Rib Fixation for Clinically Severe Rib Fractures From Trauma

Status unconfirmed · Not applicable

Conditions studied: Rib Fracture, Flail Chest

In brief

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.

Key facts

Study ID

NCT02595593

Run by

Darwin Ang

People needed

236

Starts

2015-04-01

Expected to finish

2023-12-01

Last updated by the study team

2022-05-10

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Florida Regional Hospital — Sanford, Florida, United States (enrolling)
• Kendall Regional Medical Center — Miami, Florida, United States (enrolling)
• Grand Strand Regional Medical Center — Myrtle Beach, South Carolina, United States (enrolling)
• Chippenham Johnston-Willis Hospital — Richmond, Virginia, United States (enrolling)
• Ocala Regional Medical Center - Health Trauma — Ocala, Florida, United States (enrolling)
• Lawnwood Regional Medical Center — Ft. Pierce, Florida, United States (enrolling)
• Orange Park Medical Center — Orange Park, Florida, United States
• Osceola Regional Medical Center — Kissimmee, Florida, United States
• Fort Walton Beach Medical Center — Fort Walton Beach, Florida, United States
• Research Medical Center — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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