NCT00926991

Brief Summary

This is a prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 22, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

June 22, 2009

Last Update Submit

March 21, 2011

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (3)

  • pain scales

    daily

  • ventilator requirement

    daily

  • hospital days

    discharge

Study Arms (1)

traumatic rib fractures

Other: No intervention

Interventions

No interventionOTHER

No intervention; observation only

traumatic rib fractures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Vanderbilt University Trauma Center.

You may qualify if:

  • Subjects must be at least \>18 years of age
  • Subjects must have one of the following clinical indications:
  • \>3 rib flail segments with paradoxical chest wall movement
  • Non-repair of defect may result in pulmonary hernia
  • Minimal associated injuries
  • Severely displaced fractures are significantly impeding lung expansion.
  • Failure of narcotics or epidural pain catheter to control pain

You may not qualify if:

  • Significant pulmonary contusion
  • Significant brain injury (AIS 4 and/or ICP monitoring)
  • Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization
  • Subjects not expected to survive the 90-day follow-up period
  • Known pregnancy
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Study Officials

  • Jose J Diaz, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

March 22, 2011

Record last verified: 2011-03

Locations

US(1)