Flail Chest - Rib Fixation Study

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Collaborator:
Synthes Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01147471
First received: June 7, 2010
Last updated: August 4, 2015
Last verified: August 2015
Results First Received: August 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Flail Chest
Interventions: Device: operative rib fixation
Procedure: operative rib fixation surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult patients, 21 to 75 years old, admitted to the trauma unit with injuries that include either stove in chest (contiguous rib fractures with at least 2 ribs pushed in a distance greater than the rib diameter of the pushed in rib) or a unilateral flail chest (3 or more ribs fractures at two places). Patients must be on a ventilator.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

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.


Participant Flow for 4 periods

Period 1:   Through Initial Hospital Discharge
    Operative Rib Fixation     Non-operative Arm  
STARTED     13     11  
COMPLETED     13     11  
NOT COMPLETED     0     0  

Period 2:   Post-discharge Follow Up (Approx 2 Wks)
    Operative Rib Fixation     Non-operative Arm  
STARTED     13     11  
COMPLETED     13     8  
NOT COMPLETED     0     3  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 0                 1  
incarcerated                 0                 1  

Period 3:   3 Month Follow Up
    Operative Rib Fixation     Non-operative Arm  
STARTED     13     8  
COMPLETED     12     6  
NOT COMPLETED     1     2  
Lost to Follow-up                 1                 1  
Physician Decision                 0                 1  

Period 4:   6 Month Follow Up
    Operative Rib Fixation     Non-operative Arm  
STARTED     12     6  
COMPLETED     8     4  
NOT COMPLETED     4     2  
Lost to Follow-up                 4                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adult patients, 21 to 75 years old, admitted to the trauma unit with injuries that include either stove in chest (contiguous rib fractures with at least 2 ribs pushed in a distance greater than the rib diameter of the pushed in rib) or a unilateral flail chest (3 or more ribs fractures at two places). Patients must be on a ventilator.

Reporting Groups
  Description
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.

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.

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.

Total Total of all reporting groups

Baseline Measures
    Operative Rib Fixation     Non-operative Arm     Total  
Number of Participants  
[units: participants]
  13     11     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     11     23  
>=65 years     1     0     1  
Gender  
[units: participants]
     
Female     3     1     4  
Male     10     10     20  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     1     2  
Not Hispanic or Latino     8     6     14  
Unknown or Not Reported     4     4     8  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     7     6     13  
More than one race     0     0     0  
Unknown or Not Reported     5     4     9  
Region of Enrollment  
[units: participants]
     
United States     13     11     24  
Mechanism of injury  
[units: participants]
     
Fall from height     1     0     1  
Motor cycle crash     2     5     7  
Motor vehicle crash     7     5     12  
Pedestrian struck     3     1     4  
Side & position of flail  
[units: participants]
     
right side flail     7     7     14  
left side flail     6     4     10  
Postero-lateral     10     9     19  
Antero-lateral     3     2     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Morbidity   [ Time Frame: Measured daily during hospitalization (approx 1 month) ]

2.  Primary:   Mortality   [ Time Frame: Measured any time during hospital stay (approx 30 days) ]

3.  Secondary:   Quality of Life   [ Time Frame: Measured at 3 and 6 months post-discharge ]

4.  Secondary:   Pulmonary Function   [ Time Frame: Measured at 3 and 6 months post-discharge ]

5.  Other Pre-specified:   Still on Narcotics at Post-discharge Follow-up   [ Time Frame: approx 2 weeks post discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Subject enrollment too low leading to insufficient data to analyze.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ajai K Malhotra, MD
Organization: Virginia Commonwealth University
phone: 804-827-2409
e-mail: akmalhot@mcvh-vcu.edu


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
Results First Received: August 4, 2015
Last Updated: August 4, 2015
Health Authority: United States: Institutional Review Board