ANALYSIS OF SURGICAL TREATMENT EFFECTIVENESS IN BORDERLINE PATIENTS WITH UNSTABLE PELVIC TRAUMA

ANALYSIS OF SURGICAL TREATMENT EFFECTIVENESS IN BORDERLINE PATIENTS WITH UNSTABLE PELVIC TRAUMA

Gvenetadze V. V., Dulaev A. K., Samokhvalov I. M., Badalov V. I., Tsed A. N., Kazhanov I. V., Ganin V. N., Borisov M. B., Maiorov B. A.

First Saint Petersburg State Medical University named after Academician I. P. Pavlov,  Kirov Military Medical Academy, Elizabethan Hospital, Saint Petersburg, Russia,
Vsevolozhsk Clinical Interdistrict Hospital, Vsevolozhsk, Russia

Unstable pelvic injuries are high energy injuries which are often accompanied by concomitant injuries to other anatomic regions. The most severe complication in such victims is massive blood loss associated, on the one hand, with abundant blood supply to this area, and on the other hand, with large volumes of cellular spaces into which blood can flow before the bleeding stops. Such blood loss results in a whole cascade of pathological processes and life-threatening complications [1, 2].
Another important problem is the development of an excessive immune response to injury, leading to the occurrence of systemic inflammatory response syndrome (SIRS), acute lung injury (ALI), multiple organ dysfunction syndrome (MODS), subsequent immunosuppression and, as a result, infectious complications [3, 4] .
Therefore, the use of internal and external fixation of the pelvis for a patient with severe concomitant injury should result in arresting of ongoing bleeding and restoration of hemodynamic values in the first period of the traumatic process. The chosen method of fixation should be minimally traumatic to prevent the development of complications associated with an excessive immune response, but, at the same time, it should reduce the need for repeated surgical interventions and help to activate the victim more quickly [5, 19].
Currently, there are two most popular strategies for patients with polytrauma: Early Total Care (ETC), and Damage Control Orthopaedics (DCO). ETC is required to provide definitive surgical care in the acute period of injury, including osteosynthesis of bone fractures and restoration of organ integrity. Previous studies have shown that in patients with high-energy pelvic injury, ETC can reduce the length of stay in the intensive care unit (ICU), the total duration of hospitalization, and also help in the early mobilization of victims with traumatic fractures. However, in a number of studies, the use of ETC in severe combined head and chest injury was associated with an increased risk of developing SIRS, ALI, ARDS, and MODS [8, 9].
Damage Control Orthopaedics allows to solve problems of hemostasis in the shortest possible time, to stabilize bone fractures with the help of external fixation devices (EFD), and to postpone more traumatic interventions until the relative stabilization of homeostasis [10, 11]. However, according to modern ideas about the course of a traumatic disease, after a period of relative stabilization of vital functions (12-48 hours from the moment of injury), the third period begins, i.e. the maximum likelihood of complications (3-10 days), in which any surgical intervention is extremely undesirable [4]. This leads to a forced delay in the activation of the victim, creates the risk of developing complications associated with physical inactivity, and complicates care. Also, recently, many experts have questioned the reliability of the thesis that the imposition of EFD can reduce the volume of the pelvic cavity and stabilize injuries with violation of the integrity of the pelvic ring, thereby solving the issue of stopping bleeding, since EFD itself is located in front of the patient, and the instability of the pelvic ring is predominantly posterior [12].
This dichotomy creates the problem of choosing treatment strategy due to the large number of factors that surgeons must take into account at the same time, since the condition of the victim, especially those in a borderline state, can change dramatically. Therefore, Rixen et al. concluded that this ultimately leads to overuse of external fixation devices where they are not required [13].
The way out of this situation can be a symbiosis of DCO and ETC −  Early Appropriate Care (EAC). In this case, surgical treatment is carried out under constant monitoring of the condition of the patient. After submersible fixation of a fracture in one localization, it is possible to apply EFD to another anatomical region if the condition of the victim during the operation is in doubt. And it will be possible to perform the final fixation later, when the patient is stabilized, before the onset of the third period of traumatic disease [14, 15].
However, treatment strategy is the general concept that a doctor can adhere to. Despite the extreme relevance of the problem of treating severe combined pelvic injuries, there are a small number of clinical protocols and recommendations for their treatment that would make the choice of a strategy more reasonable, based on specific selection criteria, and would also be universal for most specialists and institutions [16, 18].
Concerning the current clinical protocols of treatment of patients with concomitant pelvic injury, the most common and tested protocol is the protocol of World Society of Emergency Surgery (WSES), which was published in 2017. It includes the own classification of severity of pelvic injuries, and the treatment strategy.
The WSES guidelines emphasize that the optimal treatment strategy should be determined by complex hemodynamic status, concomitant injuries, and the severity of anatomical changes. The priority criterion that determines the strategy of treatment is the stability of hemodynamics. The protocol also implements the concept of continuous monitoring of the condition of the patient with an assessment of the possibility of further treatment, that is, the key principle of EAC is used.
However, the disadvantages of the WSES protocol include the lack of integration with already existing and proven criteria and classifications of the severity of the condition, for example, a more flexible system for assessing hemodynamic stability.
To determine the most promising ways to improve existing treatment protocols, it is necessary to analyze the results of treatment of patients.
There is still a need to reach consensus on many aspects of management, especially for patients who fall into the borderline category, are in a stable condition before surgery, but whose condition may worsen during or after surgery [8].
The objective of the study was to analyze the effectiveness of early necessary and multi-stage strategy for providing surgical care in the treatment of patients with unstable pelvic injury in a borderline state, and also, based on the analysis data, to propose ways to improve the existing protocol.

