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

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.

Study Overview

• Status: Recruiting
• Conditions: Flail Chest; Rib Fracture
• Intervention / Treatment: Device: Rib Fixation System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donna Nayduch, RN, MSN; Phone Number: 352-401-1022; Email: donna.nayduch@hcahealthcare.com

Study Locations

• United States
  • Florida
    • Fort Pierce, Florida, United States, 34950
      • Recruiting
      • Lawnwood Regional Medical Center
      • Contact: Jamie Santos, RN
    • Fort Walton Beach, Florida, United States, 32547
      • Active, not recruiting
      • Fort Walton Beach Medical Center
    • Kissimmee, Florida, United States, 34741
      • Active, not recruiting
      • Osceola Regional Medical Center
    • Miami, Florida, United States, 33175
      • Recruiting
      • Kendall Regional Medical Center
      • Contact: Mark McKenney, MD
    • Ocala, Florida, United States, 34471
      • Recruiting
      • Ocala Regional Medical Center - Health Trauma
      • Contact: Donna A Nayduch, RN, MSN; Phone Number: 352-401-1022; Email: dnayduch@cfl.rr.com
      • Principal Investigator: Darwin Ang, MD
    • Orange Park, Florida, United States, 32073
      • Active, not recruiting
      • Orange Park Medical Center
    • Sanford, Florida, United States, 32771
      • Recruiting
      • Central Florida Regional Hospital
      • Contact: William Campbell, RN; Email: william.campbell5@hcahealthcare.com
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Active, not recruiting
      • Research Medical Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Grand Strand Regional Medical Center
      • Contact: Heather Rhodes, RN
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Recruiting
      • Chippenham Johnston-Willis Hospital
      • Contact: Stanley Kurek, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rib Fixation System; This group of subjects will receive a surgical rib plating procedure after trauma	Device: Rib Fixation System; This intervention involves a surgical procedure to affix rib plates to broken ribs; Other Names: DePuySynthes MatrixRIB Contoured Rib Implants
No Intervention: Critical Care and Pain Control; This group will receive critical care and pain control after trauma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Length of Stay	length of stay in days	measured through study completion, up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Total cost of treatments	measured based on total costs during length of hospital stay	measured through study completion, up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Rates	including, but not limited to, pneumonia, urinary tract infection, arrhythmia, sepsis, reintubation, wound infection	measured at 1 week, 3 months, 6 months
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
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
Narcotic usage	converted to units of morphine	measured at 1 week, 3 months, 6 months
Hospital length of stay	measured in days	measured through study completion, up to 2 years
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
Time to wean from ventilator	measured in days	measured through study completion, up to 2 years
Tracheostomy rates	overall rate of tracheostomy in population	measured at 1 week, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Darwin Ang
• Investigators: Principal Investigator: Darwin Ang, MD, HCA Trauma Network

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Trauma; Rib Plate; Rib Fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Flail Chest; Rib Fractures
• Other Study ID Numbers: SCRI HEOR_02