RANDOMIZED CONTROLLED TRIAL OF SURGICAL RIB FIXATION TO NON-OPERATIVE MANAGEMENT IN SEVERE CHEST WALL INJURY
David Meyer*1, John Harvin1, Laura Vincent2, Kandice Motley2, Michael Wandling1, Thaddeus Puzio1, Laura Moore1, Bryan A. Cotton1, Charles Wade2, Lillian Kao1
1Surgery, McGovern Medical School at UTHealth, Houston, TX; 2Center for Translational Injury Research, McGovern Medical School at UTHealth, Houston, TX
OBJECTIVE: Surgical stabilization of rib fractures (SSRF) has been shown to improve outcomes in patients with clinical flail chest and respiratory failure. However, the effect of SSRF on clinical and patient-reported outcomes in severe chest wall injuries without clinical flail chest is unknown. METHODS: Randomized controlled trial comparing the effectiveness of SSRF to non-operative management in blunt trauma patients with a severe chest wall injury, defined as: 1) a radiographic flail segment without clinical flail, or 2) five or more consecutive rib fractures, or 3) any rib fracture with bicortical displacement. Randomization was stratified by unit of admission as a proxy for injury severity. Primary outcome was hospital length of stay (LOS). Secondary outcomes included intensive care unit (ICU) LOS, ventilator days, mortality, and the 30-day incidences of pneumonia, tracheostomy, surgical drainage of retained hemothorax, regional analgesia for refractory pain, and opioid prescription at discharge. Quality of life (QoL) at 1 month was measured using the EuroQOL-5D-5L survey. Frequentist and Bayesian generalized linear models were used to compare outcomes. RESULTS: Eighty-four patients were randomized in an intention-to-treat analysis (Usual Care=42, SSRF=42). Age, gender, mechanism, injury severity, and allocation unit were similar between groups. The numbers of total fractures (7 [6-10] vs 8 [7-10]), displaced fractures (2 [0-2] vs 1 [0-2]), and segmental fractures (2 [0-4] vs 1 [0-4]) per patient were also similar, as were the incidences of displaced fractures (25 [60%] vs 24 [57%]) and radiographic flail segments (17 [40%] vs 15 [36%]). Hospital LOS was greater in the SSRF group. ICU LOS and ventilator days were similar (TABLE). Relative risk adjusted for the stratification variable also showed greater hospital LOS in the SSRF group (RR 1.48, 95%CI 1.17-1.88). ICU LOS (RR 1.65, 95%CI 0.94-2.92) and ventilator days (RR 1.49, 95%CI 0.61-3.69) were similar. Tests for interaction in a priori subgroups showed that patients with displaced fractures were more likely to have LOS outcomes similar to their Usual Care counterparts. This benefit was not observed in patients with radiographic flails segments. At 1 month, SSRF patients had greater impairment in the Mobility (3 [2-3] vs 2 [1-2], p=0.012) and Self Care (2 [1-2] vs 2 [2-3], p=0.034) dimensions of the EQ-5D-5L. Usual Activities, Pain, and Anxiety scores were similar, as were Index and Visual Analog Scores. The percentage of patients in each treatment group with no or minor impairment (scores of 1-2) are compared to those with moderate, severe, or extreme impairment (scores of 3-5) in the FIGURE. CONCLUSION: In severe chest wall injury, even in the absence of clinical flail chest, the majority of patients still reported moderate to extreme pain and impairment of usual physical activity at one month. SSRF increased hospital stay and did not provide any short-term QoL benefit at 1 month.
TABLE. Hospital Outcomes by Treatment Group
| Usual Care (n = 42) | SSRF (n = 42) | p value | |
| Regional analgesia for refractory pain | 3 (7%) | 7 (17%) | 0.312 |
| Surgical drainage of retained hemothorax | 2 (5%) | 5 (12%) | 0.430 |
| Tracheostomy | 2 (5%) | 7 (17%) | 0.158 |
| Hospital days | 9.9 (9.8) | 14.5 (10.7) | 0.046 |
| Hospital-free days (up to 30 days) | 24 (19-27) | 21 (10-24) | 0.005 |
| ICU days | 0 (0, 1) | 0 (0, 10) | 0.410 |
| ICU-free days (up to 30 days) | 30 (29-30) | 30 (20-30) | 0.416 |
| Ventilator days | 0 (0-0) | 0 (0-1) | 0.264 |
| Tramadol prescription at discharge | 24 (60%) | 22 (53%) | 0.637 |
| Opioid prescription at discharge | 4 (10%) | 3 (7%) | 0.946 |
| Discharge to home | 34 (81%) | 33 (79%) | 1.000 |
| Deep vein thrombosis | 0 (0%) | 1 (2%) | 1.000 |
| Pulmonary embolus | 3 (7%) | 1 (2%) | 0.609 |
| Pneumonia | 5 (12%) | 9 (21%) | 0.380 |
| Mortality | 0 (0%) | 0 (0%) | 1.000 |
Continuous data are presented as mean (±SD). Discrete data are presented as median (IQR). Categorical data are presented as n (%). SSRF = surgical stabilization of rib fractures; ICU = intensive care unit.
Figure. Percentage of patients in each treatment group with no or mild impairment (scores of 1-2) compared to those with moderate, severe, or extreme impairment (scores of 3-5) in each dimension of the EQ-5D-5L. Mean Health Status Visual Analog Score (0-100) is also presented.
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