Early fixation versus conservative therapy of multiple, simple rib fractures (FixCon): protocol for a multicenter randomized controlled trial

Abstract

Background Multiple rib fractures are common injuries in both the young and elderly. Rib fractures account for 10% of all trauma admissions and are seen in up to 39% of patients after thoracic trauma. With morbidity and mortality rates increasing with the number of rib fractures as well as poor quality of life at long-term follow-up, multiple rib fractures pose a serious health hazard. Operative fixation of flail chest is beneficial over nonoperative treatment regarding, among others, pneumonia and both intensive care unit (ICU) and hospital length of stay. With no high-quality evidence on the effects of multiple simple rib fracture treatment, the optimal treatment modality remains unknown. This study sets out to investigate outcome of operative fixation versus nonoperative treatment of multiple simple rib fractures. Methods The proposed study is a multicenter randomized controlled trial. Patients will be eligible if they have three or more multiple simple rib fractures of which at least one is dislocated over one shaft width or with unbearable pain (visual analog scale (VAS) or numeric rating scale (NRS) > 6). Patients in the intervention group will be treated with open reduction and internal fixation. Pre- and postoperative care equals treatment in the control group. The control group will receive nonoperative treatment, consisting of pain management, bronchodilator inhalers, oxygen support or mechanical ventilation if needed, and pulmonary physical therapy. The primary outcome measure will be occurrence of pneumonia within 30 days after trauma. Secondary outcome measures are the need and duration of mechanical ventilation, thoracic pain and analgesics use, (recovery of) pulmonary function, hospital and ICU length of stay, thoracic injury-related and surgery-related complications and mortality, secondary interventions, quality of life, and cost-effectiveness comprising health care consumption and productivity loss. Follow-up visits will be standardized and daily during hospital admission, at 14 days and 1, 3, 6, and 12 months. Discussion With favorable results in flail chest patients, operative treatment may also be beneficial in patients with multiple simple rib fractures. The FixCon trial will be the first study to compare clinical, functional, and economic outcome between operative fixation and nonoperative treatment for multiple simple rib fractures. Trial registration www.trialregister.nl , NTR7248. Registered May 31, 2018.

What is the optimal timing to perform surgical stabilization of rib fractures?

“…Historically, rib fractures have been managed nonoperatively. Nonoperative treatment includes multimodal pain management, oxygen support or mechanical ventilation if required, and pulmonary physical therapy such as incentive spirometry (29). Even with improved critical care technology and widespread adoption of adjunctive pain management techniques, outcomes after multiple severe rib fractures have not significantly improved over the past 15 years (30).…”

Trends in incidence rate, health care use, and costs due to rib fractures in the Netherlands

“…Second, patients from the DISS were registered as having sustained one or multiple rib fractures where multiple was defined as 2 or more rib fractures. In current literature, multiple rib fractures are defined as having three or more rib fractures, regardless of side or adjacency [42,45,46]. Only for the HLOS, which was covered by the HDR, a third subgroup, patients with a flail chest, was available.…”

Analysis of the therapeutic effect and prognosis in 86 cases of rib fractures and atelectasis

“…Once the effusion and blood clot have been removed, bronchoscopy can be used for sputum suction during open reduction and internal fixation, and the effect of pulmonary reexpansion can be observed under direct vision. A large number of clinical studies have demonstrated that, in cases of multiple rib fractures, treatment with internal fixation is superior to the conservative treatments used to prevent pulmonary complications like atelectasis [14][15][16][17][18][19].…”