Flail Chest - Rib Fixation Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Synthes Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01147471
First received: June 7, 2010
Last updated: January 16, 2014
Last verified: January 2014

June 7, 2010
January 16, 2014
September 2010
March 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01147471 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Flail Chest - Rib Fixation Study
Flail Chest: Early Operative Fixation Versus Non-operative Management - a Prospective Randomized Study

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Flail Chest
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
  • 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.

    Intervention: Device: operative rib fixation
  • 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.


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
March 2014
March 2014   (final data collection date for primary outcome measure)

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.

Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01147471
VCU-20100582
Yes
Virginia Commonwealth University
Virginia Commonwealth University
Synthes Inc.
Principal Investigator: Ajai K Malhotra, MD Virginia Commonwealth University
Virginia Commonwealth University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP