UnknownNot Applicable

Rib Fixation for Clinically Severe Rib Fractures From Trauma

United States236 participantsStarted 2015-04

Plain-language summary

This is a multicenter randomized study investigating the differences in clinical outcomes of patients between two standard of care pathways for rib trauma: patients who receive rib fixation versus patients who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.

Who can participate

Age range

18 Years – 90 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: * Flail chest, defined as 3 or more consecutive ribs fractured in more than one place * Pain and disability of an FPS (Functional Pain Scale) rating of 3 or higher * Deformity and Defect * Non-Union * Thoracotomy for other indications * 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter * Failure to wean from ventilator Exclusion Criteria: * Active bacteremia * Active shock * Severe Traumatic Brain Injury with GCS \< 8 * Age 17 years or less or age greater than 90 years old * Chronic pulmonary disease requiring home oxygenation * Acute Respiratory Distress Syndrome * Penetrating chest trauma * Chronic opioid dependence * Fractures less than 3cm from vertebral spine

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

ICU Length of Stay

Timeframe: measured through study completion, up to 2 years

Trial details

NCT IDNCT02595593

SponsorDarwin Ang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01

Contact for this trial

Donna Nayduch, RN, MSN

352-401-1022 donna.nayduch@hcahealthcare.com

View on ClinicalTrials.gov More Rib Fracture trials