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

CAMC Health System

Status: Terminated

Conditions: Femur Fracture

Treatments: Device: Pressure monitoring device; Device: This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture; Device: Compartmental fracture pressure monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT00919464

06-04-1803

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Needle Insertion into Femur

Other group

Description:

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

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