is in detecting fractures of the pelvis. METHODS: We extensively searched various medical databases for studies that reported on the accuracy of pelvic examination in severely injured adults or children. Individual study results were summarized in a receiver operating characteristics (ROC) curve and pooled in a meta-analysis. RESULTS: Twelve studies with a total of 5454 patients met our inclusion criteria and provided data in sufficient detail. Pooled sensitivity and specificity were 0.90 (95% confidence interval: 0.85-0.93) and 0.90 (0.84-0.94), respectively. Results were better in those studies which excluded neurologically impaired patients [e.g., Glasgow Coma Scale (GCS) <13]. Among the 49 false negative cases whose fractures went undetected on clinical examination, the majority of patients had either altered consciousness or minor pelvic fracture only. Only 3 clinically relevant pelvic fractures were missed among 441 patients with fracture within a total population of 5235 patients. CONCLUSION: In stable and alert trauma patients, a thorough clinical examination will detect pelvic fractures with nearly 100% sensitivity, thus rendering initial radiography unnecessary in this group of patients.