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CompletedNCT03840434COLONIAUpdated Apr 7, 2023

COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure

An interventional study of MyotonPRO in Compartment Syndrome, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Compartment Syndrome

Keywords

  • compartment syndrome
  • intramuscular punction Versus non invasive assessment
03

In context

Compartment Syndromes

75 studies on the registry are indexed under Compartment Syndromes; 12 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 43 interventional studies indexed under Compartment Syndromes.

Browse Compartment Syndromes studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Affiliation to the French National healthcare system
  • French speaking patients
  • Referred for investigation of compartment syndrome causing

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Inability to understand the study goal
  • Patients protected by decision of law
  • Extended dermatosis
  • Coagulation disorder
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Other
    CCS group

    Measurements by intramuscular punction and non invasive tool

    Diagnostic Test: MyotonPRO

Interventions

  • Diagnostic testMyotonPRO

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years

Secondary outcomes

  1. 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.

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

07

Study locations

1 site
  • Centre hospitalier universitaire
    Angers, 49933, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03840434
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Feb 15, 2019
Start date
Jun 19, 2019
Primary completion
Mar 27, 2023
Completion
Mar 27, 2023
Last update
Apr 7, 2023

Study contacts

Antoine BRUNEAU, PhD
principal investigator · UH Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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