6
Borderline femur fracture patients: early total care or damage control orthopaedics?Ben Nicholas, Laszlo Toth, Karlijn van Wessem, Julie Evans, Natalie Enninghorst and Zsolt J. Balogh Department of Traumatology, John Hunter Hospital and University of Newcastle, Newcastle, New South Wales, Australia Key words damage control, damage control orthopaedics, early total care, external fixation, femur, intramedullary nailing. Correspondence Professor Zsolt J. Balogh, Department of Traumatology, Division of Surgery, John Hunter Hospital and University of Newcastle, Locked bag 1, Hunter Regional Mail Centre, NSW 2300, Australia. Email: [email protected] B. Nicholas MD; L. Toth MD; K. van Wessem MD; J. Evans RN; N. Enninghorst MD; Z. J. Balogh MD, PhD, FRACS(ortho). The authors received no financial support for this manuscript. The authors have no conflicts of interests to declare. Accepted for publication 10 June 2010. doi: 10.1111/j.1445-2197.2010.05582.x Abstract Background: A recent randomized controlled trial (RCT) favours damage control orthopaedics (DCO) over early total care (ETC) in the management of high-energy femoral shaft fracture (FSF) patients with borderline physiology. The purpose of this study was to compare the borderline physiology FSF demographics, management and outcomes of a Level-1 trauma centre, John Hunter Hospital (JHH) with those of the RCT. Methods: A 41-month study of the prospective FSF database was performed. FSF patients were categorized according to the Pape system. Stable (JHH-S) and borderline (JHH-BL) patients’ demographics, injury severity, methods of treatment and outcomes were compared with the corresponding groups of the RCT (RCT-S and RCT-BL). Results: Sixty-six patients met the inclusion criteria of which 45 (68%) were in JHH-S and 21 (32%) were in JHH-BL group. In comparison, there were 121 (73%) RCT-S and 44 (28%) RCT-BLpatients in the RCT study population. The demograph- ics and injury severity were similar in the borderline groups, while JHH-S patients were less severely injured. DCO was utilized more frequently in the RCT in both the stable group (JHH-S: 2% versus RCT-S: 41%), and the borderline group (JHH-BL: 14% versus RCT-BL: 48%). The outcomes between the JHH-S and RCT-S groups were comparable, except for intensive care unit (ICU) hours (JHH-S: 20 64 versus RCT-S: 165 187, P < 0.0001) and ventilator hours (JHH-S: 13 46 versus RCT-S: 98 120, P < 0.0001). Among borderline patients, JHH-BL had a tendency to show a lower incidence of both acute respiratory distress syndrome (0% versus 14%) and multiple organ failure (4.8% versus 19.6%). JHH-BL patients had sepsis less fre- quently (4.8% versus 24.5%, P < 0.05), fewer ICU hours (98 129 versus 436 347, P < 0.0001) and fewer ventilator hours (82 119 versus 337 305, P = 0.0005) compared with the RCT-BL. Conclusions: The incidence of S and BL patients, demographics and injury severity (among BL patients) is comparable with the RCT. Our current practice of employing predominantly ETC among S (98%) and BL (86%) patients results in shorter ICU and ventilator days, fewer septic complications and a potentially lower incidence of organ failure than in the RCT which had 57% overall utilization of ETC. Introduction The fixation of femoral shaft fractures (FSF) in polytrauma patients remains a controversial subject. 1 Historically the timing of definitive fixation has ranged from traction with delayed fixation 2 to early total care (ETC), 3,4 and more recently damage control orthopaedics (DCO). 5,6 Evidence put forward in the 1980s supported a move away from traction and bed rest towards ETC, citing a reduction in the rates of pulmonary complications, hospital and intensive care unit (ICU) stays. 7 In the 1990s, the universal approach to ETC was challenged 8 as it was realized that providing definitive fixation of FSF with intramedullary nailing had detrimental physiologic effects on the already compromised polytrauma patient. 9 The instrumenta- tion of the medullary canal with reaming and nail insertion became known as a modifiable ‘second hit’ in the development of post injury complications such as acute lung injury (ALI), acute respiratory ORIGINAL ARTICLE ANZJSurg.com © 2010 The Authors ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons ANZ J Surg 81 (2011) 148–153

Borderline femur fracture patients: early total care or damage control orthopaedics?

