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

  Hide Detailed Description

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 and symptoms of CS, and if needed, measuring the pressure within the muscle compartment (intramuscular pressure, IMP). Currently, IMP measurements are made by placing a percutaneous pressure sensor into the targeted muscle compartment, which is then attached to a pressure monitor. Whenever the clinical exam and/or pressure measurements suggest that CS is developing, fasciotomy is generally performed immediately.

Twin Star Medical has developed a novel Compartment Monitoring System (CMS) that consists of a pressure monitoring module and two types of catheters. Both Twin Star Catheters remove interstitial tissue fluid, which may contribute to a reduction in compartment pressure, and which may be used for clinical analysis to determine if certain analyte indicators of muscle injury (biomarkers) can be predictive of CS development. One type of catheter Pressure Measurement/Fluid Collection, (PMFC), removes fluid and monitors pressure via a solid-state fiber optic transducer at the tip of the catheter. The other type of catheter, Fluid Collection (FC), only removes fluid and does not have a pressure transducer at the tip. The monitoring module senses, displays and records pressure as measured by the PMFC catheter as well as provides a vacuum source, which is required for the operation of the fluid removal catheter. The Twin Star CMS Monitoring Module has been successfully tested to (1) ensure the delivery of the specified functional performance requirements needed to reliably operate the Twin Star Catheter, and (2) meet current electrical safety standards established for clinical use. The first model of the Twin Star catheter and monitor was reviewed and approved by the Food and Drug Administration (FDA) for the indications of pressure measurement and the withdrawal of interstitial fluid. The devices being used for this clinical study represent the newly designed catheter and monitor and are not FDA approved and are therefore considered investigational. It is anticipated that the second-generation model of the catheter and monitor will be submitted to the FDA for approval while this study is being conducted.

The purpose of this Study is to determine if the removal of interstitial fluid by the Twin Star Catheter can lower muscle compartment pressure and impact other measures of subject clinical status, including possible reduction of the need for fasciotomy. The Study population will be Subjects who have suffered an isolated tibial fracture (open or closed) requiring surgical stabilization within 72 hours of injury. This Study will use an Adaptive study design in which a total of up to 90 subjects will be enrolled. All Subjects will receive the Twin Star catheters, which will be inserted at the end of the surgical procedure to stabilize the tibia fracture and will be connected to the pressure monitor before leaving the surgical room. The catheters will be used for the first 24-hours after surgical fixation of the affected lower leg in order to (1) measure and record muscle compartment pressure, and (2) remove accumulated interstitial fluid in the subset of subjects that are randomized to the Treatment Group. The first 20 Subjects (Phase 1) will not be randomized; all will be actively treated but with different combinations of catheters and vacuum levels. The purpose of Phase I of the study is to optimize treatment parameters that will be used in the remaining 70 subjects, which will constitute Phase II. All subjects will receive a total of 3 catheters placed in the anterior compartment. Subjects in Phase 1 will be enrolled into two groups: 1) receiving constant vacuum (-150 mmHg) and fluid removal or, 2) receiving intermittent vacuum (-50 mmHg) and fluid removal. Within the anterior compartment, there will be one PMFC and 2 FC catheters inserted.

The first 10 subjects in Phase 1 will all be treated with single-fiber catheters, but with one of two different vacuum levels (intermittent at -50 mmHg or constant at -150 mmHg). After the first 10 subjects have completed the study, fluid removal results will be analyzed. If results demonstrate that fluid in the anterior compartment is being withdrawn at a rate of ≥ 0.5 mls/24 hours, the second group of 10 subjects will continue using the same single fiber catheters. If the results of the first 10 subjects demonstrate fluid is being withdrawn in the anterior compartment at < 0.5 mls/24 hours, the next 10 subjects will instead receive treatment with two multi-fiber FC catheters plus the same PMFC catheter.

After the first 20 subjects have been enrolled in the study, the remaining subjects to be enrolled in Phase 2 will be randomized to either a Treatment or Control group. Both groups will receive treatment with whichever combination of catheter type (single or multi-fiber) and vacuum (constant or intermittent) was most efficacious in terms of fluid removal in Phase 1. The randomization will determine whether subjects will receive no vacuum at all (Control Group: Monitoring alone) or the fluid removal mode that was shown to be best in the first phase of the study (Treatment Group: Monitoring plus Fluid Removal).

The rationale for the adaptive study design is that we have developed second-generation catheters whose fluid removal function has not been optimized in vivo in humans. Although our first generation catheter used multi-fibers, animal study results have demonstrated that single-fiber catheters remove the same amount of fluid in vivo as multi-fiber catheters, but can be made much smaller than multi-fiber catheters.

The Subject's length of initial hospital stay will be determined by the attending physician based on the subject's medical condition(s). The standard-of-care for routine clinical compartment pressure monitoring will apply to both the vacuum and non-vacuum groups in this Study with the catheters being left in place for 24 hours. Compartment syndrome is a dignosis that depends on clinical assessment supplemented by pressure measurement. Throughout the study, the treating physicians will monitor the subjects according to standard clinical practice and will apply standard clinical judgment regarding the diagnosis of compartment syndrome. Treating physicians may end the study and perform fasciotomy if they feel it is necessary because of clinical suspicion that compartment syndrome is developing. A two-week and a 3-month follow-up visit will be required post discharge, coinciding with typical clinical follow-up visits. The purpose of the two-week visit will be primarily to assess whether there have been any adverse consequences related to the catheter. The purpose of the three-month assessment will be primarily to look for any evidence of the sequelae of missed or untreated compartment syndrome, such as clawing of the toes or persistent neurologic dysfunction. Functional outcomes will be measured during these follow-up visits as well as the occurrence of any adverse events since discharge. Functional outcomes will include an assessment of whether any loss of motor function resulted as part of the primary injury.

  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:
Syndrome
Compartment Syndromes
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014