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| Name | Class |
|---|---|
| Synthes Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative rib fixation | Active Comparator | 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. |
|
| Non-operative arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| operative rib fixation | Device | Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system. |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | total days on ventilator, ICU length of stay, hospital length of stay | Measured daily during hospitalization (approx 1 month) |
| Mortality | Number of participants who died during any hospital stay. | Measured any time during hospital stay (approx 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Rand 36 health survey. | Measured at 3 and 6 months post-discharge |
| Pulmonary Function | Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1). |
| Measure | Description | Time Frame |
|---|---|---|
| Still on Narcotics at Post-discharge Follow-up | Number of people still on narcotics at time of routine care post-discharge follow-up | approx 2 weeks post discharge |
Inclusion Criteria:
Adults >21 years and <75 years
"Stove-in chest" to encompass both
Mechanically ventilated
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ajai K Malhotra, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trauma Research & Education Foundation of Fresno | Fresno | California | 93721 | United States | ||
| Carolinas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16676852 | Background | Nirula R, Allen B, Layman R, Falimirski ME, Somberg LB. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006 Apr;72(4):307-9. doi: 10.1177/000313480607200405. | |
| 7396078 | Background | Baker CC, Oppenheimer L, Stephens B, Lewis FR, Trunkey DD. Epidemiology of trauma deaths. Am J Surg. 1980 Jul;140(1):144-50. doi: 10.1016/0002-9610(80)90431-6. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Through Initial Hospital Discharge |
| |||||||||||||
| Post-discharge Follow Up (Approx 2 Wks) |
| |||||||||||||
| 3 Month Follow Up |
| |||||||||||||
| 6 Month Follow Up |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morbidity | total days on ventilator, ICU length of stay, hospital length of stay | analysis is the mean and standard deviation for # days spent on each item measured | Posted | Mean | Standard Deviation | days | Measured daily during hospitalization (approx 1 month) |
|
through 6 month post initial hospital discharge
Only serious adverse events and related adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Operative Rib Fixation | Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize 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 stove-in segment. Post-operatively, the patients would receive 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. operative rib fix |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial infarction | Cardiac disorders | DHHS | Non-systematic Assessment | Unrelated. |
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Subject enrollment too low leading to insufficient data to analyze.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ajai K Malhotra, MD | Virginia Commonwealth University | 804-827-2409 | akmalhot@mcvh-vcu.edu |
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| ID | Term |
|---|---|
| D005409 | Flail Chest |
| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
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| operative rib fixation surgery | Procedure |
|
| Measured at 3 and 6 months post-discharge |
| Charlotte |
| North Carolina |
| 28203 |
| United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| The Board of Regents of the University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| The University of Tennessee | Knoxville | Tennessee | 37920 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| 3656472 | Background | Shorr RM, Mirvis SE, Indeck MC. Tension pneumopericardium in blunt chest trauma. J Trauma. 1987 Sep;27(9):1078-82. doi: 10.1097/00005373-198709000-00021. |
| 2911786 | Background | LoCicero J 3rd, Mattox KL. Epidemiology of chest trauma. Surg Clin North Am. 1989 Feb;69(1):15-9. doi: 10.1016/s0039-6109(16)44730-4. |
