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

NCT ID: NCT00919464

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-01-31

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.

Conditions

Femur Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Needle Insertion into Femur

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

Group Type: OTHER

Pressure monitoring device

Intervention Type: DEVICE

monitoring device inserted to measure thigh compartment pressures

Compartmental fracture pressure monitoring

Intervention Type: DEVICE

This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture

Intervention Type: DEVICE

Interventions

Pressure monitoring device

monitoring device inserted to measure thigh compartment pressures

Intervention Type: DEVICE

Compartmental fracture pressure monitoring

Intervention Type: DEVICE

This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Michael Whitler, BS

IRB Admin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John DeLuca, MD

Role: PRINCIPAL_INVESTIGATOR

WVU Department of Surgery

Other Identifiers

06-04-1803

Identifier Type: -

Identifier Source: org_study_id