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

Natural History of Anterior Compartment Pressures of the Thigh Following Femur

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

Study Overview

• Status: Terminated
• Conditions: Femur Fracture
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Needle Insertion into Femur; Data gathering with monitoring of pressures in the thigh via via needle in femur.	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: John DeLuca, MD, WVU Department of Surgery

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 12, 2009

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: femur fracture; compartment syndrome; Compartment pressure
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 06-04-1803