Rib Fracture Clinical Trial
Official title:
Clinical Evaluation of the U-plate Fracture Repair System for the Fixation of Rib Fractures
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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