DESIGN, MATERIALS AND RESEARCH METHODS

The results of treatment of patients with severe concomitant pelvic injury admitted for treatment in large multidisciplinary hospitals in St. Petersburg and the Leningrad Region from 2010 to 2020 were analyzed. Inclusion and exclusion criteria were determined to meet the objectives of the study.
Inclusion criteria: patients of any gender, age of 18-0 years; Injury Severity Score > 16 or severity of injury on Military Field Surgery-Injury score > 3; the severity of the condition is defined as borderline according to the classification of Pape et al.; type B and C fractures according to the Tile classification - AO/ASIF; all injuries correspond to degrees II-III according to the classification of pelvic injuries of the World Society for Emergency Surgery (WSES).
The exclusion criteria were the following: fractures of the acetabulum, pelvic wings and ischium; the presence of chronic diseases affecting regenerative abilities: diabetes mellitus, chronic anemia, HIV infection; severe traumatic brain injury requiring emergency surgery.
The material of the study was the data of the case histories of 165 victims who met the selection criteria. The circumstances of the injury were traffic accidents - 84 (50.9 %), falls from a height - 71 (43 %), other - 10 (6.1 %) cases.

Treatment options

Treatment according to the orthopedic damage control protocol consists of 4 stages: (1) life-saving procedures in the acute period of traumatic disease; (2) control of bleeding, temporary stabilization of fractures with external fixation, and treatment of soft tissue injuries; (3) observation in the intensive care unit; (4) definitive fixation of fractures when the patient's condition allows.
When treated according to the protocol of early appropriate surgical care, the final stabilization of pelvic injuries was performed within 24 hours after the injury. All fixation procedures were performed in minimally invasive manner using cannulated screws.
In accordance with the strategy used, 2 groups were formed. The control group consisted of patients treated with multi-stage damage control strategy - 86 cases. The study group consisted of patients who received early appropriate surgical care - 79 cases.
To form homogeneous groups, the protocol of the World Society of Emergency Surgery (WSES) was chosen as the standard algorithm for providing care to patients with pelvic trauma. All victims included in the study received assistance in accordance with the WSES protocol, without significant deviations from it.

