Compartment SyndromeCOLONIANCT03840434
COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure
A study testing MyotonPRO in people with Compartment Syndrome, run by University Hospital, Angers at 1 site in France.
Trial summary
Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed. Currently, the reference technique is invasive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compartment Syndrome
- What is being tested?
- MyotonPRO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2019to 27 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affiliation to the French National healthcare system
- French speaking patients
- Referred for investigation of compartment syndrome causing
Who cannot join
- Pregnancy
- Inability to understand the study goal
- Patients protected by decision of law
- Extended dermatosis
- Coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)
Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed.
Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS.
Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.
Read the detailed description
Patients referred for suspected chronic compartment syndrome causing will be included.
After signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted. Once the consent is collected, the patient performs, according to the data of the literature and service habits a stress test aimed at triggering the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as the same time.
- Conditions
- Compartment Syndrome
- Being tested
- MyotonPRO
- Keywords
- compartment syndrome, intramuscular punction Versus non invasive assessment
- Medical subject headings
- Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyotonPRODiagnostic test
Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO
| Study group | Role | What they receive |
|---|---|---|
| CCS group | Other | Measurements by intramuscular punction and non invasive tool Receives: Diagnostic Test: MyotonPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of MyotonPRO
To study the diagnostic performance of tissue stiffness measurement by MyotonPRO at 1 minute post-exercise in patients suspected of anterolateral of leg
Measured: 3 years
Secondary outcomes (2)
Diagnostic performance of MyotonPRO at 1 minute post-exercise
To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 1 minute post-exercise.
Measured: 3 years
Diagnostic performance of MyotonPRO at 5 minute post-exercise
To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 5 minute post-exercise.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start19 Jun 2019
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
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.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Antoine BRUNEAU, PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840434
- Sponsor's protocol ID
- 2019-A00141-56
- Acronym
- COLONIA
- Status last verified
- Apr 2023
- First submitted
- 28 Jan 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)
- ClinicalTrials.gov ID
- NCT03840434
- Acronym / sponsor ID
- COLONIA / 2019-A00141-56
- Conditions
- Compartment Syndrome
- Keywords
- compartment syndrome, intramuscular punction Versus non invasive assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 15 Feb 2019 (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.
Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed.
Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS.
Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.
Detailed description
Patients referred for suspected chronic compartment syndrome causing will be included.
After signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted. Once the consent is collected, the patient performs, according to the data of the literature and service habits a stress test aimed at triggering the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as the same time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO.
| Arm | Type | Receives |
|---|---|---|
| CCS group | Other | Diagnostic Test: MyotonPROMeasurements by intramuscular punction and non invasive tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Affiliation to the French National healthcare system
- French speaking patients
- Referred for investigation of compartment syndrome causing
Key exclusion criteria (5 listed)
- Pregnancy
- Inability to understand the study goal
- Patients protected by decision of law
- Extended dermatosis
- Coagulation disorder
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 |
|---|---|---|
| MyotonPROEach patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO | Diagnostic test | CCS group |
Primary outcome
Diagnostic performance of MyotonPRO
Time frame: 3 years
To study the diagnostic performance of tissue stiffness measurement by MyotonPRO at 1 minute post-exercise in patients suspected of anterolateral of leg
2 secondary outcomes
Diagnostic performance of MyotonPRO at 1 minute post-exercise
Time frame: 3 years
Diagnostic performance of MyotonPRO at 5 minute post-exercise
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Compartment Syndrome
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Recruiting
Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?
Compartment Syndrome Nontraumatic Lower Leg
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
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.
Antoine BRUNEAU, PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyotonPRO in people with Compartment Syndrome, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 7 Apr 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic performance of MyotonPRO (time frame: 3 years). 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 7 Apr 2023.