Trial Outcomes & Findings for Flail Chest - Rib Fixation Study (NCT NCT01147471)
NCT ID: NCT01147471
Last Updated: 2015-08-06
Results Overview
total days on ventilator, ICU length of stay, hospital length of stay
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Measured daily during hospitalization (approx 1 month)
Results posted on
2015-08-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Through Initial Hospital Discharge
STARTED
|
13
|
11
|
|
Through Initial Hospital Discharge
COMPLETED
|
13
|
11
|
|
Through Initial Hospital Discharge
NOT COMPLETED
|
0
|
0
|
|
Post-discharge Follow Up (Approx 2 Wks)
STARTED
|
13
|
11
|
|
Post-discharge Follow Up (Approx 2 Wks)
COMPLETED
|
13
|
8
|
|
Post-discharge Follow Up (Approx 2 Wks)
NOT COMPLETED
|
0
|
3
|
|
3 Month Follow Up
STARTED
|
13
|
8
|
|
3 Month Follow Up
COMPLETED
|
12
|
6
|
|
3 Month Follow Up
NOT COMPLETED
|
1
|
2
|
|
6 Month Follow Up
STARTED
|
12
|
6
|
|
6 Month Follow Up
COMPLETED
|
8
|
4
|
|
6 Month Follow Up
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Post-discharge Follow Up (Approx 2 Wks)
Lost to Follow-up
|
0
|
1
|
|
Post-discharge Follow Up (Approx 2 Wks)
Withdrawal by Subject
|
0
|
1
|
|
Post-discharge Follow Up (Approx 2 Wks)
incarcerated
|
0
|
1
|
|
3 Month Follow Up
Lost to Follow-up
|
1
|
1
|
|
3 Month Follow Up
Physician Decision
|
0
|
1
|
|
6 Month Follow Up
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Flail Chest - Rib Fixation Study
Baseline characteristics by cohort
| Measure |
Operative Rib Fixation
n=13 Participants
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
n=11 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Mechanism of injury
Fall from height
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Mechanism of injury
Motor cycle crash
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Mechanism of injury
Motor vehicle crash
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Mechanism of injury
Pedestrian struck
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Side & position of flail
right side flail
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Side & position of flail
left side flail
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Side & position of flail
Postero-lateral
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Side & position of flail
Antero-lateral
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured daily during hospitalization (approx 1 month)Population: analysis is the mean and standard deviation for # days spent on each item measured
total days on ventilator, ICU length of stay, hospital length of stay
Outcome measures
| Measure |
Operative Rib Fixation
n=13 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Morbidity
days in ICU
|
23.1 days
Standard Deviation 20.3
|
13.0 days
Standard Deviation 6.1
|
|
Morbidity
days on ventilator
|
12.6 days
Standard Deviation 8.5
|
7.0 days
Standard Deviation 4.2
|
|
Morbidity
days in hospital
|
27.4 days
Standard Deviation 18.7
|
20.8 days
Standard Deviation 8.8
|
PRIMARY outcome
Timeframe: Measured any time during hospital stay (approx 30 days)Number of participants who died during any hospital stay.
Outcome measures
| Measure |
Operative Rib Fixation
n=13 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Mortality
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at 3 and 6 months post-dischargePopulation: Data not collected - insufficient participants completed follow up visits
Rand 36 health survey.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at 3 and 6 months post-dischargePopulation: Data not collected - insufficient participants completed follow up visits
Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: approx 2 weeks post dischargeNumber of people still on narcotics at time of routine care post-discharge follow-up
Outcome measures
| Measure |
Operative Rib Fixation
n=12 Participants
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
n=8 Participants
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.
|
|---|---|---|
|
Still on Narcotics at Post-discharge Follow-up
|
7 participants
|
6 participants
|
Adverse Events
Operative Rib Fixation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-operative Arm
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Operative Rib Fixation
n=13 participants at risk
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
|
Non-operative Arm
n=11 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/13 • through 6 month post initial hospital discharge
Only serious adverse events and related adverse events were collected.
|
9.1%
1/11 • Number of events 1 • through 6 month post initial hospital discharge
Only serious adverse events and related adverse events were collected.
|
|
Cardiac disorders
cardiac tamponade
|
0.00%
0/13 • through 6 month post initial hospital discharge
Only serious adverse events and related adverse events were collected.
|
9.1%
1/11 • Number of events 1 • through 6 month post initial hospital discharge
Only serious adverse events and related adverse events were collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place