Collection of initial data

For all patients included in this study, the database included: demographic parameters (age, gender); the nature of the injury (mechanism, type of pelvic injury); ISS; physiological parameters at admission, which were used to categorize casualties according to severity (body temperature, blood pressure, respiratory rate, heart rate); information about blood transfusion; information about the method of primary stabilization of fractures; information about the final fixation (time since injury, method); outcome indicators (length of stay in the intensive care unit, postoperative complications, including acute respiratory distress syndrome and multiple organ failure, infectious complications, hypocoagulation).
ISS was measured based on the scoring system described in the literature [20, 21]. ARDS and MODS were diagnosed according to the criteria set out in the literature [22, 23].
Patients were stratified according to treatment strategy (DCO vs. EAC), fracture type (Tile classification - AO/ASIF; unilateral or bilateral injury), body mass index (<30; 30 or more), hemodynamic parameters (systolic BP < 75 mm Hg or heart rate of 110 bpm or more, systolic blood pressure of 75 mm Hg or more, or heart rate < 110).

Statistical analysis

Statistical analysis was performed using StatPlus:mac Pro software (AnalystSoft Inc., Version 8). All quantitative variables were tested for normal distribution using the Kolmogorov-Smirnov test and presented as mean ± standard deviation. Categorical variables were expressed as numbers or percentages. The statistical significance of quantitative variables between groups was assessed using Student's t-test for independent samples. Statistical significance of categorical input variables was assessed using Pearson's chi-square test or Fisher's exact test. Pearson's correlation coefficient was used to determine the relationship between two quantitative variables. P value less than 0.05 was considered statistically significant.
The study complies with the WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, and the Rules for clinical practice in the Russian Federation confirmed by the Order of Health Ministry of RF on June 19, 2003, No. 266. All patients gave informed consent to the use of medical records in the study. The study protocol was approved by the local ethics committee.

RESULTS

Baseline patient characteristics

The study included 165 patients with high-energy concomitant pelvic injuries who met the inclusion criteria. Baseline data are presented in Table 1. Variables such as age, gender, cause of a fracture, and type of instability were comparable between the two treatment groups.

Table 1. Initial characteristics of victims

Criterion

DCO group
(n = 86)

EAC group
(n = 79)

p

Gender (male/female)

51/35

42/37

0.394

Age

34.8 ± 5.7

31.3 ± 4.9

0.257

Fracture type (closed/open)

82/4

79/0

 

Cause of fracture (traffic accident/catatrauma/other)

46/40/4

38/31/6

 

Body mass index(BMI)

31.07 ± 8.35

29.01 ± 6.98

0.192

Tile – AO/ASIF (B/C)

54/30

58/21

 

Injury severity (ISS)

20.72 ± 3.86

19.42 ± 3.18

0.301

Head injury (AIS)

0.9 ± 0.6

0.6 ± 0.5

0.035


The difference in ISS was not statistically significant (p = 0.301). The severity of head injury on AIS was slightly higher in the DCO group than in the EAC group (p = 0.035). Of the 165 victims, 114 (69.1 %) received blood transfusion. In the DCO group the transfusion volume was 990.42 ± 239.14 ml of the components, in the EAC group - 755.69 ± 192.78 ml.

Peri- and postoperative results

A statistically significant difference was found in the duration of stay in the ICU, which was 7.28 ± 4.65 days in the DCO group and 3.88 ± 2.91 days in the EAC group (p value = 0.038 and 0.047, respectively). In the DCO group, the mean waiting time between external fixation of the pelvis and subsequent definitive fixation was 9.6 ± 2.1 days (p = 0.025).
The table 3 presents the postsurgical complications. The incidence of ALI and ARDS was higher in the DCO group than in the EAC group. In the DCO group, the number of local complications significantly differed − 9 patients had inflammation in the area of transosseous elements. These problems were solved by treating wounds or removing individual rods. There were no local infectious complications in the early submerged fixation group. Mortality rate was 5 cases (5.81 %) in the DCO group and 2 cases in the EAC group (2.53 %).
When dividing the types of damages into unilateral and bilateral, a statistical difference in the amount of blood loss was noted (Table 2).

