Rib FracturePhase 4NCT00774618
Evaluation of Surgical Treatment on Pain and Disability for Chronic, Non-healing Rib Fracture
A Phase 4 study testing Resection with or without plate fixation in people with Rib Fracture, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Individuals with non-healing rib fractures may experience significant pain and disability. This is called rib fracture non-union, an unusual problem and one that most physicians have little experience with. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture
- What is being tested?
- Resection with or without plate fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be at least 18 years of age
- Subjects must have rib fracture non-union (3 months or greater since injury), confirmed with Chest CT or MRI
- The subject will have signed an IRB approved written informed consent and HIPAA authorization to participate in the study
- Subjects will be able to participate in interviews with study staff and complete study surveys reliably
Who cannot join
- Subjects who are enrolled in another investigational treatment trial
- Subjects who have received an investigational drug or device within 30 days of enrollment
- Female subjects who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Prospective Trial of Operative Management of Rib Fracture Non-Union
Individuals with non-healing rib fractures may experience significant pain and disability. This is called rib fracture non-union, an unusual problem and one that most physicians have little experience with. The investigators hypothesize that surgical repair of rib fracture non-union is clinically efficacious and safe in 6 month follow-up. The objective of this study is to evaluate how repairing non-healing rib fractures affects pain and disability.
Read the detailed description
Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 350,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2006. The Healthcare Cost and Utilization Project's Nationwide Inpatient Sample for the year 2003 indicated that 102,000 patients with rib fractures were admitted to U.S. hospitals, representing 7 % of all injured patients.
Within the past decade a subgroup of patients with symptomatic rib fracture non-unions has been identified. These are patients who present to primary care physicians and surgical clinics more than 3 months, or in some cases several years, following a rib fracture injury with complaints of rib pain associated with persistent fracture movement. They are usually told by their physician that surgical intervention is either unnecessary or fruitless and are treated with chronic pain management regimens. The true incidence and the long-term outcome of this syndrome are completely unknown.
At OHSU, the investigators have had a long interest in the indications for and the outcomes of rib fracture repair. One of the first of three nearly simultaneous reports of successful surgical intervention of symptomatic rib fracture non-union originated here at OHSU in 2001. Two other successful case reports have appeared more recently. The investigators are currently being contacted frequently by patients or their physicians, mostly out of state, for consideration of rib fracture non-union repair. Our ongoing experience with rib fracture non-union repair has been favorable, but the investigators believe that a prospective clinical study with at least 6 months of post-operative outcome is necessary. In addition, because the insurance company approval process for surgical intervention for rib fracture non-union is often 2 - 3 months and occasionally longer, the investigators have an opportunity to follow the intermediate-term natural history of rib fracture non-unions for several months prior to surgical intervention.
The rationale for conducting this study is to demonstrate in a prospective study that the RibLoc ® repair system is durable and safe in a population of patients with rib fracture non-union. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that to establish the clinical benefit of the RibLoc ® device for non-union repair, prospectively collected outcome data are necessary. Investigators may use other FDA approved devices (i.e. BioBridge ™ Bioresorbable Bone Fracture Plate), or determine that no device is indicated (i.e. rib resection without hardware). The investigators expect to learn about clinical outcomes for surgical care in this group of patients, both with the use of a device, and without.
- Conditions
- Rib Fracture
- Being tested
- Resection with or without plate fixation
- Keywords
- Rib Fracture, Thoracic Injuries, Flail Chest, Rib Fracture Repair, Rib Fracture ORIF, Chronic rib fractures, Non-healing rib fractures, Rib Fracture Non-union
- Medical subject headings
- Rib Fractures, Thoracic Injuries, Flail Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection with or without plate fixationDevice
Some enrolled subjects will undergo rib fracture surgery at OHSU. Devices used in the repair of rib fracture non-union could include RibLoc® or BioBridge ™. RibLoc® is a U-shaped permanent device that secures to the rib with screws locking from the front to the back of the metal plate (through the rib). BioBridge ™ is a resorbable, non-permanent device that stabilizes the ribs. Both devices are designed to stabilize the rib fracture non-union and promote healing of the non-union rib. For some patients, it may be determined that resection of the rib fracture non-union without an implanted device is the most appropriate treatment. The goal of surgical intervention is to improve the pain and disability associated with rib fracture non-union in appropriate patients.
| Study group | Role | What they receive |
|---|---|---|
| Resection | Experimental | Those subjects undergoing resection with or without plate fixation Receives: Device: Resection with or without plate fixation |
| Nonoperative | No intervention | These patients were not considered candidates for surgical intervention by the investigators, declined surgical intervention, or did not receive insurance approval for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of employment or disability status
Measured: At study entry (day 1) and 2 month intervals for up to 12 months.
