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Clinical Trial 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.


Clinical Trial Description

Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 300,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2004. Rib fracture patients are significantly more disabled at 30 days post-injury than patients with chronic medical illness and lose an average of 70 days of work or usual activity during their acute recovery.

The rationale for conducting this study is to demonstrate in a prospective study that the U-plate repair system is durable and safe. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that in order for the U-plate to be widely accepted, prospectively collected outcome data are necessary.

With the goal of improving the durability of fixation of rib fractures over the techniques currently available and with the additional goal of developing a minimally invasive technique, a U-shaped plate was developed. The design of the U-plate theoretically overcomes the inherent softness of the human rib by grasping the rib over its superior margin and by securing the plate with anterior to posterior locking screws that do not rely on screw purchase in bone. Thus much of the strength and durability of the fixation is transferred from the relatively soft rib to the plate itself. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00556543
Study type Interventional
Source Oregon Health and Science University
Contact
Status Completed
Phase N/A
Start date November 2006
Completion date October 2008

See also
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Completed NCT02749968 - Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma Phase 2
Completed NCT02487264 - Analysis of the Status, Treatment and Outcomes of Rib Fractures
Completed NCT02028611 - Comparison of Gray-scale Inverted Rib Series With Conventional Ones in Rib Fracture Detection by Emergency Physicians and Medical Students N/A
Terminated NCT03846024 - Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function N/A
Active, not recruiting NCT01367951 - Treatment of Acute, Unstable Chest Wall Injuries N/A
Terminated NCT01327287 - Early Aggressive Pain Management is Associated With Improved Outcomes in Blunt Thoracic Trauma N/A
Recruiting NCT02595593 - Rib Fixation for Clinically Severe Rib Fractures From Trauma N/A