COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure

NCT03840434 | Completed

• 1 other identifier: 2019-A00141-56
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Compartment Syndrome

Keywords

compartment syndrome; intramuscular punction Versus non invasive assessment

Outcome Measures

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

  3 years

Secondary Outcomes (2)

• Diagnostic performance of MyotonPRO at 1 minute post-exercise

  3 years

• Diagnostic performance of MyotonPRO at 5 minute post-exercise

  3 years

Study Arms (1)

CCS group

OTHER

Measurements by intramuscular punction and non invasive tool

Diagnostic Test: MyotonPRO

Interventions

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

CCS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antoine BRUNEAU, PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: January 28, 2019
• First Posted: February 15, 2019
• Study Start: June 19, 2019
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

FR (1)