Compartment Syndrome of LegNCT03604029
Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities
An observational study of Compartment Syndrome of Leg, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Compartment Syndrome of Leg
- What is being tested?
- Near Infrared Spectroscopy
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 28 Feb 2022
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the trauma bay, surgical wards and ICU of the four participating facilities. This study will enroll approximately 300 subjects over four sites: Piedmont Athens Regional Medical Center, Grady Memorial Hospital, Mayo Clinic, and San Antonio Military Medical Center, over a period of approximately 24 months.
Who may be able to join
- Aged 18 to 65 years
- Ability to be enrolled within 12 hours of qualifying injury
- Must have at least one uninjured upper or lower extremity
- Must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury.
- Anatomic Location:
- Tibia/fibula shaft fracture
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- Tibial plateau fracture (including lateral split depression, lateral depression, medial plateau, bicondylar, and bicondylar with metaphyseal extension)
- Gunshot wound to leg without tibia fracture
- High Energy Mechanism of Injury (MOI):
- Fall from more than 5-foot height
- Motor vehicle collision (more than 15mph)
- Motor vehicle versus pedestrian accident
- High velocity gunshot wound (with or without tibia fracture)
- Crush injury
- Sport/recreation
Who cannot join
- Application of NIRS monitoring would be an impediment to care
- Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
- Admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis)
- Consent cannot be obtained from the patient or their LAR within 12 hours of injury
- Has already undergone fasciotomy of the injured leg prior to enrollment
- Has spinal injuries that result in complete loss of function (complete spinal cord injuries)
Show all 10Show fewer
- Has bilateral upper and lower extremity injuries greater than simple soft tissue injuries
- Is in police custody at presentation to the hospital
- Is a woman who is pregnant
- Has open injury on the injured leg that is large enough that at least two NIRS sensor cannot be safely placed. At a minimum two sensors must be placed on the injured leg(s).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brett A. Freedman, Col, MD
Rochester, Minnesota, 55901
About this study
Official title: Evaluating the Diagnostic Performance of Near Infrared Spectroscopy (NIRS) in the Setting of Acute Compartment Syndrome (ACS) in Traumatized Lower Extremities
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.
Read the detailed description
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). We have shown NIRS can be helpful in diagnosing ACS. We think two of the primary advantages of this device are that it is noninvasive (not painful) and it collects data continuously, so that if the disease develops, it can be detected early and treated appropriately. We have studied the capabilities of NIRS for many years. The last step in the process of proving NIRS and its use in ACS will be to test our recommendations and guidelines. The goal of this study is to test and prove our clinical guidelines we developed through previous work. This is an interventional study, which means the data we collect will be used to manage the patient and their care.
- Conditions
- Compartment Syndrome of Leg
- Being tested
- Near Infrared Spectroscopy
- Keywords
- ACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDevice
Near Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| Qualifying Subjects | Qualifying subjects who are high risk for ACS. Receives: Device: Near Infrared Spectroscopy | |
| Qualifying Subjects with ACS | Qualifying subjects who are diagnosed with ACS Receives: Device: Near Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Compartment Syndrome
The subject develops and diagnosed with Acute Compartment Syndrome
Measured: Zero to seventy two hours from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start7 Jan 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Compartment Syndrome of LegStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chevas R. Yeoman, MPH, Study director, The Geneva FoundationWilliam M. Reisman, MD, Principal investigator, Emory Department of OrthopedicsCharles L. Ogburn, MD, Principal investigator, Athens Orthopedic ClinicPatrick M. Osborn, MD, Principal investigator, San Anontio Military Medical CenterBrandon J. Yuan, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604029
- Sponsor's protocol ID
- W81XWH17C0029
- Status last verified
- Sep 2020
- First submitted
- 18 Jul 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to make IPD available to other researchers.
Publications
Reisman WM, Shuler MS, Roskosky M, Kinsey TL, Freedman BA. Use of Near-Infrared Spectroscopy to Detect Sustained Hyperaemia Following Lower Extremity Trauma. Mil Med. 2016 Feb;181(2):111-5. doi: 10.7205/MILMED-D-14-00689.
