Rib Fixation for Clinically Severe Rib Fractures From Trauma
- Conditions
- Flail ChestRib Fracture
- Interventions
- Device: Rib Fixation System
- Registration Number
- NCT02595593
- Lead Sponsor
- Darwin Ang
- Brief 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.
- Detailed Description
This study will compare the outcomes of patients between two standard of care pathways for rib trauma: those who have their ribs plated versus those who are managed by modern critical care and pain control. A study nurse (project) coordinator will identify subjects based on inclusion and exclusion criteria, then obtain consent for each of these patients prior to randomization. Randomization will be decided by a web-based computer program, accessible to the project coordinator. Although this randomization occurs, the study itself is purely observational, as the intervention is currently standard of care. None of the subjects or study group members will be blinded since it is not possible to disguise the intervention. Patients will be evaluated and a survey will be administered at set post-intervention intervals to determine endpoints and quality of life when data analysis will also take place.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 236
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rib Fixation System Rib Fixation System This group of subjects will receive a surgical rib plating procedure after trauma
- Primary Outcome Measures
Name Time Method ICU Length of Stay measured through study completion, up to 2 years length of stay in days
- Secondary Outcome Measures
Name Time Method Quality of Life, as determined by SF-36 survey measured at 1 week, 3 months, 6 months post-intervention measured at 3 different time points post-hospital stay
Number of participants with pneumonia as defined by the Centers for Disease Control measured monthly through course of study, up to 2 years based on classification as complication of rib trauma treatment
Total cost of treatments measured through study completion, up to 2 years measured based on total costs during length of hospital stay
Trial Locations
- Locations (10)
Osceola Regional Medical Center
🇺🇸Kissimmee, Florida, United States
Kendall Regional Medical Center
🇺🇸Miami, Florida, United States
Lawnwood Regional Medical Center
🇺🇸Fort Pierce, Florida, United States
Ocala Regional Medical Center - Health Trauma
🇺🇸Ocala, Florida, United States
Central Florida Regional Hospital
🇺🇸Sanford, Florida, United States
Grand Strand Regional Medical Center
🇺🇸Myrtle Beach, South Carolina, United States
Orange Park Medical Center
🇺🇸Orange Park, Florida, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Chippenham Johnston-Willis Hospital
🇺🇸Richmond, Virginia, United States
Fort Walton Beach Medical Center
🇺🇸Fort Walton Beach, Florida, United States