Status:
UNKNOWN
Double Blinded, Randomized Clinical Trial of the Twin Star ECSPRESS Monitoring System for the Reduction of the Incidence of Fasciotomy
Lead Sponsor:
Twin Star Medical, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Compartment Syndrome
Eligibility:
All Genders
18-44 years
Phase:
NA
Brief Summary
The proposed study is a double-blinded, randomized clinical trial of tissue pressure monitoring only (Control group) vs. tissue pressure monitoring plus tissue ultrafiltration (Treatment group) in pat...
Detailed Description
Eligible patients who are enrolled in the study will receive standard surgical stabilization within 72 hours of injury. All Subjects will receive the Twin Star ECSPRESS catheters, which will be insert...
Eligibility Criteria
Inclusion
- • Subject with an isolated tibial shaft fracture requiring intramedullary nailing, or bicondylar tibial plateau fracture or tibial plateau fracture-knee dislocation requiring application of a knee-spanning external fixator. OR Subject with an isolated tibial shaft fracture requiring intramedullary nailing, or bicondylar tibial plateau fracture or tibial plateau fracture-knee dislocation requiring application of a knee-spanning external fixator AND another major fracture in a different body region or injuries to one other major organ system (head, chest, abdomen, pelvis, genitourinary, or spine) excluding those with injuries to the opposite leg that would preclude them from completing required tests (see exclusion criteria).
- • Subject with an isolated tibial shaft fracture requiring intramedullary nailing, or bicondylar tibial plateau fracture or tibial plateau fracture-knee dislocation requiring application of a knee-spanning external fixator AND another major fracture in a different body region or injuries to one other major organ system (head, chest, abdomen, pelvis, genitourinary, or spine) excluding those with injuries to the opposite leg that would preclude them from completing required tests (see exclusion criteria).
- All Subjects
- Operative procedure (nailing or external fixation) performed within 72 hours of injury.
- The Subject is at least 18 years of age and no older than 44 years of age. Subject or legally acceptable representative must able to understand what he/she is being asked to do, willing/able to understand and sign the Informed Consent to return for the required follow-up visits at 2 weeks, 3 months, 6 months, and 12 months post-surgery. A legally acceptable representative may sign the Informed Consent on the patient's behalf.
- In the study investigators opinion, patient's co-morbidity condition(s) at enrollment WILL allow patient to return and complete the required testing for all return visits for the duration of this 12-month clinical study.
Exclusion
- • Current evidence of CS prior to the decision regarding enrollment. Surgical stabilization that resulted in the presence of a bead pouch, VAC, negative-pressure wound therapy device, or other dressing that would interfere with placement of any of the four catheters in the anterior deep posterior compartments.
- 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.
- An Injury to the ipsilateral knee, ankle, and/or foot that would influence results of muscle testing.
- Opposite leg knee injury or tibia, ankle, foot fracture, or any other injury that would preclude or influence the results of mechanical muscle testing.
- Incision into the anterior or deep posterior compartments of the leg to be studied that would release the fascia as this would constitute a partial fasciotomy and would affect leg pressures.
- The Subject is currently enrolled in one or more clinical studies.
- 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.).
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01879696
Start Date
June 1 2013
End Date
June 1 2015
Last Update
June 18 2013
Active Locations (1)
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1
University of Missouri-Columbia
Columbia, Missouri, United States, 65212