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Flail Chest - Rib Fixation Study

This study is currently recruiting participants.
Verified August 2012 by Virginia Commonwealth University
Sponsor:
Collaborator:
Synthes Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01147471
First received: June 7, 2010
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to determine whether operative fixation of unilateral flail chest provides greater benefit than non-operative treatment.


Condition Intervention Phase
Flail Chest
 Device: operative rib fixation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Flail Chest: Early Operative Fixation Versus Non-operative Management - a Prospective Randomized Study

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Morbidity [ Time Frame: Measured daily during hospitalization and at 3 and 6 months post-discharge ] [ Designated as safety issue: No ]

    Pain as measured on analog pain scale, infections, days on ventilator, days in ICU, days in hospital, and operative complications during hospital stay.

    At 3 and 6 months post-discharge analog pain measurement, infections and operative complications.


  • Mortality [ Time Frame: Measured any time during hopsital stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Measured at 3 and 6 months post-discharge ] [ Designated as safety issue: No ]
    Rand 36 health survey.

  • Pulmonary function [ Time Frame: Measured at 3 and 6 months post-discharge ] [ Designated as safety issue: No ]
    Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Operative rib fixation

Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.

Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.

 Device: operative rib fixation
Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.
Other Name: MatrixRib
No Intervention: Non-operative arm

Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):

a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry - after extubation.

Detailed Description:

Chest trauma is frequent in the multiply-injured patient and is directly responsible for 20-25% of trauma deaths. Additionally, chest trauma is a major contributory factor in another 25% of deaths after trauma. Besides short term mortality, injuries to the chest result in significant morbidity and cost of care and long term disability. Among patients sustaining chest trauma, flail chest is one of the more serious injuries. Patients require prolonged ventilation, ICU and hospital stays and have a high incidence of pulmonary infections. Survivors often go on to have significant impairment of pulmonary function and over half may never return to gainful employment.

The standard therapy of injuries to the chest wall, including flail chest has been effective analgesia, pulmonary toilet with postural drainage and aggressive chest physical therapy. Despite these measures, flail chest patients often do not do well. Early operative fixation (surgical anchoring and bracing of bones) to stabilize the chest wall and restore pulmonary dynamics has always been an attractive option. With improvements in patient selection, availability of good modern anesthesia and critical care, and mechanical fixation devices, small studies and several case reports testify to the feasibility of the concept and possible short and long term benefits. All but one small institutional study are retrospective in nature limiting the generalizability of the conclusions. In that small single institutional prospective trial in which patients with flail chest were randomized to either early operative fixation or standard non-operative therapy, patients randomized to early operative fixation showed significant improvements in both short- and long-term health outcomes resulting in lower in-hospital costs in the surgically treated group. Despite these very impressive results, although prospective, it is one study with a small number of patients from a single institution. The question of the benefits of operative fixation can only be conclusively answered by a larger multi-institutional prospective randomized study.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults >21 years and <75 years

  2. "Stove-in chest" to encompass both

    1. Unilateral flail chest (>3 ribs fractures at two places) or
    2. Contiguous rib fractures with at least 2 ribs pushed in > the rib diameter of the pushed in rib
  3. Mechanically ventilated

Exclusion Criteria:

  1. Patient unlikely to survive due to the trauma or age or multiple co-morbidities
  2. Stove-in chest patients that do not require early (less than or equal to 48 hours of injury) ventilatory support
  3. Bilateral flail chest
  4. Sternal flail
  5. P/F ratio < 200:1 over a period of greater than or equal to 6 hours while on the ventilator.
  6. Other injuries that will likely prolong tracheal intubation and mechanical ventilation eg significant head injury resulting in low GCS (Glasgow Coma Score, a scale used to assess the central nervous system in patients who have undergone trauma), spinal cord injury resulting in paralysis of some or all of the respiratory muscles etc. These are merely examples. It is in the opinion of the investigator/surgeon what injuries would prolong tracheal intubation.
  7. Any contra-indication to surgery including severe immunosuppression or severe chronic disease making elective surgery dangerous in the opinion of the surgeon
  8. Inability to proceed with any aspect of critical care due to personal beliefs, living will etc eg non acceptance of blood products
  9. Inability to obtain informed consent.
  10. Subject's refusal for follow up
  11. Pregnant women
  12. Prisoners
  13. Any other reason for which the potential subject is not a good candidate, in the opinion of the investigator.

