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

Femur Fracture Clinical Trial

Official title:

Natural History of Anterior Compartment Pressures of the Thigh Following Femur

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00919464
• Other study ID #: 06-04-1803
• Status: Terminated
• Phase: N/A
• Start date: April 2006
• Est. completion date: January 2010

Study information

• Verified date: March 2020
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Device:
• Pressure monitoring device
monitoring device inserted to measure thigh compartment pressures
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compartment pressures		Pre-operative to 50 hours post operation