Natural History of Anterior Compartment Pressures of the Thigh Following Femur Fracture
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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 |
- 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) |
-
Device: Pressure monitoring device
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 |
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
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 Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 21, 2013