Compartmental Overpressures Associated to Reamed Intramedullary Nails

NCT ID: NCT00842101

Last Updated: 2009-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-09-30

Brief Summary

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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

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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

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Tibial Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pressure monitor

Tibial Fracture

Quick Pressure Monitor

Intervention Type DEVICE

The monitor measures actively the actual pressure inside the compartment affected.

Interventions

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Quick Pressure Monitor

The monitor measures actively the actual pressure inside the compartment affected.

Intervention Type DEVICE

Other Intervention Names

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Slit catheter

Eligibility Criteria

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Inclusion Criteria

* Tibial shaft fractures treated with intramedullary reamed nails

Exclusion Criteria

* Tibial fractures treated with other types of fixation or nails not reamed.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Andorra

OTHER

Sponsor Role lead

Responsible Party

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ORTHOPAEDIC AND TRAUMA UNIT. ANDORRA´S HOSPITAL

Principal Investigators

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JOSE I TORRERO, M.D.

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic and Trauma Unit. Andorra´s Hospital

Locations

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Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital

Les Escaldes, , Andorra

Site Status

Countries

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Andorra

Other Identifiers

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UA002

Identifier Type: -

Identifier Source: org_study_id

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