Multicenter RCT of SSRF in Non Flail Patients (NCT03221595) | Clinical Trial Compass
CompletedNot Applicable
Multicenter RCT of SSRF in Non Flail Patients
United States110 participantsStarted 2018-01-02
Plain-language summary
This study evaluates the efficacy of surgical stabilization of rib fractures, as compared to best medical management, for patients with multiple, displaced rib fractures.
Half of patients will be randomized to surgery (in addition to best medical management), whereas the other half will be randomized to medical therapy only.
The primary outcome will be the subjects overall quality of life measured at two months following injury.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Hospitalization with ≥ 3 severely displaced (≥ 50% of rib width) acute rib fractures.
. Two or more of the following pulmonary physiologic derangements (at the time of consideration for enrollment and after best medical therapy).
. Poor cough (as documented by respiratory therapist)
. Surgery anticipated \< 72 hours from injury
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numeric Pain Score
Timeframe: Hospital days 1-7, day of discharge (an average of 1 week) and at 2, 4 and 8 weeks following discharge from hospital.
. Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
. Moderate or severe traumatic brain injury (GCS at the time of consideration for enrollment \< 12)
. Intubation
. Severe pulmonary contusion, defined as Blunt Pulmonary Contusion 18 (BPC18) score \> 12 \[19\].
. Prior or expected emergency exploratory laparotomy during this admission.
. Prior or expected emergency thoracotomy during this admission.
. Prior or expected emergency craniotomy during this admission.