COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure

Compartment Syndrome Clinical Trial

— COLONIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840434
• Other study ID #: 2019-A00141-56
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: March 27, 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 27, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compartment Syndrome
• Compartment Syndromes
• Syndrome

Intervention

Diagnostic Test:
• MyotonPRO
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

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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