Compartmental Overpressures Associated to Reamed Intramedullary Nails

February 11, 2009 updated by: University of Andorra

Effect of Reamed Intramedullary Nails in Tibial Fractures as a Factor of Rising Intracompartmental Pressures: A Clinical Study

The purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compartmental overpressure is a serious problem in relation to the treatment of tibial shaft fractures. When reamed intramedullary nails are used, the risk of suffering a compartmental syndrome must be in mind of surgeons. Diagnostic of compartmental syndrome could be difficult just after the surgical intervention, because the patient is under conditions of regional anesthesia or opioids and analgesics, which could mask the symptomatology. In fact, when there is a great suspicion of this syndrome, we recommend measuring compartmental pressures; therefore, physicians might apply the term delta-P value, which is the result of the mean arterial pressure minus compartmental pressure. If this one is less than 30 mm Hg, a fasciotomy should be performed even when the clinical diagnostic is not clear.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Andorra
      • Escaldes, Andorra, AD700
        • Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with tibial shaft fractures

Description

Inclusion Criteria:

  • Tibial shaft fractures treated with intramedullary reamed nails

Exclusion Criteria:

  • Tibial fractures treated with other types of fixation or nails not reamed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pressure monitor
Tibial Fracture
Device: Quick Pressure Monitor
The monitor measures actively the actual pressure inside the compartment affected.
Other Names:
  • Slit catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intracompartmental pressures
Time Frame: 0-2 hours
0-2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Andorra

Investigators

  • Principal Investigator: JOSE I TORRERO, M.D., Orthopaedic and Trauma Unit. Andorra´s Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UA002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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