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Completed

NCT Number: NCT03840434

COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure

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.

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Key information

Conditions

Compartment Syndrome Cardiovascular Diseases Compartment Syndromes Muscular Diseases Musculoskeletal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire

Angers, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyotonPRO

Diagnostic 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

Primary outcomes

  1. 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

Secondary outcomes

  1. Diagnostic performance of MyotonPRO at 1 minute post-exercise

    Time frame: 3 years

    To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 1 minute post-exercise.

  2. Diagnostic performance of MyotonPRO at 5 minute post-exercise

    Time frame: 3 years

    To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 5 minute post-exercise.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: COLONIA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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