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Page 1: Borderline femur fracture patients: early total care or damage control orthopaedics?

Borderline femur fracture patients: early total care or damage

control orthopaedics?ans_5582 148..153

Ben Nicholas, Laszlo Toth, Karlijn van Wessem, Julie Evans, Natalie Enninghorst and Zsolt J. BaloghDepartment of Traumatology, John Hunter Hospital and University of Newcastle, Newcastle, New South Wales, Australia

Key words

damage control, damage control orthopaedics, earlytotal care, external fixation, femur, intramedullarynailing.

Correspondence

Professor Zsolt J. Balogh, Department of Traumatology,Division of Surgery, John Hunter Hospital and Universityof Newcastle, Locked bag 1, Hunter Regional MailCentre, NSW 2300, Australia. Email:[email protected]

B. Nicholas MD; L. Toth MD; K. van Wessem MD;J. Evans RN; N. Enninghorst MD; Z. J. Balogh MD,PhD, FRACS(ortho).

The authors received no financial support for thismanuscript. The authors have no conflicts of intereststo declare.

Accepted for publication 10 June 2010.

doi: 10.1111/j.1445-2197.2010.05582.x

Abstract

Background: A recent randomized controlled trial (RCT) favours damage controlorthopaedics (DCO) over early total care (ETC) in the management of high-energyfemoral shaft fracture (FSF) patients with borderline physiology. The purpose of thisstudy was to compare the borderline physiology FSF demographics, management andoutcomes of a Level-1 trauma centre, John Hunter Hospital (JHH) with those of theRCT.Methods: A 41-month study of the prospective FSF database was performed. FSFpatients were categorized according to the Pape system. Stable (JHH-S) and borderline(JHH-BL) patients’ demographics, injury severity, methods of treatment and outcomeswere compared with the corresponding groups of the RCT (RCT-S and RCT-BL).Results: Sixty-six patients met the inclusion criteria of which 45 (68%) were inJHH-S and 21 (32%) were in JHH-BL group. In comparison, there were 121 (73%)RCT-S and 44 (28%) RCT-BL patients in the RCT study population. The demograph-ics and injury severity were similar in the borderline groups, while JHH-S patientswere less severely injured. DCO was utilized more frequently in the RCT in both thestable group (JHH-S: 2% versus RCT-S: 41%), and the borderline group (JHH-BL:14% versus RCT-BL: 48%). The outcomes between the JHH-S and RCT-S groupswere comparable, except for intensive care unit (ICU) hours (JHH-S: 20 � 64 versusRCT-S: 165 � 187, P < 0.0001) and ventilator hours (JHH-S: 13 � 46 versus RCT-S:98 � 120, P < 0.0001). Among borderline patients, JHH-BL had a tendency to showa lower incidence of both acute respiratory distress syndrome (0% versus 14%) andmultiple organ failure (4.8% versus 19.6%). JHH-BL patients had sepsis less fre-quently (4.8% versus 24.5%, P < 0.05), fewer ICU hours (98 � 129 versus 436 � 347,P < 0.0001) and fewer ventilator hours (82 � 119 versus 337 � 305, P = 0.0005)compared with the RCT-BL.Conclusions: The incidence of S and BL patients, demographics and injury severity(among BL patients) is comparable with the RCT. Our current practice of employingpredominantly ETC among S (98%) and BL (86%) patients results in shorter ICU andventilator days, fewer septic complications and a potentially lower incidence of organfailure than in the RCT which had 57% overall utilization of ETC.

