Flail ChestNCT01147471
Flail Chest - Rib Fixation Study
A study testing operative rib fixation and operative rib fixation surgery in people with Flail Chest, run by Virginia Commonwealth University at 7 sites in United States.
Trial summary
The purpose of this study is to determine whether operative fixation of unilateral flail chest provides greater benefit than non-operative treatment. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Flail Chest
- What is being tested?
- operative rib fixation and operative rib fixation surgery
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >21 years and <75 years
- "Stove-in chest" to encompass both
- Unilateral flail chest (>3 ribs fractured at two places) or
- Contiguous rib fractures with at least 2 ribs pushed in > the rib diameter of the pushed in rib
- Mechanically ventilated
Who cannot join
- Patient unlikely to survive due to the trauma or age or multiple co-morbidities
- Stove-in chest patients that do not require early (less than or equal to 48 hours of injury) ventilatory support
- Bilateral flail chest
- Sternal flail
- P/F ratio < 200:1 over a period of greater than or equal to 6 hours while on the ventilator.
- 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.
Show all 14Show fewer
- Any contra-indication to surgery including severe immunosuppression or severe chronic disease making elective surgery dangerous in the opinion of the surgeon
- Inability to proceed with any aspect of critical care due to personal beliefs, living will etc eg non acceptance of blood products
- Inability to obtain informed consent.
- Subject's refusal for follow up
- Pregnant women
- Prisoners
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Trauma Research & Education Foundation of Fresno
Fresno, California, 93721
The University of Tennessee
Knoxville, Tennessee, 37920
Eastern Virginia Medical School
Norfolk, Virginia, 23507
The Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, 73104
Virginia Commonwealth University
Richmond, Virginia, 23298
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Flail Chest
- Being tested
- operative rib fixation, operative rib fixation surgery
- Keywords
- flail chest, rib fixation
- Medical subject headings
- Flail Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operative rib fixationDevice
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 fixation surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: operative rib fixation; Procedure: operative rib fixation surgery |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
total days on ventilator, ICU length of stay, hospital length of stay
Measured: Measured daily during hospitalization (approx 1 month)
Mortality
Number of participants who died during any hospital stay.
Measured: Measured any time during hospital stay (approx 30 days)
Secondary outcomes (2)
Quality of Life
Rand 36 health survey.
Measured: 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).
Measured: Measured at 3 and 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Flail ChestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Inc.
- Responsible party
- Sponsor
- Investigators
- Ajai K Malhotra, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147471
- Sponsor's protocol ID
- VCU-20100582
- Status last verified
- Aug 2015
- First submitted
- 7 Jun 2010
- Last updated
- 6 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 16676852Baker 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.
PubMed 7396078Shorr 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.
PubMed 3656472LoCicero 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.
PubMed 2911786Shackford 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.
PubMed 998864Relihan 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.
PubMed 4720987Landercasper 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.
PubMed 6716518Sankaran S, Wilson RF. Factors affecting prognosis in patients with flail chest. J Thorac Cardiovasc Surg. 1970 Sep;60(3):402-10. No abstract available.
PubMed 5271286Menard 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.
PubMed 6876866Paris 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.
PubMed 1105874Thomas 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.
PubMed 661347Landreneau 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.
PubMed 1998429Engel 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.
PubMed 15674171Lardinois 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.
PubMed 11509269Ahmed 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.
PubMed 8523879
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flail Chest: Early Operative Fixation Versus Non-operative Management - a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01147471
- Acronym / sponsor ID
- VCU-20100582
- Conditions
- Flail Chest
- Keywords
- flail chest, rib fixation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Synthes Inc.
- Study start
- Sep 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 6 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether operative fixation of unilateral flail chest provides greater benefit than non-operative treatment.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative rib fixation | Active comparator | Device: operative rib fixation, Procedure: operative rib fixation surgeryRandomized 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults >21 years and <75 years
- "Stove-in chest" to encompass both
- Mechanically ventilated
Key exclusion criteria (14 listed)
- Patient unlikely to survive due to the trauma or age or multiple co-morbidities
- Stove-in chest patients that do not require early (less than or equal to 48 hours of injury) ventilatory support
- Bilateral flail chest
- Sternal flail
- P/F ratio < 200:1 over a period of greater than or equal to 6 hours while on the ventilator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| operative rib fixationRandomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system. | Device | Operative rib fixation |
| operative rib fixation surgery | Procedure or surgery | Operative rib fixation |
Primary outcome
Morbidity
Time frame: Measured daily during hospitalization (approx 1 month)
total days on ventilator, ICU length of stay, hospital length of stay
Mortality
Time frame: Measured any time during hospital stay (approx 30 days)
Number of participants who died during any hospital stay.
2 secondary outcomes
Quality of Life
Time frame: Measured at 3 and 6 months post-discharge
Pulmonary Function
Time frame: Measured at 3 and 6 months post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16676852Nirula 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.
- Background: PubMed 7396078Baker 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.
- Background: PubMed 3656472Shorr 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.
- Background: PubMed 2911786LoCicero 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.
- Background: PubMed 998864Shackford 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.
- Background: PubMed 4720987Relihan 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.
- Background: PubMed 6716518Landercasper 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.
- Background: PubMed 5271286Sankaran S, Wilson RF. Factors affecting prognosis in patients with flail chest. J Thorac Cardiovasc Surg. 1970 Sep;60(3):402-10. No abstract available.
- Background: PubMed 6876866Menard 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.
- Background: PubMed 1105874Paris 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.
- Background: PubMed 661347Thomas 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.
- Background: PubMed 1998429Landreneau 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.
Related trials for Flail Chest
Not yet recruiting
Surgery for Unstable Chest Wall Injuries - How Many Fractures Should be Fixed?
Rib Fracture Multiple, Flail Chest
Recruiting
UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture
Rib Fractures, Rib Fracture Multiple
RecruitingObservational study
RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Rib; Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajai K Malhotra, MD principal investigator
Virginia Commonwealth University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing operative rib fixation and operative rib fixation surgery in people with Flail Chest, run by Virginia Commonwealth University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: Measured daily during hospitalization (approx 1 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147471, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.