Clinical Trials Directory

Trials / Completed

CompletedNCT00842101

Compartmental Overpressures Associated to Reamed Intramedullary Nails

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

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
University of Andorra · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
DEVICEQuick Pressure MonitorThe monitor measures actively the actual pressure inside the compartment affected.

Timeline

Start date
2005-12-01
Primary completion
2008-04-01
Completion
2008-09-01
First posted
2009-02-12
Last updated
2009-02-12

Locations

1 site across 1 country: Andorra

Source: ClinicalTrials.gov record NCT00842101. Inclusion in this directory is not an endorsement.