Introduction

The fixation of femoral shaft fractures (FSF) in polytrauma patientsremains a controversial subject.1 Historically the timing of definitivefixation has ranged from traction with delayed fixation2 to earlytotal care (ETC),3,4 and more recently damage control orthopaedics(DCO).5,6 Evidence put forward in the 1980s supported a move awayfrom traction and bed rest towards ETC, citing a reduction in the

rates of pulmonary complications, hospital and intensive care unit(ICU) stays.7 In the 1990s, the universal approach to ETC waschallenged8 as it was realized that providing definitive fixation ofFSF with intramedullary nailing had detrimental physiologic effectson the already compromised polytrauma patient.9 The instrumenta-tion of the medullary canal with reaming and nail insertion becameknown as a modifiable ‘second hit’ in the development of post injurycomplications such as acute lung injury (ALI), acute respiratory

ORIGINAL ARTICLEANZJSurg.com

© 2010 The AuthorsANZ Journal of Surgery © 2010 Royal Australasian College of SurgeonsANZ J Surg 81 (2011) 148–153

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distress syndrome (ARDS) and multiple organ failure (MOF). DCOwas adapted from the successful implementation of damage controlsurgery used in the treatment of exsanguinating torso traumapatients.10 The principle is to provide adequate skeletal stability onlong bones to prevent further bleeding, soft tissue damage, potentialfat embolism and to permit better positioning for the patient in theICU without the potential adverse effects of early definitive fixa-tion.6,11 This abbreviated procedure (usually external fixation) allowsthe patients to recover from the initial hit of severe trauma andoptimizes their condition for later definitive fixation (usuallyintramedullary nailing).12 The current literature is equivocal aboutthe DCO versus ETC concept.13 A recent randomized control trial(RCT) by Pape et al. concluded that the ‘borderline’ group ofpatients has significantly less incidence of ALI when treated usingDCO principles.5

The purpose of this study was to evaluate the demographics,management and outcomes of the high energy, polytrauma FSFpatients of our Level-1 trauma centre in comparison with those ofthe RCT.

Methods

Setting, inclusion and exclusion criteria

A 41-month retrospective study of the specific prospective databases(long bone fracture database, MOF database and trauma registry)was performed from 1 January 2005 to 31 May 2008. The study wasobservational only and the Hunter New England Area Health ServiceEthics Committee provided a waiver for this research and publica-tion. The study was conducted at the John Hunter Hospital (JHH), aLevel-1, university-affiliated trauma centre. JHH covers a catchmentarea of 140 000 km and has a population upward of 900 000. It is thebusiest trauma centre in the state averaging 4500 trauma admissionseach year including 420 admissions with an Injury Severity Score(ISS) of greater then 15.

To ensure comparability with the RCT, identical inclusion andexclusion criteria were adopted. The inclusion criteria consisted ofhigh energy, polytrauma patients with a New Injury Severity Score(NISS)14 of greater than 16. Patients included had a FSF (classifiedas 3–2 using the Arbeitsgemeinschaft fuer Osteosynthesefragen(AO)/Orthopaedic Trauma Association (OTA) classification sys-tem),15 ideally treated with intramedullary nail. Patients youngerthan 16 years of age, with chest abbreviated injury scale (AIS)16

score � 4, and patients in ‘unstable’ or ‘in extremis’ condition (Papeclassification)2,17 were excluded from the study.

