NCT02595593

Rib Fixation for Clinically Severe Rib Fractures From Trauma

A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Darwin Ang · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rib Fracture
• Flail Chest

Interventions

Type	Name	Description
DEVICE	Rib Fixation System	This intervention involves a surgical procedure to affix rib plates to broken ribs

Timeline

• Start date: 2015-04-01
• Primary completion: 2023-01-01
• Completion: 2023-12-01
• First posted: 2015-11-03
• Last updated: 2022-05-10

Locations

10 sites across 1 country: United States