Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg

Status unconfirmed · Not applicable

Conditions studied: Compartment Syndrome

In brief

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 too much fluid builds up in the muscles of the injured leg. This causes a lot of swelling and increases pressures within the leg that can cause permanent damage muscles and nerves in the leg.

Key facts

Study ID

NCT00681616

Run by

Twin Star Medical, Inc.

People needed

90

Starts

2009-01-01

Expected to finish

2010-12-01

Last updated by the study team

2009-03-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.).

Where it is running

• Brooke Army Medical Center — Fort Sam Houston, Texas, United States (enrolling)
• Denver Health Medical Center — Denver, Colorado, United States (enrolling)
• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)
• Hennepin County Medical Center — Minneapolis, Minnesota, United States (enrolling)
• St. Louis University — St Louis, Missouri, United States (enrolling)
• University of Tennessee/Campbell Clinic-InMotion Musculoskeletal Institute — Memphis, Tennessee, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States
• University of California, Irvine Medical Center — Orange, California, United States
• University of California - San Francisco / San Franciso General Hospital — San Francisco, California, United States
• Washington University Orthopedics — St Louis, Missouri, United States
• ECMC - SUNY Buffalo — Buffalo, New York, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.