Data collection, collected variables

As a state-designated and Royal Australasian College of Surgeons-verified Level-1 Trauma Centre, JHH currently maintains a pro-spective trauma registry. Apart from the trauma registry, the JHHTraumatology Research Centre has maintained prospective regis-tries of some focused areas of its research interests since 2005. Thesedatabases (long bone fracture classification database, a femur frac-ture database and MOF), which are relevant to this study, are basedon prospective clinical data collection by senior research nurses anddoctors committed to the specific research task. Focused chart

review was performed to address potential missing data. From thesesources, the following parameters were collected: demographics(name, sex, age); injury pattern (mechanism, energy, fracture site);injury severity (Glasgow coma scale, ISS, NISS, AIS scores); physi-ological parameters, which on admission, were used for patientclassification and were not reported separately in the results (hae-moglobin, neutrophil count, platelets, prothrombin time (PT), acti-vated partial thromboplastin time (APTT), pH, base excess, lactate,PaO2, FiO2, heart rate, blood pressure, respiratory rate); initial treat-ment details (blood transfused within the first 24 h, primary fixationmethod, date of operation, time of operation, length of operation);definitive fixation details (date, method); and outcome measures(ICU length of stay, ventilator time, pneumonia, ALI, ARDS, MOF,sepsis, systemic inflammatory response syndrome (SIRS)). All out-comes were defined according to definitions used in the RCT.5

Treatment of femur fractures

The JHH (level-1 trauma centre) is supported by an orthopaedicservice of eight experienced general orthopaedic surgeons (includ-ing one orthopaedic trauma specialist). During the entire studyperiod, the decision on the fixation method was at the discretion ofthe attending orthopaedic surgeon with or without consultation withthe trauma specialist. All intramedullary nails were performed afterreaming with anterograde or retrograde nail insertion and bothproximal and distal locking. External fixation was performed usinga unilateral frame with two or three pins in both main fragments ofthe broken femur.

Classification of patient subgroups

Patients were classified into one of four groups – stable, borderline,unstable and in-extremis in accordance with criteria developedduring several previous studies by the co-authors of the RCT.17,18 Theclassification system is based on clinical parameters in four separatecategories: shock, coagulopathy, hypothermia and soft tissue inju-ries. Patients are allocated to a group if they satisfy the equivalent ofthree out of the four categories. For further analysis, only the stable(JHH-S) and borderline (JHH-BL) patients were considered giventhat these groups were the focus of the RCT (RCT stable (RCT-S)and RCT borderline (RCT-BL)). Demographics, injury pattern,surgical approach (DCO or ETC) and outcomes were comparedbetween the relevant groups of the JHH and the RCT.

Data are presented as mean � standard deviation or percentages.Statistical analysis was performed by using Fisher’s exact testfor continuous variables and Chi-squared tests for categorical data.Statistical significance was considered at P < 0.05.

Results

During the 41-month study period, a total of 66 high-energy mid-shaft femur fractures, which satisfied the inclusion/exclusion criteriaof the study, were prospectively identified from the trauma data-bases. The RCT enrolled 165 patients from 10 centres during 74months. The mean age of the JHH patients was 33.6 � 17.4 yearsand they were predominantly male (77%) which is comparable withthe RCT with an average age of 32.6 � 11.7 years and 80.0% males.The mean NISS was 26.0 � 8.1 in the JHH group and 29.0 � 9.7 in

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the RCT. The mechanism of injury in the JHH group was a motorvehicle accident in 56%, a motorcycle accident in 33%, a pedestrianaccident in 6%, a bicycle accident in 3% and a fall in 1% of cases.The RCT reported a motor vehicle accident in 70.3% of cases amotorcycle accident in 18.8%, a pedestrian accident in 6.1%, asuicide attempt in 2.4% and a fall in 2.4%. Similar to the RCT all 66JHH patients survived until hospital discharge.

