Flail ChestMatrixRIBNCT00810251
MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry
An observational study of Flail Chest, run by Legacy Biomechanics Laboratory at 1 site in United States.
Trial summary
The purpose of this observational study is to document the treatment of serial rib fractures with MatrixRIB implants in a registry. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Flail Chest
- What is being tested?
- MatrixRIB (FDA Approval # K081623)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to May 2011
- Phase
- Observational
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Flail chest patients admitted to Level I and Level II trauma centers.
Who may be able to join
- Patients with mono-lateral or bi-lateral flail chest injury and paradoxical motion of the chest wall, whereby a flail chest is defined by three or more consecutive ribs broken in at least two locations.
- Male and female patients, ages 21 to 80 years.
- Able and willing to obtain informed consent from patient or next of kin.
- Able and willing to adhere to 3-months follow-up visit
Who cannot join
- Pregnant women
- Patients who are enrolled in another investigational treatment trial.
- Severe closed head injury (AIS head > 3)
- Severe spinal injury with neurological deficit above thoraco-lumbar junction.
- Chronic preexisting heart, pulmonary, hepatic, and/or renal disease.
- Patients who are not expected to survive the follow-up period.
- Patient with an acutely paralyzed hemidiaphragm.
- Considered an inappropriate participant by the study physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Site Prospective, Non-Randomized Observational Study Utilizing MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries
The purpose of this observational study is to document the treatment of serial rib fractures with MatrixRIB implants in a registry.
Read the detailed description
This is a multiple site, prospective, non-randomized single arm observational study. It has been designed to document the treatment of serial rib fractures with MatrixRIB implants in a registry. A flail chest is an injury in which three or more consecutive ribs are broken. This injury causes a segment of the chest wall to become unstable und prevents effective respiration. Non-operative management requires long-term mechanical ventilation and is associated with a mortality rate of 17-47%. Surgical stabilization of the rib fractures has shown to decrease this mortality by 38% - 72%. Surgical stabilization is typically performed with generic plates that require extensive bending during surgery to conform the plate to the rib in a difficult and time-consuming procedure.
The MatrixRIB system is the first implant system that has been specifically designed for fixation of flail chest injuries. It has been developed at Legacy Health System, has been extensively tested in biomechanical studies, and has been approved by the FDA. It provides anatomically contoured rib plates that can reduce the time and complexity of intra-operative plate contouring. These plates will be used in the present study in place of generic plates. It furthermore provides intramedullary rib splints that enable less invasive fixation of posterior rib fractures that are difficult to access for plate fixation.
The primary objective of this study is to document stabilization of flail chest injuries with MatrixRIB implants in a registry. Twenty consecutive patients with flail chest injury that receive surgical stabilization of rib fractures with MatrixRIB implants will be documented in the registry. Data collected will include baseline patient demographics, and information related to injury severity, surgical procedures, and post-operative recovery. The patients' functional outcome will be assessed up to the standard follow-up visit 3 months after surgery.
- Conditions
- Flail Chest
- Being tested
- MatrixRIB (FDA Approval # K081623)
- Keywords
- rib fracture, flail chest, plate, chest trauma, osteosynthesis, mechanical ventilation, respirator
- Medical subject headings
- Flail Chest, Rib Fractures, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatrixRIB (FDA Approval # K081623)Device
Also called rib plates
MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.
| Study group | Role | What they receive |
|---|---|---|
| MatrixRIB | Not described Receives: Device: MatrixRIB (FDA Approval # K081623) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery.
Measured: 3 months post surgery
Secondary outcomes (6)
Length of ICU stay and hospitalization.
Measured: up to 3 months
Incidence of pneumonia, localized infection.
Measured: up to 3 months
Duration of post-operative requirement for ventilatory support
Measured: up to 3 months
Duration of post-operative medication for chest pain
Measured: up to 3 months
RAND 36-Item Short Form Health Survey (SF-36)
Measured: 3 months post surgery
Intra-operative complications related to fixation hardware.
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Biomechanics Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Inc.
