Flail Chest - Rib Fixation Study

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01147471
• Collaborator: Synthes Inc. (Industry)
• Enrollment: 24
• Locations: 7
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Sep 1, 2010
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Morbidity [Measured daily during hospitalization (approx 1 month)]

   total days on ventilator, ICU length of stay, hospital length of stay

2. Mortality [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 [Measured at 3 and 6 months post-discharge]

   Rand 36 health survey.

2. Pulmonary Function [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 [approx 2 weeks post discharge]

   Number of people still on narcotics at time of routine care post-discharge follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• 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

3. Unilateral flail chest (>3 ribs fractured at two places) or

4. Contiguous rib fractures with at least 2 ribs pushed in > the rib diameter of the pushed in rib

5. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trauma Research & Education Foundation of Fresno	Fresno	California	United States	93721
2	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
3	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
4	The Board of Regents of the University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
5	The University of Tennessee	Knoxville	Tennessee	United States	37920
6	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507
7	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University
• Synthes Inc.

Investigators

• Principal Investigator: Ajai K Malhotra, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Baker CC, Oppenheimer L, Stephens B, Lewis FR, Trunkey DD. Epidemiology of trauma deaths. Am J Surg. 1980 Jul;140(1):144-50.
• 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.
• 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. Review.
• Landercasper J, Cogbill TH, Lindesmith LA. Long-term disability after flail chest injury. J Trauma. 1984 May;24(5):410-4.
• 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.
• 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.
• LoCicero J 3rd, Mattox KL. Epidemiology of chest trauma. Surg Clin North Am. 1989 Feb;69(1):15-9.
• 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.
• 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.
• París F, Tarazona V, Blasco E, Cantó A, Casillas M, Pastor J, París M, Montero R. Surgical stabilization of traumatic flail chest. Thorax. 1975 Oct;30(5):521-7.
• 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.
• Sankaran S, Wilson RF. Factors affecting prognosis in patients with flail chest. J Thorac Cardiovasc Surg. 1970 Sep;60(3):402-10.
• 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.
• Shorr RM, Mirvis SE, Indeck MC. Tension pneumopericardium in blunt chest trauma. J Trauma. 1987 Sep;27(9):1078-82.
• 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.
• 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.
• 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.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT01147471
• Other Study ID Numbers: VCU-20100582
• First Posted: Jun 22, 2010
• Last Update Posted: Aug 6, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Virginia Commonwealth University: flail chest; rib fixation
• Additional relevant MeSH terms: Flail Chest

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Operative Rib Fixation	Non-operative Arm
Arm/Group Description	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.	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.
Period Title: Through Initial Hospital Discharge
STARTED	13	11
COMPLETED	13	11
NOT COMPLETED	0	0
Period Title: Through Initial Hospital Discharge
STARTED	13	11
COMPLETED	13	8
NOT COMPLETED	0	3
Period Title: Through Initial Hospital Discharge
STARTED	13	8
COMPLETED	12	6
NOT COMPLETED	1	2
Period Title: Through Initial Hospital Discharge
STARTED	12	6
COMPLETED	8	4
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Operative Rib Fixation	Non-operative Arm	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	13	11	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 92.3%	11 100%	23 95.8%
>=65 years	1 7.7%	0 0%	1 4.2%
Sex: Female, Male (Count of Participants)
Female	3 23.1%	1 9.1%	4 16.7%
Male	10 76.9%	10 90.9%	20 83.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 7.7%	1 9.1%	2 8.3%
Not Hispanic or Latino	8 61.5%	6 54.5%	14 58.3%
Unknown or Not Reported	4 30.8%	4 36.4%	8 33.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 7.7%	1 9.1%	2 8.3%
White	7 53.8%	6 54.5%	13 54.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	5 38.5%	4 36.4%	9 37.5%
Region of Enrollment (participants) [Number]
United States	13 100%	11 100%	24 100%
Mechanism of injury (participants) [Number]
Fall from height	1 7.7%	0 0%	1 4.2%
Motor cycle crash	2 15.4%	5 45.5%	7 29.2%
Motor vehicle crash	7 53.8%	5 45.5%	12 50%
Pedestrian struck	3 23.1%	1 9.1%	4 16.7%
Side & position of flail (participants) [Number]
right side flail	7 53.8%	7 63.6%	14 58.3%
left side flail	6 46.2%	4 36.4%	10 41.7%
Postero-lateral	10 76.9%	9 81.8%	19 79.2%
Antero-lateral	3 23.1%	2 18.2%	5 20.8%

Outcome Measures

1. Primary Outcome

Title	Morbidity
Description	total days on ventilator, ICU length of stay, hospital length of stay
Time Frame	Measured daily during hospitalization (approx 1 month)

Outcome Measure Data

Analysis Population Description

analysis is the mean and standard deviation for # days spent on each item measured

Arm/Group Title	Operative Rib Fixation	Non-operative Arm
Arm/Group Description	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.	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.
Measure Participants	13	11
days on ventilator	12.6 (8.5)	7.0 (4.2)
days in ICU	23.1 (20.3)	13.0 (6.1)
days in hospital	27.4 (18.7)	20.8 (8.8)

2. Primary Outcome

Title	Mortality
Description	Number of participants who died during any hospital stay.
Time Frame	Measured any time during hospital stay (approx 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operative Rib Fixation	Non-operative Arm
Arm/Group Description	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.	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.
Measure Participants	13	11
Number [participants]	0 0%	0 0%

3. Secondary Outcome

Title	Quality of Life
Description	Rand 36 health survey.
Time Frame	Measured at 3 and 6 months post-discharge

Outcome Measure Data

Analysis Population Description

Data not collected - insufficient participants completed follow up visits

Arm/Group Title	Operative Rib Fixation	Non-operative Arm
Arm/Group Description	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.	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.
Measure Participants	0	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected - insufficient participants completed follow up visits

Arm/Group Title	Operative Rib Fixation	Non-operative Arm
Arm/Group Description	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.	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.
Measure Participants	0	0

5. Other Pre-specified Outcome

Title	Still on Narcotics at Post-discharge Follow-up
Description	Number of people still on narcotics at time of routine care post-discharge follow-up
Time Frame	approx 2 weeks post discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operative Rib Fixation	Non-operative Arm
Arm/Group Description	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.	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.
Measure Participants	12	8
Number [participants]	7 53.8%	6 54.5%

Adverse Events

Time Frame	through 6 month post initial hospital discharge
Adverse Event Reporting Description	Only serious adverse events and related adverse events were collected.
Arm/Group Title	Operative Rib Fixation		Non-operative Arm
Arm/Group Description	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		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.
All Cause Mortality
	Operative Rib Fixation		Non-operative Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Operative Rib Fixation		Non-operative Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		2/11 (18.2%)
Cardiac disorders
myocardial infarction	0/13 (0%)	0	1/11 (9.1%)	1
cardiac tamponade	0/13 (0%)	0	1/11 (9.1%)	1
Other (Not Including Serious) Adverse Events
	Operative Rib Fixation		Non-operative Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)

Limitations/Caveats

Subject enrollment too low leading to insufficient data to analyze.

More Information

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.