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Evaluation of Surgical Treatment on Pain and Disability for Chronic, Non-healing Rib Fracture

NCT00774618 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-03-22

No results posted yet for this study

Summary

Individuals with non-healing rib fractures may experience significant pain and disability. This is called rib fracture non-union, an unusual problem and one that most physicians have little experience with. The investigators hypothesize that surgical repair of rib fracture non-union is clinically efficacious and safe in 6 month follow-up. The objective of this study is to evaluate how repairing non-healing rib fractures affects pain and disability.

Conditions

  • Rib Fracture

Interventions

DEVICE

Resection with or without plate fixation

Some enrolled subjects will undergo rib fracture surgery at OHSU. Devices used in the repair of rib fracture non-union could include RibLoc® or BioBridge ™. RibLoc® is a U-shaped permanent device that secures to the rib with screws locking from the front to the back of the metal plate (through the rib). BioBridge ™ is a resorbable, non-permanent device that stabilizes the ribs. Both devices are designed to stabilize the rib fracture non-union and promote healing of the non-union rib. For some patients, it may be determined that resection of the rib fracture non-union without an implanted device is the most appropriate treatment. The goal of surgical intervention is to improve the pain and disability associated with rib fracture non-union in appropriate patients.

Sponsors & Collaborators

  • ACUTE Innovations, LLC

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-08-31
Completion
2011-12-31

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 NCT00774618 on ClinicalTrials.gov