- Investigators
- Michael Bottlang, PhD, Principal investigator, Legacy Clinical Research & Technology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810251
- Sponsor's protocol ID
- S08-001
- Acronym
- MatrixRIB
- Status last verified
- Jul 2011
- First submitted
- 16 Dec 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Prospective, Non-Randomized Observational Study Utilizing MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries
- ClinicalTrials.gov ID
- NCT00810251
- Acronym / sponsor ID
- MatrixRIB / S08-001
- Conditions
- Flail Chest
- Keywords
- rib fracture, flail chest, plate, chest trauma, osteosynthesis, mechanical ventilation, respirator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Legacy Biomechanics LaboratoryUniversity, hospital or other
- Collaborators
- Synthes Inc.
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Dec 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.
The purpose of this observational study is to document the treatment of serial rib fractures with MatrixRIB implants in a registry.
Detailed description
This is a multiple site, prospective, non-randomized single arm observational study. It has been designed to document the treatment of serial rib fractures with MatrixRIB implants in a registry. A flail chest is an injury in which three or more consecutive ribs are broken. This injury causes a segment of the chest wall to become unstable und prevents effective respiration. Non-operative management requires long-term mechanical ventilation and is associated with a mortality rate of 17-47%. Surgical stabilization of the rib fractures has shown to decrease this mortality by 38% - 72%. Surgical stabilization is typically performed with generic plates that require extensive bending during surgery to conform the plate to the rib in a difficult and time-consuming procedure.
The MatrixRIB system is the first implant system that has been specifically designed for fixation of flail chest injuries. It has been developed at Legacy Health System, has been extensively tested in biomechanical studies, and has been approved by the FDA. It provides anatomically contoured rib plates that can reduce the time and complexity of intra-operative plate contouring. These plates will be used in the present study in place of generic plates. It furthermore provides intramedullary rib splints that enable less invasive fixation of posterior rib fractures that are difficult to access for plate fixation.
The primary objective of this study is to document stabilization of flail chest injuries with MatrixRIB implants in a registry. Twenty consecutive patients with flail chest injury that receive surgical stabilization of rib fractures with MatrixRIB implants will be documented in the registry. Data collected will include baseline patient demographics, and information related to injury severity, surgical procedures, and post-operative recovery. The patients' functional outcome will be assessed up to the standard follow-up visit 3 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MatrixRIB | – | Device: MatrixRIB (FDA Approval # K081623) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Flail chest patients admitted to Level I and Level II trauma centers.
Key inclusion criteria (4 listed)
- Patients with mono-lateral or bi-lateral flail chest injury and paradoxical motion of the chest wall, whereby a flail chest is defined by three or more consecutive ribs broken in at least two locations.
- Male and female patients, ages 21 to 80 years.
- Able and willing to obtain informed consent from patient or next of kin.
- Able and willing to adhere to 3-months follow-up visit
Key exclusion criteria (8 listed)
- Pregnant women
- Patients who are enrolled in another investigational treatment trial.
- Severe closed head injury (AIS head > 3)
- Severe spinal injury with neurological deficit above thoraco-lumbar junction.
- Chronic preexisting heart, pulmonary, hepatic, and/or renal disease.
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 |
|---|---|---|
| MatrixRIB (FDA Approval # K081623)Also: rib platesMatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures. | Device | MatrixRIB |
Primary outcome
Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery.
Time frame: 3 months post surgery
6 secondary outcomes
Length of ICU stay and hospitalization.
Time frame: up to 3 months
Incidence of pneumonia, localized infection.
Time frame: up to 3 months
Duration of post-operative requirement for ventilatory support
Time frame: up to 3 months
Duration of post-operative medication for chest pain
Time frame: up to 3 months
RAND 36-Item Short Form Health Survey (SF-36)
Time frame: 3 months post surgery
Intra-operative complications related to fixation hardware.
Time frame: intra-operative
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 6 Jul 2011.
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.
Michael Bottlang, PhD principal investigator
Legacy Clinical Research & Technology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flail Chest, run by Legacy Biomechanics Laboratory 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 8 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 6 Jul 2011. 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.
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?
Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery. (time frame: 3 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2011.