Abstract
Unstable chest wall injuries have high rates of mortality and morbidity. These injuries can lead to respiratory dysfunction, and are associated with high rates of pneumonia, sepsis, prolonged ICU stays, and increased health care costs. Numerous studies have demonstrated improved outcomes with surgical fixation compared to non-operative treatment. However, an adequately powered multi-centre randomized controlled study using modern fixation techniques has been lacking.
We present a multi-centred, prospective, randomized controlled trial comparing surgical fixation of acute, unstable chest wall injuries with the current standard of non-operative management. Patients aged 16–85 with a flail chest (3 or more consecutive, segmental, displaced rib fractures), or severe deformity of the chest wall, were recruited from multiple trauma centers across North America. Exclusion criteria included: severe pulmonary contusion, severe head trauma, randomization>72 hours from injury, inability to perform surgical fixation within 96 hours from injury (in those randomized to surgery), fractures of the floating ribs, or fractures adjacent to the spine not amendable to surgical fixation. Patients were seen in follow-up for one year. The primary outcome was days free from mechanical ventilation in the first 28 days following injury. Secondary outcomes were days in ICU, rates of pneumonia, sepsis, need for tracheostomy, mortality, general health outcomes, pulmonary function testing, and other complications of treatment. A sample size of 206 was required to detect a difference of 2 ventilator-free days between the two groups, using a 2-tailed alpha error of 0.05 and a power of 0.80.
A total of 207 patients were recruited from 15 sites across Canada and USA, from 2011–2018. Ninety-nine patients were randomized to non-operative treatment, and 108 were randomized to surgical fixation. Overall, the mean age was 53 years, and 75% of patients were male, with 25% females. The commonest mechanisms of injury were: motor vehicle collisions (34%), falls (20%), motorcycle collisions (14%), and pedestrian injuries (11%). The mean injury severity score (ISS) at admission was 26, and patients had a mean of 10 rib fractures. Eighty-nine percent of patients had pneumothorax, 76% had haemothorax, and 54% had pulmonary contusion. There were no differences between the two groups in terms of demographics. The final results will be available and presented at the COA meeting in Halifax.
This is the largest randomized controlled trial to date, comparing surgical fixation to non-operative treatment of unstable chest wall and flail chest injuries. The results of this study will shed light on the best treatment options for patients with such injuries, help understand outcomes, and guide treatment. The final results will be available and presented at the COA meeting in Halifax.
