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Compartmental Overpressures Associated to Reamed Intramedullary Nails

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00842101
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : February 12, 2009
Information provided by:
University of Andorra

Brief 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.

Condition or disease Intervention/treatment
Tibial Fractures Device: Quick Pressure Monitor

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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Reamed Intramedullary Nails in Tibial Fractures as a Factor of Rising Intracompartmental Pressures: A Clinical Study
Study Start Date : December 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. intracompartmental pressures [ Time Frame: 0-2 hours ]

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tibial shaft fractures

Inclusion Criteria:

  • Tibial shaft fractures treated with intramedullary reamed nails

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00842101

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Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital
Escaldes, Andorra, AD700
Sponsors and Collaborators
University of Andorra
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Principal Investigator: JOSE I TORRERO, M.D. Orthopaedic and Trauma Unit. Andorra´s Hospital
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Other Study ID Numbers: UA002
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009
Keywords provided by University of Andorra:
Intramedullary nails
Compartmental syndrome
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries