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

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.