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

NCT00556543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-07-01

Study results available
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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.

Conditions

  • Rib Fracture
  • Flail Chest

Interventions

DEVICE

U-plate fracture repair system

All subjects meeting inclusion criteria will undergo surgery for the repair of their fractured rib/s using the U-plate device. Subjects will be monitored daily during the entire course of their hospitalization for adverse experiences. Subjects will be contacted by phone to complete the MPQ and SF-36 Health Survey. Subjects will be asked if and when they have returned to work or to their previous level of functioning. Subjects will be asked if they had any complications or problems associated with their surgery.

Sponsors & Collaborators

  • ACUTE Innovations, LLC

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • John C. Mayberry, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00556543 on ClinicalTrials.gov