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

University Hospital, Angers

Status: Completed

Conditions: Compartment Syndrome

Treatments: Diagnostic Test: MyotonPRO

Study type: Interventional

Funder types: Other

Identifiers

NCT03840434

2019-A00141-56

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

CCS group

Other group

Description:

Measurements by intramuscular punction and non invasive tool

Treatment:

Diagnostic Test: MyotonPRO