Status:
COMPLETED
MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry
Lead Sponsor:
Legacy Biomechanics Laboratory
Collaborating Sponsors:
Synthes Inc.
Conditions:
Flail Chest
Eligibility:
All Genders
21-80 years
Brief Summary
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 fla...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00810251
Start Date
December 1 2008
End Date
May 1 2011
Last Update
July 6 2011
Active Locations (1)
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1
Legacy Emanuel Hospital
Portland, Oregon, United States, 97227