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
Recruitment status was Recruiting
Sponsor:
Twin Star Medical, Inc.
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
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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 |
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:
Device: Compartment Monitoring System with Active Fluid Removal
Compartment Monitoring System with Active Fluid Removal
Other Names:
|
|
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:
Device: Compartment Monitoring System without fluid removal
Compartment Monitoring System without fluid removal
Other Names:
|
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, 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:
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.
| 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 Muscular Diseases Musculoskeletal Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013