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

Primary Purpose

Femur Fracture

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pressure monitoring device
Compartmental fracture pressure monitoring
This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture
Sponsored by
CAMC Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Femur Fracture focused on measuring Compartment pressure, compartment syndrome, femur fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Needle Insertion into Femur

    Arm Description

    Data gathering with monitoring of pressures in the thigh via via needle in femur.

    Outcomes

    Primary Outcome Measures

    Compartment pressures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2009
    Last Updated
    March 2, 2020
    Sponsor
    CAMC Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00919464
    Brief Title
    Natural History of Anterior Compartment Pressures of the Thigh Following Femur Fracture
    Official Title
    Natural History of Anterior Compartment Pressures of the Thigh Following Femur
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    low enrollment
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CAMC Health System

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Femur Fracture
    Keywords
    Compartment pressure, compartment syndrome, femur fracture

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Needle Insertion into Femur
    Arm Type
    Other
    Arm Description
    Data gathering with monitoring of pressures in the thigh via via needle in femur.
    Intervention Type
    Device
    Intervention Name(s)
    Pressure monitoring device
    Intervention Description
    monitoring device inserted to measure thigh compartment pressures
    Intervention Type
    Device
    Intervention Name(s)
    Compartmental fracture pressure monitoring
    Intervention Type
    Device
    Intervention Name(s)
    This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture
    Primary Outcome Measure Information:
    Title
    Compartment pressures
    Time Frame
    Pre-operative to 50 hours post operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John DeLuca, MD
    Organizational Affiliation
    WVU Department of Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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