Stable patients

According to the classification system, 68.2% (45/66) of patientsidentified were found to be in a stable condition (JHH-S). The RCThad 73.33% (121/165) stable patients. Table 1 presents the demo-graphics and injury severity, injury patterns and the first 24-h trans-fusions of the JHH-S and RCT-S patients. The average age andgender distribution were similar in both stable groups. The JHH-Spatients had markedly lower ISS (15 � 5 versus 24 � 8, P < 0.0001)and slightly lower NISS (24 � 6 versus 27 � 9, P = 0.04) than theRCT-S patients. The AIS scores were similar in all regions excludingthe chest and abdomen, where the JHH-S group scored chest 0.6 �

1.1 and abdomen 0.1 � 0.2 compared with the RCT-S with chest1.75 � 1.58 and abdomen 1.01 � 1.45 (both P < 0.0001). The shockparameters were not presented in the RCT. The JHH-S patients hadmild metabolic acidosis (base deficit (BD) -2.1 � 2.1, lactate 2.1 �

1.0). A higher proportion of the JHH stable patients (40%) receivedblood transfusion within the first 24 h of presentation to the hospital,compared with 23% in the RCT (P = 0.026).

Table 2 shows treatment modalities and clinical outcomes com-paring the JHH-S and RCT-S groups. Two percent of the JHH-Spatients were treated using DCO compared with 41% in the RCT-Sgroup. No patients in either stable group developed MOF. There wasa tendency towards better outcomes among the JHH-S patients butthe incidence of ALI, ARDS and sepsis were not statistically differ-ent. The JHH-S patients had a significantly lower incidence of SIRS(15.56% versus 30.6%, P = 0.037). There was a notable differencebetween the two groups in ICU length of stay (20 � 64 h versus165 � 187 h, P < 0.0001) and ventilator times (13 � 46 h versus98 � 120 h, P < 0.0001) favouring the JHH-S group.

Borderline patients

Twenty-one patients out of the 66 (31.8%) high-energy FSF patientswere classified as borderline (JHH-BL). The RCT had 26.66% (44/165) borderline patients (RCT-BL). The demographics, injury sever-ity data and transfusion data of the borderline patients are presentedin Table 3. The two groups were remarkably similar. There wasno statistical difference in average age, gender, ISS, NISS, all AISregion scores and first 24 h transfusion requirements between theJHH-BL and RCT-BL patients. The JHH-BL patients had moderatemetabolic acidosis (BD -5.0 � 3.0, lactate 3.8 � 2.1).

The treatment modalities and clinical outcomes of the borderlinegroups are presented in Table 4. Only 14% of the JHH-BL patientswere treated with DCO principles, while by definition, almost half(47.7%) of the RCT-BL patients received DCO treatment. JHH-BLpatients had a similar incidence of ALI (38% versus 35%) and SIRS(57.1% versus 51.4%). There was an obvious trend towards lowerincidence of ARDS (0% versus 14%) and MOF (4.8% versus 19.6%)favouring the JHH-BL group but neither reached statistical signi-ficance (P = 0.08 and P = 0.09, respectively). The incidence of sepsiswas significantly higher (4.8% versus 24.5%, P = 0.04) amongRCT-BL patients. The major statistical differences between the

Table 1 Demographics, injury severity and transfusion requirements ofthe stable patients

JHH-S RCT-S P valuen = 45 n = 121

Age (yrs) 35 � 18 33 � 12 0.2171Male % 78% 80% 0.829ISS 15 � 5 24 � 8 <0.0001NISS 24 � 6 27 � 9 0.0401AIS Head 1.0 � 1.2 1.23 � 1.35 0.3166AIS Face 0.4 � 0.7 0.4 � 0.9 1AIS Chest 0.6 � 1.1 1.75 � 1.58 <0.0001AIS Abdomen 0.1 � 0.2 1.01 � 1.45 <0.0001AIS Extremities 3.1 � 0.3 3.26 � 0.66 0.1195AIS External 0.2 � 0.5 0.35 � 0.70 0.1897PBRC first 24 h 40% 23% 0.0265

JHH-S, stable patients of the John Hunter Hospital; RCT-S, stable patients ofthe randomized control trial; ISS, Injury Severity Score; NISS, New InjurySeverity Score; AIS, Abbreviated Injury Scale; PRBC, packed red blood cells;BD, base deficit.

