Compartmental Overpressures Associated to Reamed Intramedullary Nails

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.

Completed

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Key information

Conditions

Tibial Fractures Cardiovascular Diseases Compartment Syndromes Fractures, Bone Leg Injuries Muscular Diseases Musculoskeletal Diseases Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital

Les Escaldes, AD700, Andorra

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Tibial shaft fractures treated with intramedullary reamed nails

Exclusion criteria

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

Treatment and study plan

Quick Pressure Monitor

Device

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

Other names: Slit catheter

Primary outcomes

intracompartmental pressures

Time frame: 0-2 hours

Sponsors and collaborators

Lead sponsor

University of Andorra

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Feb 12, 2009
Registry last updated: Feb 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed