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A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma
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.
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.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Fort Walton Beach Medical Center
Fort Walton Beach, Florida, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, United States
Osceola Regional Medical Center
Kissimmee, Florida, United States
Kendall Regional Medical Center
Miami, Florida, United States
Ocala Regional Medical Center - Health Trauma
Ocala, Florida, United States
Orange Park Medical Center
Orange Park, Florida, United States
Central Florida Regional Hospital
Sanford, Florida, United States
Research Medical Center
Kansas City, Missouri, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, United States
Chippenham Johnston-Willis Hospital
Richmond, Virginia, United States
Start Date
April 1, 2015
Primary Completion Date
January 1, 2023
Completion Date
December 1, 2023
Last Updated
May 10, 2022
236
ESTIMATED participants
Rib Fixation System
DEVICE
Lead Sponsor
Darwin Ang
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06299137