Table 2. The volume of blood loss and the need for the volume of blood transfusion

Criterion

DCO subgroup
(n = 86)

EAC  subgroup
(n = 79)

Blood loss (ml)

Unilateral damage

Bilateral damage

p

Unilateral damage

Bilateral damage

p

959.48 ± 582.07

1518.66 ± 732.97

0.0063

773.83 ± 355.80

1202.51 ± 526.49

0.0045

Hemotransfusion V (ml)

990.42 ± 239.14

755.69 ± 192.78

N of patients with hemotransfusion

63

51


Patients were also stratified by BMI (< 30; 30 or more) to assess the effectiveness of treatment in patients with different body weights. The highest indicators of the incidence of severe complications, the duration of the operation, and the volume of blood transfusion were found in the subgroup of patients with a BMI of 30 or more, treated according to EAC.
In the subgroup of early internal fixation in non-obese patients, there were no cases of multiple organ failure, deep vein thrombosis, or deaths. In patients with obesity, a lethal outcome was noted in 2 cases (7.69 %). In general, among the subgroups stratified by BMI, the subgroup of early internal fixation with the presence of obesity had the worst rates of complications. All of them are presented in table 3.

Table 3. Complication rates

Damage Control Group

Complications

N of patients

ARDS

MODS

DVT

AP < 75 mm Hg

Hypothermia

Acidosis

Blood loss (ml)  (p = 0.029)

Lethal outcome

Total

86

6 (6.98 %)

5 (5.81 %)

2 (2.33 %)

15 (17.44 %)

29 (33.72 %)

21 (24.41 %)

1320.39 ± 468.51

5 (5.81 %)

BMI

< 30

55

3 (5.45 %)

2 (3.63 %)

0 (0.00 %)

7 (12.72 %)

18 (32.72 %)

13 (23.63 %)

1091.26 ± 339.40

2 (3.63 %)

30 and more

31

3 (9.67 %)

3 (9.67 %)

2 (6.45 %)

8 (19.35 %)

11 (35.48 %)

8 (25.80 %)

1470.29 ± 588.59

3 (9.67 %)

Group of early submersible fixation

Complications

N of patients

ARDS

MODS

DVT

AP < 75 mm Hg

Hypothermia

Acidosis

Blood loss (ml)
(p = 0.008)

Lethal outcome

Total

79

3 (3.80 %)

3 (3.80 %)

0 (0.00 %)

9 (11.39 %)

17 (21.52 %)

12 (15.18 %)

951.70 ± 361.04

2 (2.53 %)

BMI

< 30

53

1 (1.88 %)

0 (0.00 %)

0 (0.00%)

5 (9.43 %)

9 (16.98 %)

7 (13.20%)

684.11 ± 308.66

0 (0.00 %)

30 and more

26

2 (7.69 %)

3 (11.53 %)

0 (0.00 %)

4 (15.38 %)

8 (30.76 %)

5 (19.23 %)

1349.20 ± 752.13

2 (7.69 %)


In addition, Pearson's correlation coefficient was calculated for body mass index and blood loss. A moderate positive correlation was found in both study groups: RDCO/BMI = 0.693, p = 0.005; REAC/BMI = 0.588, p = 0.011.
Evaluation of long-term results (after 1.5 years or more) was possible only for 38 patients (23.03 %): DCO group - 16 patients, EAC group - 22 patients. So this is not enough for reliable statistical analysis. During the survey, the return of the patients to the previous work was assessed (DCO group - 11 patients, EAC group - 19 patients), as well as the need to change the place of work due to disability (DCO group - 5, EAC group - 3), permanent disability (not revealed).

