Compartment SyndromeECSPRESSNCT01879696
Double Blinded, Randomized Clinical Trial of the Twin Star ECSPRESS Monitoring System for the Reduction of the Incidence of Fasciotomy
A study testing ECSPRESS catheter with active vacuum in people with Compartment Syndrome, run by Twin Star Medical, Inc. at 1 site in United States.
Trial 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 patients with tibia fractures presenting to the trauma or emergency departments at participating clinical sites. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Compartment Syndrome
- What is being tested?
- ECSPRESS catheter with active vacuum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65212
Abigail K Stidham, LPN, 573-882-7615, harrisabi@missouri.edu
David Volgas, MD
About this study
Official title: Double Blinded Study for the Reduction of the Incidence of Fasciotomy
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 patients with tibia fractures presenting to the trauma or emergency departments at participating clinical sites. Tissue ultrafiltration refers to the removal of muscle interstitial fluid by the ECSPRESS PMFC. The primary objective of the study is to demonstrate whether the removal of interstitial fluid by the ECSPRESS PMFC/FC catheters decrease the incidence of fasciotomy in the Treatment group when compared to the Control group. Fasciotomy was chosen as the primary outcome because it is clearly defined and clinically relevant; reduction of fasciotomy is of clear clinical benefit. Enrolled patients may have isolated tibia fractures OR be multiple trauma patients (those with another major fracture in a different body region or two distinct body system injuries, excluding those with injuries to the opposite leg that would preclude them from completing required tests).
Read the 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 inserted at the end of the surgical procedure to stabilize the tibia fracture and will be connected to the pressure monitor in the operating room or immediately upon arrival in the recovery room. The catheters will be used for up to 24-hours after surgical fixation of the affected lower leg in order to (1) measure and record muscle compartment pressure, and (2) remove interstitial fluid in the subset of subjects that are randomized to the Treatment Group. Subjects will be followed closely during the 24 hours the catheter is inserted to gather muscle pressure data, occurrance of a fasciotomy, adverse events, etc. and then followed up at 2 weeks, 3 months, 6 months and 12 months post study enrollment after which the subjects participation in the study will be completed. There will no interim data analysis of the study outcomes during the conduct of this study. Data analysis and presentation of the data will be made after study closure.
- Conditions
- Compartment Syndrome
- Being tested
- ECSPRESS catheter with active vacuum
- Medical subject headings
- Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECSPRESS catheter with active vacuumDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment are subjects will have catheter vacuum active for the removal of fluid from the muscle compartment. Receives: Device: ECSPRESS catheter with active vacuum |
| Control | No intervention | Treatment are subjects will have catheter vacuum in-active for the removal of fluid from the muscle compartment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fasciotomies
Measured: End of study once all subjects have completed their 12 month follow-up interval.
Secondary outcomes (1)
Area under the curve (AUC) for time-pressure
Measured: End of study once all subjects have completed their 12 month follow-up interval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Twin Star Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879696
- Sponsor's protocol ID
- 09-10000
- Other IDs
- G110163
- Acronym
- ECSPRESS
- Status last verified
- Jun 2013
- First submitted
- 11 Jun 2013
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Study for the Reduction of the Incidence of Fasciotomy
- ClinicalTrials.gov ID
- NCT01879696
- Acronym / sponsor ID
- ECSPRESS / 09-10000
- Conditions
- Compartment Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Twin Star Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Jun 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patients with tibia fractures presenting to the trauma or emergency departments at participating clinical sites. Tissue ultrafiltration refers to the removal of muscle interstitial fluid by the ECSPRESS PMFC. The primary objective of the study is to demonstrate whether the removal of interstitial fluid by the ECSPRESS PMFC/FC catheters decrease the incidence of fasciotomy in the Treatment group when compared to the Control group. Fasciotomy was chosen as the primary outcome because it is clearly defined and clinically relevant; reduction of fasciotomy is of clear clinical benefit. Enrolled patients may have isolated tibia fractures OR be multiple trauma patients (those with another major fracture in a different body region or two distinct body system injuries, excluding those with injuries to the opposite leg that would preclude them from completing required tests).
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 inserted at the end of the surgical procedure to stabilize the tibia fracture and will be connected to the pressure monitor in the operating room or immediately upon arrival in the recovery room. The catheters will be used for up to 24-hours after surgical fixation of the affected lower leg in order to (1) measure and record muscle compartment pressure, and (2) remove interstitial fluid in the subset of subjects that are randomized to the Treatment Group. Subjects will be followed closely during the 24 hours the catheter is inserted to gather muscle pressure data, occurrance of a fasciotomy, adverse events, etc. and then followed up at 2 weeks, 3 months, 6 months and 12 months post study enrollment after which the subjects participation in the study will be completed. There will no interim data analysis of the study outcomes during the conduct of this study. Data analysis and presentation of the data will be made after study closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: ECSPRESS catheter with active vacuumTreatment are subjects will have catheter vacuum active for the removal of fluid from the muscle compartment. |
| Control | No intervention | –Treatment are subjects will have catheter vacuum in-active for the removal of fluid from the muscle compartment. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • 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.
Key exclusion criteria (7 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECSPRESS catheter with active vacuum | Device | Treatment |
Primary outcome
Incidence of fasciotomies
Time frame: End of study once all subjects have completed their 12 month follow-up interval.
1 secondary outcome
Area under the curve (AUC) for time-pressure
Time frame: End of study once all subjects have completed their 12 month follow-up interval.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECSPRESS catheter with active vacuum in people with Compartment Syndrome, run by Twin Star Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David A Volgas, MD (573-882-6562, volgasd@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of fasciotomies (time frame: End of study once all subjects have completed their 12 month follow-up interval.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.