Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg
TS2
Randomized Clinical Trial of Tissue Ultrafiltration and Pressure Monitoring for the Diagnosis and Prevention of Compartment Syndrome
3 other identifiers
interventional
90
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 4, 2009
February 1, 2009
1.5 years
May 19, 2008
March 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
fluid removal will be collected & recorded at 2, 4, 8, 16, & 24 hrs after catether insertion.
Secondary Outcomes (1)
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.
Perfusion pressure will be collected and recorded at 2, 4, 8, 16 & 24 hrs post-catheter insertion
Study Arms (2)
1
PLACEBO COMPARATORCompartment Monitoring System with Active Fluid Removal
2
ACTIVE COMPARATORCompartment Monitoring System (CMS) without fluid removal
Interventions
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.
Compartment Monitoring System with Active Fluid Removal
Compartment Monitoring System without fluid removal
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Twin Star Medical, Inc.lead
- United States Department of Defensecollaborator
Study Sites (13)
University of California, Irvine Medical Center
Orange, California, 92868, United States
University of California - San Francisco / San Franciso General Hospital
San Francisco, California, 94110, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
Loyola University Medical Center
Maywood, Illinois, 60153-3328, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48109-0328, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
St. Louis University
St Louis, Missouri, 63110-0250, United States
Washington University Orthopedics
St Louis, Missouri, 63110, United States
ECMC - SUNY Buffalo
Buffalo, New York, 14215, United States
Ohio State University
Columbus, Ohio, 43210-1240, United States
University of Tennessee/Campbell Clinic-InMotion Musculoskeletal Institute
Memphis, Tennessee, 38103, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Related Publications (8)
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.
PMID: 3782206BACKGROUNDHargens 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.
PMID: 670272BACKGROUNDHargens 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.
PMID: 7217130BACKGROUNDHeppenstall 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.
PMID: 3733772BACKGROUNDJanzing HM, Broos PL. Routine monitoring of compartment pressure in patients with tibial fractures: Beware of overtreatment! Injury. 2001 Jun;32(5):415-21. doi: 10.1016/s0020-1383(01)00005-5.
PMID: 11382429BACKGROUNDSchmidt AH, Tvedte E. The Financial Implications of Compartment Syndrome. Poster, American Academy of Orthopaedic Surgeons Annual Meeting, San Diego, CA, Feb 13-18, 2007.
BACKGROUNDTornetta P 3rd, Templeman D. Compartment syndrome associated with tibial fracture. Instr Course Lect. 1997;46:303-8. No abstract available.
PMID: 9143975BACKGROUNDWoll TS, Duwelius PJ. The segmental tibial fracture. Clin Orthop Relat Res. 1992 Aug;(281):204-7.
PMID: 1499212BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Schmidt, MD
Hennepin County Medical Center (HCMC)
- STUDY DIRECTOR
Janelle M Antil
Twin Star Medical, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
January 1, 2009
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
March 4, 2009
Record last verified: 2009-02