N/A
N=10
Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures
Rib Fracture · Flail Chest
Bottom Line
View on ClinicalTrials.gov: NCT00556543 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: Adverse Post-op Events Related to the Repair and Plating System — 1; 3 Participants — p=0.190
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- U-plate fracture repair system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Post-op Events Related to the Repair and Plating System |
1; 3 | 0.190 |
| PRIMARY The Rand 36-Item Health Survey Results - Physical Functioning Scale |
65.6 | — |
| PRIMARY The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale |
33.3 | — |
| PRIMARY The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale |
81.4 | — |
| PRIMARY The Rand 36-Item Health Survey Results - Vitality Scale |
57.2 | — |
| PRIMARY The Rand 36-Item Health Survey Results - Emotional Well-being Scale |
73.3 | — |
| PRIMARY The Rand 36-Item Health Survey Results - Social Functioning Scale |
76.4 | — |
| PRIMARY The Rand 36-Item Health Survey Results - Bodily Pain Scale |
66.0 | — |
| PRIMARY The Rand 36-Item Health Survey Results - General Health Scale |
62.2 | — |
| PRIMARY The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI) |
1.22 | — |
| PRIMARY The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI) |
17.78 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00556543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.