Secondary outcomes (3)
quality of life evaluation
(Rand 36-Item Short Form Health Survey)
Measured: At study entry (day 1) and 2 month intervals for up to 12 months.
an assessment of rib fracture pain
McGill Pain Questionnaire or MPQ
Measured: At study entry (day 1) and 2 month intervals for up to 12 months.
complications related to injury or treatment
Measured: At study entry (day 1) and 2 month intervals for up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rib FractureStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- ACUTE Innovations, LLC
- Responsible party
- Principal investigator, John C. Mayberry, Oregon Health and Science University
- Investigators
- John C Mayberry, MD, FACS, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774618
- Sponsor's protocol ID
- IRB e4073
- Status last verified
- Mar 2013
- First submitted
- 16 Oct 2008
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cacchione RN, Richardson JD, Seligson D. Painful nonunion of multiple rib fractures managed by operative stabilization. J Trauma. 2000 Feb;48(2):319-21. doi: 10.1097/00005373-200002000-00023. No abstract available.
PubMed 10697096Ng AB, Giannoudis PV, Bismil Q, Hinsche AF, Smith RM. Operative stabilisation of painful non-united multiple rib fractures. Injury. 2001 Oct;32(8):637-9. doi: 10.1016/s0020-1383(01)00017-1. No abstract available.
PubMed 11587704Slater MS, Mayberry JC, Trunkey DD. Operative stabilization of a flail chest six years after injury. Ann Thorac Surg. 2001 Aug;72(2):600-1. doi: 10.1016/s0003-4975(00)02262-1.
PubMed 11515905Beelen R, Rumbaut J, De Geest R. Surgical stabilization of a rib fracture using an angle stable plate. J Trauma. 2007 Nov;63(5):1159-60. doi: 10.1097/01.ta.0000222536.91745.b4. No abstract available.
PubMed 17514061Richardson JD, Franklin GA, Heffley S, Seligson D. Operative fixation of chest wall fractures: an underused procedure? Am Surg. 2007 Jun;73(6):591-6; discussion 596-7.
PubMed 17658097Sales JR, Ellis TJ, Gillard J, Liu Q, Chen JC, Ham B, Mayberry JC. Biomechanical testing of a novel, minimally invasive rib fracture plating system. J Trauma. 2008 May;64(5):1270-4. doi: 10.1097/TA.0b013e31804a7fd5.
PubMed 18469649Nirula R, Diaz JJ Jr, Trunkey DD, Mayberry JC. Rib fracture repair: indications, technical issues, and future directions. World J Surg. 2009 Jan;33(1):14-22. doi: 10.1007/s00268-008-9770-y.
PubMed 18949513
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Operative Management of Rib Fracture Non-Union
- ClinicalTrials.gov ID
- NCT00774618
- Acronym / sponsor ID
- IRB e4073
- Conditions
- Rib Fracture
- Keywords
- Rib Fracture, Thoracic Injuries, Flail Chest, Rib Fracture Repair, Rib Fracture ORIF, Chronic rib fractures, Non-healing rib fractures, Rib Fracture Non-union
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- ACUTE Innovations, LLC
- Study start
- Oct 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with non-healing rib fractures may experience significant pain and disability. This is called rib fracture non-union, an unusual problem and one that most physicians have little experience with. The investigators hypothesize that surgical repair of rib fracture non-union is clinically efficacious and safe in 6 month follow-up. The objective of this study is to evaluate how repairing non-healing rib fractures affects pain and disability.
Detailed description
Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 350,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2006. The Healthcare Cost and Utilization Project's Nationwide Inpatient Sample for the year 2003 indicated that 102,000 patients with rib fractures were admitted to U.S. hospitals, representing 7 % of all injured patients.
Within the past decade a subgroup of patients with symptomatic rib fracture non-unions has been identified. These are patients who present to primary care physicians and surgical clinics more than 3 months, or in some cases several years, following a rib fracture injury with complaints of rib pain associated with persistent fracture movement. They are usually told by their physician that surgical intervention is either unnecessary or fruitless and are treated with chronic pain management regimens. The true incidence and the long-term outcome of this syndrome are completely unknown.
At OHSU, the investigators have had a long interest in the indications for and the outcomes of rib fracture repair. One of the first of three nearly simultaneous reports of successful surgical intervention of symptomatic rib fracture non-union originated here at OHSU in 2001. Two other successful case reports have appeared more recently. The investigators are currently being contacted frequently by patients or their physicians, mostly out of state, for consideration of rib fracture non-union repair. Our ongoing experience with rib fracture non-union repair has been favorable, but the investigators believe that a prospective clinical study with at least 6 months of post-operative outcome is necessary. In addition, because the insurance company approval process for surgical intervention for rib fracture non-union is often 2 - 3 months and occasionally longer, the investigators have an opportunity to follow the intermediate-term natural history of rib fracture non-unions for several months prior to surgical intervention.
