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

Sponsors and Collaborators:	Twin Star Medical, Inc. 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

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.

Department of Defense

Investigators

Principal Investigator:	Andrew Schmidt, MD	Hennepin County Medical Center (HCMC)
Study Director:	Janelle M Antil	Twin Star Medical, Inc.

More Information

Publications:

Blick SS, Brumback RJ, Poka A, Burgess AR, Ebraheim NA. Compartment syndrome in open tibial fractures. J Bone Joint Surg Am. 1986 Dec;68(9):1348-53.

Hargens AR, Akeson WH, Mubarak SJ, Owen CA, Evans KL, Garetto LP, Gonsalves MR, Schmidt DA. Fluid balance within the canine anterolateral compartment and its relationship to compartment syndromes. J Bone Joint Surg Am. 1978 Jun;60(4):499-505.

Hargens AR, Schmidt DA, Evans KL, Gonsalves MR, Cologne JB, Garfin SR, Mubarak SJ, Hagan PL, Akeson WH. Quantitation of skeletal-muscle necrosis in a model compartment syndrome. J Bone Joint Surg Am. 1981 Apr;63(4):631-6.

Heppenstall RB, Scott R, Sapega A, Park YS, Chance B. A comparative study of the tolerance of skeletal muscle to ischemia. Tourniquet application compared with acute compartment syndrome. J Bone Joint Surg Am. 1986 Jul;68(6):820-8.

Janzing HM, Broos PL. Routine monitoring of compartment pressure in patients with tibial fractures: Beware of overtreatment! Injury. 2001 Jun;32(5):415-21.

Schmidt AH, Tvedte E. The Financial Implications of Compartment Syndrome. Poster, American Academy of Orthopaedic Surgeons Annual Meeting, San Diego, CA, Feb 13-18, 2007.

Tornetta P III, Templeman D. Compartment syndrome associated with tibial fracture. J Bone Joint Surg Am. 1996; 78A:1438-1444.

Woll TS, Duwelius PJ. The segmental tibial fracture. Clin Orthop Relat Res. 1992 Aug;(281):204-7.

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

Study placed in the following topic categories:

Nerve Compression Syndromes
Roussy Levy Hereditary Areflexic Dystasia
Muscular Diseases
Musculoskeletal Diseases
Compartment Syndrome
Charcot Marie Tooth Disease

Hereditary Motor and Sensory Neuropathies
Charcot-Marie-Tooth Disease
Vascular Diseases
Wounds and Injuries
Compartment Syndromes
Tomaculous Neuropathy

Additional relevant MeSH terms:

Pathologic Processes
Disease
Muscular Diseases
Musculoskeletal Diseases

Syndrome
Vascular Diseases
Compartment Syndromes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 06, 2009