MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry (NCT00810251) | Clinical Trial Compass
CompletedNot Applicable
MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry
United States20 participantsStarted 2008-12
Plain-language summary
The purpose of this observational study is to document the treatment of serial rib fractures with MatrixRIB implants in a registry.
Who can participate
Age range21 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery.