MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry
MatrixRIB
A Multi-Site Prospective, Non-Randomized Observational Study Utilizing MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries
1 other identifier
observational
20
1 country
1
Brief Summary
The purpose of this observational study is to document the treatment of serial rib fractures with MatrixRIB implants in a registry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJuly 6, 2011
July 1, 2011
2.3 years
December 16, 2008
July 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery.
3 months post surgery
Secondary Outcomes (6)
Length of ICU stay and hospitalization.
up to 3 months
Incidence of pneumonia, localized infection.
up to 3 months
Duration of post-operative requirement for ventilatory support
up to 3 months
Duration of post-operative medication for chest pain
up to 3 months
RAND 36-Item Short Form Health Survey (SF-36)
3 months post surgery
- +1 more secondary outcomes
Study Arms (1)
MatrixRIB
Interventions
MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.
Eligibility Criteria
Flail chest patients admitted to Level I and Level II trauma centers.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Legacy Biomechanics Laboratorylead
- Synthes Inc.collaborator
Study Sites (1)
Legacy Emanuel Hospital
Portland, Oregon, 97227, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bottlang, PhD
Legacy Clinical Research & Technology Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 18, 2008
Study Start
December 1, 2008
Primary Completion
April 1, 2011
Study Completion
May 1, 2011
Last Updated
July 6, 2011
Record last verified: 2011-07