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Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg (TS2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Twin Star Medical, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Twin Star Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00681616
First received: May 19, 2008
Last updated: March 3, 2009
Last verified: February 2009
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Tissue Ultrafiltration and Pressure Monitoring for the Diagnosis and Prevention of Compartment Syndrome

Resource links provided by NLM:


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
Placebo Comparator: 1
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.
Other Names:
  • Twin Star Monitor
  • Twin Star Catheters
Device: Compartment Monitoring System with Active Fluid Removal
Compartment Monitoring System with Active Fluid Removal
Other Names:
  • Twin Star Monitor
  • Twin Star Catheters
Active Comparator: 2
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.
Other Names:
  • Twin Star Monitor
  • Twin Star Catheters
Device: Compartment Monitoring System without fluid removal
Compartment Monitoring System without fluid removal
Other Names:
  • Twin Star Monitor
  • Twin Star Catheters

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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         
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         
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: Janelle Antil, Director, Clinical Affairs, Twin Star Medical, Inc.
ClinicalTrials.gov Identifier: NCT00681616     History of Changes
Other Study ID Numbers: GE-4073, DoD Proposal:06275001, Award #:W81XWH-07-1-0243
Study First Received: May 19, 2008
Last Updated: March 3, 2009
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:
Compartment Syndromes
Syndrome
Cardiovascular Diseases
Disease
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014