Compartmental Overpressures Associated to Reamed Intramedullary Nails

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842101
• Other study ID #: UA002
• Status: Completed
• Phase: N/A
• First received: February 10, 2009
• Last updated: February 11, 2009
• Start date: December 2005
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• Source: University of Andorra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Andorra: Ministeri de Salut i Benestar
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tibial Fractures

Intervention

Device:
• Quick Pressure Monitor
The monitor measures actively the actual pressure inside the compartment affected.

Locations

Country	Name	City	State
Andorra	Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital	Escaldes

Sponsors (1)

Lead Sponsor	Collaborator
University of Andorra

Country where clinical trial is conducted

Andorra, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracompartmental pressures		0-2 hours	Yes