Status:
UNKNOWN
Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg
Lead Sponsor:
Twin Star Medical, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Compartment Syndrome
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
An investigation of a new catheter and pressure monitor system that may help to prevent a complication called compartment syndrome from developing in an injured leg. Compartment syndrome occurs when t...
Detailed Description
Compartment Syndrome (CS) may occur in patients with a fracture or crushing injury to an extremity. The current standard-of-care for patients at risk of developing CS is clinical by watching for signs...
Eligibility Criteria
Inclusion
- Subject with a tibial shaft fracture requiring intramedullary nailing or bicondylar tibial plateau fracture requiring application of a knee-spanning external fixator.
- Operative procedure (nailing or external fixation) performed within 72 hours of injury.
- The Subject is between 18 and 60 years of age.
- Able to understand what he/she is being asked to do, willing/able to understand and sign the Informed Consent to return for follow-up visits at 2 weeks and 3 months post surgery.
Exclusion
- Current evidence of CS prior to Study.
- Surgical stabilization will result in the presence of a bead pouch or wound vac or other dressing that would interfere with placement of any of the three Catheters in the anterior compartment.
- The Subject has a medical condition(s) that precludes use of Catheters, such as dermatologic conditions, immunological deficits or traumatic skin lesions that interfere with Catheter placement.
- The Subject has co-morbidities that may place the Subject at risk of hypotension (e.g., significant blood loss, heart failure, significant chest or abdominal trauma, septicemia, pelvic fractures, femur fractures or massive soft tissue trauma.)
- Likely problems, in the investigator's judgment, with maintaining follow-up (including developmental delay, address greater than 2 hours drive from the treating institution, substance abuse problems, intoxication, current or pending incarceration, etc.).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00681616
Start Date
January 1 2009
End Date
December 1 2010
Last Update
March 4 2009
Active Locations (13)
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1
University of California, Irvine Medical Center
Orange, California, United States, 92868
2
University of California - San Francisco / San Franciso General Hospital
San Francisco, California, United States, 94110
3
Denver Health Medical Center
Denver, Colorado, United States, 80204
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153-3328