DISCUSSION

Possible Ways to Improve Treatment Protocols for Combined Pelvic Trauma

Currently, the treatment of patients with high-energy pelvic injury in a borderline state is a difficult task. The choice between DCO and ETC as the most appropriate strategy is often made based on the experience of the surgeon rather than established criteria [24].
Pelvic fractures caused by high-energy forces account for 3 to 8 % of all traumatic bone fractures. Such injuries account for about 72 % of the total number of pelvic injuries (52 % − rotationally unstable, 19.5 % − with rotational and vertical components of instability) [25]. According to the literature, mortality in high-energy associated pelvic injuries is about 10 %. Death within the first 24 hours is most often due to hemorrhagic shock caused by acute and massive blood loss, and temporary stabilization of large skeletal fractures is the top priority during the acute phase of resuscitation. It is believed that external fixation can reduce blood loss by rapidly reducing pelvic volume and providing temporary fracture stabilization. Thus, it is considered an effective approach to reduce early mortality rates associated with high-energy pelvic fractures [26].
In the current study, patients in both treatment groups had similar injury severity, although patients in the DCO group had higher head injury scores according to AIS. The patients of DCO groups had a higher transfusion volume requirement, which means that DCO using external fixation is at least not superior in blood loss control compared to EAC. This result may support the theory, at least in part, that external fixation can widen the posterior pelvic ring and exacerbate blood loss [27].
Thus, when making a decision about what damage needs to be fixed with submersible structures, and which with the help of EFD in the acute period of injury, it may be preferable to give preference to pelvic injuries, since the invasiveness of fixation with cannulated screws is comparable to the application of EFD, more effectively copes with the function of hemostasis, does not interfere with surgical interventions in other anatomical areas, and also greatly facilitates the care and early activation of the patient.
Stubig et al. in their retrospective study reported that patients with combined trauma of the femoral shaft, treated with DCO, had a longer stay in the ICU and the time spent on mechanical ventilation than those in the ETC group. The authors of the present study found that the time spent in the ICU was slightly longer for those in the DCO group than for those in the ETC group. However, this may be related to the more severe head injuries found in the DCO group [29].
One of the most important issues at the stage of admission of the patient to the anti-shock operating room is the stability of hemodynamics. It determines the sequence and scope of activities that doctors will have to perform. Most authors of practical guidelines for the treatment of concomitant trauma adhere to the established mark of 90 mm Hg as the standard.
However, there is increasing evidence that it is much more preferable if the patient with concomitant injury is in a state of controlled hypotension, when arterial systolic pressure is maintained at 75-90 mm Hg. This allows to significantly reducing the amount of blood loss and, accordingly, the amount of blood transfusion.
Duton et al. studied patients with blunt and penetrating trauma, ongoing bleeding, and SBP < 90 mm Hg at the time of admission to the anti-shock operating room. In the control group, the patients underwent aggressive fluid therapy to achieve the targeted SBP >100 mm Hg. A combination of blood components and crystalloid solutions was used. In the study group, the targeted SBP was set at > 70 mm Hg. Over the 20-month period, 110 patients were included in the study, 55 in each group. The authors did not find differences in the level of hospital mortality between groups, although the risk of complications was not assessed [29].
Schreiber M. A. et al. conducted a study of young patients (14-45 years old) with penetrating wounds who underwent laparotomy or thoracotomy to stop bleeding. Hypotensive strategy of resuscitation was implemented intraoperatively. In the study group, the targeted mean arterial pressure (MAP) for resuscitation was 50 mm Hg (LMAP). In the control group, the targeted SBP was set at around 65 mm Hg (HMAP). A total of 168 patients (86 LMAP, 82 HMAP) were included in the study. The difference in mortality in patients with hypotension was 5 %, but it was not statistically significant. Secondary complications were studied. There were no differences between the two study groups in the risk of developing acute myocardial infarction, stroke, renal failure, arterial hypotension, coagulopathy, thrombocytopenia, anemia, and infection [30].
Similar results were found in this study. In the subgroup of patients with controlled hypotension and the subgroup with blood pressure levels of 90 mm Hg and above, statistically significant differences in the volume of blood transfusion, blood loss and the risk of developing severe complications were not found. However, it should be noted that patients with systolic blood pressure below 70 mm Hg were not included in the study, which may be due to more severe injuries, the physiological state of such patients and did not allow them to pass the initial selection filter.
Another important parameter that can significantly complement the existing criteria for choosing treatment technique can be body mass index.
A study by Sems et al. included 182 patients with unstable pelvic injury. They studied the effect of BMI on the incidence of complications. Complications studied included deep and superficial infection, hardware instability, deep vein thrombosis, PE, nosocomial pneumonia, decubitus ulcers, and neurological deficit (p < 0.0001). The control group included patients with BMI < 30, the study group - with BMI > 30. In the study group, the incidence of complications was 54.2 %, in the control group - 14.9 %. The authors concluded that body weight correlates with an increase in the incidence of complications and the need for reoperations after surgical treatment of unstable pelvic injuries [31].
We analyzed the subgroups of patients according to BMI to determine the volume of blood loss, which pathogenetically may be associated with the risk of developing other complications. A positive correlation was found in both study groups. Thus, the influence of this parameter on the outcome of treatment of patients with pelvic trauma cannot be ruled out, but this assumption still requires additional research.
Concerning the clinical classification (WSES) of the protocol for the treatment of concomitant pelvic injury, it should be noted that anatomical damage is an important classification criterion. However, the use of this classification is difficult given the limited time for decision making.
Abdelrahman et al. conducted an analysis of the influence of the type of unstable injury on the risk of developing hemodynamic complications in patients with concomitant injury. The study included patients with injuries of types A, B and C according to the Tile classification - AO/ASIF. It is expected that hemodynamically unstable patients were more likely to have unstable type B and C pelvic fractures and higher rates of lung intubation, positive eFAST results, in-hospital complications, transfusion volume of blood components, as well as longer stay on mechanical ventilation, stay in ICU and inpatient care (p < 0.001) [32].
It is also obvious that, to a greater extent, the severity of the condition is affected not by the morphological nature of the fracture, but by the area of the damaged vascular bed.
We stratified the patients into the DCO and EAC groups according to the variants of anatomical changes for unilateral and bilateral injuries of the posterior semiring of the pelvis. The thesis was that bilateral injuries significantly affect the volume of blood loss due to an increase in the internal volume of the pelvis, as well as the area of damage to the vascular bed. At the same time, the time spent on stabilization of bilateral injuries increases significantly.
The main limitation of this study is its retrospective nature, which could introduce some selection bias and limit the accuracy of the analysis. The authors are currently conducting a prospective clinical study with a larger population to further evaluate the effectiveness of DCO and EAC in the treatment of patients with severe associated pelvic injury.

CONCLUSION

The concept of Damage Control Orthopedics is the gold standard for the treatment of patients with severe concomitant trauma, but the use of external fixation devices often remains unjustified. The most convenient variants of external fixation are not stable enough for the necessary fixation and compression of the posterior half-ring of the pelvis. In its turn, configuration options that allow effective stabilization of the posterior pelvis, in most cases, significantly complicate the care of the patient and his/her activation.
Therefore, the need for external fixation in case of damage to the posterior pelvis is increasingly controversial and criticized by many studies. It is likely that the use of minimally invasive fixation with cannulated screws is an effective alternative in the acute period of injury. However, the implementation of this approach is currently not possible in all institutions, since the lack of specific protocols for the treatment of combined trauma creates tactical problems for specialists.

Funding and conflict of interest information

The study was not sponsored.
The authors declare the absence of obvious and potential conflicts of interest related to the publication of this article.

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