| 998864 | Background | Shackford SR, Smith DE, Zarins CK, Rice CL, Virgilio RW. The management of flail chest. A comparison of ventilatory and nonventilatory treatment. Am J Surg. 1976 Dec;132(6):759-62. doi: 10.1016/0002-9610(76)90453-0. |
| 4720987 | Background | Relihan M, Litwin MS. Morbidity and mortality associated with flail chest injury: a review of 85 cases. J Trauma. 1973 Aug;13(8):663-71. doi: 10.1097/00005373-197308000-00001. No abstract available. |
| 6716518 | Background | Landercasper J, Cogbill TH, Lindesmith LA. Long-term disability after flail chest injury. J Trauma. 1984 May;24(5):410-4. doi: 10.1097/00005373-198405000-00007. |
| 5271286 | Background | Sankaran S, Wilson RF. Factors affecting prognosis in patients with flail chest. J Thorac Cardiovasc Surg. 1970 Sep;60(3):402-10. No abstract available. |
| 6876866 | Background | Menard A, Testart J, Philippe JM, Grise P. Treatment of flail chest with Judet's struts. J Thorac Cardiovasc Surg. 1983 Aug;86(2):300-5. |
| 1105874 | Background | Paris F, Tarazona V, Blasco E, Canto A, Casillas M, Pastor J, Paris M, Montero R. Surgical stabilization of traumatic flail chest. Thorax. 1975 Oct;30(5):521-7. doi: 10.1136/thx.30.5.521. |
| 661347 | Background | Thomas AN, Blaisdell FW, Lewis FR Jr, Schlobohm RM. Operative stabilization for flail chest after blunt trauma. J Thorac Cardiovasc Surg. 1978 Jun;75(6):793-801. No abstract available. |
| 1998429 | Background | Landreneau RJ, Hinson JM Jr, Hazelrigg SR, Johnson JA, Boley TM, Curtis JJ. Strut fixation of an extensive flail chest. Ann Thorac Surg. 1991 Mar;51(3):473-5. doi: 10.1016/0003-4975(91)90871-m. |
| 15674171 | Background | Engel C, Krieg JC, Madey SM, Long WB, Bottlang M. Operative chest wall fixation with osteosynthesis plates. J Trauma. 2005 Jan;58(1):181-6. doi: 10.1097/01.ta.0000063612.25756.60. No abstract available. |
| 11509269 | Background | Lardinois D, Krueger T, Dusmet M, Ghisletta N, Gugger M, Ris HB. Pulmonary function testing after operative stabilisation of the chest wall for flail chest. Eur J Cardiothorac Surg. 2001 Sep;20(3):496-501. doi: 10.1016/s1010-7940(01)00818-1. |
| 8523879 | Background | Ahmed Z, Mohyuddin Z. Management of flail chest injury: internal fixation versus endotracheal intubation and ventilation. J Thorac Cardiovasc Surg. 1995 Dec;110(6):1676-80. doi: 10.1016/S0022-5223(95)70030-7. |
| 9704957 | Background | Voggenreiter G, Neudeck F, Aufmkolk M, Obertacke U, Schmit-Neuerburg KP. Operative chest wall stabilization in flail chest--outcomes of patients with or without pulmonary contusion. J Am Coll Surg. 1998 Aug;187(2):130-8. doi: 10.1016/s1072-7515(98)00142-2. |
| 11956391 | Background | Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020. |
| 18420125 | Background | Bastos R, Calhoon JH, Baisden CE. Flail chest and pulmonary contusion. Semin Thorac Cardiovasc Surg. 2008 Spring;20(1):39-45. doi: 10.1053/j.semtcvs.2008.01.004. |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mechanism of injury | Number | participants |
|
| Side & position of flail | Number | participants |
|
| OG001 | 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 | Mortality | Number of participants who died during any hospital stay. | Posted | Number | participants | Measured any time during hospital stay (approx 30 days) |
|
|
|
| Secondary | Quality of Life | Rand 36 health survey. | Data not collected - insufficient participants completed follow up visits | Posted | Measured at 3 and 6 months post-discharge |
|
|
| Secondary | Pulmonary Function | Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1). | Data not collected - insufficient participants completed follow up visits | Posted | Measured at 3 and 6 months post-discharge |
|
|
| Other Pre-specified | Still on Narcotics at Post-discharge Follow-up | Number of people still on narcotics at time of routine care post-discharge follow-up | Posted | Number | participants | approx 2 weeks post discharge |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 2 | 11 | 0 | 11 |
| cardiac tamponade | Cardiac disorders | DHHS | Non-systematic Assessment | unplanned hospitalization. Unrelated |
|
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