If the site investigator believes that a patient is a good candidate for the study (i.e. requires ventilation primarily due to altered chest wall mechanics) but fails to meet all criteria, site may contact Dr Ajai Malhotra to see if a waiver will be granted.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147471

Contacts
Contact: Judith S Katzen, MS, RN 804-827-0283 jkatzen@vcu.edu
Contact: Jinfeng Han, BSN 804-828-4281 jhan@vcu.edu

Locations
United States, California
Trauma Research & Education Foundation of Fresno Recruiting
Fresno, California, United States, 93721
Contact: Krista L Kaups, MD     559-459-3770     kkaups@fresno.ucsf.edu    
Principal Investigator: Krista L Kaups, MD            
Sub-Investigator: John F Bilello, MD            
Sub-Investigator: James W Davis, MD            
Sub-Investigator: Lawrence P Sue, MD            
Sub-Investigator: Mary M Wolfe, MD            
Sub-Investigator: Kelly A Dinnan, DO            
Sub-Investigator: Jennifer L Hubbard, MD            
United States, Florida
University of Florida Withdrawn
Jacksonville, Florida, United States, 32209
University of Miami Withdrawn
Miami, Florida, United States, 33136
United States, Massachusetts
Massachusettes General Hospital Withdrawn
Boston, Massachusetts, United States, 02114
United States, New Jersey
University of Medicine and Dentristry of New Jersey Withdrawn
New Brunswick, New Jersey, United States, 08903
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: David G Jacobs, MD     704-355-3176     David.Jacobs@carolinashealthcare.org    
Principal Investigator: David G Jacobs, MD            
Sub-Investigator: Ashley B Christmas, MD            
Sub-Investigator: Susan L Evans, MD            
Sub-Investigator: John M Green, MD            
Sub-Investigator: Toan T Huynh, MD            
Sub-Investigator: William S Miles, MD            
Sub-Investigator: Lynette M Schiffern, MD            
Sub-Investigator: Ronald F Sing, DO            
Sub-Investigator: Michael H Thomason, MD            
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Preston Miller, III, MD     336-716-3813     pmiller@wfubmc.edu    
Principal Investigator: Preston R Miller, III, MD            
United States, Oklahoma
The Board of Regents of the University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Roxie M Albrecht, MD     405-271-5781     roxie-albrecht@ouhsc.edu    
Principal Investigator: Roxie M Albrecht, MD            
Sub-Investigator: Jason S Lees, MD            
Sub-Investigator: William S Havron, III, MD            
Sub-Investigator: Jacquelyn K O'Herrin, MD            
United States, South Carolina
Medical University of South Carolina Withdrawn
Charleston, South Carolina, United States, 29425
United States, Tennessee
The University of Tennessee Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Todd A Nickloes, DO     865-305-9433     tnickloe@utmck.edu    
Principal Investigator: Todd A Nickloes, DO            
Sub-Investigator: Brian J Daley, MD, MBA            
Sub-Investigator: Blaine L Enderson, MD            
Sub-Investigator: Stanley J Kurek, Jr, DO            
Sub-Investigator: Dana A Taylor, MD            
United States, Virginia
Eastern Virginia Medical School Terminated
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Jinfeng Han, BSN     804-828-4281     jhan@vcu.edu    
Principal Investigator: James F Whelan, MD            
Sub-Investigator: Therese M Duane, MD            
Sub-Investigator: Ajai K Malhotra, MD            
Sub-Investigator: Rao R Ivatury, MD            
Sub-Investigator: Michel B Aboutanos, MD, MPH            
Sponsors and Collaborators
Virginia Commonwealth University
Synthes Inc.
Investigators
Principal Investigator: Ajai K Malhotra, MD Virginia Commonwealth University
  More Information

Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01147471     History of Changes
Other Study ID Numbers: VCU-20100582
Study First Received: June 7, 2010
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
flail chest
rib fixation

Additional relevant MeSH terms:
Flail Chest
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013