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

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.