Rib Fixation for Clinically Severe Rib Fractures From Trauma (SOFRIB)

Darwin Ang

Status: Unknown

Conditions: Flail Chest; Rib Fracture

Treatments: Device: Rib Fixation System

Study type: Interventional

Funder types: Other

Identifiers

NCT02595593

SCRI HEOR_02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Rib Fixation System

Active Comparator group

Description:

This group of subjects will receive a surgical rib plating procedure after trauma

Treatment:

Device: Rib Fixation System

Critical Care and Pain Control

No Intervention group

Description:

This group will receive critical care and pain control after trauma