A multicenter, prospective, controlled clinical trial of surgical stabilization of rib fractures in patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL)

Abstract

BACKGROUND The efficacy of surgical stabilization of rib fracture (SSRF) in patients without flail chest has not been studied specifically. We hypothesized that SSRF improves outcomes among patients with displaced rib fractures in the absence of flail chest. METHODS Multicenter, prospective, controlled, clinical trial (12 centers) comparing SSRF within 72 hours to medical management. Inclusion criteria were three or more ipsilateral, severely displaced rib fractures without flail chest. The trial involved both randomized and observational arms at patient discretion. The primary outcome was the numeric pain score (NPS) at 2-week follow-up. Narcotic consumption, spirometry, pulmonary function tests, pleural space complications (tube thoracostomy or surgery for retained hemothorax or empyema >24 hours from admission) and both overall and respiratory disability-related quality of life (RD-QoL) were also compared. RESULTS One hundred ten subjects were enrolled. There were no significant differences between subjects who selected randomization (n = 23) versus observation (n = 87); these groups were combined for all analyses. Of the 110 subjects, 51 (46.4%) underwent SSRF. There were no significant baseline differences between the operative and nonoperative groups. At 2-week follow-up, the NPS was significantly lower in the operative, as compared with the nonoperative group (2.9 vs. 4.5, p < 0.01), and RD-QoL was significantly improved (disability score, 21 vs. 25, p = 0.03). Narcotic consumption also trended toward being lower in the operative, as compared with the nonoperative group (0.5 vs. 1.2 narcotic equivalents, p = 0.05). During the index admission, pleural space complications were significantly lower in the operative, as compared with the nonoperative group (0% vs. 10.2%, p = 0.02). CONCLUSION In this clinical trial, SSRF performed within 72 hours improved the primary outcome of NPS at 2-week follow-up among patients with three or more displaced fractures in the absence of flail chest. These data support the role of SSRF in patients without flail chest. LEVEL OF EVIDENCE Therapeutic, level II.

Surgical Stabilization of Rib Fracture to Mitigate Pulmonary Complication and Mortality: A Systematic Review and Bayesian Meta-Analysis

“…[5][6][7] However, recent studies comparing SSRF with non-operative management have not undergone evidence synthesis. [8][9][10][11][12][13][14][15][16] Conventional frequentist meta-analysis may be suboptimal because few randomized controlled trials (RCTs) have compared SSRF with nonoperative management. [17][18][19][20][21] Bayesian meta-analysis has distinct advantages over conventional meta-analysis for comparing SSRF with nonoperative management: it allows intuitive interpretation (eg, there is an x% probability that SSRF is associated with lower mortality than non-operative management); it incorporates inherent bias of observational evidence rather than equally pooling observational and RCT evidence, and it accurately presents uncertainty of pooled effect estimates.…”

Surgical management of multiple rib fractures/flail chest

“…A more recent study corroborated these findings and further demonstrated shorter hospital stay (11.1% vs. 15.9%, P=0.013), fewer respiratory infections (4.6% vs. 17.0%, P=0.025), and an earlier return to work (28 vs. 42 days, P=0.028) (18). A further multicentre, randomised control trial of surgical stabilisation of rib fractures in patients with non-flail fracture patterns is ongoing (19). Given the current evidence an appropriate pathway has been created ( Figure 2).…”

Surgical stabilization of rib fractures is associated with improved survival but increased acute respiratory distress syndrome

“…One potential explanation is that there has been a considerable increase in knowledge and improvement in techniques with SSRF, leading to improved outcomes not seen in prior studies. While studies are beginning to show a benefit in early SSRF 30 , patients that receive early rib plating are unlikely to have severe injuries that place the patient at risk for death, making it difficult to demonstrate a survival advantage. Further studies are needed to examine whether there is a subset of patients with rib fractures that may actually have improved survival with SSRF.…”

“…More specifically, SSRF resulted in decreased use of epidurals 6 . For patients that do not have flail chest, early rib plating resulted in decreased Numeric Pain Score at 2 weeks 30 .…”

“…However, this is likely a marker of more severe injury as these patients were more likely to have flail chest and had higher ISS. Prior studies have shown that early SSRF leads to decreased chest tube time, shorter time in the ICU 36 , and decreased pleural space complications 30 . While the NTDB could not be used to specifically measure pain control, previous work has suggested that SSRF may result in improved pain for patients with rib fractures.…”