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

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
Carrie Croson, CAMC Health System
ClinicalTrials.gov Identifier:
NCT00919464
First received: June 9, 2009
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Natural History of Anterior Compartment Pressures of the Thigh Following Femur

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Compartment pressures [ Time Frame: Pre-operative to 50 hours post operation ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: April 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919464

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

No publications provided

Responsible Party: Carrie Croson, IRB Admin, CAMC Health System
ClinicalTrials.gov Identifier: NCT00919464     History of Changes
Other Study ID Numbers: 06-04-1803
Study First Received: June 9, 2009
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014