Flail Chest - Rib Fixation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01147471
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : June 22, 2010
Results First Posted : August 6, 2015
Last Update Posted : August 6, 2015
Synthes Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University

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

Condition or disease Intervention/treatment Phase
Flail Chest Device: operative rib fixation Procedure: operative rib fixation surgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Flail Chest: Early Operative Fixation Versus Non-operative Management - a Prospective Randomized Study
Study Start Date : September 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
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.

Procedure: operative rib fixation surgery
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.

Primary Outcome Measures :
  1. Morbidity [ Time Frame: Measured daily during hospitalization (approx 1 month) ]
    total days on ventilator, ICU length of stay, hospital length of stay

  2. Mortality [ Time Frame: Measured any time during hospital stay (approx 30 days) ]
    Number of participants who died during any hospital stay.

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Measured at 3 and 6 months post-discharge ]
    Rand 36 health survey.

  2. Pulmonary Function [ Time Frame: Measured at 3 and 6 months post-discharge ]
    Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).

Other Outcome Measures:
  1. Still on Narcotics at Post-discharge Follow-up [ Time Frame: approx 2 weeks post discharge ]
    Number of people still on narcotics at time of routine care post-discharge follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adults >21 years and <75 years
  2. "Stove-in chest" to encompass both

    1. Unilateral flail chest (>3 ribs fractured 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01147471

United States, California
Trauma Research & Education Foundation of Fresno
Fresno, California, United States, 93721
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
The Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
The University of Tennessee
Knoxville, Tennessee, United States, 37920
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Synthes Inc.
Principal Investigator: Ajai K Malhotra, MD Virginia Commonwealth University


Responsible Party: Virginia Commonwealth University Identifier: NCT01147471     History of Changes
Other Study ID Numbers: VCU-20100582
First Posted: June 22, 2010    Key Record Dates
Results First Posted: August 6, 2015
Last Update Posted: August 6, 2015
Last Verified: August 2015

Keywords provided by Virginia Commonwealth University:
flail chest
rib fixation

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