Table 2 Treatment method and outcomes of the stable patients

JHH-S RCT-S P valuen = 45 n = 121

DCO (%) 2% 41% <0.0001ALI (%) 8.89% 19.20% 0.0871ARDS (%) 0.00% 7.60% 0.0534MOF (%) 0.00% 0% 1Sepsis (%) 2.22% 8.60% 0.148SIRS (%) 15.56% 30.60% 0.0367ICU stay (hrs) 20 � 64 165 � 187 <0.0001Ventilator hours 13 � 46 98 � 120 <0.0001

JHH-S, stable patients of the John Hunter Hospital; RCT-S, stable patients ofthe randomized control trial; DCO, damage control orthopaedics; ALI, acutelung injury; ARDS, acute respiratory distress syndrome; MOF, multiple organfailure; SIRS, systemic inflammatory response syndrome; ICU, intensive careunit

Table 3 Demographics, injury severity and transfusion requirements ofthe borderline patients

JHH-BL RCT-BL P valuesn = 21 n = 44

Age (yrs) 30 � 15 33 � 12 0.3886Male (%) 76% 80% 0.7565ISS 27 � 9 32 � 11 0.0748NISS 31 � 10 35 � 10 0.1365AIS Head 2.24 � 1.86 1.86 � 1.73 0.4219AIS Face 0.95 � 1.20 0.52 � 1.07 0.1502AIS Chest 2.20 � 1.29 2.75 � 1.59 0.1721AIS Abdomen 0.71 � 1.23 1.07 � 1.63 0.3736AIS Extremities 3.10 � 0.45 3.30 � 0.76 0.2697AIS External 0.1 � 0.22 0.34 � 0.75 0.1571PBRC first 24 h 71% 50% 0.0854

JHH-BL, borderline patients of the John Hunter Hospital; RCT-BL, borderlinepatients of the randomized control trial; ISS, injury severity score, NISS: newinjury severity score, AIS: abbrevi ated injury scale, PRBC: packed red bloodcells, BD: Base deficit.

150 Nicholas et al.

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groups were in shorter ICU stay (98 � 129 h versus 436 � 347 h,P < 0.0001) and fewer ventilator hours (82 � 119 h versus337 � 305 h, P = 0.0005), favouring the JHH-BL patients.

Discussion

The obvious advantages of early definitive fixation of long bonefractures are faster recovery, shorter hospitalization and less sys-temic complications.7 Based on retrospective studies and compari-son with historic cohorts, European traumatologists managed toshow that the universal application of ETC to femur fractures cancause adverse outcomes among polytrauma patients.18 Damagecontrol approach to polytrauma patients’ FSF fixation was uniformlyaccepted in the German-speaking parts of Europe and CentralEuropean countries with Traumatology training.19 A series of studiesprovided progressively better levels of evidence on the DCOconcept,19–21 but the ideology did not gain widespread acceptance onother continents, especially in North America.22 Most of the trauma-tologists and orthopaedic surgeons agree that the most criticalgroups (‘unstable’ and ‘extremis’ based on Pape classification)benefit from DCO and the ‘stable’ patients are candidates for ETC.12

Robust clinical and basic science data shows that intramedullarynailing of the femur has major immunological consequences, whichis a preventable second hit in the development of post injurycomplications.9,23–25 There is clinical evidence which shows that theeffects of intramedullary nailing are not clinically significant enoughto cause major pulmonary complications.13

One of the frequently debated topics among trauma experts is theapplicability of DCO to patients with ‘borderline’ physiology.Unfortunately, in the orthopaedic trauma literature, there is an overemphasis on the severity of the anatomic injury rather than on thepatient’s acute physiology, which should be the main factor to con-sider when deciding between DCO and ETC. The European Poly-trauma Study on Management of Femur Fractures aimed to clarifythe situation with a prospective, randomized interventional trialcarried out in 10 level-1 trauma centres.5 The study illustrated theclear advantage of ETC among stable patients in terms of shorterICU stay and less time on the ventilator. Despite randomization,there was a tendency to perform more intramedullary nails thanexternal fixation (94 versus 71). In the borderline group, the authors

found that ETC patients had higher incidence of ALI and concludedthat ‘in borderline patients, an external fixateur should be applied fortemporizing purposes’.

