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Natural History of Anterior Compartment Pressures of the Thigh Following Femur Fracture

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ClinicalTrials.gov Identifier: NCT00919464
Recruitment Status : Terminated (low enrollment)
First Posted : June 12, 2009
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Carrie Croson, CAMC Health System

Brief Summary:
This study is to determine the natural history of compartment pressures in the anterior thigh secondary to a fracture of the femoral shaft.

Condition or disease Intervention/treatment Phase
Femur Fracture Device: Pressure monitoring device Device: Compartmental fracture pressure monitoring Device: This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture Not Applicable

Detailed Description:
Compartment syndrome is a painful condition where increased tissue pressure in a restricted area compromises circulation and endangers the tissue within that area possibly leading to surgery, amputation, major loss of function and in rare cases, death. Compartment syndrome of the thigh can be particularly devastating because of the size of the muscle and large amount of blood flow to the area, however it is one of the more rare and therefore least understood of all compartment syndromes. The purpose of this study is to determine the natural history of pressures of the anterior compartment of the thigh following femur fracture, which could help elucidate the diagnostic and treatment algorithms for thigh compartment syndrome. This small project is designed to be a non-randomized, investigational prospective trail to be conducted at the General Division of Charleston Area Medical Center. The target population consists of males and non-pregnant females age 18 and over who have suffered a mid-shaft femur fracture.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Natural History of Anterior Compartment Pressures of the Thigh Following Femur
Study Start Date : April 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Pressure monitoring device
    monitoring device inserted to measure thigh compartment pressures
  • Device: Compartmental fracture pressure monitoring
  • Device: This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture


Primary Outcome Measures :
  1. Compartment pressures [ Time Frame: Pre-operative to 50 hours post operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • femur fracture
  • age 18 and older

Exclusion Criteria:

  • patients who are not candidates for surgical repair of femur fracture
  • patients not expected to survive more than 1 week

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 ClinicalTrials.gov identifier (NCT number): NCT00919464


Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: John DeLuca, MD WVU Department of Surgery

Responsible Party: Carrie Croson, IRB Admin, CAMC Health System
ClinicalTrials.gov Identifier: NCT00919464     History of Changes
Other Study ID Numbers: 06-04-1803
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Carrie Croson, CAMC Health System:
Compartment pressure
compartment syndrome
femur fracture

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries