NCT01147471.

Trial name or title	Flail Chest: Early Operative Fixation Versus Non‐operative Management ‐ a Prospective Randomized Study
Methods	Study design: RCT Multicenter Setting: Virginia Commonwealth University, Virginia, US Period: ongoing, but not recruiting participants Sample size: 100 participants Follow‐up: 6 months
Participants	Inclusion criteria: adults aged > 21 years and < 75 years "Stove‐in chest" to encompass both unilateral flail chest (> 3 ribs fractures at 2 places) or contiguous rib fractures with at least 2 ribs pushed in more than the rib diameter of the pushed in rib mechanically ventilated Exclusion criteria: people unlikely to survive due to the trauma or age or multiple comorbidities people with stove‐in chest that do not require early (≤ 48 hours of injury) ventilatory support bilateral flail chest sternal flail P/F ratio < 200:1 over a period ≥ 6 hours while on the ventilator other injuries that will likely prolong tracheal intubation and mechanical ventilation, e.g. significant head injury resulting in low Glasgow Coma Score (a scale used to assess the central nervous system in people who have undergone trauma), spinal cord injury resulting in paralysis of some or all of the respiratory muscles etc. (these are merely examples. It is in the opinion of the investigator/surgeon what injuries would prolong tracheal intubation) any contraindication to surgery including severe immunosuppression or severe chronic disease making elective surgery dangerous in the opinion of the surgeon inability to proceed with any aspect of critical care due to personal beliefs, e.g. living will, nonacceptance of blood products inability to obtain informed consent person's refusal for follow‐up; pregnant women prisoners any other reason for which the potential participant is not a good candidate, in the opinion of the investigator
Interventions	Surgical rib fixation: randomized participants will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove‐in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove‐in segment. Postoperatively, the participants will receive the standard of care, similar to what is outlined for the nonoperative arm. Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, US) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices Nonsurgical management: randomized participants will receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols): ventilatory support; timing of extubation (removal from ventilator); analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks, etc.; chest physical therapy; postural drainage; incentive spirometry ‐ after extubation
Outcomes	Primary outcomes Morbidity (measured daily during hospitalization and at 3 and 6 months postdischarge) Pain as measured on analog pain scale, infections, days on ventilator, days in ICU, days in hospital, and surgical complications during hospital stay. At 3 and 6 months postdischarge analog pain measurement, infections and surgical complications Mortality (measured any time during hospital stay) Secondary outcomes Quality of life (measured at 3 and 6 months postdischarge) SF‐36 Health Survey Pulmonary function (measured at 3 and 6 months postdischarge) Pulmonary function tests to measure forced vital capacity and forced expiratory volume in 1 second
Starting date	September 2010
Contact information	Trauma Research & Education Foundation of Fresno, Fresno, CA, US Carolinas Medical Center, Charlotte, NC, US Wake Forest University Health Sciences, Winston‐Salem, NC, US The Board of Regents of the University of Oklahoma, Oklahoma City, OK, US The University of Tennessee, Knoxville, TN, US Eastern Virginia Medical School, Norfolk, VA, US Virginia Commonwealth University, Richmond, VA, US
Notes	This study is ongoing, but not recruiting participants