JHH’s specific prospective databases made it possible to evalu-ate the local practice compared with the findings of the currentlyhighest level of evidence on borderline FSF patients. Our traumacentre can be considered a high-volume centre for FSF; with iden-tical inclusion and exclusion criteria, the JHH had 66 consecutiveeligible patients during 41 months while the RCT had 165 patientsduring 74 months in 10 centres. Both studies had very similarratios of stable/borderline patients and surprisingly, similar age andgender distribution. The reason for lower ISS and NISS in theJHH-S group was due to the lower AIS scores in the chest andabdominal regions. There were no inclusion criteria in the RCTspecifying chest and abdominal injuries, but it can represent aselection bias of patients in the RCT while in our database con-secutive patients were entered. The injury severity scores in theborderline group (which is the main focus of this paper) were notdifferent. The JHH-S group’s care was in accordance with theRCT’s recommended ETC approach (98% of the cases). Regard-less of the significantly higher percentage of patients who requiredtransfusions during the first 24 h (likely due to more operativeblood loss) JHH-S patients had a lower incidence of SIRS andtrends towards less ALI/ARDS. Measures of resource utilization(ICU and ventilator hours) were clearly superior in the JHH-Sgroup compared with the RCT-S group (P < 0.0001). This is anexpected finding because the randomization process prevented theRCT-S patients from having similar good outcomes with ETC,which was not the case in our non-interventional study. The mainfinding of our study is that the JHH practice of borderline FSFmanagement is very distinct from the one recommended by theRCT. In the JHH-BL group 86% of FSF patients were managedwith ETC (reamed intramedullary nailing). Based on the conclu-sion of the RCT, adverse outcomes could be expected given themajor deviation from its recommended practice. Our resultsshowed the opposite. Highly comparable groups of borderline FSFpatients with primarily ETC management had a similar incidenceof pronounced acute inflammatory response (ALI, SIRS) withoutprogression to more relevant clinical syndromes such as ARDSand MOF. RCT-BL patients had a significantly higher (five-fold)incidence of sepsis. This may partly explain why with only 52%utilization of ETC the RCT-BL patients had more than four timeslonger ICU stay and ventilator hours. This enormous differenceshould be considered in clinical decision-making even with thepotential flaws of our study design.

Both of our study groups had higher 24-h transfusion require-ments, which only reached significance in the JHH-S versus RCT-Scomparison. ETC utilizing reamed femoral nailing technique cancause more blood loss during surgery than DCO utilizing externalfixateur. The frequently described adverse effects of increased earlytransfusion after trauma (SIRS, ALI, ARDS and MOF) did noteventuate in our study population. Surprisingly, our patients had lessSIRS in the stable group and less sepsis in the borderline group asboth of these outcomes are often shown as consequences of bloodtransfusion. The RCT published only the first 24 h transfusion data;it is unknown how often their DCO patients get transfused at the

Table 4 Treatment method and outcomes of the borderline patients

JHH-BL RCT-BL P valuesn = 21 n = 44

DCO (%) 14% 47.70% 0.008ALI (%) 38.10% 35.40% 0.5519ARDS (%) 0.00% 14.00% 0.0855MOF (%) 4.80% 19.60% 0.097Sepsis (%) 4.80% 24.50% 0.0452SIRS% 57.10% 51.40% 0.4603ICU stay (hrs) 98 � 129 436 � 347 <0.0001Ventilator hours 82 � 119 337 � 305 0.0005

JHH-BL, borderline patients of the John Hunter Hospital; RCT-BL: borderlinepatients of the randomized control trial; DCO, damage control orthopaedics;ALI, acute lung injury; ARDS, acute respiratory distress syndrome; MOF,multiple organ failure; SIRS, systemic inflammatory response syndrome; ICU:intensive care unit.

