Recruiting

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

Sponsor:

Twin Star Medical, Inc.

Code:

NCT00681616

Conditions

Compartment Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Compartment Monitoring System (CMS)

Compartment Monitoring System with Active Fluid Removal

Compartment Monitoring System without fluid removal

Study Details

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 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.

Conditions

Compartment Syndrome

Study ID

NCT00681616

Start date

Jan, 2009

Status verified date

Feb, 2009

Completion date

Dec, 2010

Anticipated

Primary completion date

Jul, 2010

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

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 Criteria:

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.).

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: 1

Compartment Monitoring System with Active Fluid Removal

active comparator: 2

Compartment Monitoring System (CMS) without fluid removal

Interventions

Compartment Monitoring System (CMS)

The CMS consists of an Introducer, Pressure Measurement \& Fluid Collection (PMFC) catheter, a Fluid Collection (FC) catheter and Compartment Pressure Monitor. The PMFC catheter removes fluid and monitors pressure via a solid-state fiber optic transducer at the tip of the catheter. The FC catheter only removes fluid and does not have a pressure transducer at the tip. The CMS Monitor senses, displays and records compartment pressure as measured by up to two PMFC catheters. In addition, the CMS Monitor measures subject blood pressure using a provided cuff for calculating the perfusion pressure of the muscle compartment.

Compartment Monitoring System with Active Fluid Removal

Compartment Monitoring System without fluid removal

Primary outcome measure

To determine if use of Twin Star catheter with active fluid removal reduces muscle compartment pressure vs Twin Star catheter without fluid removal by comparing the randomized groups. Success will be defined by a p-value less than 0.05 (two-sided). [ Time Frame: fluid removal will be collected & recorded at 2, 4, 8, 16, & 24 hrs after catether insertion. ]

Central Contacts and Locations

Central contacts

Janelle M Antil

651-209-0556

Debbie A Cooper

651-209-0556

Locations

Denver Health Medical Center

Recruiting

Denver, Colorado, United States, 80204

Contacts

Andrea Baron

303-436-5825 Andrea.Baron@dhha.org

Principal Investigator:

Steven Morgan, MD

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153-3328

Contacts

Leslie Manion, RN

708-216-5494 Lmanion@LUMC.edu

Principal Investigator:

Michael Stover, MD

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

JR Westberg

612-873-4634 Jerald.Westberg@hcmed.org

Principal Investigator:

Andrew Schmidt, MD

St. Louis University

Recruiting

St. Louis, Missouri, United States, 63110-0250

Contacts

Barb Scott, RN

314-256-3853 scottb@SLU.EDU

Principal Investigator:

J. Tracy Watson, MD

University of Tennessee/Campbell Clinic-InMotion Musculoskeletal Institute

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Jennifer Vest

901-271-0013

Principal Investigator:

Edward Perez, MD

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Socorro Garcia

210-916-3365 Socorro.garcia1@us.army.mil

Principal Investigator:

James Ficke, MD

More Information

Sponsor

Twin Star Medical, Inc.

Last update posted

Mar 4, 2009

Last verified

Feb, 2009

Keywords

Anterior compartment syndrome
Tibia
Trauma
Blood circulation
Nerve compression syndromes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Twin Star Medical, Inc. on 2009-03-04.