Rib Fixation for Clinically Severe Rib Fractures From Trauma

Rib Fracture Clinical Trial

— SOFRIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02595593
• Other study ID #: SCRI HEOR_02
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: SCRI Development Innovations, LLC
• Contact: Donna Nayduch, RN, MSN
• Phone: 352-401-1022
• Email: donna.nayduch[@]hcahealthcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Flail Chest
• Fractures, Bone
• Rib Fracture
• Rib Fractures

Intervention

Device:
• Rib Fixation System
This intervention involves a surgical procedure to affix rib plates to broken ribs

Locations

Country	Name	City	State
United States	Lawnwood Regional Medical Center	Fort Pierce	Florida
United States	Fort Walton Beach Medical Center	Fort Walton Beach	Florida
United States	Research Medical Center	Kansas City	Missouri
United States	Osceola Regional Medical Center	Kissimmee	Florida
United States	Kendall Regional Medical Center	Miami	Florida
United States	Grand Strand Regional Medical Center	Myrtle Beach	South Carolina
United States	Ocala Regional Medical Center - Health Trauma	Ocala	Florida
United States	Orange Park Medical Center	Orange Park	Florida
United States	Chippenham Johnston-Willis Hospital	Richmond	Virginia
United States	Central Florida Regional Hospital	Sanford	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Darwin Ang

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication Rates	including, but not limited to, pneumonia, urinary tract infection, arrhythmia, sepsis, reintubation, wound infection	measured at 1 week, 3 months, 6 months
Other	Pain Control documented by the Functional Pain Scale	measured using the Functional Pain Scale	measured before and after surgery and at time of discharge, through study completion, up to 2 years
Other	Ventilator/Ventilator Free Days	measured in days on or off ventilation, based on length of stay in hospital	measured through study completion, up to 2 years
Other	Narcotic usage	converted to units of morphine	measured at 1 week, 3 months, 6 months
Other	Hospital length of stay	measured in days	measured through study completion, up to 2 years
Other	Pulmonary Function	as measured by FVC (forced vital capacity), FEV1, and TLC by spirometry	measured at discharge, 3 months, and 6 months, through study completion, up to 2 years
Other	Time to wean from ventilator	measured in days	measured through study completion, up to 2 years
Other	Tracheostomy rates	overall rate of tracheostomy in population	measured at 1 week, 3 months, 6 months
Primary	ICU Length of Stay	length of stay in days	measured through study completion, up to 2 years
Secondary	Quality of Life, as determined by SF-36 survey	measured at 3 different time points post-hospital stay	measured at 1 week, 3 months, 6 months post-intervention
Secondary	Number of participants with pneumonia as defined by the Centers for Disease Control	based on classification as complication of rib trauma treatment	measured monthly through course of study, up to 2 years
Secondary	Total cost of treatments	measured based on total costs during length of hospital stay	measured through study completion, up to 2 years