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time of the definitive fixation. In our cohort, the transfusion require-ment after the first 24 h was negligible.

There are several limitations of our study. First is the retrospectivesingle-centre nature of the study design, even though the quality ofthe data is believed to be superior to retrospective trauma registry-based studies because the availability of focused prospective data-bases in our institution (femur shaft fractures, long bone fracture andMOF databases). Our shorter and more recent study time frameeliminated the potential bias of the different treatment strategies(ventilator management, fluid resuscitation, orthopaedic equip-ment), which are due to rapidly evolving medical science.26–29 TheJHH orthopaedic trauma volume made it possible to get a compa-rable number of borderline patients during a shorter timeframe. Thesecond limitation is the fact that statistical comparison between theJHH and the RCT results has obviously occurred without the accessto the RCT’s raw data; all calculations were based on the publishedmeans, standard deviations and the number of subjects. This limi-tation is addressed by identical inclusion/exclusion criteria, a verycomparable borderline population and highly significant differencesin outcomes (ICU and ventilator times).

While the reason for the better outcomes in the stable groups(JHH-S versus RCT-S) is obvious, in the borderline groups it is moredifficult to explain. SIRS and ALI were used as outcomes in the RCTbut we do not consider them as adverse outcomes, rather an essentialresponse to trauma and major surgery. JHH-BL and RCT-BL groupshad similar incidence of ALI and SIRS, JHH-BL patients had atendency to receive more blood but fewer JHH-BL patients pro-gressed to ARDS, sepsis or MOF. We believe that in the context ofprecise inclusion and exclusion criteria, the application of identicalpatient classification system and definitions of outcomes, ourfindings can have a significant impact on the management of FSFpatients with borderline physiology. The applicability of DCO toborderline trauma patients should be periodically reassessed as thecare of the injured patient gradually changes/improves. The currentincidence of ARDS and MOF and the severity of these complica-tions are significantly lower than was the case 15 years ago when theDCO concept began to gain popularity.30 A recent prospective epi-demiological study of post injury MOF showed that the incidenceand severity of the syndrome at JHH is following internationaltrends.31 Lung protective ventilation,29 haemostatic resuscitation,26–28

tight glucose control,32 adrenal replacement therapy,33 betterintramedullary reamers34 are all potential confounders of theimproved outcome. In the context of modern resuscitation strategiesand critical care in our center ETC seems to be a safe and efficientoption to manage multiply injured FSF patients with stable andborderline physiology. Based on our current results and the overallimprovement in critical care, we believe that damage control ortho-paedics is overused in many centres which are following the indica-tions established during the early 1990s.

In conclusion, the reported experience with a cohort of FSFpatients with borderline physiology is in addition to the controversyof a DCO approach in the borderline patient group. Our currentpractice of 86% utilization of ETC among borderline patients resultsin a similar acute phase response (ALI and SIRS) but potentially lesscomplications (ARDS, sepsis, MOF) and major reduction of ICUstay compared with the current best evidence provided by an RCT

with only 52% utilization of ETC. Based on these results, our traumacentre will not implement the recommendations of the RCT to useprimary external fixateur in borderline patients and perform laterintramedullary nailing. The applicability of ETC to borderline FSFpatients warrants larger scale reassessment.

Acknowledgement

The authors thank Helen Thursby for reviewing the manuscript.

References1. Scalea TM. Optimal timing of fracture fixation: have we learned any-

thing in the past 20 years? J. Trauma 2008; 65: 253–60.2. Pape H-C, Giannoudis P, Krettek C. The timing of fracture treatment in

polytrauma patients – relevance of damage control orthopaedic surgery.Am. J. Surg. 2002; 183: 622–9.

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