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Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg (TS2)
This study is currently recruiting participants.
Verified by Twin Star Medical, Inc., February 2009
First Received: May 19, 2008   Last Updated: March 3, 2009   History of Changes
Sponsor: Twin Star Medical, Inc.
Collaborator: Department of Defense
Information provided by: Twin Star Medical, Inc.
ClinicalTrials.gov Identifier: NCT00681616
  Purpose

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.


Condition Intervention
Compartment Syndrome
Device: Compartment Monitoring System (CMS)
Device: Compartment Monitoring System with Active Fluid Removal
Device: Compartment Monitoring System without fluid removal

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Clinical Trial of Tissue Ultrafiltration and Pressure Monitoring for the Diagnosis and Prevention of Compartment Syndrome

Further study details as provided by Twin Star Medical, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compares the treatment and control groups on change in perfusion pressure (defined as diastolic blood pressure minus IMP) over time. The randomized groups will be compared with a two-sided p-value less than 0.05 defining success. [ Time Frame: Perfusion pressure will be collected and recorded at 2, 4, 8, 16 & 24 hrs post-catheter insertion ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Compartment Monitoring System with Active Fluid Removal
Device: 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.
Device: Compartment Monitoring System with Active Fluid Removal
Compartment Monitoring System with Active Fluid Removal
2: Active Comparator
Compartment Monitoring System (CMS) without fluid removal
Device: 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.
Device: Compartment Monitoring System without fluid removal
Compartment Monitoring System without fluid removal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681616

Contacts
Contact: Janelle M Antil 651-209-0556 ext fax
Contact: Debbie A Cooper 651-209-0556 ext fax

Locations
United States, California
University of California - San Francisco / San Franciso General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Contact: Cindy Lin     415-206-4977     cindyl@orthosurg.ucsf.edu    
Principal Investigator: Theodore Miclau, MD            
Sub-Investigator: Utku Kandemir, MD            
University of California, Irvine Medical Center Not yet recruiting
Orange, California, United States, 92868
Contact: Emilia Castaneda     714-456-5759        
Principal Investigator: David Zamorano, MD            
Sub-Investigator: Marty Tynan, MD            
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Andrea Baron     303-436-5825     Andrea.Baron@dhha.org    
Principal Investigator: Steven Morgan, MD            
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153-3328
Contact: Leslie Manion, RN     708-216-5494     Lmanion@LUMC.edu    
Principal Investigator: Michael Stover, MD            
Sub-Investigator: Hobie Summers, MD            
United States, Massachusetts
Boston Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Lisa Shaughnessy     617-414-6295     lisa.shaughnessy@bmc.org    
Principal Investigator: Paul Tornetta, III, MD            
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109-0328
Contact: Amy Drongowski     734-647-6936     adrongo@umich.edu    
Principal Investigator: Jim Goulet, MD            
Sub-Investigator: Paul Dougherty, MD            
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: JR Westberg     612-873-4634     Jerald.Westberg@hcmed.org    
Principal Investigator: Andrew Schmidt, MD            
United States, Missouri
St. Louis University Recruiting
St. Louis, Missouri, United States, 63110-0250
Contact: Barb Scott, RN     314-256-3853     scottb@SLU.EDU    
Principal Investigator: J. Tracy Watson, MD            
Sub-Investigator: Dave Karges, DO            
Washington University Orthopedics Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Angel D Brandt     314-747-2811        
Principal Investigator: William M Ricci, MD            
United States, New York
ECMC - SUNY Buffalo Not yet recruiting
Buffalo, New York, United States, 14215
Contact: Cathy Buyea, MS     716-898-3383     buyea@buffalo.edu    
Principal Investigator: Mark Anders, MD            
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Skye Macalester     614-293-9013     skye.macalester@osumc.edu    
Principal Investigator: Laura Phieffer, MD            
Sub-Investigator: Ronald Lakatos, MD            
Sub-Investigator: Thomas Ellis, MD            
Sub-Investigator: Teresa DiMeo, CNP            
United States, Tennessee
University of Tennessee/Campbell Clinic-InMotion Musculoskeletal Institute Recruiting
Memphis, Tennessee, United States, 38103
Contact: Jennifer Vest     901-271-0013        
Principal Investigator: Edward Perez, MD            
Sub-Investigator: George Wood, MD            
United States, Texas
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Socorro Garcia     210-916-3365     Socorro.garcia1@us.army.mil    
Principal Investigator: James Ficke, MD            
Sub-Investigator: Daniel Stinner, MD            
Sub-Investigator: Josh Wenke, MD            
Sub-Investigator: Joseph Hsu, MD            
Sponsors and Collaborators
Twin Star Medical, Inc.
Investigators
Principal Investigator: Andrew Schmidt, MD Hennepin County Medical Center (HCMC)
Study Director: Janelle M Antil Twin Star Medical, Inc.
  More Information

Publications:
Responsible Party: Twin Star Medical, Inc. ( Janelle Antil, Director, Clinical Affairs )
Study ID Numbers: GE-4073, DoD Proposal:06275001, Award #:W81XWH-07-1-0243
Study First Received: May 19, 2008
Last Updated: March 3, 2009
ClinicalTrials.gov Identifier: NCT00681616     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Twin Star Medical, Inc.:
Anterior compartment syndrome
Tibia
Trauma
Blood circulation
Nerve compression syndromes

Additional relevant MeSH terms:
Pathologic Processes
Disease
Muscular Diseases
Musculoskeletal Diseases
Syndrome
Vascular Diseases
Compartment Syndromes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 09, 2009