Flail Chest - Rib Fixation Study
The purpose of this study is to determine whether operative fixation of unilateral flail chest provides greater benefit than non-operative treatment.
|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|
- 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 ]
- 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).
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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.
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.
|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|
|Principal Investigator:||Ajai K Malhotra, MD||Virginia Commonwealth University|