Study design and participants
All patients with three or more rib fractures admitted to one of the two contributing hospitals between January 2014 and January 2017 were retrospectively included in this multicenter cohort study. Both hospitals are academic tertiary referral centers with a level one trauma facility of similar size. Patients were included if they fulfilled the following criteria: age 18 years and older, blunt thoracic trauma resulting in multiple rib fractures (defined as three or more rib fractures) or a flail chest (defined as three or more consecutive ribs fractured in at least two places and clinical signs of paradoxical chest wall movement), and being alive 2 days after hospital admission (mean time till surgery). Exclusion criteria were: transfer to another hospital, initial admission in another hospital, no availability of a computed tomography (CT) scan, and rib fixation more than 4 days after trauma. Patients were followed from admission until discharge or death.
Eligible patients were identified using procedural codes and the Dutch National Trauma Registry. The non-operative group was formed by all patients with rib fractures admitted to the Radboud University Medical Center where treatment consisted of adequate pain management, supportive mechanical ventilation when indicated, and physiotherapy for breathing exercises according to standard national guidelines. Per protocol every patient with three or more rib fractures was considered for epidural analgesia, if needed this was supported by patient-controlled anesthesia (intravenous opioids). Epidural therapy was provided between days 1–5 after trauma. The epidural was removed after 5 days in situ due to the considered risk for infection. The surgical group consisted of all patients who had rib fixation performed in the University Medical Center Utrecht where the same non-operative treatment guidelines were followed, but in addition, rib fixation was considered according to a clinical-based algorithm (Fig. 1). Pain was arbitrarily defined as a numerical rating scale of 5 or higher during coughing or deep inspiration and if pain was suspected not to decrease over the subsequent days with adequate pain management. It was the subjective decision of the surgeon-on-call to perform rib fixation.
This study was approved by the institutional review board of the participating centers (METC 17–544/C and 2016–2861).
Surgical procedure rib fixation
All procedures were performed by one of the even senior trauma surgeons experienced in surgical treatment of rib fractures. Rib fixation is performed in this center since 2006. Preoperative planning of the procedure was done using chest computed tomography (CT) with 3D reconstructions. Preoperative antibiotic prophylaxis (2 g of Cefazolin) was administered intravenously in all patients. Depending on the site of the fractures, patients were positioned in the supine, lateral or prone position and the surgical approach was performed as described by Taylor [15]. In the case of intercostal muscle interposition, debridement was performed. After reduction, internal fixation using the MatrixRIB™ system (Depuy Synthes®, Amersfoort, The Netherlands) was performed. Fixation was preferably done with three bicortical screws on each side of the fracture. The number of fixed ribs was at the discretion of the surgeon, and depended upon the possibility to regain stability of the chest wall during respirations. Tube thoracostomy was only performed in the case of clinical suspicion of pneumothorax during surgery. Postoperative chest radiography was performed in all patients to document surgical result and to rule out complications. Patients were allowed to perform their daily activities as soon as possible.
Baseline characteristics
Data for the following baseline characteristics were extracted from medical records: age, sex, American Society of Anesthesiologists (ASA) score, trauma mechanism, Injury Severity Score (ISS), thoracic trauma severity score (TTSS), abbreviated injury scale (AIS) head, AIS face, AIS thorax, AIS abdomen, AIS extremities, number of rib fractures, bilateral rib fractures, concomitant injuries (pulmonary contusion, pneumothorax, hemothorax, sternum fracture) as recorded on the admission CT scan, and first available blood pH and base excess; additionally, for the surgical group: duration until surgery in days, duration of surgery in minutes, and number of surgically-fixated rib fractures. The ISS is a measure (range 0–75) of the severity of traumatic injury and is calculated by adding the square of the three highest AIS scores. The AIS is a standardized anatomical-based coding system ranging from 0 to 5 to classify the severity of traumatic injury per body region. The AIS is registered in the Dutch National Trauma Registry by trained data managers based on radiology reports from admission CT scans and medical records. The TTSS is a score (range 0–25) based on number of rib fractures, pulmonary contusion, PaO2/FiO2 ratio, age, and pleural involvement, and helps to predict outcome after thoracic trauma [16,17,18]. Rib fractures, pulmonary contusion, pneumothorax, and hemothorax were assessed on the admission CT scan.
Outcome measures
In line with previous trial reports, the primary outcome measure for patients with a flail chest was intensive care unit length of stay (ILOS) and for patients with multiple rib fractures, and hospital length of stay (HLOS). For both patient groups, secondary outcome measures were duration of invasive mechanical ventilation (IMV), duration of epidural analgesia, pneumonia, need for tracheostomy and in hospital mortality. Pneumonia was defined as having clinical signs (fever, coughing, desaturation) requiring antibiotic treatment, with or without positive cultures. Additionally, we assessed in hospital complications after rib fixation.
Statistical analysis
All analyses were stratified by patient group, i.e., performed separately for patients with a flail chest and patients with multiple rib fractures. Baseline characteristics were presented as proportions for categorical variables, mean and standard deviation (SD) for normally distributed continuous variables, and median and interquartile range (IQR) for non-normally distributed continuous variables. Differences in distributions of baseline characteristics between the study groups were quantified by means of standardized differences and statistical tests (t-test for normally distributed continuous data, Mann–Whitney test for non-normally distributed data, and chi-square test for categorical data) [19].
We applied multiple imputation (25 times) to impute missing values for ASA [2.1% (7/332)], TTSS [20% (67/332)], AIS head [0.6% (2/332)], pulmonary contusion [0.6% (2/332)], pH [9.0% (30/332)], and base excess [9.0% (30/332)]. Multiple imputation was performed using the mice() algorithm in R [20].
To control for potential confounding, propensity score (PS) matching was applied. To minimize the effects of selection bias, we matched patients from the ‘operating’ center with patients from the ‘nonoperative’ center, based on all baseline characteristics. First, a PS model was fitted using logistic regression analysis, with rib fracture fixation as the dependent variable, and age, sex, ASA-score, trauma mechanism, ISS, TTSS, AIS head, AIS face, AIS thorax, AIS abdomen, AIS extremities, number of rib fractures, bilateral rib fractures, concomitant injuries, blood pH, and base excess were included as covariates in the model. We performed 2:1 nearest neighbor matching, with a maximum caliper of 0.2 of the standard deviation of the logit of the PS using the Matchit() algorithm in R [21]. After matching, the balance in the distributions of baseline characteristics between the study groups was quantified using standardized differences, where a standardized difference < 0.1 is generally accepted as indicating fair balance of confounders between the matched treatment groups (i.e., successful matching) [19].
In the primary analysis, for patients with a flail chest, we estimated the relation between rib fracture fixation and ILOS by means of linear regression analysis. For patients with multiple rib fractures, we estimated the relation between rib fracture fixation and HLOS by means of linear regression analysis. Secondary analyses focused on the relation of rib fracture fixation with duration of IMV and duration of epidural analgesia using linear regression analysis. The relation between rib fixation, pneumonia, tracheostomy, and in hospital mortality was assessed by means of a logistic regression analysis.
A two-tailed p value less than 0.05 was considered significant. All analyses were performed using R v3.4.1 [22].