PubMed 26837078Shuler MS, Roskosky M, Kinsey T, Glaser D, Reisman W, Ogburn C, Yeoman C, Wanderman NR, Freedman B. Continual near-infrared spectroscopy monitoring in the injured lower limb and acute compartment syndrome: an FDA-IDE trial. Bone Joint J. 2018 Jun 1;100-B(6):787-797. doi: 10.1302/0301-620X.100B6.BJJ-2017-0736.R3.
PubMed 29855235
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Diagnostic Performance of Near Infrared Spectroscopy (NIRS) in the Setting of Acute Compartment Syndrome (ACS) in Traumatized Lower Extremities
- ClinicalTrials.gov ID
- NCT03604029
- Acronym / sponsor ID
- W81XWH17C0029
- Conditions
- Compartment Syndrome of Leg
- Keywords
- ACS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 27 Jul 2018 (actual)
- 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.
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.
Detailed description
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). We have shown NIRS can be helpful in diagnosing ACS. We think two of the primary advantages of this device are that it is noninvasive (not painful) and it collects data continuously, so that if the disease develops, it can be detected early and treated appropriately. We have studied the capabilities of NIRS for many years. The last step in the process of proving NIRS and its use in ACS will be to test our recommendations and guidelines. The goal of this study is to test and prove our clinical guidelines we developed through previous work. This is an interventional study, which means the data we collect will be used to manage the patient and their care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualifying Subjects | – | Device: Near Infrared SpectroscopyQualifying subjects who are high risk for ACS. |
| Qualifying Subjects with ACS | – | Device: Near Infrared SpectroscopyQualifying subjects who are diagnosed with ACS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the trauma bay, surgical wards and ICU of the four participating facilities. This study will enroll approximately 300 subjects over four sites: Piedmont Athens Regional Medical Center, Grady Memorial Hospital, Mayo Clinic, and San Antonio Military Medical Center, over a period of approximately 24 months.
Key inclusion criteria (15 listed)
- Aged 18 to 65 years
- Ability to be enrolled within 12 hours of qualifying injury
- Must have at least one uninjured upper or lower extremity
- Must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury.
- Tibia/fibula shaft fracture
Key exclusion criteria (10 listed)
- Application of NIRS monitoring would be an impediment to care
- Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
- Admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis)
- Consent cannot be obtained from the patient or their LAR within 12 hours of injury
- Has already undergone fasciotomy of the injured leg prior to enrollment
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 |
|---|---|---|
| Near Infrared SpectroscopyNear Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation. | Device | Qualifying Subjects, Qualifying Subjects with ACS |
Primary outcome
Acute Compartment Syndrome
Time frame: Zero to seventy two hours from enrollment.
The subject develops and diagnosed with Acute Compartment Syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Results publication: PubMed 26837078Reisman WM, Shuler MS, Roskosky M, Kinsey TL, Freedman BA. Use of Near-Infrared Spectroscopy to Detect Sustained Hyperaemia Following Lower Extremity Trauma. Mil Med. 2016 Feb;181(2):111-5. doi: 10.7205/MILMED-D-14-00689.
- Results publication: PubMed 29855235Shuler MS, Roskosky M, Kinsey T, Glaser D, Reisman W, Ogburn C, Yeoman C, Wanderman NR, Freedman B. Continual near-infrared spectroscopy monitoring in the injured lower limb and acute compartment syndrome: an FDA-IDE trial. Bone Joint J. 2018 Jun 1;100-B(6):787-797. doi: 10.1302/0301-620X.100B6.BJJ-2017-0736.R3.
- Individual participant dataSharing planned: No. We do not plan to make IPD available to other researchers.
Related trials for Compartment Syndrome of Leg
Recruiting
Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.
Chronic Exertional Compartment Syndrome
Recruiting
Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?
Compartment Syndrome Nontraumatic Lower Leg
Recruiting
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication
Recruiting
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
Acute Compartment Syndrome, Fracture, Bone
RecruitingObservational study
Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
Compartment Syndromes
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.
Chevas R. Yeoman, MPH study director
The Geneva Foundation
William M. Reisman, MD principal investigator
Emory Department of Orthopedics
Charles L. Ogburn, MD principal investigator
Athens Orthopedic Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compartment Syndrome of Leg, run by Nonin 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 15 inclusion and 10 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 9 Sep 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Compartment Syndrome (time frame: Zero to seventy two hours from enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604029, which also lists 2 linked publications.
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 9 Sep 2020.