The rationale for conducting this study is to demonstrate in a prospective study that the RibLoc ® repair system is durable and safe in a population of patients with rib fracture non-union. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that to establish the clinical benefit of the RibLoc ® device for non-union repair, prospectively collected outcome data are necessary. Investigators may use other FDA approved devices (i.e. BioBridge ™ Bioresorbable Bone Fracture Plate), or determine that no device is indicated (i.e. rib resection without hardware). The investigators expect to learn about clinical outcomes for surgical care in this group of patients, both with the use of a device, and without.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resection | Experimental | Device: Resection with or without plate fixationThose subjects undergoing resection with or without plate fixation |
| Nonoperative | No intervention | –These patients were not considered candidates for surgical intervention by the investigators, declined surgical intervention, or did not receive insurance approval for surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be at least 18 years of age
- Subjects must have rib fracture non-union (3 months or greater since injury), confirmed with Chest CT or MRI
- The subject will have signed an IRB approved written informed consent and HIPAA authorization to participate in the study
- Subjects will be able to participate in interviews with study staff and complete study surveys reliably
Key exclusion criteria (3 listed)
- Subjects who are enrolled in another investigational treatment trial
- Subjects who have received an investigational drug or device within 30 days of enrollment
- Female subjects who are pregnant
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 |
|---|---|---|
| Resection with or without plate fixationSome enrolled subjects will undergo rib fracture surgery at OHSU. Devices used in the repair of rib fracture non-union could include RibLoc® or BioBridge ™. RibLoc® is a U-shaped permanent device that secures to the rib with screws locking from the front to the back of the metal plate (through the rib). BioBridge ™ is a resorbable, non-permanent device that stabilizes the ribs. Both devices are designed to stabilize the rib fracture non-union and promote healing of the non-union rib. For some patients, it may be determined that resection of the rib fracture non-union without an implanted device is the most appropriate treatment. The goal of surgical intervention is to improve the pain and disability associated with rib fracture non-union in appropriate patients. | Device | Resection |
Primary outcome
Evaluation of employment or disability status
Time frame: At study entry (day 1) and 2 month intervals for up to 12 months.
3 secondary outcomes
quality of life evaluation
Time frame: At study entry (day 1) and 2 month intervals for up to 12 months.
an assessment of rib fracture pain
Time frame: At study entry (day 1) and 2 month intervals for up to 12 months.
complications related to injury or treatment
Time frame: At study entry (day 1) and 2 month intervals for up to 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
- Background: PubMed 10697096Cacchione RN, Richardson JD, Seligson D. Painful nonunion of multiple rib fractures managed by operative stabilization. J Trauma. 2000 Feb;48(2):319-21. doi: 10.1097/00005373-200002000-00023. No abstract available.
- Background: PubMed 11587704Ng AB, Giannoudis PV, Bismil Q, Hinsche AF, Smith RM. Operative stabilisation of painful non-united multiple rib fractures. Injury. 2001 Oct;32(8):637-9. doi: 10.1016/s0020-1383(01)00017-1. No abstract available.
- Background: PubMed 11515905Slater MS, Mayberry JC, Trunkey DD. Operative stabilization of a flail chest six years after injury. Ann Thorac Surg. 2001 Aug;72(2):600-1. doi: 10.1016/s0003-4975(00)02262-1.
- Background: PubMed 17514061Beelen R, Rumbaut J, De Geest R. Surgical stabilization of a rib fracture using an angle stable plate. J Trauma. 2007 Nov;63(5):1159-60. doi: 10.1097/01.ta.0000222536.91745.b4. No abstract available.
- Background: PubMed 17658097Richardson JD, Franklin GA, Heffley S, Seligson D. Operative fixation of chest wall fractures: an underused procedure? Am Surg. 2007 Jun;73(6):591-6; discussion 596-7.
- Background: PubMed 18469649Sales JR, Ellis TJ, Gillard J, Liu Q, Chen JC, Ham B, Mayberry JC. Biomechanical testing of a novel, minimally invasive rib fracture plating system. J Trauma. 2008 May;64(5):1270-4. doi: 10.1097/TA.0b013e31804a7fd5.
- Background: PubMed 18949513Nirula R, Diaz JJ Jr, Trunkey DD, Mayberry JC. Rib fracture repair: indications, technical issues, and future directions. World J Surg. 2009 Jan;33(1):14-22. doi: 10.1007/s00268-008-9770-y.
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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.
John C Mayberry, MD, FACS principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resection with or without plate fixation in people with Rib Fracture, run by Oregon Health and Science University at 1 site 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of employment or disability status (time frame: At study entry (day 1) and 2 month intervals for up to 12 months.). 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 NCT00774618, which also lists 7 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 22 Mar 2013.