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

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

Detailed Description
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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.

Official Title
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Natural History of Anterior Compartment Pressures of the Thigh Following Femur

Conditions
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Femur Fracture

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Needle Insertion into Femur<br>Data gathering with monitoring of pressures in the thigh via via needle in femur. | Device: Pressure monitoring device<br>* monitoring device inserted to measure thigh compartment pressures<br>Device: Compartmental fracture pressure monitoring<br> <br> Device: This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compartment pressures |  | Pre-operative to 50 hours post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compartment pressure, compartment syndrome, femur fracture