CompletedNot Applicable

Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures

United States10 participantsStarted 2006-11

Plain-language 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.

Who can participate

Age range18 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

✓. 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

What they're measuring

Adverse Post-op Events Related to the Repair and Plating System

Timeframe: 180 days

The Rand 36-Item Health Survey Results - Physical Functioning Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Vitality Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Emotional Well-being Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Social Functioning Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Trial details

NCT IDNCT00556543

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-10

Results submitted2011-03-17

View on ClinicalTrials.gov More Rib Fracture trials

Plain-language summary

Who can participate

Age range18 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

✓. 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

What they're measuring

Adverse Post-op Events Related to the Repair and Plating System

Timeframe: 180 days

The Rand 36-Item Health Survey Results - Physical Functioning Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Vitality Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Emotional Well-being Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

The Rand 36-Item Health Survey Results - Social Functioning Scale

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days