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

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

ChemIDplus related topics:

Calcium polycarbophil Psyllium

U.S. FDA Resources

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:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (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	Not yet 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	Not yet 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	Not yet 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	Not yet 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	Not yet 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	Not yet recruiting
	Fort Sam Houston, Texas, United States, 78234
	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.

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
First Received:	May 19, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00681616
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

Tomaculous neuropathy

Muscular Diseases

Musculoskeletal Diseases

Roussy Levy hereditary areflexic dystasia

Hereditary Motor and Sensory Neuropathies

Charcot-Marie-Tooth Disease

Vascular Diseases

Wounds and Injuries

Compartment Syndromes

Compartment syndrome

Charcot Marie Tooth disease

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Twin Star Medical, Inc. Department of Defense
Information provided by:	Twin Star Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00681616