COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure

COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03840434

Acronym

COLONIA

Enrollment

100

Registered

2019-02-15

Start date

2019-06-19

Completion date

2023-03-27

Last updated

2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compartment Syndrome

Keywords

compartment syndrome, intramuscular punction Versus non invasive assessment

Brief 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.

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.

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance of MyotonPRO	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

Secondary

Measure	Time frame	Description
Diagnostic performance of MyotonPRO at 1 minute post-exercise	3 years	To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 1 minute post-exercise.
Diagnostic performance of MyotonPRO at 5 minute post-exercise	3 years	To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 5 minute post-exercise.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026