COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure

Not Applicable

Completed

• Conditions: Compartment Syndrome
• Interventions: Diagnostic Test: MyotonPRO

• Registration Number: NCT03840434
• Lead Sponsor: University Hospital, Angers

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.

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2019-06-19
• Primary Completion: 2023-03-27
• Study Completion: 2023-03-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCS group	MyotonPRO	Measurements by intramuscular punction and non invasive tool

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Angers, France