Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures
Completed · Not applicable
Conditions studied: Rib Fracture, Flail Chest
In brief
The purpose of this study is to gather information about a device used to help fix broken ribs. Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for the indications of flail chest repair, acute pain control, chest wall defect repair, and rib fracture non-union.
Key facts
- Study ID
- NCT00556543
- Run by
- Oregon Health and Science University
- People needed
- 10
- Starts
- 2006-11-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2011-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must be at least 18 years of age
- Subjects must have one of the four clinical indications listed below:
- Flail chest with failure to wean from ventilator (> 5 days post-injury) and Paradoxical chest wall movement visualized; no significant pulmonary contusion and no significant brain injury
- Painful, displaced rib fractures (acute pain control) and failure of narcotics or epidural pain catheter to control pain; fracture movement exacerbates pain (after 7 - 10 days) and minimal associated injuries
- Chest wall defect/severely displaced fractures and non-repair defect may result in pulmonary hernia and severely displaced fractures are significantly impeding lung expansion in hemi-thorax
- Symptomatic rib fracture non-union and CT scan evidence of fracture non-union at least 2 months post-injury
You may not qualify if…
- Subjects who are enrolled in another investigational treatment trial
- Subjects who have received an investigational drug or device within 30 days of enrollment
- Subjects who are unable to complete the follow-up questionnaires
- Subjects with severe head injuries or other severe associated injuries
- Subjects who are not expected to survive the follow-up period
- Female subjects who are pregnant
- Non-English or English as Second Language speakers
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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