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Randomized Controlled Trial
. 2020 Feb;88(2):249-257.
doi: 10.1097/TA.0000000000002559.

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

Fredric M Pieracci  1 , Kiara Leasia, Zach Bauman, Evert A Eriksson, Lawrence Lottenberg, Sarah Majercik, Ledford Powell, Babak Sarani, Gregory Semon, Bradley Thomas, Frank Zhao, Cornelius Dyke, Andrew R Doben
Affiliations
Randomized Controlled Trial

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

Fredric M Pieracci et al. J Trauma Acute Care Surg. 2020 Feb.

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.

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References

    1. Kane ED, Jeremitsky E, Pieracci FM, Majercik S, Doben AR. Quantifying and exploring the recent national increase in surgical stabilization of rib fractures. J Trauma Acute Care Surg. 2017;83(6):1047–1052.
    1. Pieracci FM, Rodil M, Stovall RT, Johnson JL, Biffl WL, Mauffrey C, Moore EE, Jurkovich GJ. Surgical stabilization of severe rib fractures. J Trauma Acute Care Surg. 2015;78(4):883–887.
    1. Ali-Osman F, Mangram A, Sucher J, Shirah G, Johnson V, Moeser P, Sinchuk NK, Dzandu JK. Geriatric (G60) trauma patients with severe rib fractures: is muscle sparing minimally invasive thoracotomy rib fixation safe and does it improve post-operative pulmonary function? Am J Surg. 2018;216(1):46–51.
    1. Thiels CA, Aho JM, Naik ND, Zielinski MD, Schiller HJ, Morris DS, Kim BD. Infected hardware after surgical stabilization of rib fractures: outcomes and management experience. J Trauma Acute Care Surg. 2016;80(5):819–823.
    1. Sarani B, Allen R, Pieracci FM, et al. Characteristics of hardware failure in patients undergoing surgical stabilization of rib fractures: a Chest Wall Injury Society Multicenter Study. J Trauma Acute Care Surg. 2019;87(6):1277–1281.

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